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MEDBOARD: https://www.medboard.com/ EUROPE TEAM-NB high level position - Making Medical Devices Safer and Faster: https://www.team-nb.org/wp-content/uploads/2024/12/Team-NB-HighLevel-Strategy- PositionPaper-20241130.pdf -   MDCG 2024-15 - Reporting Medical Device Trials Made Easy!: https://health.ec.europa.eu/document/download/0e076d19-62dc-4ff9-83f2-be6072a45993_en? filename=mdcg_2024-15_en.pdf -   EMA activities on Combination products - Reminder on Drug-Device assessment.: https://www.ema.europa.eu/en/documents/presentation/presentation-sme-info-day- session-4-ema-activities-medical-devices_en.pdf -   MDCG 2024-16 Interruption or Discontinuation - For certain devices: https://health.ec.europa.eu/document/download/b431b10f-8512-4f47-9191-e1b84b2f9a27_en? filename=mdr_qna-article10a_mdr-ivdr_en.pdf and annex https://health.ec.europa.eu/document/download/b4a7dea7-ae73-4e13-a8a8-11dcd2678d38_en?filename=md_mdc-2024-16 _annex_en.pdf -   Joint Paper from 9 Member states - Council of the European Union: https://data.consilium.europa.eu/doc/document/ST-15380-2024-INIT/en/pdf Reduction of Administrative Burdens Centralization of System Management to the EMA Predictable Certification Procedures Enhanced Coordination and Support Impact Assessment and Resource Allocation   -   MDCG 2024-14 Master UDI-DI - Contact lenses: https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14 _en.pdf Master UDI-DI Assignment Labelling Requirements Vigilance Reporting EUDAMED Registration Implementation Timeline   -   Artificial Intelligence in Medical Devices . Joint publication Team NB and IG-NB: https://www.team-nb.org/wp-content/uploads/2024/11/Team-NB-PositionPaper-AI-in-MDQuestionnaire-V1-20241125.pdf -   Gradual Roll-out of EUDAMED - Be ready to start: https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf -   Spain application for in-house devices - For hospitals: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-una-nueva-aplicacion-para-la-comunicacion-de-fabricacion-de-productos-sanitarios-in-house-por-hospitales/ SMARTEYE - Eqms Smarteye: https://eqms-smarteye.com/ EVENTS - Arab Health - January 27 to 30th, 2025: https://medtechconf.com/event/total-radiology-conference/ TRAINING -  Mini-Course MDR: https://easymedicaldevice.com/resource/resource-medical-device-regulation/mini-course-mdr/ ROW -   US - Some healthcare software are not devices - WARNING: https://www.fda.gov/media/184083/download?attachment Administrative support in healthcare settings. Promoting healthy lifestyles without direct links to disease management. Serving as electronic patient records without interpreting or analyzing data. Transferring, storing, converting, or displaying medical data without interpretation. Providing limited clinical decision support to healthcare providers without interpreting clinical tests or device data.   -   US - PCCP Final guidance - Submit a PCCP with your submission: https://www.fda.gov/media/166704/download • Webinar January 14, 2025 - https://www.fda.gov/medical-devices/cdrhnew-news-andupdates/webinar-final-guidance-marketing-submission-recommendations-predetermined-change-control-plan?utm_source=FDALinkedin - South Korea Guidance - Enhancing Medical Device Safety!: https://www.mfds.go.kr/law/board/boardDetail.do?menuKey=29&brdId=data0011&seq=15564 we're talking about new guidance from South Korea's Ministry of Food and Drug Safety, or MFDS. They just released a document to help improve the safety and quality of medical devices." "This guidance focuses on stricter standards for manufacturing and testing medical devices to ensure they are safe and effective for patients." "The MFDS is also emphasizing the importance of proper documentation and reporting, so that any issues can be quickly identified and addressed." The MFDS aims to make medical devices safer through several key measures: Stricter Standards: They are implementing more rigorous manufacturing and testing standards to ensure devices meet high safety and quality benc Enhanced Oversight: Increased oversight and regular inspections of manufacturing processes ensure compliance with safety regulations. Training and Education: Providing training and resources to manufacturers to help them understand and meet the new standards. These steps are designed to ensure that medical devices are safe, effective, and reliable for patients. "In short, this new guidance aims to make medical devices safer and more reliable for everyone." -  Australia - Guidelines for Medical Devices - Bookmark the link: https://www.tga.gov.au/resources/resource/reference-material/australian-regulatory-guidelines-medical-devices- argmd -  Australia - Submit Custom-made device - Guidance step-by-step: https://www.tga.gov.au/resources/resource/user-guide/how-submit-custom-made-medical-device-notification -  Malaysia - Advertisement application - Approve your Advertising: https://www.mda.gov.my/index.php/industry/medical-device-advertisements/medical-device-advertisement PODCAST -  How MDR and IVDR code can save you money? Stefan Bolleininger: https://podcast.easymedicaldevice.com/309-2/ -  Is FMEA bad for your Risk Management? Rod Beuzeval: https://podcast.easymedicaldevice.com/310-2/ -  How to build the perfect Quality Management System? https://podcast.easymedicaldevice.com/311-2/ -  IEC 60601-1-8 How to test your Medical Device Alarms? Beat Keller https://podcast.easymedicaldevice.com/312-2/ -  PCCP - The magic tool for planned changes in the US? Maria Diez: https://podcast.easymedicaldevice.com/313-2/ 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

