Podcasts about ivd

New Mix Alert: The July EditionDropping a brand new, highly produced live set packing multi-genre dance anthems. This mix is a curated selection of fresh, all-new tracks that have been hitting the spot lately.Recorded completely live in one take on the decks—no safety nets, no post-production edits, just pure selection and seamless transition flow.Where to Listen & WatchAudio: Stream the full high-energy mix here or on SoundCloud.Video: Watch the full live performance and catch the tracking over on YouTube.Dj Murphy - July 2026 (Podcast 142) TracklistToby Romeo - Fly HighKosimo, Elong Wong, B2air - Fall In Love Perfect Pitch - I Love It (Extended)Roman Messer, Rocco - Dreams (Will Come Alive) Gryffin, Lavern, Ar/Co - Higher Power Alex Byrne - Say It Right Daxson ft Susan Boyle - Wild horsesKatseye - Pinky UpHyperNoiz - Family MattersMr Bounce - Over YouFKA Twigs - PerfectlyCj Stone - Euphoria (Dj Murphy's Skepta Mashup)Laszewo - 3am Suzie Mac - Lonely Rocco, Perfect Pitch, L'exais - Streets Of Gold Gino Caporale, Adina, The Scene Kings - Stranger (The Scene Kings Rmx)Telykast, Oaks - Super Powers (Giuseppe Ottaviani Extended)The Chainsmokers, Oaks - Wild (Extended Versions)Netsky, Bebe Rexha - Light That Leads Me (Younotus Extended)Lizot, Rivendale - I Think We're Alone NowPowers & Paterson - Hardcore Disco (Extended Mix)Marlon Hoffstadt, Peter Xan - Hold You Close Danny L Harle, Caroline Polachek - Azimuth2hot2play, Paul Meier - Give It To Me (Club)Mashmex, Rocco, Stereo Amp Surfer - Go! (Dj Murphy's Live Doja Edit)Maroon 5, Fisher, Tones & I - Payphone X Favour (Wado's Mashup)Klaas - My Money (Extended)Jsphn - EchoRoman Messer, Rocco, Thoba, Noah Seven - Hate Me Taylor Swift - Opalite (Ely Oaks Extended)Cj Stone, Quiz - The Sun Dallin Dance - Down To Your Bones (Original Mix)T78 & Rexanthony & Don Paolo - Recapturing Matrix (Dj Murphy's Dre Mash)Demi Lovato, Zoe Gitter Alex Chapman, Avedon - Kiss (Gag Extended)Cj Stone, Rocco, Ivd, Mily Orchard - Will I4 Strings - Acid Phase (Extended)Lum1na, Carly Lind, Ivd - Castles In The SkyGalantis - Do You MindDjdtime - Ghost On The Dancefloor (Sky Rmx) Covered In Dirt - Ocean Avenue (Emo Garage Rmx)Daniel Wanrooy, Jes - We'll Be Together (C-Systems Rmx) Gorgon City - Work It Out Ampris - Behind Blue Eyes Aquagen, Perfect Pitch, Rocco - Lay All Your Love On Me Art Directors - Money On The Dash Robyn - Dopamine (Marlon Hoffstadt Rmx) SoLow - For You (Slowed)#DanceMusic #DanceAnthems #LiveMix #OneTake #NewMusic #ElectronicMusic #DJSet #GlasgowDJ #MixCloud #SoundCloud Hosted on Acast. See acast.com/privacy for more information.

Allison Komiyama, a consultant and senior regulatory strategist at DuVal & Associates and founder of Bluestocking Health, shares her journey from neuroscience and an FDA reviewer role into regulatory affairs and consulting. Allison explains why companies should educate FDA about their device by telling a compelling, respectful story, and discusses why “getting through FDA” is often the starting line. She highlights the post-clearance work of launch, adoption, and promotion while staying within FDA marketing rules. Allison also reflects on leadership, relying on community and advisory boards, her volunteer work, and the moments that affirm her impact when devices reach patients.  Guest links: https://www.bluestocking.health/  Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 083 - Allison Komiyama [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Allison Komiyama. Allison is a consultant focused on getting medical devices to market and helping them stay there. She frequently presents at conferences, is an advisor at numerous technology incubators, and teaches students around the world about the regulatory submissions as a faculty member at SDSU Global Campus. She received her doctorate in neuroscience in 2009, was an FDA reviewer from 2010 to 2011, received her Regulatory Affairs Certification US in 2014, and became a RAPS Fellow in 2024. Throughout her career, she's been actively involved in hundreds of pre-submissions and pre-market submissions for a wide variety of medical device companies. She recently started a medical device hype company called Bluestocking Health, where she continues to elevate and amplify the message of exciting technologies entering the market. She's also a senior regulatory strategist at DuVal & Associates, where she helps companies navigate the FDA pre-market process. Alright, well, welcome to the show. I'm so glad you're here today. [00:01:59] Allison Komiyama: Thank you so much. I'm so glad to be here. [00:02:02] Lindsey Dinneen: Well, I've been looking forward to this conversation very much. I got to meet you, I think it was maybe last fall, and it was after watching a video where I believe you were chopping wood while explaining a medtech concept, I and was like, "I have to meet this person." [00:02:21] Allison Komiyama: I like that that is how we, we, yeah, that you were introduced to me is through a wood chopping video. But yes, that was me. I love... I am a lumberjill, so yeah. [00:02:31] Lindsey Dinneen: See? And we will get into this, let's start with just a little intro into who you are, your background, and what led you to medtech. [00:02:39] Allison Komiyama: Sure. So background's actually biology, neuroscience. Left academia after graduate school and went and worked at FDA. I was just there for a brief period of time, but it was very instrumental in having me understand what I wanted to do with my life. I knew I loved regulatory affairs. I knew that I loved med devices and the intersection of medtech and innovation and regulatory and, and, and, and, and, right? Like, so all the things I was just super excited to be part of this space. But after leaving FDA, sort of tried to figure out what... You know, did I wanna work at a company? Did I actually wanna be at a specific industry job? Tried that on. Tried that hat on for a little over a year at an IVD company and just sort of missed all the stuff I got to work on at FDA. So I kind of saw it as the second-best thing after FDA is to go into consulting. So really worked with a lot of startups and companies that were bringing their technologies to market, and yeah, never looked back. I did sort of change positions over the years from going from a small consulting company to my own consulting company to a large consulting company, and now I'm sort of back at a, a smaller regulatory law firm. It's not that small, but, you know, 15-some people at DuVal & Associates working with companies that need help with strategy and regulatory support as well. And also started my passion project, which is Bluestocking Health. It is a medtech hype company, is what I call us. And we really work on helping companies after they've made it through FDA onto what... you know, what does, what does their launch look like? How do they get people to adopt their technologies and not sort of flounder and, and fail, right? So I, I love seeing really cool, nerdy, geeky tech get to market, and I think we all have a sort of inner geek that loves stuff like that, and it's my happy place where I can just kind of talk about those things and share it with patients and caregivers alike. [00:04:47] Lindsey Dinneen: Amazing. I love that. Yeah, and so much to dive into. But one of the things also I remember, so so I, I watch this video and you're chopping wood, and you're, you're clearly super passionate about medtech. And then I think the next one, were you possibly like baking or doing some sort of maybe chopping? [00:05:08] Allison Komiyama: Yes. I do flower arranging, so it might've been that one. I, I-- That's a great idea, though. I love to bake. I love protocol, so I think you're onto something. I need to come up with a video maybe where I'm talking about, like, the de novo process and, like, baking a cake or something. So. [00:05:27] Lindsey Dinneen: Amazing. And you're right, it was flower arranging, and I was thinking at the time, "Is there anything you don't do?" [00:05:35] Allison Komiyama: Yes. I-- There's a lot of things I don't do or don't even dare to do. Mostly dangerous sports. I, I'm a rower, so I love to row where no one's touching you. You know, like no one... There's no physical contact. You're just in a boat pulling an oar, and it's quiet and peaceful and, you know, also you're working hard. So, but otherwise, yeah, don't want any contact sports in my life. And but there's a lot of things I don't do, of course. I just have a lot of hobbies and things that I enjoy doing. [00:06:10] Lindsey Dinneen: Okay. So did the idea for Bluestocking Health come from? I mean, I know you explained a little bit about what the company does and who it helps, but first of all, I'm really curious about the name, and second of all, I'm just curious about, yeah, what made you go, "Gosh, this is the right time for this"? [00:06:27] Allison Komiyama: Yeah, great question. I-- So Bluestockings were... I'll, I'll go first into the origin story 'cause I think it kind of helps explain why I picked up that name. The Bluestockings were a group of mostly women in the 1700s in England who were, you know, kind of tired of sitting around playing card games and, you know, learning new dance routines-- not that there's anything wrong with that-- I love doing all of those things. But they decided they wanted to pursue some more intellectual and intellectually stimulating conversations with people. So they would invite women and men into their salons to have these conversations, and they would talk about botany and, yeah, science, art, literature, theater, all of the things that sort of sparked their interest. And they would say, you know, "Don't worry about wearing your black stockings," which were, like, the highly fashionable, expensive stockings of the day. They said, "Just come in your blue stockings. It's fine." You know, which were wool and, you know, cheaper. And I was like, oh, I love that idea of just people getting together, talking about stuff that they find interesting, and having it be like, "Come as you are. Wear your sweats," you know? "Don't worry about getting fancy." And that resonated with me. And so I thought, you know, what I want to build is something similar to what the Bluestockings had, but have it be more medtech or health-focused, and so hence Bluestocking Health was born. I, yeah, I really... A-as I said earlier, I saw a lot of companies feel like getting through FDA was the finish line, and I s- you know, I would tell them, like, "No, that's kind of the starting line with a lot of what you're going to now need to build." You know? It's-- I, I think historically FDA was seen as, like, the hardest thing to get through, which isn't always the case, right? The, the 510K program is historically very successful with getting devices cleared. You know, FDA does wanna work with you, and that was my narrative and my mantra always was like, you know, "How do you work with FDA to get through FDA?" And then once you're through FDA, what's next? And I wanted to have those honest conversations, you know, as these companies were considering the product development, their quality system, their regulatory, and, you know, even reimbursement is also part of that post-market conversation. And I wanted them to also think about, "How are you gonna get patients to know about this? Like, what are ways that you can promote yourself and promote what you're doing without misbranding or mislabeling or adulterating anything, right?" You wanna stay within FDA's regulations and not do anything wrong marketing-wise. But it's also something to get really excited about, and I think we've often forgotten that a lot of these medtech devices do really, really cool things, do really amazing work to help people, help people s- you know, improve their quality of life. Let-- Help them survive, get them to live longer, let kids actually make it to adulthood, right? So there's so much good that I wanted to amplify that more. I wanted to get people to not just focus on the negative, right? There is, there is a lot of harm that can come from any sort of drug, device, anything, but there's also a lot of good. And so I think especially right now in the world we need more good things to talk about. Not that I wanna, you know, look at everything through rose-colored glasses. But I do think if we can focus on some of the good that's going on in the world and the things that we have in common, what a great conversation to have. [00:10:14] Lindsey Dinneen: Oh, yeah, I couldn't agree more. And I love the fact that and you're so much fun. You're helping these companies also get excited too, because I think sometimes it's really easy-- I mean, we need to take our industry seriously. It's a serious industry and real life consequences, good and bad, from innovation... [00:10:29] Allison Komiyama: Yes. [00:10:30] Lindsey Dinneen: ...But I think you know, we've, we've talked a lot about this recently, even ar- along amongst just some of my colleagues, is like we're gonna take, we're gonna take our actual work very seriously, of course, but we're gonna not take ourselves super seriously. We're gonna have fun. We're gonna celebrate. We're going to each other why we're here and why we're doing this, 'cause otherwise it can get easy to get kind of bogged down in the, the nitty-gritty. [00:10:52] Allison Komiyama: Oh, it's so easy to spiral. I-- And I feel like a lot of media allows us a-and, and capitalizes on that doom scroll/spiraling of, "Oh gosh, everything's bad." And I wanna be informed, but I also, as you said, I don't wanna take myself that seriously. Like, I have so many hobbies. I laugh a lot. I have really great conversations with people, and I think that's what I, you know... the legacy I wanna le- leave behind is that I made the world a little better than when I started here. And also that I had a lot of joy to share. So yeah. [00:11:31] Lindsey Dinneen: Okay. So I-I'm curious, going back to your days at the FDA, what are some of the common things that you saw where perhaps there's either a misconception about the process of approval or just mistakes you might have seen that were kind of common that maybe those who are listening who are trying to, you know, get through it as, as easily as possible could benefit from? [00:11:54] Allison Komiyama: I think one of the biggest misconceptions and it wasn't anyone's fault, was that FDA are the experts in what you're building. And maybe, maybe folks knew that that wasn't the case. You know, they walk in and they know that they're living and breathing their technology and their device day in and day out. They've been building it for years oftentimes. And so to think that FDA understands your patient population, understands the, the sensor technology or whatever technology you're building understands your software, your materials, all, all the various things that go into a s- a pre-market submission, is a terrible assumption to make, right? Not that you wanna treat FDA like a bunch of dummies, that you're like, "Oh, you guys don't know anything. I'm gonna have to start from, you know, square one here to really walk you through everything." But you definitely want to communicate and be able to tell a really solid story to FDA about what you're building or what you've built, and why you believe it's either safe and effective, or why you believe it's substantially equivalent, or why you believe the benefits outweigh the risks. And so I think if you can be that storyteller, if you can really walk FDA through what it is you've built, and why you think it should be, you know, allowed to enter interstate commerce, you've w- you know, you, you're already ahead of the game. So I think any company that really is trying to figure out what's that first interaction they're gonna have with FDA, whether it be at a pre-submission or just straight to pre-market submission, right? They're just gonna file the, the, the 510K or what have you. Really making sure that you've explained your product and they know why you're there. Otherwise, you are going to cause more questions than answers from FDA, and that's a big concern when you have somebody who doesn't understand what you're doing or why you've built it the way you've built it. That can really set you back. [00:13:56] Lindsey Dinneen: That's great advice. So, so being really prepared to kindly educate while telling the story, but you know, doing so, of course, in a, like you said, a respectful way. But, but having those answers ready, having the narrative really thought out so that you can walk in with that authority, but also explanation and storytelling. Yeah. Okay. [00:14:19] Allison Komiyama: Exactly. Yeah. It is. I mean, I always my-- I've actually, I have a podcast that I f- a few of my guests recently, they've all been expert or experts in how we tell stories, which I love even just... I mean, how we tell stories to our children is very different to how you tell a story to a colleague at work or, you know, the... and there's a way that, once you know your audience and once you know what it is you're trying to convey, there's a very clean path that you can follow. I'm still working on it. I have to, I have to confess, I am not a great storyteller. I have a tendency to get sidetracked and off topic, probably like what I'm doing right now. But, but you know, bringing it back and, like, what are, what are we trying to do? What are we trying to accomplish? And that I think that storytelling is really valuable when you have FDA as your audience. [00:15:15] Lindsey Dinneen: So I know, like you said, you have many hobbies and lots of things that keep you occupied, but you also do a lot of volunteering for boards. And I was wondering if you could share just a little bit about some of that experience and what you're passionate about there. [00:15:29] Allison Komiyama: Yeah. I think I've always been a big fan of volunteering. I think it's one of the ways that I I meet new people, I get involved in s- things that are outside medtech, which I think is extremely valuable. There's so many voices that even if it's not directly in medtech, everyone's impacted by medtech in some way, right? Like I always say, "You're either gonna start in a hospital or end in a hospital, and you're probably gonna go into a hospital at many different times or use a medical device, whether it be on your phone or, well, while you sleep or," you know, for any-- I don't know, there's a million purposes that people use medical devices. And I wanted to have more voices around me that that are, that are helping humanity, but in a different way. So, one of the boards that's always been near and dear to my heart, of course, my rowing club. I love... It's the oldest women's rowing club in the world. It's called Slack Rowing Club, based here in San Diego, and I help with a lot of the programs, but also fundraising, membership, and just, you know, having this really dynamic group of 400 women that some of them row, some of them are just there to be part of a community and help each other, which is pretty marvelous. And we do a lot of actually talks. Like we'll have a speaker series and we'll bring in physicians or we'll bring in people who are talking about sleep and perimenopause and menopause or, you know, various topics that definitely impact our our cohort. It, it's actually kind of similar to Bluestockings, like the original Bluestockings, where we'll have someone come in and talk about architecture. Like there's various things. So I love doing that. It's also-- They're-- The members are from like 12 years old to 102 years old. It's pretty amazing, and just, like, this great dynamic group of women who are fun to volunteer with and also sit in a boat with. The other one that I've joined last year was the International Relief Teams, which works on helping bring some sort of relief to an emergency situation, whether it be floods or fires or famine or war. Like, there's, They partner-- We partner with different organizations that are, like, boots on the ground in those areas to either build houses or get m- meals or get water to where it needs to be in an emergency. So IRT is fantastic. They get, like, one of the highest ratings of nonprofits. The other one is Indy Medtech. Really cool. That's a very medtech-based one. It's a virtual board, but it is building a community of medtech suppliers and people who are just needing support from each other or you know, either hiring or, "Hey, I have a question. Can someone help answer this 'cause I don't know where to go to get the answer to this?" So really cool, and they, they're doing a podcast as well. I love it. And then last but not least is the San Diego Regulatory Affairs Network. So I have been in San Diego, moved here back here, I should -- i'm from San Diego-- but moved back here in 2011, 2012, and I joined the San Diego Regulatory Affairs Network. It's the SoCal... Like, there's a similar one in Orange County, the Orange County Regulatory Affairs, so OCRA, and then there's also, of course, RAPS, and there's a Southern California chapter. And it's just a group of regulatory folks that love to meet up, love to support each other. "Hey, I have this job opening coming up. Hey is there a mentee that would like a mentor?" And so I'm now the VP of programs for that, and once a month we try to have a speaker either virtually or in person. There's gonna be some in-person ones. And I love it. It's just a great way to network, to support each other, and also to learn more cool stuff going on in regulatory. So yeah, that's a smattering of the ones that I'm part of. So, you know, as, as you said, like, it's kind of like they're all over the place, but it definitely makes me feel more connected with humans, with our-- you know, like, and, and not doomscroll. I'm, I'm too busy to doomscroll. So. [00:19:44] Lindsey Dinneen: That's, that's a good thing, I feel like. So, I love that. Okay. Those are g- those are such cool organizations. Thank you for sharing a bit about them. [00:19:51] Allison Komiyama: Yeah. Thanks for asking. [00:19:52] Lindsey Dinneen: Yeah. So all right, I'm curious. Going back, could eight-year-old Allison have ever imagined what you're doing now? [00:20:02] Allison Komiyama: Never in a million years. Yeah, I think I, I knew I loved biology and bugs and science at a very young age, so I knew that I was probably on that trajectory. But if you asked eight-year-old-- or actually, I-- if you asked five-year-old Alison what she wanted to be, the first was hummingbird, and I did... That did not pan out. [00:20:29] Lindsey Dinneen: Dang it. [00:20:29] Allison Komiyama: But and then I would say florist 'cause I love flower arranging, so that is something that I've s- I've kept up with, as you said, like you saw the video of me arranging flowers. I still love doing that. I, I enjoy that creative outlet. But not in regulatory. I didn't really know that regulatory affairs existed as a career especially until I was 26. I mean, which is crazy to think, like I was in grad school, and I took a course on the history of FDA, and I was like, "What is this? This is so exciting, so interesting." And I knew that was something, that something along those lines is what I wanted to do with using my biology and, and neuroscience background, but also how do I maybe get closer to medicine in a certain way? Like, I, I didn't wanna be a medical doctor, but I knew I wanted to help people. Like, I think most people wanna help people. And that was, that was the right pivot for me at that point. [00:21:32] Lindsey Dinneen: Amazing. So, all right. So you've had a bunch of different leadership positions now over the years. And of course, you have led your own company now a couple different iterations, I suppose, of, of what you've been doing. But what has that leadership journey been like for you, especially perhaps how different it is between working for another company where you might be in a leadership role versus leading yourself and your company? [00:21:56] Allison Komiyama: Great question. I-- what was it, what's it been like? I would say there's like equal parts fearlessness, excitement, and terror. I don't know, like I-- maybe those are all kind of, of the same like ilk of those, those feelings. My daughter always says, she's like, "I'm nervous and I'm excited," like before she goes on stage in the talent show, and she's like, "I'm nerve-cited." And I, I, I use that a lot now too 'cause, you know, before I give a talk or before I you know, go on a podcast like this, I'm like, "I'm nerve-cited," 'cause it's gonna be something that I haven't done before, right? Every day is a little different and... But it's also exciting to do. I Yeah. I, I feel like it was not always easy. Like, people are like, "Oh, you made it look so easy and, and just, you know, seamless." And oof, there were moments that I really struggled. It's... You know, there have been times that I really relied on my family, on therapy, on my friends to really help me. And even just, you know, something as simple as I had a friend who made my first website for me. He was like, "You're so busy and stressed," like, "Let me help you." And so I think calling on others and really having people be your community that you've built, right? Like, I think sometimes we try and go it alone, and maybe that's the worst thing to do when you're building something 'cause you really need to rely on others to help you out. And so I've had, you know, I've, I've, I've worked really hard on my network and to build the friends and colleagues that I want to surround myself with, and then I have reached out to them when I knew I need them. So I, for example, I think with Bluestocking Health, I... When I was-- Before I launched in last year, so September of 2025, I called a bunch of folks that I really trusted to tell me if I was going off course or to also help me build stuff. And my advisory board for Bluestocking Health is amazing. Like, they're not all in regulatory, 'cause that's not what I wanted to build. They're in media. They're in quality system, reimbursement, business strategy. Like, there's such a diverse group of folks that will also help be my sounding board, right? Like, I had a couple medical doctors that I reached out to that are on the advisory board that I was like, "I'm thinking of doing this. Can you give me, like, your thoughts pro/con?" And they always are so willing to help, right, if they have the time. It's been extremely rewarding. So I would say that leadership journey, again, not the easiest at times, but also when it gets hard calling on those friends to really support me has been really marvelous. [00:24:49] Lindsey Dinneen: Yeah. You know, that's such an interesting thing because this has come up a lot, especially in the last few episodes and just conversations I've had in the industry of the importance of community and mentorship and surrounding yourself with those good people who you can call and go, "Okay, I have this, I have this, I think maybe crazy idea. What do you think?" Or just, "Hey, life is a little tough right now. Can we just, can we just talk?" So that's... [00:25:15] Allison Komiyama: Yeah. [00:25:15] Lindsey Dinneen: ...Really cool. [00:25:17] Allison Komiyama: Yeah. Absolutely [00:25:19] Lindsey Dinneen: Yeah. Okay. So as you've gone through your career, and especially within the medtech industry, which seems like you've really just, you know, fell in love with and, and stayed, so that's wonderful. Are there any moments that stand out to you as really affirming that, "Yes, I am in the right place at the right time"? [00:25:40] Allison Komiyama: I think every clearance De Novo granting that I've ever been part of, even if my name's not on the file, has been one of those moments where, oh, it feels so good. It feels so great to see those companies make it through FDA. And then also, you know, to the next point or d- you know once they are selling and they're, they're helping patients, I've had clients reach out to me and say, "I just got this amazing testimonial from somebody and I wanted to share it with you because you were part of that journey." And oftentimes I'll say, "Can I share that with the FDA reviewer that helped us 'cause they're still there and I really think that they would value that, that piece of information, just that commentary and that validation." I mean, w- I've had ones where the testimonial was like, "Because of this device, my kid is alive today. My kid would have been-- would have died two years ago if it hadn't been for this product." And like, I even just got chills. Like I-- honestly, it feels like even though I'm not a medical doctor, even though I was, you know, integral maybe in putting their 510K together or their submission together, and I've never touched the device necessarily, I feel so rewarded that it's like, we did it. We did it together, right? And I, I wanna share that with others. I think that's part of what I'm trying to do with Bluestocking Health is like we all are part of this community, and it's not that we just like clock in and we, you know, do document control or, you know, work on our risk assessments and, you know, clock out for the day. It's like, no, we, we do all help save lives, right? What a, what a powerful thing to be part of and to know that that's, that's something that you helped do. I don't know. I, I-- maybe that sounds again a little too like look how great we are. Like how, you know, look at, look at how amazing this space is, but oh, it is. It 100% is, so. [00:27:43] Lindsey Dinneen: No, I could not agree with you more. I've, I've always felt the same way of just like, "Okay, I'm, I'm not the scientist, I'm not the engineer, I'm not the regulatory affairs person. I, you know, I play a very small role. I, I help talk about the devices." I sh- you know, the marketing... [00:27:59] Allison Komiyama: Yes. [00:28:00] Lindsey Dinneen: ...And that's, you know, that's, that's not the biggest component of bringing these devices to market by any stretch of the imagination. But I do get to play a role, and I think that is the coolest thing ever. Yeah. [00:28:12] Allison Komiyama: Yeah. Well, and think of-- I mean, I'm gonna be your hype woman for a second because think of all the people who learn about that tech or understand, "Hey, this might be something right for me or my loved one, and if I hadn't learned about it or if I hadn't you know, been exposed to this idea or even knowing that this is in clinical trials, okay, now I'm gonna go look into the clinical trial." Like, that information sharing and even just talking to people or talking to laypeople, like, there's such an important piece of the marketing and the strategy around that, that it's huge. I-- you know, like, directly or indirectly, you've saved a life, right? How cool is that? [00:28:56] Lindsey Dinneen: Yeah, exactly. How cool is that? It's, it's remarkable. Okay. So, all right. Pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. [00:29:09] Allison Komiyama: Ooh, yes. [00:29:10] Lindsey Dinneen: What would you choose? [00:29:10] Allison Komiyama: I mean, all of the things in my header, I think at LinkedIn. So I lo- but I'll, I'll give you a real answer in a second. I think, I mean, all of the... I love my creative outlets. So I love flower arranging, I love face painting, I love chopping wood. I love cross-stitch and needlepoint, and my daughter and I just started doing crocheting together. So I feel all of those things are so I... Not that I'm a master in any of those things, but maybe it's being willing to try new things or having that, I don't feel, I don't consider myself to be a totally fearless person, but maybe channeling some of that fearlessness and a willingness to try new things, and where do we find that and how do we kinda overcome some of that activation energy sometimes to get to try those new things? And I think innovators have that in spades, right? So a lot of the companies that we work with, they're like, "I have an idea, and I don't know if this is gonna work, but I'm gonna go for it." And I think a lot of those cre- it, it's a creative outlet for them as well, right? They're trying something new. And so maybe it's giving people more more support or more confidence that they can try new things. I feel like I don't love change. Like I, I, as a child, I like, I liked the things that just stay the same. But when you look at my arc and my, my origin story, it has been all about very unsettling moments or, you know, like where I was felt, feeling very unsettled or like trying something new, and I'm so grateful for all of those things, and I'm also really grateful that I did it, right? So a- and again, it came down to a lot of my community, my friends, my family that supported me and said, "Yeah, you can do this," right? Having those hype people to help me. So maybe a masterclass in just like being the hype person for people who wanna try new things and try leadership, right? Or try a new path that they hadn't thought about yet. [00:31:24] Lindsey Dinneen: Like, I think to your point too, the more that you're willing to do that and kind of step a little bit outside of your comfort zone and have that potential for quote unquote "failure." But, you know, first of all, the more you do that, the more resilient you get, which means it's easier and easier and easier to take those first steps, right, into something new. [00:31:43] Allison Komiyama: Yes. [00:31:44] Lindsey Dinneen: But I also think-- I, I often think about it in terms of if you can frame those kinds of moments as "I am exploring, this is an exploration" and not like pass-fail, if you're exploring, there's, there's no chance of failure, right? You can, you can explore something and go, "Ugh, not for me," or you can go, "Oh, I actually love this, but it's hard and I'm gonna have to keep working at it." But I think if you can like kind of maybe take it in a slightly different mental direction, that also helps, you know? [00:32:13] Allison Komiyama: Ooh, I like that. Yeah. Like reframing. This is not, this is not something that's gonna, you know, end in failure, 'cause I agree with you. You know, I've called it failure in the past where it's like, "I'm gonna try things. If this fails, then I'll go do something else," right, which then it's not really a failure. You learned something. But it is being able to change directions. It is the ability to say, "Okay, I figured out that I something from that, and then what am I, what am I gonna do with that information?" So I love that. [00:32:48] Lindsey Dinneen: Oh, that'll be a masterclass. I can't wait. okay. And how do you wish to be remembered after you leave this world? [00:32:55] Allison Komiyama: Oof. I hope I... It's, oof. I, I, I hope to be remembered. Yeah. What does my dash look like? Isn't that what they say? Like, what is the dash between the, the birth year and your the year of your death? I definitely wanna be remembered for, like, what my kids are doing, 'cause I'm pretty proud of, like, how badass both of those girls are. But back to your question. I would like to be remembered as somebody who helped innovators and people who were building in the medtech space to grow their brand, to get their message out there, and to really bring awareness to the benefits of medtech. I think it's so easy, as I said earlier, it's very easy for us to get caught up in the bad and the negative, and here are the risks, and we really are so nervous about the risks of things, as we should be. We should be a res- risk-averse population. Like, they-- I don't wanna be walking towards something that's gonna cause me harm. And at the same time, there's a lot of benefit to what we're doing, and I think if we can I guess what we were just talking about, reframe a little bit and say, "Yes, there's risk. There's inevitable things that are gonna happen, but here's the potential benefit," and how do we h- in a human way, weigh those things so that we can get other people to also see that this is something that could benefit them. So it's sharing that message. I wanna know, be, you know, considered somebody who also didn't take herself too seriously, made people laugh. You know, maybe they showed their, their kid a, a video of me doing something silly, but also maybe there's some kid out there that's like, "Oh, she was talking about regulatory affairs. What's that? Maybe I should look into that as a career option." So, yeah, I hope some of it is inspiring to others. [00:34:48] Lindsey Dinneen: Okay. That's, that's great. And then final question: What's one thing that makes you smile every time you see or think about it? [00:34:59] Allison Komiyama: I wanna say my kids, but really it's probably hummingbirds. I have never lost the total fascination with hummingbirds. They are so interesting. They're so beautiful. There's a lot of them here in San Diego where I live, and I kid you not, last year, a mother hummingbird built her nest right outside of our front door. And so we'd have-- we told our guests, like, "Come through the, the side gate 'cause do not walk close to, to our sweet hummingbird." And she laid two eggs, and I was able to watch these two little hummingbirds grow and fledge. And I... It was just one of-- again, it makes me smile every time I think about it. Every time I see a hummingbird, I'm like, "That might be our girl that, that had, that had her nest right here." So yeah, I think that whimsy, the, the, the fun and just how gorgeous they are. They always bring... sparks me joy, for sure. [00:35:58] Lindsey Dinneen: Absolutely. Me too. I adore hummingbirds. One of my favorites. Yeah, love that. Oh my goodness. Well, this has been an amazing conversation. Allison, thank you so much for taking time today to speak with me, and we are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support. Oh my gosh, and just thank you so much for everything you're doing to change lives for a better world. We're grateful for you. [00:36:42] Allison Komiyama: Thank you. It's so nice to be here. Thank you so much for having me on. [00:36:45] Lindsey Dinneen: Absolutely. Until next time. [00:36:49] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Das erste Halbjahr ist schon fast vorbei, Zeit Bilanz zu ziehen: Wo steht der Immobilienmarkt aktuell, welche Erwartungen haben sich bestätigt, wo gab es böse Überraschungen? Unser 1aLAGE Spezial vom Deutschen Immobilientag 2026 des IVD in Erfurt. Und hier die Fragen im Einzelnen: Anfang des Jahres gab es die Hoffnung auf ein Konjunkturplus, wie sieht es aktuell aus? Wie entwickeln sich die Zinsen? Was bedeutet dies für die Immobilienpreise, droht ein erneuter Preisrutsch? Damit kommen wir zum Neubau – wann gibt es den Turnaround? Wir sind heute beim ivd, für Makler sind natürlich Transaktionen wichtig. Wie sieht es hier aus? Die Bundesregierung plant neue Mietpreisregulierungen, u. a. bei möblierten Wohnungen und bei Indexvermietungen. Ist noch mit mehr zu rechnen? Zum Schluss: Makler werden von Kunden oft gefragt: Lohnt sich der Kauf überhaupt, bei all den Regulierungen und Standortnachteilen. Was würdest Du antworten? Die Antworten auf all diese Fragen und einige mehr findet ihr in dieser Episode 1aLAGE und nun wünschen wir euch spannende Insights und gute Unterhaltung. Viel Spaß! **Unser Kooperationspartner:** Für Immobilien-Investoren und Unternehmer: Erfahre mehr über die IMMOBILIEN FREUNDE und informiere Dich unter www.immobilien-freunde.de oder schreib uns an kontakt@immobilien-freunde.de, um Dich in einem exklusiven Kreis mit Gleichgesinnten zu vernetzen sowie von hochkarätigen Veranstaltungen zu profitieren. ***
 *** **Die Podcastredaktion:** Wenn Du eine Frage hast, dann schreib mir gerne eine E-Mail an hw@haukewagner.de Wenn Du mir ein Projekt verkaufen oder vermieten willst, dann ruf mich bitte an unter 01712627868 oder schreibe mir eine E-Mail an hw@kontriva.com - Vielen herzlichen Dank und bis gleich! Außerdem findest du uns auf X unter @mvoigtlaender und @haukewagner YouTube Kanal: https://www.youtube.com/@1aLAGE-Immobilienpodcast