Holly Caggiano is an Assistant Professor in Climate Justice and Environmental Planning at the University of British Columbia's School of Community and Regional Planning. Her research explores social dimensions of climate transitions in the US and Canada, and how diverse stakeholder groups form coalitions to advocate for energy systems change.  In this episode, we chat about efforts to mobilize towards a just energy transition, ranging from the Green New Deal as a framework for community action to building cultures of sustainability and care on campuses and beyond. Paper by Holly discussed in podcast:  A new framework for imagining the climate commons? The case of a Green New Deal in the US  Some valuable resources mentioned by Holly:  Planning the Green New Deal: Climate Justice and the Politics of Sites and Scales by Kian Goh Mutual Aid Disaster Relief - a group that gives Holly hope! 

Stephen "The UK Carnivore" Thomas is co-host of the annual Carnivoreathon, a Carnivore/Keto Coach specializing in OBESITY & DIABETES, a personal trainer, and a qualified PHLEBOTOMIST! TIME STAMPS: 02:31 Rosanna's “4-Year-CARNIVERSARY” victories including reversing type II diabetes, and losing over 100 lbs! 07:38 AX THROWING & CHOPPING WOOD is Primal Exercise!

Hertz filed (at least) hundreds of false police reports against customers falsely accusing them of stealing Hertz's vehicles. This resulted in life-altering changes to innocent people's lives: arrests, jailing, criminal records, losing employment, suffering health problems, etc. Even after getting sued, Hertz has tried to escape responsibility by trying to keep documents sealed that detail their abuse. Corporations don't change until their bottom line is hurt. Let's use our power as consumers to vote with our dollar and #BoycottHertz #truthHertz For more reading: ‘I Could've Been Dead': Hundreds of False Stolen Car Reports Put Black Hertz Customers At Risk, Leading to Arrests at Gunpoint, Lost Wages, a Miscarriage and Other Traumas - Atlanta Black Star Hertz will pay $168 million to customers it falsely accused of stealing its cars - NPR Senators call for investigations into Hertz following CBS News reports of hundreds of customers allegedly being falsely arrested - CBS News Hertz agrees to pay $168 to settle false arrest claims by hundreds of customers - USA Today Hertz to pay $168M to settle lawsuits involving false police reports filed against its own customers - 13 WTHR And the Supreme Court case that allows police to conduct pretextual traffic stops? Whren v. US Some arguments on why we need to get police out of traffic stops: The Case For Ending All Traffic Stops - Jalopnik Get Police Out of The Business of Traffic Stops - The Washington Post --- Send in a voice message: https://podcasters.spotify.com/pod/show/natasha-t-baker/message Support this podcast: https://podcasters.spotify.com/pod/show/natasha-t-baker/support