Politik will Enteignung durch zwei GesetzeEin Kommentar von Claudia Töpper.Am vergangenen Mittwoch, den 29. April 2026 wurden 86 Stellungnahmen zum geplanten Gesetzesentwurf des Baugesetzes mit dem Namen „Entwurf eines Gesetzes zur Modernisierung des Städtebau- und Raumordnungsrechts“ veröffentlicht. (1) Der Immobilienverband Deutschland IVD und der Bundesverband Freier Immobilien- und Wohnungsunternehmen kritisieren beide diesen Entwurf teils sehr scharf. So schreibt der IVD beispielsweise wörtlich:„Kritisch zu bewerten sind insbesondere Regelungen, die Eigentümer und Investoren verunsichern und die Bereitschaft zur Bereitstellung privaten Kapitals mindern können. Dies gilt vor allem für die vorgesehene Ausweitung kommunaler Vorkaufsrechte und flankierender Erwerbsinstrumente. Auch wenn dieser Schwerpunkt in der Einleitung des Gesetzentwurfs nur begrenzt hervorgehoben wird, nimmt er im Normtext erhebliches Gewicht ein. Die im Koalitionsvertrag angelegten Vereinbarungen werden insoweit nicht nur umgesetzt, sondern teilweise überschritten. […] Regelungen, die zusätzliche Rechtsunsicherheit, Kosten oder Eingriffsrisiken für Eigentümer und Investoren schaffen, sind dagegen kritisch zu prüfen.“(2)Die direkte EnteignungSpätestens seit 2022 wird immer wieder vor einer geplanten Enteignung der deutschen Hausbesitzer gewarnt.(3) Doch nun steht dieser Gesetzesentwurf des Baugesetzes im Baugesetzbuch (BauGB) 2025/2026 seit dem 02. April 2026 zur Diskussion, der faktisch eine Enteignung der Hauseigentümer für die Gemeinde bzw. den Staat noch leichter und schneller möglich machen soll. Unter dem § 177 Modernisierungs- und Instandsetzungsgebot soll nun ein Zusatz für den Umgang mit sogenannten „Schrottimmobilien“ erfolgen.(4) Interessant ist hierbei, dass die Regierung im Entwurf ausdrücklich festhält, dass es sich um ein nicht zustimmungspflichtiges Gesetz handelt. Der Bundesrat kann die Einführung der Neuerungen somit nicht blockieren, sondern lediglich Einspruch einlegen.(5)Im Entwurf des BauGB lautet es wie folgt: „In § 177 wird nach Absatz 5 der folgende Absatz 6 eingefügt:(6) Bezieht sich eine Maßnahme nach Absatz 1 auf ein Grundstück, das die Voraussetzungen von § 24 Absatz 1 Satz 1 Nummer 8 erfüllt, gelten § 176 Absätze 7 bis 9 entsprechend.“Was ist eine Schrottimmobilie?In diesem verklausulierten Satz ist weder zu erkennen, was eine Schrottimmobilie ist, noch das hier eine Enteignung ohne Rechtsmittel droht. Zwar ist auf der ersten Seite dieses Gesetzesentwurfes zu lesen, dass ein Haus als Schrottimmobilie gilt, wenn Vandalismus erkennbar ist und sich Ratten oder Müll auf dem Grundstück befinden. Jedoch wird hier nicht das nötige Ausmaß konkretisiert. Zudem stehen diese Kriterien nicht direkt im Gesetz und können deshalb nicht angewendet werden. Im Gesetz selbst wird durch die neu eingefügte Nummer 8 des § 24 auf den bereits bestehenden § 177 verwiesen, um zu definieren, was eine „Schrottimmobilie“ ist. Dieser Paragraph 177 besagt in Absatz 3 folgendes:„(3) Mängel liegen insbesondere vor, wenn durch Abnutzung, Alterung, Witterungseinflüsse oder Einwirkungen Dritter1. die bestimmungsgemäße Nutzung der baulichen Anlage nicht nur unerheblich beeinträchtigt wird,2. die bauliche Anlage nach ihrer äußeren Beschaffenheit das Straßen- oder Ortsbild nicht nur unerheblich beeinträchtigt oder3. die bauliche Anlage erneuerungsbedürftig ist und wegen ihrer städtebaulichen, insbesondere geschichtlichen oder künstlerischen Bedeutung erhalten bleiben soll.“ (6)...https://apolut.net/der-staat-greift-nach-deinem-haus-von-claudia-topper/ Hosted on Acast. See acast.com/privacy for more information.

 MedboardSponsor: Medboard: https://www.medboard.com/ EUExtension of WET Class Iib - A new list with new products mentioned: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=PI_COM:C(2026)1809Update your MIR form - Version 7.3.1: https://health.ec.europa.eu/document/download/e8ce9f53-82cb-44c8-a06e-91ad71c16b01_en?filename=md_new-reg_mir-form-v7.3.1_en.pdf UKFuture Regulation -Implementation: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulationsConsultation on indefinite recognition of CE marked medical devices and current transitional arrangementsPre-market Statutory Instrument (SI)Future Enhancemens: Exceptional Use Authorization and Health Institution exemptionPost-market Surveillance RequirementsUpdate to guidances Learn Clinical Investigation in the UK - Lot of questions answered: Clinical investigations for electrically powered devices : https://www.gov.uk/government/publications/clinical-investigations-for-electrically-powered-devices/clinical-investigations-for-electrically-powered-devicesClinical investigations: investigators' responsibilities : https://www.gov.uk/government/publications/clinical-investigations-investigators-responsibilities/guidance-for-clincal-investigatorsClinical investigations: statistical considerations : https://www.gov.uk/government/publications/clinical-investigations-statistical-considerations/statistical-considerationsMedical devices that need a clinical investigation: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigationDetermining if Clinical Investigation is required: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigation/determining-if-a-clinical-investigations-is-requiredClinical Investigation Flow chart: https://assets.publishing.service.gov.uk/media/696f850b5b6060ca6736a0ae/flow_chart_for_clinical_investigations_v3.png EventsTeam NB: Training IVDR -July 2nd 2026: https://www.team-nb.org/wp-content/uploads/2026/03/Leaflet-IVD-TD-Manufacturers-Training-20260702.pdfEgypt: Vigilance reporting Training - April 7 to 9, 2026: https://tinyurl.com/emdpodcastMedtechConf.com - Check the MAPEUSwiss Medtech Day 2026 - June 10, 2026: https://medtechconf.com/event/why-swiss-medtech-day-matters-what-you-should-know/Medtech Forum - May 11, 2026: https://medtechconf.com/event/the-medtech-forum-2026-shaping-the-future-of-medical-technology-in-europe/USVeeva Medtech US Summit- May 11. 2026: https://medtechconf.com/event/veeva-medtech-us-summit-2026-innovation-data-modernization-in-medical-devices/BrazilHospitalar - May 19,2026: https://medtechconf.com/event/hospitalar-the-reference-event-for-healthcare-innovation-and-solutions-in-latin-america/  RoWAustralia: Software Advertisment -What to say: https://www.tga.gov.au/resources/guidance/advertising-software-based-medical-devices-australiaYour advertisement must contain:an accurate description of the devicethe trade name of the devicethe intended purpose(s) of the deviceany mandatory statements and, where relevant, health warnings.For example, you must not:claim your product is “TGA approved”make unsubstantiated claims about the product's performanceinclude endorsements or testimonials from health professionals or medical researchers.Malaysia: Guidance Creation/Update - Medical Device Act 2012 Guidance on Definition of Medical Devices: https://portal.mda.gov.my/index.php/announcement/1777-publication-of-second-edition-of-guidance-document-on-definition-of-medical-devicesGuidance on confirmation of obsolete and discontinued medical device: https://portal.mda.gov.my/index.php/announcement/1778-publication-of-first-edition-of-guidance-document-on-application-for-confirmation-status-of-obsolete-and-discontinued-medical-devicesGuidance on import and/or supply of unregistered medical devices under special access exemption application: https://portal.mda.gov.my/index.php/announcement/1779-publication-of-third-edition-of-guidance-document-on-import-and-or-supply-of-unregistered-medical-devices-under-special-access-exemption-applicationIndia: FAQ on IVD products - 24 questions with answers: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Addendum-Doc-No-CDSCOIVDFAQ-042022dated-13032026.pdfEgypt: What you need to register - List of documents: https://tinyurl.com/EmdEgyptRegistration  PodcastPodcast Nostalgia -Let's remember: https://podcast.easymedicaldevice.com/Episode 381: EUDAMED deadline 2026:  https://podcast.easymedicaldevice.com/381-2/Episode 382: Best-of of 3 podcasts: https://podcast.easymedicaldevice.com/382-2/  ServiceNew Website: https://easymedicaldevice.comAuthorized RepresentativeConsultingTrainingEasyIFU: https://easyifu.comSmarteye: https://eqms-smarteye.com/ This podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

Embryo transfer has become increasingly popular on US dairy farms to rapidly advance the genetic profile of the herd. This month's feature article looks at the associations between fertility traits on the success of embryo transfer. Fertility traits such as daughter pregnancy rate (DPR), cow conception rate (CCR) and heifer conception rate (HCR) are consistently classified with low heritability. However, this retrospective study takes a deep dive into the data stored at the Council of Dairy Cattle Breeding (CDCB) to use the statistical power of dairy farmers data. There, the researchers were able to find a clear impact of these traits on the success of an ET program and long term impact on herd fertility. Because ultimately  … we're just interested in more calves on the ground, so listen in to better understand how data is improving ET fertility setbacks. Topics of discussion 1:39      Introduction of Dr. Sophia Ortega   2:18      Fertility traits discussion 3:47      How to improve these traits with low heritability                6:25      In vivo (IVD) and in vitro procedures (IVP) definition 8:11      Grade 1 embryo improvements when selecting females using fertility traits 9:27      Embryo loss discussion 10:30    Difference preg rate between cow vs. heifer 12:03    Global impact of ET improvements using fertility traits 13:45    How ET trends in the dairy industry in the past 5 years 16:02    Limitation of in-vitro procedures and expected preg rate 16:57    Blastocyst rate improvement 19:19    Impact of fertility of ET recipients 21:08    Where to find the fertility traits when selecting 27:20    What do you want ‘boots on the ground' dairymen to know about your project  Featured Articles: Association of fertility traits with embryo development and pregnancy establishment Resources: Dairy Records Management Systems Council of Dairy Cattle Breeding #2xAg2030; #journalofdairyscience; #openaccess; #MODAIRY; #embryo; #ET; #DPR; #CCR; #HCR; #embryotransfer; #CDCB; #DRMS; #dairysciencedigest; #ReaganBluel

Follow me: Facebook: fb.me/xabionly Twitter: twitter.com/xabionly Youtube: youtube.com/xabionly Mixcloud: mixcloud.com/xabionly Instagram: instagram.com/xabionly TRACKLIST: https://1001.tl/1zxk6ht1 Spotify playlist: https://open.spotify.com/playlist/4STV7DPVgwI4ntvi1sQvjh?si=CU6lCNZcRkKiZytdXaI5TQ TRACKLIST: 01. Rivo & Fideles ft. Brieanna Grace - Into The Sun [SPINNIN' DEEP] 02. Argy & Massano - WAIT [SIMULATE] 03. Agents Of Time & Miss Monique - Rajada [TOMORROWLAND] [TRACK OF THE WEEK] 04. Dominique Jardin - Don't Call Me [BON VOYAGE!] 05. Trope - SO IGNORANT [ON THE WAY] 06. Layton Giordani - Open Up [MADMINDS] 07. DRIMR & J-RD & Diego Antoine - Conspiracy [DIGITAL EMPIRE] 08. Fred Lenix & Amnix - Rabbit Hole [MADMINDS] 09. Matt Dylan & Linney - Moments [IMMERSED] 10. BIPOLUR - Solstice [MODERN DELIVERY] 11. AMINTO - Show Me All Your Love (Tonerush pres. Pragma Remix)[AMINTO] 12. HILLS & Shilla - Right Now [MADMINDS] [PROMO OF THE WEEK] 13. Plastik Funk & Chester Young - Money [FUNK YOU MUSIK] 14. Dannic - Wake Me Up (I'm Alive) [REVEALED] 15. Zarka - Hit The Throttle 16. Jay Crusoe - Passionate Sensation [MADMINDS] 17. HILLS & Wave Wave ft. Mary Jensen - Clarity [MADMINDS] 18. TH;EN & Mia Mendi - Fade Away [SIONA] 19. ARTBAT & Giuseppe Ottaviani & Conor Ross - Break The Loop [UPPERGROUND] 20. Larza & Atro_Bex - Fly [EUPHONIX] 21. Krevix & Kadett - Awaken [FIND YOUR HARMONY] 22. Danny Avila - My Love For You [KINETICA] 23. CamelPhat & Rafael Cerato & Amarha - Don't Stop [WHEN STARS ALIGN] 24. Ruslan Radriges & Redspace - Let Me Go [INTERPLAY] 25. MOGUAI & Luciana - Coming Up [WALL] 26. Layla Benitez & Jono Stephenson & Henri Bergmann - Parallax [MAHOOL] 27. Benny Benassi & Laherte - Dead Limit [ULTRA] 28. Mark Knight & Wh0 - Clap Your Hands [TOOLROOM] 29. Modapit - On Fiyah [MADMINDS] 30. Calvin Harris & Kasabian - Release The Pressure (LUSSO Bootleg) [FREE] 31. Hardwell ft Amba Shepherd - United We Are (Mark Sixma Rework) [REVEALED] [RELEASE OF THE WEEK] 32. BRISA (ES) - No Pares [KURAI] 33. LUKE WAVE - NO SLEEP [OFFGRYD] 34. LUKE WAVE - EVERYBODY DANCIN' [OFFGRYD] 35. Stisema & IVD & Rachel Woznow - Pressure [ACTUATION] 36. KX CHR - TUTU [BOUNCE & BASS] 37. Fision & JUULS & NLW - Cricket [EXTATIC] 38. LUKE WAVE - THE WAVE [OFFGRYD] 39. ZYNØX - Shake The Ground [REVEALED RADAR] 40. HYPERKID - Core [BOUNCE & BASS] 41. VIVID - Like This [REVEALED] 42. Tiscore - Rave Forever [ARMADA/KONTOR]

„Es gibt kein Argument gegen Erfolg.“ Mit diesem Satz beschreibt Klaus Saloch, was den Markt gerade stärker prägt als jedes Stimmungsbarometer: Reichweite, Nutzungsintensität und die Fähigkeit, Nachfrage in Echtzeit zu bündeln. Genau deshalb sprechen wir über Kleinanzeigen, eine Plattform mit über 16 Millionen monatlichen Nutzern, rund 90 Millionen Besuchen und einer Dynamik, die für einige Verticals längst zur strategischen Herausforderung geworden ist. Ich spreche mit Klaus darüber, warum dieses Portal in der Immobilienbranche wächst, obwohl der Markt insgesamt im Krisenmodus ist, welche Rolle Künstliche Intelligenz bei der Qualifizierung von Anfragen übernimmt und wie Homestaying, virtuelle Vermessung und automatisierte Prozesse das Nutzerverhalten und auch den Beruf des Maklers verändern. Wir schauen darauf, weshalb der persönliche Eindruck trotz aller Technologie an Bedeutung gewinnt: Kommunikation, Präsentation, Professionalität, alles Faktoren, die im Wettbewerb um Aufmerksamkeit zunehmend entscheiden. Klaus ist ein Urgestein der Branche, ich darf das genauso benennen. Deshalb muss es auch um seine Erfahrungen gehen und die Veränderungen im Markt. Seit Mitte des Jahres ist er als Head of Industry Relations für das Netzwerk verantwortlich und dazu beispielsweise im Austausch mit dem IVD oder dem GdW. Ich will von ihm wissen, was eine digitale Plattform im Land-Stadt-Gefälle bewirken kann, welche Abstrahleffekte entstehen, welche Logiken dahinterstecken und warum in Sachsen und Thüringen immer mehr Angebot zu verzeichnen ist. Fakt ist: „Nach wie vor kauft man eine Immobilie mit sehr viel Empfindung, sogar viele Kapitalanleger.“

Wie entwickelt sich der Immobilienmarkt 2026? Darüber spricht Marco, Gründer von immocation, mit immocation Coach, Immobilieninvestor und Ehrenpräsident des IVD, Jürgen Michael Schick. Der Zinshaus Marktbericht schaut sich Transaktionen und Volumen des Marktes an und auch die Städte, wo viel verkauft oder gekauft wird. Was kann man hier an Trends ablesen? Welche Regionen sind aktuell eine echte Chance? Welche Rückschlüsse kann man auf den eigenen Standort ziehen und diesen besser verstehen? Wie es rund um die Vermietung, Zinsen und Zukunft von Immobilien aussieht, das erfährst du in dieser Folge. immocation. Lerne Immobilien.

欢迎收听雪球出品的财经有深度，雪球，国内领先的集投资交流交易一体的综合财富管理平台，聪明的投资者都在这里。今天分享的内容叫A股医药股7月涨幅背后的逻辑，来自userfield。如果说25年上半年，医药指数只有个位数涨幅，仍然无法确认医药板块的牛市，那么7月份医药单边大幅上涨14%，创新药主题概念蔓延，批量股票大幅上涨——我们可以确认，我们正在经历2017年、2020年之后，第三个创新药牛市已经来临。首先我们来分析一下医药指数的涨幅，过去一个月内，是投资医药股非常舒服的日子，7月份几乎没有回调，只有单边上涨。也就是说，如果手里的医药组合涨幅没超过14%，相当于没吃到医药大牛市的全部红利。当然，我们拆开看，医药板块内部分化仍然很明显，中位数涨幅11%，涨幅前10%分位差不多要涨38%，而整个板块仍然有近30支股票处于月度下跌状态。其次，我们再分析一下医药行业个股的涨跌情况。我对以下四个分类进行说明。第一是与药品相关的个股，我们看到前10%，也就是涨幅大于40%的股票中，基本都是与药品相关的股票。医疗设备、IVD、医疗服务、疫苗等其他细分领域的股票较少。第二，我们在涨幅前10%的医药行业个股中，可以看到不少CXO板块的个股。我的理解是创新药二级市场热起来让大家对CXO需求预期发生变化，并且本身CXO公司中报业绩回暖，也让市场对这个板块的边际变化给予很正面的反馈，所以看到美迪西、昭衍新药、博腾、药明康德这些CXO板块在7月份的涨幅都在前10%分位。第三，当我们看到创新药达到重要里程碑进展时，对应的个股在短期内积极反馈多，涨幅巨大。比如说广生堂的乙肝创新药GST-HG141在7月经历了临床3期伦理批件和正式开始3期临床的重要里程碑，而对于“乙肝治愈”这个概念，已经在资本市场热了十几年，从重庆啤酒到特宝生物，再到广生堂。而广生堂终于有重磅药进入临床3期，带动股价在1个月内涨了200%。再比如说悦康药业的小核酸概念股。在6月的时候就因为高血压siRNA药物临床前数据在SCI期刊发表，股价涨了37%，到了7月份，YKYY029这款小核酸药物中美双双获批临床，并且国内临床1期已经开始首例给药。随着YKYY02的临床进展里程碑，股价过去2个月上涨了140%。第四，就是海外技术映射。当创新药新技术在海外有了新突破，而国内还初露端倪时，这时海外技术有进展或者相关产品商业化有突破的时候，国内技术或者靶点映射类资产就会涨一波。比如当海外小核酸头Alnylam Q2业绩超预期，上调全年销售预期。国内股市的成都先导、前沿生物、悦康药业就来一波涨幅再比如在三生PD-1/VEGF超重磅交易，以及信达PD-1/IL-2双抗热度下，很多PD-1多抗产品也带动各种公司股价大幅上涨。像汇宇制药、奥赛康等相关个股都迎来了巨大的涨幅。第五，即使公司不是研发型biotech，总会参股子公司或者参股并购基金，总会与一些创新药资产沾边，相关股价也会迎来大的涨幅。比如说塞力医疗，7月涨幅超过100%，主要逻辑就是子公司武汉华纪元生物的高血压疫苗ATRQβ-001申报临床，公司也追加近千万元投资，持股比例由15%增至 30%。不要问为啥增资千万，就能带来30亿市值增长，问就是高血压疫苗有足够想象力！说完个股方面，再说题材轮动方面。几个月前，常山药业、通化金马、浩欧博等创新药热门炒标的，由于各种原因，导致7月份处于下跌状态。可以说风水轮流转，偏主题概念型开始轮动了！我们对比个股的7月涨幅和6月涨幅，发现6月涨幅较好股票中，只有少数股票在7月份仍然涨幅排名靠前，很多6月涨幅高的票，在7月行情中已经熄火！最后是总结部分。创新药火热的7月份，A股市场围绕着创新药产品临床新进展、海外技术突破映射、挖掘非创新药企业的“创新药含量”，龙腾飞舞的狂欢了一个月。牛市来临，我们无法轻易言顶。但通过复盘，我们可以看到市场逐步接近顶部状态。譬如说牛市初期的688-U类的纯Biotech已经不再是涨幅主线，而参股资产的临床前资产挖掘却轻易让股价上涨20cm，都意味着股市热度已经演绎到极致。所以，基于现状，我觉得创新药牛市可能不是戛然而止，但我们应该保持一丝清醒，对于某些票就是按照“主题投资模式”来参与，如果真信，最后可能会吃药。当然硬币的另一面，我们也的确看到的创新药产业趋势在澎湃汹涌，也许创新药产业在不断的资产泡沫中前行，才是真实的发展状态。

Guest: Jay Shaw, MS, CGC, Senior Product Manager, Fulgent Genetics Host: Dan Bulger, Progyny    The Fertility 101 Series, because there's no shortage of daunting terms to keep your mind running, is a quick and dirty breakdown on a specific topic with insights from a fertility expert.  Today's episode is a deep dive into the role of genetics in fertility care and planning. We're joined by Jay Shaw, a certified genetic counselor and Senior Product Manager at Fulgent Genetics, who walks us through the basics and beyond when it comes to genetic testing.  We start with a foundational overview, and Jay makes sure to break down the medical jargon for us. What is genetic testing? And what do terms like “carrier screening,” “single gene disorder,” and “pathogenic variant,” actually mean?   From there, Jay explains how test results can inform decisions around IVF, embryo selection, and prenatal diagnostic testing. She also walks us through options available to people and couples when carrier screening reveals shared risks, including IVF with genetic testing, sperm or egg donation, and early interventions during pregnancy or at birth.   Jay also shares how genetic testing is expanding with new tools for cancer screening, direct-to-consumer options, and exciting advancements on the horizon, including genome sequencing and the potential for AI to transform how we interpret genetic results.   Genetic testing is a crucial part of the family-building journey, protecting the health of your baby and ensuring a well-informed pregnancy. Tune in to hear all that it has to offer.  For more information, visit Progyny's Podcast page and Progyny's Education page for more resources. Be sure to follow us on Instagram, @ThisisInfertilityPodcast and use the #ThisisInfertility. Have a question, comment, or want to share your story? Email us at thisisinfertility@progyny.com.  

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Adam Sherlock, CEO at Qinecsa. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Adam, covering: How he developed his professional CEO skills over the years to complement is entrepreneurial spirit The combination of micro and macro factors that help determine when the right time is to go to market, and sell The importance of your gut instinct when assessing M&A targets... and painting a picture of why the world is a better place when together Several attempts at failing to retire... and being tempted back into another pharma services CEO role How R&D services will be impacted by AI, and why we all need to be eating our own lunch Adam is a serial entrepreneur and executive leader with nearly 40 years of experience in the international life sciences industry, particularly in bio/pharma, IVD, and medical device sectors. A scientist by training, he has led successful growth and M&A efforts, creating exceptional value in four private equity-backed businesses over the past decade.  Adam is also a sought-after NED, Chair, and independent advisor. Currently, he serves as CEO of Qinecsa, a global provider of pharmacovigilance technology and services. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is also sponsored by Bora Pharma (boracdmo.com) and Charles River (www.criver.com), and supported by ramarketing.

Blessing CEO and IVD sit down with The Honest Bunch to spill the REAL tea on their relationship, controversies, and life in the spotlight. From love and loyalty to public backlash and the rumors that shook social media, nothing is off-limits in this explosive conversation! Are they the ultimate power couple or a ticking time bomb? Tune in for raw truths, shocking revelations, and unfiltered insights.

  How familiar are you with partnerships and collaborations between the laboratory and the diagnostics industry? In this episode Luis is joined by Dr. Andrea Prinzi and Dr. Kristen Smith to explore how partnerships between clinical labs, public health institutions, and the diagnostics industry drive innovation in in-vitro diagnostics (IVDs).  What is the IVD pipeline? From discovery to product launch and beyond, these collaborations improve patient care, accelerate access to new technologies, and enhance public health outcomes. Why breaking silos and fostering inclusive partnerships is essential for the future of diagnostics? Tune in to find out.  Link to article: https://doi.org/10.1016/j.clinmicnews.2025.04.001 Questions? Feedback? Send those to letstalkmicro@outlook.com Want to support the podcast? Here's how: Venmo: https://venmo.com/u/letstalkmicro Buy me a Ko-fi: https://ko-fi.com/letstalkmicro  