Florian is co-founder and Partner at astorya.vc, a European seed / insurance fund launched in October 2017. He has been investing in tech startups for ~15 years, and his former positions include investor at Newfund, a tech VC based in Paris, and investor at AXA Ventures, a VC fund investing in European insurance startups. Florian is an engineering graduate from Telecom ParisTech and business school graduate from HEC. He regularly writes and tweets about InsurTech, AI and Startups. Highlights from the Show astorya.vc looks at early investments (seed/pre-seed), which they found to be a gap in the market Their focus is on Europe because of their ability to help startups in Europe given their experience and networks Their LPs tend to be corporates who would otherwise not be able to get in at early stages as they themselves are geared up for Series A, or, more often, B and C investments This focus exclusively on early stage and InsurTech has meant founders seek out Astorya.vc as an investor of choice, meaning they see more of the early startups than anyone (in addition to technology they've built to scan the market and spot opportunities) All of the activity in the market right now makes it even harder for corporates to spot the right places to focus their efforts, so having astorya.vc as a place to turn for guidance is even more valuable Astorya.vc focuses only on Europe because that is where Florian and his co-founder have a network, and they believe that at seed stage, it's not just about money but what you can do to help the business, so they need to stay within the realm of where they can truly help as investors  They try to invest in any business line rather than just P&C or Life or Health, Personal or Commercial They focus on B2B/Enterprise software, which is a function of their size and seed focus because B2C/DTC businesses tend to need huge rounds and it takes a long time to get to revenue This also fits with their network, again, allowing astorya.vc to help those they invest in more They like to invest in new risks where incumbents don't have a competitive edge because there's no (or limited) historical data, leveling the playing field between startups and corporates, and that allows the ability to leverage new approaches, data, etc faster and better Since they are investing in the enabling tech, it's not about incumbents vs. startups, but rather InsurTechs enabling the market, including incumbents  Seed investing is not about spotting unicorns as it is about anticipating trends, spotting needs and building companies step-by-step They start with spotting the needs in the market, identifying the best team to solve it, and then helping them go to market and grow Some of the needs they see are around parametric, cyber risk, downtime of networks and platforms, freelancing/gig work and more Trends in InsurTechs European startups are replicating what they've seen in the US Some geographic differences by sub-market, like tech-enablers/B2B solutions in France (like Shift Technologies); commercial lines in the UK, perhaps because of Lloyds (like Zigo); Germany is more Health-focused (like Autonova) In all markets, you see B2C trends like Luko, Bought by Many and others In the US, we see some places where established InsurTechs spawn new startups from alumni leaving to create something, but it's a bit too early in Europe to see as much of this just yet with fewer exits like in the US that are generally needed to see this kind of activity Some of the European InsurTechs are achieving real numbers, like a B2C players in France acquiring as many new customers as a tier 1 mutual insurer InsurTech is unbundling the value chain, and especially between reinsurers and insurers as reinsurers are starting to work directly with InsurTech MGAs, with an estimated $1.5B in capacity going directly to InsurTech MGAs from reinsurers We see SCOR, Swiss Re, Munich, Covea and others making moves here This makes sense as reinsurers are all about and very good at managing data, and the InsurTechs are so often a data play, so it's a really good alignment Since most InsurTech insurers start as MGAs and become full stack carriers, by design they will need a direct relationship with a reinsurer, so it seems natural that they're starting that relationship more directly from the start Distribution will shift, but not from 0% direct to 100% quickly, but some lines and some segments will move at scale A proxy astorya.vc looks at is the share of e-commerce vs. brick and mortar, and in some segments in the pandemic, they saw the mix going to over 50% online, so those segments are signaling that they may shift direct more, even if not over 50% This matters for existing distributors and insurers who need to think about whether they could afford ten or 20% (or more) of their market moving online, direct Special thanks to Insure National (insure-national.com) for sponsoring this episode. Follow the podcast at future-of-insurance.com/podcast for more details and other episodes. Music courtesy of UPbeat Music, available to stream on Spotify, Apple Music, Amazon Music and Google Play. Just search for "UPbeat Music"