Welcome to the electrifying world of drum and bass with the Stress Factor Drum and Bass Podcast episode 323, featuring the unparalleled DJ B-12. Celebrating 15 years of online excellence, this episode marks his second stunning studio mix for March 2025. Prepare to be transported on a transcendent journey as DJ B-12 masterfully blends an array of styles, showcasing his signature sound that has captivated listeners for over a decade and a half. This mix is not just a collection of tracks: it's an experience that resonates deeply, inviting you to lose yourself in its sexy rhythm and energy. With a remarkable runtime of just over 2 hours, this episode features an impressive 75 tracks that span the spectrum of drum and bass. From uplifting and soulful beats to the cutting-edge sounds of electro, progressive and liquid DNB, DJ B-12 has curated a set that is both diverse and cohesive. Each transition is seamless, each drop is exhilarating, and the overall flow is nothing short of breathtaking. This mix is a testament to his artistry, showcasing not only his technical skills but also his deep understanding of the emotional power of music. Whether you're a long-time fan of drum and bass or a newcomer eager to explore, this episode is a must-listen. DJ B-12's ability to weave together various elements of the genre creates a rich tapestry of sound that is both uplifting and introspective. Experience the beauty and depth of this stunning mix, and let it take you on a spiritual journey that only DJ B-12 can provide. Don't miss out on this incredible auditory adventure, tune in and elevate your listening experience today! This episode contains, track and remixes by the following artists and on the following labels: Jessee, Ayah Marar, DeVice, Genetics, Ridmic, Subkey, Fokuz Recordings, Solid State, Joy Doc, SUBBWELL, Alcemist, Pola and Bryson, DnB Allstars, Subsonic, Task Horizon, The Velvet Effect, Eatbrain, Artino, Sam Welch, Liquicity Records, Rusko, Monstercat, Cream Blade, romi, Natty Lou, Gemma Rose, Future, Matt View, Sem, Macknote7, Daniel Tales, Guena Music, 1991, IVD, Armada Music, Lee Mvtthews, Elevate Records, James Hiraeth, Rinse, KOOL, 3xil3, Neuropunk Records, Chrissie Huntley, A Little Sound, S.P.Y, CMD CTRL, Ministry of Sound Recordings, Technimatic, Spearhead Records, ALB, UKF, FinnaDrift, Messjilla, Goldfat Records, Monrroe, Let It Roll, Lexurus, Kaskade, Punctual, Poppy Baskcomb, DNMO, Monstercat, MODUS, Tiesto, Koven, Musical Freedom, INVOLVER, Soulvent Records, Paolo Tossio, Mario Tossio, Paolo Tossio Productions, Paige Cavell, Goddard., Positiva, Beyond Me, Lizplay Records, The Prototypes, Roadblock Records, T and Sugah, High Tea, ICONS, Manifest, Bloque, Keylo, Impish, Occulti Music, LSB, Etherwood, Footnotes, MusicbyAden, LVX, Shattered Nights, Subkey, Rex Hooligan, Mojoman, Beatalistics, Bailey, SUNANDBASS Recordings, Michael Calfan, S.P.Y, Dipping Sauce, Nastja Po, Sigma, Mali Koa, Day Ones, shadre, SALVAGE, Audio Suicide Recordings, Audien, Fred V, Oaks, Armada Music Albums, hayve, DRIIA, Twintone , AIRGLO, BEACON, Caleo, Deeper DNB, Drea Perlon, Forteba, AEYA Records, Natty Lou, Leemo (UK), Faye Derbyshire, Bitsune, M'Go, Lya, Manifestm, 5X, Inverse Records, Xetao (JP), MellowGang, Method, Culture Shock, Grafix, sadHAPPY, Culture Shock Music, Blean, Bloque, Interstellar Audio, Wilkinson, Julia Church, Sleepless Music Ltd., T and Sugah, HEXAGON, Andromedik, Imallryt, GNTLMAN, High Resistance, Circadian, Nu-La, Freaks and Geeks, Sub Focus, bbyclose, Gourski, Zombie Cats, Voicians, Velodic, 3LAU, Krakota, Anjunabeats, and ShockOne. Tracklist 01. Jessee - The Ones feat. Ayah Marar [DeVice] 02. Genetics - Losing Control [Ridmic] 03. Subkey - Stratos [Fokuz Recordings] 04. Solid State Ft. Joy Doc - Better Without [DeVice] 05. SUBBWELL - Away from You [Subbwell] 06. Alcemist - Us (Pola and Bryson Remix) [DnB Allstars] 07. Subsonic - Wait For Me [DnB Allstars] 08. Task Horizon and The Velvet Effect - Outrunning Dawn [Eatbrain] 09. Artino and Jessee - Bring The Rain (ft. Sam Welch) (Extended Mix) [Liquicity Records] 10. Rusko - Rubix Cube [Monstercat] 11. Cream Blade and romi - Celestial (Last Time) [Ridmic] 12. Natty Lou - Close To Me (ft. Gemma Rose) [Future] 13. Matt View - Come Clean [Ridmic] 14. Artino - Way Out feat. Sem [Liquicity Records] 15. Macknote7 - Neowise (Daniel Tales Remix) [Guena Music] 16. 1991, Subsonic and IVD - Castles In The Sky (Extended Mix) [Armada Music] 17. Lee Mvtthews - Ready 4 It [Elevate Records] 18. James Hiraeth - Glitter and Gold [Rinse KOOL] 19. 3xil3 - Satellites Fall [Neuropunk Records] 20. Artino Ft Chrissie Huntley - Insight [Elevate Records] 21. A Little Sound, S.P.Y and CMD CTRL – Area Code (Extended) [Ministry of Sound Recordings] 22. Technimatic - From Within [Spearhead Records] 23. ALB - Cold Hearted [UKF] 24. FinnaDrift - Midnight Sip of Water ft. Messjilla [Goldfat Records] 25. Monrroe - Imprisoned [Let It Roll] 26. Lexurus - Close To You [UKF] 27. Kaskade and Punctual - Heaven Knows (feat. Poppy Baskcomb) (DNMO Remix) [Monstercat] 28. Artino - Introspection [MODUS] 29. Tiesto and Poppy Baskcomb - Drifting (Koven Remix) [Musical Freedom] 30. INVOLVER - Colours [Soulvent Records] 31. Paolo Tossio - Weeping Angel (feat. Mario Tossio) [Paolo Tossio Productions] 32. Paige Cavell and Goddard. - Owe It All To You [Positiva] 33. Beyond Me - La fleur [Lizplay Records] 34. The Prototypes - Feed My Soul [Roadblock Records] 35. T and Sugah - Louder [High Tea] 36. ICONS - Paradise [Manifest] 37. Artino - World Of Lights [Liquicity Records] 38. Bloque and Keylo - Better Day [Ridmic] 39. Impish - Truth Is (Vinyl Version) [Occulti Music] 40. LSB and Etherwood - Evermade [Footnotes] 41. MusicbyAden and LVX - Retreat [Shattered Nights] 42. Subkey - Aozora [Fokuz Recordings] 43. Rex Hooligan - I'm Always Dreaming About You [Ridmic] 44. Mojoman - Tanelty [Beatalistics] 45. Bailey - Letter From Detroit [SUNANDBASS Recordings] 46. Genetics - Let You Go [Ridmic] 47. Michael Calfan - Treasured Soul (S.P.Y Remix) [Dipping Sauce] 48. Nastja Po - My Home (Daniel Tales Remix) [Guena Music] 49. Sigma - CHEMICALS Ft Mali Koa (Extended Mix) [Day Ones] 50. shadre and SALVAGE - Escalate [Audio Suicide Recordings] 51. Audien and Fred V feat. Oaks - Cold (Extended Mix) [Armada Music Albums] 52. hayve - What Are We Proving (feat. DRIIA) [Monstercat] 53. Twintone - The Encounter [Beatalistics] 54. AIRGLO - Raindrops [BEACON] 55. Caleo - Away [Deeper DNB] 56. Drea Perlon and Forteba - Better Without You [AEYA Records] 57. Natty Lou, Leemo (UK) and Faye Derbyshire - Think Of U [Ridmic] 58. Bitsune, M'Go, and Lya - On My Head [Manifest] 59. 5X - All I Knew Was You [Inverse Records] 60. Xetao (JP) - Summer Days [MellowGang] 61. Method - No More Us [Ridmic] 62. Culture Shock and Grafix - Giants (Ft. sadHAPPY) [Culture Shock Music] 63. Blean and Bloque - Hostility [Interstellar Audio] 64. Wilkinson - Back To Life (feat. Julia Church) [Sleepless Music] 65. T and Sugah - Sky [HEXAGON] 66. Andromedik - Running (ft. Imallryt) [Liquicity Records] 67. GNTLMAN - Voices [High Resistance] 68. Circadian and Nu-La - Rebirth [Elevate Records] 69. Freaks and Geeks - Oxygen [UKF] 70. Genetics - Phoenix [Ridmic] 71. Sub Focus and bbyclose - On & On (Extended Mix) [Positiva] 72. Gourski and Zombie Cats - INTRUDERS [Zombie Cats] 73. Voicians - Lost (Extended) [Velodic] 74. 3LAU - Easy feat. XIRA (Krakota Remix) [Anjunabeats] 75. ShockOne x Lee Mvtthews - Thinkin About (T and Sugah Remix) [UKF]

Was sagen die einzelnen Parteien über das Thema Immobilien in ihrem Wahlprogramm? Das besprechen Marco, Gründer von immocation, und Jürgen Michael Schick, Immobilienunternehmer und ehemaliger Präsident des IVD. Wie sieht es mit dem Wohnungsbau in der Zukunft aus? Kann eine Mietregulierung auf uns zukommen? Bei welchen Parteien wird über Mietwucher diskutiert? Was bei der energetischen Sanierung auf uns zukommen könnte und welche Prognose die beiden abgeben, das erfahrt ihr in dieser Folge. immocation. Lerne Immobilien.

Medboard EU EU MDR and IVDR article 10a - Discontinuation of Supply: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110#art_10a EU IVDR transition periods - Visual: https://health.ec.europa.eu/document/download/ff7fa114-c539-46b3-9066-4bfbb306e9de_en?filename=timeline_ivdr_en.pdfEUDAMED EMDN: UPDATE or not to UPDATE - MDCG 2024-2 Rev 1 and 2021-12 Rev 1 : https://health.ec.europa.eu/document/download/ff8d6bf6-785f-48e1-beaf-2cfe13f59fd7_en?filename=mdcg_2025-2_en.pdf MDCG 2024-2: https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf MDCG 2021-12: https://health.ec.europa.eu/document/download/d90b3f63-1d62-43e6-bf5f-fb32ea7c47a2_en?filename=md_2021-12_en.pdf Contact points of National Authorities - Bookmark them in case: https://health.ec.europa.eu/document/download/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en?filename=md_contact_points_of_national_authorities.pdf EU Battery 2023/1542 - Guidance issued by EU commission: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202500214 Swiss Maintenance of Medical Devices - Guidance for Hospitals: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing---maintenance/maintenance.html UK timeline for UKCA - Be ready for 2030: https://assets.publishing.service.gov.uk/media/6718b88738149ce9d09e3894/Infographic_-_Devices_transition_timeline.pdf UK Post-Market Surveillance - Implementation and Template of PSUR: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation https://assets.publishing.service.gov.uk/media/67813b39363ac763c8ede498/Medical_devices_periodic_safety_update_report__PSUR__formatting__1_.pdf PMS Guidance: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-periodic-safety-update-reports PMS Requirements: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-requirements-for-medical-devices-summary-of-main-changes PMS Obligations per device type: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-pms-obligations-by-medical-device-type   TUK Vigilance Reporting - Field Safety notices and Example of incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents FSN: https://www.gov.uk/guidance/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices#full-publication-update-history Devices for cardiac ablation: https://www.gov.uk/government/publications/reporting-adverse-incidents-devices-for-cardiac-ablation Joint Replacement implant: https://www.gov.uk/government/publications/reporting-adverse-incidents-joint-replacement-implants#full-publication-update-history Intraocular lenses: https://www.gov.uk/government/publications/reporting-adverse-incidents-intraocular-lenses Insulin pumps and meter systems: https://www.gov.uk/government/publications/reporting-adverse-incidents-insulin-pumps-and-meter-systems   UK guide for IVD - Learn before to re-learn: https://assets.publishing.service.gov.uk/media/67863a313ef063b15dca0f47/Guidance_on_the_regulation_of_IVD_medical_devices_in_GB.pdf Training EU MDR training - Green Belt Certification Program: https://school.easymedicaldevice.com/course/gb33/ Rest of the World: Laboaratory Developed Tests FAQ - Learn all about LDTs: https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/definitions-and-general-oversight-laboratory-developed-tests-faqs and https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/medical-device-reporting-complaints-and-corrections-removals-reporting-laboratory-developed-tests How to apply your dossier in Australia - Full guidance by TGA: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/obtain-and-maintain-regulatory-evidence/australian-regulatory-evidence-options-medical-device-application/tga-conformity-assessment-certification/application-instructions-conformity-assessment Malaysia guidance for HIV Self-test - Placement on the Malaysia Market: https://www.mda.gov.my/index.php/documents/ukk/3480-final-gd-placement-of-hiv-self-test-kit-in-malaysia-market-2nd-edition-pdf/file Import Medical Device for Personnal Use in Malaysia - What means Personal use? https://portal.mda.gov.my/index.php/documents/ukk/3468-draft-public-comment-gd-importation-of-medical-device-for-personal-use-second-edition-updated-2025-pdf/file Alert by Philippines for Product registration - Engaging consultants is not encouraged: https://www.fda.gov.ph/wp-content/uploads/2025/01/FDA-Advisory-No.2025-0033-.pdf Saudi Arabia clearance of Medical Devices - For trainings or conferences: https://www.sfda.gov.sa/sites/default/files/2025-01/Guide%20to%20Conditions%20and%20requirements%20for%20Clearing%20food%2C%20Medical%20devices%2C%20and%20cosmetics%20for%20exhibitions%2C_1.pdf China Medical Device Regulations Round-up 2024 - Cisema.com video: 2024 Round-Up of China Medical Device regulations India update classification lists - List available: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIzNDI= Podcast Episode 318 - How to register a Medical Device in South Africa - Khanysile Nkuku : https://podcast.easymedicaldevice.com/318-2/ Episode 319 - How to perform your PMS for a Drug-Device Combination - Joan D'Souza: https://podcast.easymedicaldevice.com/319-2/ Episode 320 - Top 5 common NCs on an ISO 13485 audit: https://podcast.easymedicaldevice.com/320-2/ Episode 321 - 6 Tips to grow as a QA RA Manager: https://podcast.easymedicaldevice.com/321-2/

In this episode, Khanyisile Nkuku will share with us the way companies can register an medical device in South Africa today and also what change will happen in a near future. She will also talk to us about the participation of South Africa to the AMDF – Africa Medical Device Forum, where  pilot project started to issue a continental approval within 22 countries. So this may help register more easily in Africa.  Who is Khanyisile Nkuku?  Ms Khanyisile Nkuku In her current role as a Medical device & IVD Registration  Officer  at the South Africa Competent Authority (SAHPRA) ,  she contributes her expertise in the assessment and registration of medical devices & IVD's in South Africa  to promote medical device & IVD access on a global scale, with a particular focus on African countries. She holds a Bachelor of Pharmacy  honours degree ,a Master's in Pharmacy administration & Policy Regulation ,  and is currently busy with Masters in Business Administration in Healthcare Leadership . She is an experienced Pharmacist with successful background in medical device & IVD regulations and regulatory system strengthening.  Having great strength in policy advocacy, policy development, policy implementation and compliance. She partakes in the International medical device regulatory forum (IMDRF) working groups and Africa medical device forum (AMDF)  technical mainly the MDA-TC ( Medical device Assessment Technical committee  member. She is further a committee member for two South African Bureau of Standards (SABS) Technical committees . Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Khanyisile Nkuku LinkedIn:  http://linkedin.com/in/khanyisile-nkuku-975663a9 SAHPRA Website: https://www.sahpra.org.za/medical-devices/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠reach out to RQM+⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ if you need support with clinical trials.*

Would you go under the knife to achieve the body you want? Or take a weight loss pill that comes with huge risks? Richie Brave and his guests, Justin Mob and Harmony from The Cosmetic Lane, Teacher from Birmingham Petra, rapper IVD and 1Xtra family Nadia Jae discuss cosmetic procedures and body confidence. Plus, hear stories from those who have taken different routes to achieve their body goals. @1Xtra on social

Join us for the third episode of Incarceration month where we discuss Tammy's pick of The Shawshank Redemption and answer questions like:TBS or TNT?Is this a Highlander prequel?andWhat's an IVD?Learn all about Quad Pro Quo at: https://linktr.ee/quadproquopod

On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma environments and startups, shedding light on the significant time and resource investments required for successful IVD development. ---------------------------------- Chapters: Exploring In Vitro Diagnostics with Devin Campbell In this episode of the Combinate Podcast, host Subhi Siddek welcomes back Devin Campbell, founder and managing director of Product Know You, to discuss in vitro diagnostics (IVDs). They delve into various aspects of IVD development, including the clinical implications, risk management, and distinctions between companion diagnostics and precision medicine. They also cover regulatory pathways, lab-developed tests, and the rigorous validation processes involved. The conversation aims to demystify the complexities of IVDs for professionals in pharma and medical devices. -------------------------------------- 00:00 Introduction 01:58 Understanding In Vitro Diagnostics (IVDs) 05:26 Companion Diagnostics and Precision Medicine 08:49 Lab Developed Tests (LDTs) 12:39 IVD Development Process 15:27 Risk Management in IVDs 20:17 Clinical Testing and Validation 29:12 Challenges and Considerations in IVDs 37:04 Conclusion and Contact Information Devon Campbell is the Founder, Prodct LLC and Chief Product Officer(CPO), myBiometry. He's launched and exited several MedTech ventures and has worked in large Pharma and large IVD companies in executive roles focusing on engineering and product development. https://www.devonccampbell.com/

In this episode, Martin King will share with us his practice of AI in the context of Quality and Regulatory affairs for medical devices. This will explain to you some best practices to maintain to avoid some pitfalls.  Who is Martin King?  Martin Cranston King, a Swiss consultant working with medical devices, in vitro diagnostics (IVD), and pharmaceuticals since 1979. Martin is a leading expert in quality assurance, regulatory compliance, and product development, developing active wearable devices since the 1980s.  Known for his hands-on approach and deep understanding of complex regulatory environments, Martin has guided companies around the globe through successful regulatory submissions. His expertise spans across six continents, making him a sought-after advisor in his field.  Martin holds advanced degrees in Micro-electronics and Materials Science, and Electronic Engineering. He is a trained Lead Auditor for ISO 13485:2016 and is well-versed in international standards such as 21 CFR 820 and MDR 745/2017. Recognized as one of the top 25 MedTech Leading Voices on LinkedIn, Martin also shares valuable insights through his popular weekly regulatory roundup.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Martin Kings LinkedIn: https://www.linkedin.com/in/martink2/  QARA Whatsapp group: https://chat.whatsapp.com/Dkl3XrjiXzW51Fgipf96k2  QARA Whatsapp channel: https://whatsapp.com/channel/0029VaaBTj9CxoAwG0CUBn1x  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠reach out to RQM+⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ if you need support with clinical trials.* Explore in vitro diagnostic (IVD) clinical trial site selection and monitoring with our latest videos in our educational video series on clinical trials. In these two videos (this is video 2) specific to site selection and monitoring, RQM+ experts reveal: Key considerations for selecting ideal clinical partners Red flags to watch out for during site selection Best practices for effective trial monitoring Risk-based approaches to remote and on-site monitoring Strategies for data cleaning and accountability Featuring insights from: Margot Borgel - Director, IVD Global Regulatory Affairs Brandy Chittester - Senior Director, Clinical Operations Manali Patel - Clinical Research Associate Whether you're a seasoned professional or new to IVD studies, this video series offers valuable tips to enhance your site selection process and streamline your clinical trials. Reminder that you can find all of our clinical trial videos in other places, too.

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠reach out to RQM+⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ if you need support with clinical trials.* Explore in vitro diagnostic (IVD) clinical trial site selection and monitoring with our latest videos in our educational video series on clinical trials. In these two videos (this is video 1) specific to site selection and monitoring, RQM+ experts reveal: Key considerations for selecting ideal clinical partners Red flags to watch out for during site selection Best practices for effective trial monitoring Risk-based approaches to remote and on-site monitoring Strategies for data cleaning and accountability Featuring insights from: Margot Borgel - Director, IVD Global Regulatory Affairs Brandy Chittester - Senior Director, Clinical Operations Manali Patel - Clinical Research Associate Whether you're a seasoned professional or new to IVD studies, this video series offers valuable tips to enhance your site selection process and streamline your clinical trials. Reminder that you can find all of our clinical trial videos in other places, too.

This presentation and panel was recorded 8 August 2024. We encourage you to download Michelle Tarver's presentation slides by ⁠⁠⁠⁠⁠completing the form on this page⁠⁠⁠⁠⁠. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the ⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠ ⁠⁠at RQMplus.com. Thank you for tuning in.

Our ongoing educational video series on

In this episode of Behind the Numbers, Dave Bookbinder hosts an engaging conversation with Chris Strohsahl, the President and CEO of Drummond Scientific Corp. The discussion offers deep insight into Drummond's vital role in the global medical device industry, their unique approach to impactful solution creation, and the immense importance of nurturing meaningful client relationships. Chris shares captivating details of his journey, moving from biophysics to leading Drummond Scientific Corp in developing and investing in life-saving medical devices. He sheds light on their mission of making a difference beyond just product production, from helping families conceive to assisting individuals manage crucial health conditions. He further explores the challenging journey a product takes before hitting the shelves, and Drummond's key role in scaling these devices to ensure broader accessibility. Stressing on the need for forming strategic partnerships, Chris emphasizes the vital responsibility of supporting customers in the design process, thereby securing the viability of their innovative solutions at scale. The team also scrutinises the impact of the COVID-19 pandemic, reinforcing the significance of flexibility and adaptability in preserving business operations and supply chain management. In the concluding section of the episode, they discuss the vital role and the value of efficacy of a management team, underscoring the essence of the team's synergies and collective competencies in an organization. Chis outlines the value of failure as an entrepreneur, emphasizing its role as a tool for understanding one's potential and fostering success. The significance of networking, building sustainable relationships, and running startups are other invaluable nuggets shared in this insightful discussion. As an Angel Investor, Chris advises focusing beyond a startup's monetary value, instead, keeping an eye on the people and mission behind it. About Chris Strohsahl: Chris Strohsahl is the President and CEO of Drummond Scientific Company. A biophysicist by training, with expertise in the innovation of diagnostic techniques and devices, he rose to Drummond's top position at the start of 2022 and has since led the Company's rebranding as an elite manufacturing partner to both leaders and disruptors in the IVD and IVF industries. A passionate believer that medical device development works best when end-stage manufacturing is engaged early, Chris and his colleagues have driven a paradigm-shift at the Company, as Drummond now actively seeks to engage its partners far earlier than would be expected of a typical high-throughput manufacturer. About Our Sponsor: Haefele Flanagan (HFCO) is a full-service accounting firm that's been serving clients since 1967.  Not your typical accounting firm, HFCO's services extend well beyond tax and audit to include valuation services, strategic and succession planning, leadership development, and more.  When you work with Haefele Flanagan, we help you realize your long-term goals.  Please visit them at www.hfco.com. About the Host: Dave Bookbinder is the person that clients reach out to when they need to know what their most important assets are worth. He's a corporate finance executive with a focus on business and intellectual property valuation. Known as a collaborative adviser, Dave has served thousands of client companies of all sizes and industries.  Dave is the author of two #1 best-selling books about the impact of human capital (PEOPLE!) on the valuation of a business enterprise called The NEW ROI: Return On Individuals & The NEW ROI: Going Behind The Numbers.  He's on a mission to change the conversation about how the accounting world recognizes the value of people's contributions to a business enterprise, and to quantify what every CEO on the planet claims: “Our people are this company's most valuable asset.”  

  EUROPEEU MDR 26 May 2024 - Was there any apocalypse: France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-la-periode-de-transition Netherland: https://www.igj.nl/zorgsectoren/medische-technologie/nieuws/2024/05/23/fabrikanten-van-medische-hulpmiddelen-moeten-uiterlijk-26-mei-een-aanvraag-hebben-ingediend-voor-ce-certificering EU shortage managed - EUDAMED and IVD extension also discussed: https://www.consilium.europa.eu/en/press/press-releases/2024/05/30/medical-devices-council-adopts-new-measures-to-help-prevent-shortages/?utm_source=brevo&utm_campaign=AUTOMATED%20-%20Alert%20-%20Newsletter&utm_medium=email&utm_id=320 EMA Q&A on Combination products - Do you need a Notified Body? https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf EU talks about SoHo -: Substances of Human Origin https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:PE_8_2024_INIT&qid=1716536451356 https://www.consilium.europa.eu/en/press/press-releases/2024/05/27/council-adopts-new-rules-on-substances-of-human-origin/ Italy Database error - Updating expired (AI)MDD certificates https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6569 Ireland guide on In-House IVDs - Laboratories to listen: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-for-health-institutions-who-manufacture-and-use-in-house-ivds-in-ireland-v1.pdf?sfvrsn=8 Combined Studies in the EU - COMBINE PROJECT: https://ec.europa.eu/newsroom/sante/items/830485/en https://health.ec.europa.eu/document/download/77e1409a-f4c0-45db-bff1-4873c7a0e7ae_en?filename=md_combined-analysis-phase-report.pdf Notified Bodies Survey Result: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf Team-NB Survey: https://www.team-nb.org/wp-content/uploads/2024/05/Team-NB-MD-Sector-Survey-PressRelease-20240515.pdf New Notified Bodies for EU MDR – MTIC InterCert Italy: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43390&filter=notificationStatusId:1 Kiwa Istanbul: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007731?organizationVersion=18 QMS Services GmbH Austria: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007832?organizationVersion=1   UKUK on international recognition - Approve products without CE or UKCA mark:  https://www.gov.uk/government/news/mhra-announces-a-proposed-framework-for-international-recognition-of-medical-devices https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices UK implementation of Future Regulation - When will this come in force: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations UK Common Specifications for IVD - Provide your opinion: https://www.gov.uk/government/consultations/common-specification-requirements-for-in-vitro-diagnostic-devices UK suspected counterfeit Medical Device -  How to report: https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/report-a-non-compliant-or-suspected-counterfeit-medical-device UK Ai Airlock - Be ready to help the government: https://www.gov.uk/government/news/mhra-launches-ai-airlock-to-address-challenges-for-regulating-medical-devices-that-use-artificial-intelligence Webinar planned July 23rd: https://www.eventbrite.co.uk/e/ai-airlock-the-regulatory-sandbox-for-aiamd-in-healthcare-webinar-tickets-896407919217   Easy Medical Device: eQMS SmartEye Video: One of the best eQMS for Medical Devices  One of the best eQMS for Medical Devices   Events:Medtech Conf: Title: International Medical Device Exhibition and Conference - Subtitle: Malaysia 10th to 12th December 2024 : https://medtechconf.com/event/imdec-2024-exhibition-conference/   Training Green Belt Training for EU MDR 2017/745 24th-28th June 2024: https://school.easymedicaldevice.com/gb/ EU Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/ Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/   WORLDUSUS Remanufacturing or Servicing  - Webinar replay included: https://www.fda.gov/media/150141/download Webinar: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-guidance-remanufacturing-medical-devices-06272024 US - Use of Patient Generated Data - Medical Device Development: https://www.fda.gov/medical-devices/medical-devices-news-and-events/co-sponsored-public-workshop-using-patient-generated-health-data-medical-device-development-case US Laboratory Developed Tests - Final rules defined and Webinar to explain: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-rule-medical-devices-laboratory-developed-tests-05142024 https://www.fda.gov/medical-devices/laboratory-developed-tests/laboratory-developed-tests-frequently-asked-questions https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests Australia Australia - in-house IVDs requirements - Support Australian Laboratories: https://www.tga.gov.au/resources/resource/guidance/regulatory-requirements-house-ivds Australia on boundary and Combination products List: https://www.tga.gov.au/sites/default/files/2024-05/examples-boundary-combination-products-and-product-category.pdf Saudi Arabia Saudi Arabia - Webinar Biological Evaluation - 6 June 2024 10am Saudi Time https://www.sfda.gov.sa/en/workshop/716404 NigeriaGuidance to register Medical Devices - Registration, labelling and advertising: https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Registration-Regulations-2024.pdf https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Labelling-Regulations-2024.pdf https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Advertisement-Regulations-2024.pdf India CDSCO laboratory testing - But in the Country and not outside: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEzMTg= Malaysia Malaysia Guidance for Medical Device - Change Notification support: https://www.mda.gov.my/index.php/announcement/1401-public-comment-draft-guidance-document-change-notification-for-registered-medical-device Hong-Kong Overview of a Local Responsible Person - Who? What? When? Where?: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf Singapore  Singapore Cybersecurity labelling- SAt which level is your product: https://www.csa.gov.sg/our-programmes/certification-and-labelling-schemes/cls-md   PODCASTPodcast Nostalgia - What topics were discussed Episode 283: Quality Field Service for Medical Devices with Michael Israel: https://podcast.easymedicaldevice.com/283-2/ Episode 284: How to select and evaluate your Contract Manufacturer with Keith Smith: https://podcast.easymedicaldevice.com/284-2/ Episode 285: Are you Correction or Corrective Action or Preventive Action with Vincent Cafiso: https://podcast.easymedicaldevice.com/285-2/ Episode 286: Summative Evaluation - Common Mistakes with Amandine Broussier: https://podcast.easymedicaldevice.com/286-2/      

I am sure that when we talk about usability, you are not really sure what should be done. Usually we are also following a standard for that which is IEC 62366. On this episode, Amandine Broussier will specifically focus on one part of usability which is the Summative Evaluation. She will explain what this is and when it should be done. So listen to this to be an expert in Usability.  Who is Amandine Broussier ? Amandine Broussier is an independent medical devices usability specialist who supports medical device manufacturers in their usability engineering process (EN 62366-1:2015). She has 8 years of experience in the usability engineering, working with around 30 manufacturers on different devices (hardware, software) (class II, class III and IVD).  Amandine can help you through all stages of the usability engineering process including auditing your current usability documentation with recommendations for improvement, identifying of use-related risks, writing the different documents required by the EN 62366-1 standard, and carrying out your formative and summative evaluations for CE marking and FDA approval. She also provides introductions to usability engineering for companies to help them understand the expectation of notified bodies with regards to usability standards.      Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link  Amandine Broussier Linkedin Profile: https://www.linkedin.com/in/amandine-broussier-888a41113/  IEC 62366-1 link: https://www.iso.org/fr/standard/63179.html  IEC 62366-1/A1 link: https://www.iso.org/fr/standard/73007.html  IEC 62366-2: https://www.iso.org/fr/standard/69126.html  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Do you have to manage complaints, CAPA, Non-conformances, audits, management reviews… for your company. Then you need to put in place actions. Today we will explain to you with Vincent Cafiso what are Correction, Corrective Actions and Preventive Actions.  Who is Vincent Cafiso ?  Named as one of MD+DI's 24 Medtech Voices to Follow in 2024, Vincent Cafiso is a former U.S. FDA Investigator with 30-years of medical device and in vitro diagnostics (IVD) industry experience and is currently the Founder and Managing Consultant for his firm Practical Compliance Results. Vincent prepares his clients to be ready for their next FDA inspection and Notified Body audit consulting in the areas of compliance, quality assurance, and quality systems.     Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Vincent Cafiso Linkedin Profile: https://www.linkedin.com/in/vincentcafiso/  CREO Consulting Website: https://creoconsulting.com/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Wie ist die aktuelle Marktlage und was sind die Trends in der Zukunft? Das weiß Jürgen Michael Schick, Immobilienunternehmer und ehemaliger Präsident des IVD. In diesem spannenden Interview möchte Marco, Gründer von immocation, gerne wissen, wie sich die Inflation entwickelt und wie aktuell die Auswirkung auf den Immobilienmarkt ist. Brauchen wir in Zukunft mehr Wohnraum und wie sehen faire Mieten aus? Wie sieht die Entwicklung bei Eigentumswohnungen, MFH und großen Wohnungspaketen aus? Einen Rundumblick der aktuellen Marktlage bekommt ihr in dieser Folge. Außerdem gibt unsJürgen Michael Schick einen Einblick in seine eigene Investitionsstrategie. immocation. Lerne Immobilien.