We are taking a break this week from the “Know Better. Do Better” series to hear the inspiring money memoir of one woman who is working hard to create the financial life she desires while still having the quality of life that she wants. If you are burnout and exhausted from your job, this might be an inspiring message for you to listen to. Today’s guest is Alka Kumar. She grew up in India, where she went to medical school and eventually came to the United States. She spent nearly 30 years working as a physician when she realized that she was overworked and getting close to reaching the point of being burnt out. Instead of toughing it out because she was getting closer to being able to retire, she realized she needed to make some changes in her life. She cut back her hours so she could work part-time and began to educate herself on real estate investing. Before she knew it, she bought her first property and was finally on the path to earning passive income. She now owns and manages 16 units and is continuing to grow and expand her portfolio. Alka is also excited to help give back by sharing financial and real estate information to help other professionals, especially single women learn to line up multiple income streams instead of just depending on their 9 to 5 job. In This Episode We Discuss: What it was like growing up in India and what made Alka move to Canada (and then the US) The difference between the cost of college in India vs. the US Some of the great financial principles that Alka lives by How she educated herself on investing and real estate Why she’s working as her own property manager and if she plans to continue that in the future Why she started small when buying her first investment property Some of the horror stories of being a landlord and why she still thinks it’s one of the best things The unexpected expenses that come with being a landlord How Alka has financed her properties The importance of having a “get rich slow” mindset If you want to learn more about Alka Kumar and the work she’s doing you can connect with her at: Website: https://www.yourwealthmd.com/ LinkedIn: @alka-ally-kumar-120b43149 Facebook: @YourWealthMD If you want to further connect with Lauryn Williams at Worth Winning, follow us on social media: Instagram: @worthwinning Twitter: @worth_winning Facebook: @worthwinningfp LinkedIn: @lauryn-williams

Reed Goossens Bio: Reed is a Real Estate entrepreneur with 8 years' experience in structural engineering, project management, design and real estate acquisitions. I combine my technical engineering background with my passion for real estate development and investing. He's has $250 million worth of real estate under management.

His Experience includes:
- Project Engineering Manager of various multi story high rise construction
- Raising private capital to fund projects and new developments
- Implementing different investing strategies to increase the value of the asset
- Construction scheduling, planning and risk assessment Key Insights: • How Reed go started in multifamily investing after moving from Australia to the US • Some of the challenges Reed has faced in his investing career • The importance of having a long term mindset when investing in multifamily • How Reed is finding good multifamily deals in this competitive marketplace • Reed highlights a specific deal that he acquired and managed Book Recommendations: Key Person of Influence – Daniel Priestley Contact Information: Email: info@reedgoossens.com Website: reedgoossens.com Company Website: wildhorncap.com

Liberals pushing back against cancel culture in the US Some people call it cancel culture because it is based on mainly online activism aimed at 'cancelling' or withdrawing support from a celebrity or public figure. But in the last few years it has extended away from pop culture celebrities into academic institutions, writers festivals and even mainstream newspapers like the New York Times. Advocates argue they are righting wrongs and correcting fundamental injustices in the system. Critics say it promotes illiberalism, creates a censorious culture of intolerance for opposing views and diverts attention from deeper problems. Yascha Mounk, founder of Persuasion, signatory to the Harpers Letter, Associate Professor of the Practice of International Affairs at Johns Hopkins University. Author of The People versus Democracy - Why Our Freedom Is in Danger and How to Save It. And, is the alliance between the US and South Korea unravelling? President Trump botched the North Korean nuclear deal, and he has been threatening to pull US troops out the Demilitarised Zone between the two Koreas unless South Korea pays billions more to the US. But with the tensions between the US and China growing, doesn't Washington need democratic allies in the region now, more than ever? Sue Mi Terry, Senior Fellow for Korea, and Korea Chair at the Center for Strategic and International Studies, Washington DC.

Liberals pushing back against cancel culture in the US Some people call it cancel culture because it is based on mainly online activism aimed at 'cancelling' or withdrawing support from a celebrity or public figure. But in the last few years it has extended away from pop culture celebrities into academic institutions, writers festivals and even mainstream newspapers like the New York Times. Advocates argue they are righting wrongs and correcting fundamental injustices in the system. Critics say it promotes illiberalism, creates a censorious culture of intolerance for opposing views and diverts attention from deeper problems. Yascha Mounk, founder of Persuasion, signatory to the Harpers Letter, Associate Professor of the Practice of International Affairs at Johns Hopkins University. Author of The People versus Democracy - Why Our Freedom Is in Danger and How to Save It. And, is the alliance between the US and South Korea unravelling? President Trump botched the North Korean nuclear deal, and he has been threatening to pull US troops out the Demilitarised Zone between the two Koreas unless South Korea pays billions more to the US. But with the tensions between the US and China growing, doesn't Washington need democratic allies in the region now, more than ever? Sue Mi Terry, Senior Fellow for Korea, and Korea Chair at the Center for Strategic and International Studies, Washington DC.