EU Notified Bodies TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true AFNOR 46th NB under MDR –Finally a second one for France: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43655&filter=notificationStatusId:1 MDCG 2024-4 Guidance–Safety reporting in Performance Studies or IVD: https://health.ec.europa.eu/document/download/5cc894e0-331d-4fa2-8ab3-cdd4437c48fc_en?filename=mdcg_2024-4_en.pdf Form: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fhealth.ec.europa.eu%2Fdocument%2Fdownload%2F54cbbfd4-5808-4560-93ef-017f2a3b0f41_en%3Ffilename%3Dmdcg_2024-4_appendix_en.xlsm&wdOrigin=BROWSELINK MDCG 2024-5 Guidance – SInvestigator's Brochure for Clinical Investigation: https://health.ec.europa.eu/document/download/ee7ee8eb-841a-4085-a8dc-af6d55ebf1bd_en?filename=mdcg_2024-5_en.pdf Checklist 2024-5 https://health.ec.europa.eu/document/download/a387e3e7-65e3-4af5-bb98-2281949feded_en?filename=mdcg_2024-5-appendix-a_en.docx  Survey Article 17 – Reprocessing of single use devices: https://op.europa.eu/o/opportal-service/download-handler?identifier=35ea0c60-e82c-11ee-9ea8-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=      Team-NB: ESMINT initiative –  Call for expert: https://www.team-nb.org/esmint-initiative/  Spain AEMPS Bulletin on Health Products –  From Jan - March 2024: https://www.aemps.gob.es/informa/boletin-sobre-productos-sanitarios-enero-marzo-de-2024/#vigProdSan  Germany: Classification - Bfarm to help you classify your device: https://www.bfarm.de/DE/Medizinprodukte/Antraege-und-Meldungen/Antrag-auf-Klassifizierung/_artikel.html  Swiss: SaMD –  information sheet to help Software companies: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_007d_mbmedizinprodukte-software.pdf.download.pdf/BW630_30_007e_MB%20Medical%20Device%20Software.pdf Turkey: 26 May 2024 –  Reminder of the May 26th, 2024 deadline for EU MDR https://titck.gov.tr/duyuru/imalatcisi-tarafindan-sure-uzatimindan-faydalanmayacak-urunlerin-uts-surecleri-24042024160706   Article to read European Medical Writers Association – Focus on Translation: https://journal.emwa.org/media/5111/mew-331-final.pdf   Training Training EU MDR –  Green Belt Certification Program GB31 May 2024: https://school.easymedicaldevice.com/course/gb31/  Malaysia training –  Calendar 2024: https://portal.mda.gov.my/index.php/doclink/mda-core-training-list-2024-latest-nur-izzati-adha-binti-zuman-mda-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJtZGEtY29yZS10cmFpbmluZy1saXN0LTIwMjQtbGF0ZXN0LW51ci1penphdGktYWRoYS1iaW50aS16dW1hbi1tZGEtcGRmIiwiaWF0IjoxNzE0MDEwNjUyLCJleHAiOjE3MTQwOTcwNTJ9.1KCY_1RCNi1mnJSCP30llN8kaBvcBJU6G_JMpc-OttI Team-NB training  -  IVDR technical Documentation July 3rd, 2024: https://www.team-nb.org/fourth-session-ivdr-technical-documentation-training-for-manufacturers/   Events  Events –  Check Medtech Conf: https://MedtechConf.com   Rest of the world  South Korea: Certificate Check –Verifying authenticity of certificates issued by MDFS: https://emedi.mfds.go.kr/msismext/emd/uif/issuDocTruflsEngView.do  South Korea: IVD method –How to register IVD in South Korea: https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%B2%B4%EC%99%B8%EC%A7%84%EB%8B%A8%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0%EB%B2%95/(19695,20230816)  South Korea: UDI rules to follow –Same but not the same: https://www.mfds.go.kr/eng/brd/m_40/down.do?brd_id=eng0011&seq=72636&data_tp=A&file_seq=1  Mexico: Draft Mexican official standard –Labelling of Medical Devices: https://www.dof.gob.mx/nota_detalle.php?codigo=5724246&fecha=23/04/2024#gsc.tab=0  Australia: Consultation on IFU –  Call for more flexibility: https://www.tga.gov.au/resources/consultation/consultation-availability-instructions-use-ifu-more-flexible-formats   Podcast  Radiation Sterilisation Master File   -  Adam Issacs Rae: https://podcast.easymedicaldevice.com/279-2/  What is the impact of AI Act on Medical Devices –  Erik Vollebregt: https://podcast.easymedicaldevice.com/280-2/  Why and how to build your Quality Culture – Lesley Worthington: https://podcast.easymedicaldevice.com/281-2/      

This show was recorded 25 April 2024. We encourage you to download the IVDR timeline presented at the beginning of this session by ⁠⁠completing the form on this page⁠⁠. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the ⁠⁠⁠Knowledge Center⁠⁠⁠ or ⁠⁠⁠Events⁠⁠⁠ pages at RQMplus.com. Thank you for tuning in.

On this episode, I was joined by Devon Campbell, Founder, Prodct LLC + CPO, myBiometry. Devon discusses: 02:20 The Journey to Consulting: A Year of Saying No 03:09 Advising Startups: The Role of a Consultant 05:08 The Shift to Consulting: Embracing Joy and Impact 09:21 Navigating the Startup Ecosystem: Challenges and Opportunities 13:31 Building a Positive Team Culture and Avoiding Arrogance 19:12 The Philosophy Behind Prodct: Focusing on Medical Devices 20:55 A Personal Touch: The Impact of 'Born to Run' 21:59 Closing Thoughts and Where to Find Devon Devon Campbell is the Founder, Prodct LLC and Chief Product Officer(CPO), myBiometry. He's launched and exited several MedTech ventures and has worked in large Pharma and large IVD companies in executive roles focusing on engineering and product development. https://www.devonccampbell.com/

In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the intricate world of in vitro diagnostics (IVDs) with Christie Hughes, a principal consultant and IVD expert at Qserve Group. With over 25 years of experience, Christie shares her extensive knowledge, discussing the nuances of IVDs, regulatory landscapes, and practical insights for professionals transitioning into or within the IVD sector.Key Timestamps:[00:00:45] - Christie Hughes's introduction and background in IVDs[00:03:30] - Discussion on the regulatory challenges and trends in 2023[00:15:22] - Differences between IVDs and other medical devices in terms of regulatory and operational frameworks[00:25:50] - Impact of regulatory changes on labs and manufacturers[00:40:10] - Detailed exploration of user needs and design controls in IVD development[00:52:00] - Advice for medical device professionals entering the IVD spaceNotable Quotes:"Understanding the user—whether a lab technician or a layperson—is critical in IVD development to ensure safety and effectiveness." - Christie HughesKey Takeaways:Trends in MedTech: The regulatory environment for IVDs is rapidly evolving, with increased scrutiny and changes in compliance requirements globally.Practical Tips: For those entering the IVD field, familiarize yourself with FDA decision summaries and EUA documentation to understand current regulatory expectations.Future Predictions: Expect continued integration of IVDs with digital health technologies, raising both opportunities and regulatory complexities.References and Resources:FDA decision summaries for recent IVD clearancesEuropean In Vitro Diagnostic Regulation (IVDR) updatesCDRH LearnFDA Proposed Rule for LDTsEpisode on LDTs with Shannon BennettChristie Hughes on LinkedInEtienne Nichols on LinkedInMedTech 101:In Vitro Diagnostic (IVD) Devices: Tools that analyze human samples (like blood or tissue) outside the body, used to diagnose diseases, conditions, or to monitor a person's overall health.Audience Interaction:Discussion Question: "How do you envision IVDs changing everyday healthcare practices in the future?"Call for Feedback:Love this episode? Leave us a review on iTunes and share your thoughts. Feedback drives our growth and allows us to improve. Reach out directly via email at podcast@greenlight.guru with your suggestions for future topics.Special Thanks to Our Sponsor:This episode is brought to you by Greenlight Guru, a quality management system and electronic data capture software designed...

 Sponsor: Medboard   EU EU proposal to prevent shortage - And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/ Notified Body Survey - Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf   Spain: AEMPS consultation - Qualification and Classification of Medical Devices: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-un-procedimiento-para-consultas-relativas-a-la-cualificacion-y-clasificacion-de-productos-sanitarios-incluidos-los-de-diagnostico-in-vitro/ EURL Second Call - More Lab for High Risk IVD: https://health.ec.europa.eu/latest-updates/expression-interest-open-possible-second-call-eu-reference-laboratories-high-risk-vitro-diagnostic-2024-02-22_en TEAM-NB Position Paper - Reclassification of IVD: https://www.team-nb.org/wp-content/uploads/2024/02/Team-NB-PositionPaper-Classification-of-SARS-Cov2-20240202.pdf EMDN Proposal - Suggest your updates: https://webgate.ec.europa.eu/dyna2/emdn/ MDCG 2024-2 : https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf Does your product qualify for CECP -Notified Bodies should decide: https://www.ema.europa.eu/en/documents/other/working-instructions-notified-bodies-application-article-54-regulation-eu-2017-745-medical-devices-article-48-regulation-eu-2017-746-vitro-diagnostic-medical-devices_en.pdf   Training Training Green Belt EU MDR - Learn by practicing: https://school.easymedicaldevice.com/course/gb30 Open March 25th, 2024 until March 29th, 2024TEAM-NB Training - Technical Documentation: https://www.team-nb.org/wp-content/uploads/2024/02/Leaflet-MDR-TD-Manufacturers-Training-20240429.pdfApril 29th, 2024   Services Packaging and IFU - Design and Production: https://easymedicaldevice.com/packaging-for-medical-devices/   ROW USA Fraudulent Lab -: FDA ask you to check your Third Party: https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-fda-reminds-medical-device   CANADA Consultation on Significant Changes -: Until April 22nd, 2024: https://www.canada.ca/en/health-canada/programs/draft-guidance-how-to-interpret-significant-change-medical-device.html Draft Guidance: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/interpret-significant-change-medical-device.html   Mexico Mexico to Strengthen the Medical Device industry -: Harmonization planned with other Regulatory Pathways: https://www.gob.mx/cofepris/articulos/cofepris-presenta-agenda-de-fortalecimiento-de-la-industria-de-dispositivos-medicos?idiom=es   Saudi Arabia  SFDA Harmonized Standards - Which one is accepted?: https://www.sfda.gov.sa/sites/default/files/2024-02/MDS%E2%80%93G020.pdf   Qatar  Qatar Telemedicine - Policy to use this technology: https://www.moph.gov.qa/_layouts/15/download.aspx?SourceUrl=/Admin/Lists/Announcements%20Attachments/Attachments/275/Tele%20Policy.pdf   Australia TGA SOPP requirements - System or Procedure Pack guidance: https://www.tga.gov.au/sites/default/files/2024-02/system-procedure-packs-guidance-sponsors-manufacturers-charities.pdf TGA Essential Principles - Template available: https://www.tga.gov.au/sites/default/files/essential-principles-checklist-medical-devices.pdf Transition to EU MDR cases - Evidence of transition, DCR, Non-Compliance, Recalls: https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-dcrs-and-variations-case-studies-and-scenarios.pdf   https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-conformity-assessment-essential-principles-case-studies-and-scenarios.pdf https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-manufacturer-evidence-case-studies-and-scenarios.pdf https://www.tga.gov.au/sites/default/files/2024-02/eu-mdr-recalls-and-market-notifications-case-studies-and-scenarios.pdf   PODCAST Episode 271 - How to get your interview prepared? With Elena Kyria https://podcast.easymedicaldevice.com/271-2/ Episode 272 - Will EtO gaz become a Medical Device? Christina Ziegenberg: https://podcast.easymedicaldevice.com/272-2/ Episode 272 - New EU Proposal, EUDAMED, Shortage and IVDR transition. Erik Vollebregt: https://podcast.easymedicaldevice.com/273-3/   EASY MEDICAL DEVICE Services: Training: https://school.easymedicaldevice.com/emd-course/ Authorized Representative EU: https://easymedicaldevice.com/eu-rep/ Authorized Representative UK: https://easymedicaldevice.com/uk-responsible-person/ Authorized Representative Swiss: https://easymedicaldevice.com/swiss-authorised-representative/ Backoffice Services: https://easymedicaldevice.com/backoffice-service-medical-device/ Eqms SmartEye; https://smart-eye.io Conferences: https://medtechconf.com/  

EU Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-proposal.PDF Measures: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_24_346/IP_24_346_EN.pdf Question and Answers: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_24_347/QANDA_24_347_EN.pdf Factsheet: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-factsheet_1.pdf   MDCG 2024-1 Vigilance System for CE - Guidance and Template: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1_en.pdf MDCG 2024-1-1 Device for Cardiac Ablation: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-1_en.pdf MDCG 2024-1-2 Coronary Stents and associated delivery systems: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-2_en.pdf MDCG 2024-1-3 Cardiac Implantable Electronic Devices (CIEDs): https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-3_en.pdf MDCG 2024-1-4 Breast Implants: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-4_en.pdf   Language requirements for Manufacturers (MDR & IVDR) - Check where English is not applicable: MDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-mdr.pdf IVDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-ivdr.pdf eQMS your eQMS SmartEye - The best eQMS ever:  https://eqms-smarteye.com UK Future Regulation roadmap - We still have to wait: https://assets.publishing.service.gov.uk/media/659d3539aaae22001356dc3c/Roadmap_towards_the_future_regulatory_framework_for_medical_devices__Jan_24.pdf Course Training EU MDR Green Belt - February and March 2024 : https://school.easymedicaldevice.com/gb/ Notified Bodies and Approved Bodies UK Approved bodies - They are 9 now: https://www.gov.uk/government/news/mhra-announces-two-new-uk-approved-bodies-to-certify-medical-devices LNE-GMED: https://assets.publishing.service.gov.uk/media/65b799f2a0ae1b000d52616e/LNE-GMED_Scope_Medical_Devices.pdf Scarlet NB UK: https://assets.publishing.service.gov.uk/media/65b79a11a0ae1b000d52616f/AB_Scarlet_Scope_Jan_2024.pdf   GDP video Good Documentation Practices - Check how to be sure to have good documents: https://www.youtube.com/watch?v=nkBpef5AstI ROW USA US FDA Quality Management System Regulation - Alignment to ISO 13485: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked US FDA IVD Reclassification - Move from Class III to Class II: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-intent-initiate-reclassification-process-most-high-risk-ivds FDA Remote Regulatory Assessment (RRA) - Question and Answers: https://www.fda.gov/media/160173/download Estar 5.1 version -: IVD and non-IVD: https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program Non-IVD: https://www.fda.gov/media/174458/download?attachment IVD: https://www.fda.gov/media/174459/download?attachment eStar 5.0 video with Rob Packard: https://www.youtube.com/watch?v=KDkKnRnBfgc   Saudi Arabia Webinar: Artificial Intelligence and Software -:February 13th, 2024 at 10 AM Middle East time : https://www.sfda.gov.sa/en/workshop/93262   Manufacturing Devices at Point of Care (PoC) - uidance on how to manufacture them: https://www.sfda.gov.sa/sites/default/files/2024-01/MDS%20–%20G009E.pdf   Events Medtech Conf - RAPS Workshop - Feb 27th until March 1st: https://medtechconf.com/event/raps-events/ Podcast Nostalgia - Relisten again and again Episode 267 - Warning! Apply to your Notified Body Now! with Pritam Mekala: https://podcast.easymedicaldevice.com/267-2/ Episode 268 - You are not the Physical Manufacturer, can you be MDR certified: https://podcast.easymedicaldevice.com/268-2/ Episode 269 - Why you should use Pre-Submission or Q-Sub with FDA: https://podcast.easymedicaldevice.com/269-2/ Whatsapp Community: Whatsapp community - Register even if it says no: https://chat.whatsapp.com/DvpnuGLihD98zGXsiYicQq

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, January 30, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. RenovoRX closed a $6.1 million private placement. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what RenovoRX is developing and how it wants to spend the funds.  Vicarious Surgical has picked a former Olympus executive as president. Find out who is taking on this role and some of their career history.  ReWalk Robotics rebranded to 'Lifeward' as its portfolio continues to expand. Whooley shares the reason behind the rebrand and what executives are thinking. Globus Medical is laying off 157 employees at the former NuVasive headquarters. Hear more about the reason behind the layoffs and which departments are affected. Philips has discontinued certain CPAP product lines after the ongoing recall saga. The Fast Five hosts talk about the consent decree and how the company came to this decision. BONUS: Read the top IVD and diabetes stories of 2023.

Medboard Who is Medboard Medboard: https://www.medboard.com/ EU  EU Reference laboratories EURL EU Reference laboratories for IVD products: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302713 Article : https://health.ec.europa.eu/latest-updates/designation-eu-reference-laboratories-high-risk-vitro-diagnostic-medical-devices-2023-12-06_en Letter to EU Parliament  Letter sent to the European Parliament - Cybersecurity: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_17000_2023_INITMDCG 2023-7 on Clinical Investigation MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR: https://health.ec.europa.eu/document/download/1b5f9cc0-cea0-4459-921f-eaf4b4f80983_en?filename=mdcg_2023-7_en.pdf MDCG 2019-07 rev 1 on PRRC MDCG 2019-07 Rev 1: Guidance on Article 15 of MDR and IVDR on PRRC: https://health.ec.europa.eu/system/files/2023-12/md_mdcg_2019_7_guidance_art15_mdr_ivdr_en.pdf MDCG 2021-27 on Importer and Distributor MDCG 2021-27 Rev 1 Q&A Article 13 & 14 MDR and IVDR: https://health.ec.europa.eu/system/files/2023-12/mdcg_2021-27_en.pdf MDCG 2023-5 on Annex XVI class MDCG 2023-5 Guidance on qualification and classification of Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-5_en.pdf MDCG 2023-6 on Annex XVI Equivalency MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-6_en.pdf Companion Diagnostics CDx EMA Q&A on Companion Diagnostics CDx: https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-medicinal-products-development-and-assessment-involving-companion-diagnostic-cdx_en.pdf Switzerland Guidance on Devices with no medical purpose Medical Device without Medical Intended Purpose: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_007d_mb_produkte_ohne_medizinische_zweckbestimmung.pdf.download.pdf/MU600_00_007e_MB_Devices_without_an_intended_medical_purpose.pdf Emergency use of non-conform device Exemption to Medical Device non-conforming: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw617_00_003d_mb-ausnahmebewilligung-mep.pdf.download.pdf/BW617_00_003e_MB%20Derogation%20MEP.pdf Notified Bodies: New Notified Body under EU MDR 43rd NB MDR - CESKY METROLOGICKY INSTITUT - Czech Republic: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=17f0c069619116060627ac0f430dff1c8cbc295c&group=NOTIFICATION&download=true Notified Body Situation Notified Body Situation; https://health.ec.europa.eu/system/files/2023-12/notifiedbodies_overview_en.pdf Training: EU MDR training Green Belt training 28th edition January 22nd until 28th https://school.easymedicaldevice.com/course/gb28/ 29th edition February 19th until 23rd https://school.easymedicaldevice.com/course/gb29/ 30th edition March 25th until 29th https://school.easymedicaldevice.com/course/gb30/   Medical Device e-Training eTraining Vigilance Reporting:  https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/ Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/   ROW Mexico: Mexico registration rules Guide for obtaining the Health Registry of Medical Devices - https://app.medboard.com/your-medboard/systematic-reviews/authorities-news/2243/ Brazil: Brazil is calling Innovative Medical Devices Innovative Medical Devices: Anvisa extends deadline for participation in pilot project: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/dispositivos-medicos-inovadores-anvisa-prorroga-prazo-de-participacao-em-projeto-piloto   Hong-Kong: Hong-Kong Guidances Artificial Intelligence Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR008.pdf Software Medical Devices and Cybersecurity: https://www.mdd.gov.hk/filemanager/common/mdacs/TR007.pdf Guidance note for Listing Class II/III/IV General Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf Guidance note for Listing Class B, C, D In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-06-E.pdf Classification of In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR006E.pdf USA: USA Export documents transition to digital Transition to Electronic Export Documents - Letter to Industry: https://www.fda.gov/medical-devices/industry-medical-devices/transition-electronic-export-documents-letter-industry   India: India New platform to register National Single Window System (NSWS) Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA4MTA=   Australia: Australia Boundary and Combination products guide on boundary and combination products https://www.tga.gov.au/sites/default/files/2023-12/guidance-boundary-combination-products.pdf Australia on Custom-Made and Patient Match How to submit a custom-made medical device / patient-matched medical device notification: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf   Malaysia Malaysia is telling rules on Borderline products Harmonised borderline products in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-borderline-products-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWJvcmRlcmxpbmUtcHJvZHVjdHMtaW4tYXNlYW4tc2Vjb25kLWVkaXRpb24tMi1wZGYiLCJpYXQiOjE3MDIzNDcxOTksImV4cCI6MTcwMjQzMzU5OX0.4cNrbv3GpbG2KjL6uQxcxm3KeBGLsxZy77JqQKiIXUc Malaysia is telling rules for classification of products List of harmonized classification of Medical Devices in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-classification-of-medical-device-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWNsYXNzaWZpY2F0aW9uLW9mLW1lZGljYWwtZGV2aWNlLWluLWFzZWFuLXNlY29uZC1lZGl0aW9uLTItcGRmIiwiaWF0IjoxNzAyMzQ3MTk5LCJleHAiOjE3MDI0MzM1OTl9.WbMya1V8vykQ88aQyqpraMR4G7rZ_QA36hN_DOEeqso   Podcast Nostalgia Podcast Nostalgia Episode 262 - What is usability: https://podcast.easymedicaldevice.com/262-2/ Episode 263 - Why you should invest in your Regulatory Team: https://podcast.easymedicaldevice.com/263-2/ Episode 264 - Life of a QA RA Podcaster https://podcast.easymedicaldevice.com/264-2/ Episode 265 - Heatmap: https://podcast.easymedicaldevice.com/265-2/

In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Carmen Brown, the regulatory and quality affairs manager at Proxima Clinical Research. They delve into the specifics of In Vitro Diagnostics (IVDs) and explore the challenges and considerations faced by medical device manufacturers in the IVD pathway. Whether you're an industry veteran or new to the field of medical diagnostics, this conversation will enlighten you about the nuances of IVD regulatory compliance, risk assessment, and FDA interactions.Episode Highlights:IVDs are a Specialized Medical Device: Learn how IVDs, which include reagents, instruments, or systems for diagnosis, differ from other medical devices and what specific regulatory pathways they follow.Risk Levels in IVDs: Understand the significance of classifying IVDs into class one, two, or three based on the risk of false or inaccurate results, and how this impacts regulatory strategy.Pitfalls in Performance Characteristic Evaluation: Discover the complexities involved in evaluating the performance of multiband diagnostics and why traditional measures like sensitivity and specificity may not suffice.Likelihood Ratios Over Sensitivity and Specificity: Grasp why likelihood ratios are a more appropriate statistical measure for multiband diagnostics and how they relate to pretest and posttest probabilities.Clinical Relevance is Key: Recognize the importance of ensuring that the markers detected by IVDs are clinically meaningful and relevant to the condition being diagnosed.FDA's Expectations for IVDs: Gain insights into the specific data and performance characteristics the FDA looks for in IVDs and the necessity of clinical data in regulatory submissions.Quote:"With IVDs, you're looking at it from the perspective of what's the risk of a false result or an inaccurate result. So you're looking at who's interpreting the results and the type of condition." ~Carmen BrownReference Links:Carmen BrownProxima Clinical ResearchGreenlight GuruEtienne Nichols' LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

Medboard Medboard platform  Sponsor of the podcast https://www.medboard.com/ EU EPSCO Meeting November 30th. 2023  -  MDR IVDR device risk of disruption: https://data.consilium.europa.eu/doc/document/ST-15385-2023-REV-2/x/pdf Survey on Medical Devices -   Study supporting the monitoring of the availability of Medical Devices on the EU Market. Information: https://ec.europa.eu/eusurvey/runner/MFandAR Questionary: https://ec.europa.eu/eusurvey/files/6a4fd4cd-dfce-4fe1-bcaf-9f44eb00e471/650fed06-30d2-40b1-9ff0-e96c79b4eb96   Falsification of Medical Devices - Survey result: https://act.edqm.eu/s/XcPw5MDtYe49gmj/download/CMED-Survey-Report-Final%20%281%29.pdf MDCG 2022-11 Rev 1 Position Paper - Call to NB to streamline the certification process https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf EU IVDR Technical Documentation training - TEAM-NB Survey result Training IVDR technical documentation February 1st, 2024: https://www.team-nb.org/wp-content/uploads/2023/11/Leaflet-IVD-TD-Manufacturers-Training-20240201.pdf Result on Survey of MDR training: https://www.team-nb.org/mdr-technical-documentation-training-for-manufacturers/   DEHP Substance forbidden in Medical Devices - Extension to July 1st, 2030 : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302482Notified Bodies Situation - 2 new comers: UDEM Turkey 41st NB under MDR: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1004365?organizationVersion=7Scarlett NB B.VC. 42nd NB under MDR: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=2feeb6d10d338167081ad0cf7af6683fe760cded&group=NOTIFICATION&download=true Switzerland Vigilance Reporting submission information  - Update your QMS procedures: https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/uebersicht-medizinprodukte/archiv/hinweis-einreichung-vigilance-meldungen-mep.html Training EU MDR Training EU MDR 2017/745 - December 11th - Green Belt Certification Program for EU MDR : https://school.easymedicaldevice.com/course/gb27 Medtech Conf Your Medtech Conferences -  Register all your Events, Training, Conferences: https://medtechconf.com/ USA FDA withdrawal - not anymore member of the GHWP: https://www.fda.gov/media/174142/download Discontinuation in the USA - Notifying FDA of a permanent discontinuation: https://www.fda.gov/media/155245/download Webinar on Companion Diagnostics - Oncology Drug Products used with IVD tests: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-oncology-drug-products-used-certain-in-vitro-diagnostic-tests-pilot-program-12122023Canada Medical Device Establishment Licenses annual review - You should receive your Christmas Package: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/annual-licence-review-2024.html Saudi Arabia Webinar: Clinical Trials of Medical Device Requirements - Click on the link in December 12th, 2023: https://www.sfda.gov.sa/en/workshop/93098South Africa Guideline on Q&A for Licensing of Medical Device Establishment - Learn how to start this activity: https://www.sahpra.org.za/wp-content/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device-Establishments55.pdf Brazil Argentina & Brazil signed a Mutual Recognition Agreement - For certificates for Medical Devices: https://www.argentina.gob.ar/noticias/anmat-y-anvisa-firmaron-el-primer-acuerdo-de-reconocimiento-mutuo-en-certificados-para SmartEye eQMS for Medical Device companies - Get your Demo now: https://smart-eye.io Podcast Nostalgia How to CE certify a calculator, risk score software as Medical Device? Cesare Magri: https://podcast.easymedicaldevice.com/258-2/ How to find a predicate Device for your 510k submission? Beat Keller: https://podcast.easymedicaldevice.com/259-2/ What is the situation regarding Digitalization in the Medtech industry? MedXD https://podcast.easymedicaldevice.com/260-2/ Easy Medical Device support - info@easymedicaldevice.com Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. ➕ In today's

Andy Moye is a seasoned commercial leader and corporate development executive who has worked across the molecular diagnostics, biotechnology and life sciences industries. He is currently Chief Executive Officer at Paige and previously served as Chief Commercial Officer, where he led the company's clinical sales and commercial strategy, including the U.S. launch of Paige Prostate, the first and only AI-based pathology product to receive FDA approval for in vitro diagnostic (IVD) use in detecting cancer in prostate biopsies. Previously, Moye served as Head of Commercial Operations in North America and Latin America for the Digital and Computational Pathology division of Philips, delivering significant growth in both markets for the emerging business. Moye has also served in executive roles at leading healthcare companies, including Ontada, a division of McKesson, Caris Life Sciences, and WaferGen Bio-systems, now part of Takara Bio. Prior to joining the industry, Moye served as a Lieutenant and flight officer in the U.S. Navy, completing missions in Bosnia, Kosovo, Iraq, Europe, and South America. He received a Ph.D. in health economics from Walden University, MBA from the University of Florida and B.S. in physiology from the University of Arizona.   

This episode's Community Champion Sponsor is Catalyst. To virtually tour Catalyst and claim your space on campus, or host an upcoming event: CLICK HERE---Episode Overview: During this episode, we spend time with Dr. Agim Beshiri, Chief Medical Officer of Nutromics, an international leader pioneering continuous diagnostic monitoring to transform personalized care. Bringing over 20 years of clinical and industry expertise, Agim is driven to advance patient-centric precision medicine. While together, Agim shares how Nutromics utilizes synthetic DNA sensors for real-time, first-order molecular recognition. Additionally, Agim unpacks the future of scaling personalized treatment through continuous multiplexed monitoring. We also discuss reinventing antiquated blood testing methodologies and paradigm shifts enabling preventative intervention. Join us as Agim outlines a vision for mimicking implanted diagnostic tools across diverse disease states and to gain inspiration from his dedication to elevating global standards of care through innovative diagnostics. Let's go! Episode Highlights:Agim brings deep medical affairs experience to transform diagnostic testingHow Nutromics uses synthetic DNA sensors for continuous, multiplexed monitoringWays in which Nutromics enables real-time precision dosing adjustments and early interventionsAgim envisions scaling continuous diagnostics across diverse disease statesHow Agim exemplifies commitment to profoundly advancing personalized medicine About our Guest: Agim Beshiri, M.D., is the Chief Medical Officer (CMO) at MedTech startup Nutromics. His passion is in elevating the standard of care for all patients. With over 20 years' experience in the IVD field both in the clinical setting and industry. Dr Beshiri developed methods and collaborations that enabled patient-centric application of diagnostics addressing underserved patients in disease states from cardiology to oncology.A leading industry expert in developing a medical affairs organization and driving medical research and education. With a broad background in internal medicine, hematology, general cardiology, and laboratory medicine, Dr Beshiri initiated and collaborated on research programs resulting in over 800 research collaborations and over 1000 publications.Prior to Nutromics, Dr Beshiri was Senior Medical Director at Abbott Laboratories where he developed supporting their Diagnostics organization for over 16 years. His clinical experience includes the Brooke Army Medical Center in Texas, the 452nd Combat Support Hospital in Wisconsin and Aurora/Advocate Clinical Laboratories in Wisconsin and Illinois, and South-eastern Europe.Dr. Beshiri is a member of several organizations, including the American Medical Association, American Heart Association, European Society of Cardiology, International Society for Laboratory Hematology, European Hematology Association, American Society of Hematology, and American Society of Clinical Oncology. He has also served on guideline subcommittees for the Clinical and Laboratory Standards Institute.Links Supporting This Episode:Nutromics Website: CLICK HEREDr. Agim Beshiri LinkedIn page: CLICK HERENutromics Twitter page: CLICK HERE Mike Biselli LinkedIn page:

AI is the new tool of choice for battling cancer, and Andy Moye's company is at the forefront on a mission to advance cancer detection and patient care and treatment by using cutting-edge artificial intelligence.They are revolutionizing and accelerating the way we conquer this universal enemy.Andy is CEO and Board Member at Paige AI, which is the only company that FDA approved to use AI in diagnosing cancer pathology.This includes the U.S. launch of Paige Prostate Detect, the first and only AI-based pathology product to receive FDA marketing authorization for in vitro diagnostic (IVD) use in detecting cancer in prostate biopsies.His involvement in pathology began around 2005 and he's been at the forefront of the molecular diagnostics, biotechnology, and life sciences industries for nearly two decades, focusing on pathology, oncology, genomics, and precision medicine.Before that, he served in the Navy for eight years flying P-3C aircraft.LinkedIn Profile https://www.linkedin.com/in/andymoye/Company Link: https://paige.ai/What You'll Discover in this Episode:AI's impact on the healthcare industry.The two sides of AI that will have the biggest impact in the next three to five years.Rampant physician burnout - How AI is addressing it.What company leaders should be asking their health benefit providers.The moment he realized he wanted to lead in healthcare.The one skill that's contributed most to his success.A strategy that motivates your team.Why an AI company prioritizes people first.Are you trying to get your team to like you? Don't!What he learned from having one-on-one's with 100 employees.-----Connect with the Host, #1 bestselling author Ben FanningSpeaking and Training inquiresSubscribe to my Youtube channelLinkedInInstagramTwitter

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.

IVD is in the building and spilling the tea on life as a female rapper, friendship and dating. AP and Maz talk stag do's and your men liking baddie pics on the gram. Send the girls your juicy voice notes on 07594 520 584. PRESSED is a BBC Studios and Unheard Network production. Exec Producer: Pete Strauss Producer: Pilar Nalwimba Editor: Faith Howley Production Coordinator: Sarah Nicholls