Joining Lynn and John on Cool Science Radio this week is Dr. Dalia Kirschbaum, a Research Physical Scientist in the Hydrological Sciences Lab at NASA's Goddard Space Flight Center , in Greenbelt, MD. Dr. Kirschbaum has a number of responsibilities in the study of landslides including developing new techniques for rainfall-triggered landslide hazard assessment and forecasting. She is also the Associate Deputy Project Scientist for Applications for the GPM Mission. GPM stands for Global Precipitation Measurement. GPM is a constellation of satellites that together make sophisticated measurements of rain and snow of the entire world every 3 hours including the GPM Core observatory that can CT scan a hurricane . A new video on hurricane forecasting: Daily patterns in rainfall over the US: Some new applications of GPM data: Microinsurance: Agriculture and water resources: https://svs.gsfc.nasa.gov/13592

Bill's backgrounds as a financial planner and a business owner The current trends in “robo-advice” How financial planners in the US are using technology to leverage businesses How the Financial Planning software packages work in the US Some more exciting trends he is seeing in the US with tech.

The Weekly Crypto Recap, with @zaphoid (Chris Karabats of SmartCash), and @ChrisPacia (Chris Pacia of Open Bazaar) News from the week: Kik launches a "crypto defense fund" to fight the SEC, adds $5 million and encourages the community to donate also Wei Lui challenges CSW's copyright of the Bitcoin Whitepaper and files a competing copyright claim Miner attacks BCH, leading to a "soft fork" or "51% attack" to reverse the transactions Bitcoin "toxicity" hashed out over twitter between Samson Mow and Matt Corallo First ever Tezos upgrade activated Liquidated Cryptopia owes creditors $2.7 million Salesforce unveils first blockchain product Facebook's "GlobalCoin" Crypto Around the world: US: Some lawmakers ask for blockchain to be included on Trump's list of emerging technology initiatives. "Crypto" not mentioned (ASIC) (The Australian Securities and Investments Commission) issues guidance on ICOs and crypto assets China cracks down on local bitcoin farms built "without approval" Egypt lifts ban on cryptocurrency, allows companies "approved by central authority" to operate University of Surrey (UK) to use blockchain to secure digital government records of national video archives around the world against tampering To watch the video of this episode, visit: https://youtu.be/10xc2-5Bwfs

We discuss the story of an American missionary killed on North Sentinel Island - a forbidden Island off the coast of India which has been isolated for tens of thousands of years. Also: - Complaints about the trains in the northeast US - Some updates on my sabbatical projects - Followup on my discussion with David Pietrusza: Teddy Roosevelt, and the society at the turn-of-the-20th-century. - Answer a listeners question about Google Plus's strategy localmaxradio.com/42

Date: October 10, 2013 Featuring:​ Ed Wagner, MD, MPH, MACP, Director Emeritus, MacColl Center for Health Care Innovation, Group Health Research Institute Trissa Torres, MD, MSPH, FACPM, Senior Vice President, Institute for Healthcare Improvement Kirsten Meisinger, MD, Medical Director, Union Square Family Health Center, Cambridge Health Alliance Thad Schilling, MD, Medical Director, Patient-Centered Medical Home, Harvard Vanguard Medical Associates-Medford (MA)  What does it take to be a high-functioning primary care practice today in the US? Some 30 sites of all shapes and sizes are in the midst of being studied in hopes of answering this very question. The Robert Wood Johnson Foundation and the MacColl Center for Health Care Innovation selected these practices because of their exemplary and innovative staffing models. Figuring out the best ways to delegate  responsibilities and work as a team is one of the central needs for all primary care providers today, and midway through the project  known as LEAP (Learning from Effective Ambulatory Practices) WIHI will get a look at the success factors that LEAP has identified thus far. Dr. Ed Wagner of the MacColl Center is LEAP’s Project Director (along with Margaret Flinter, APRN, Phd) and he’ll be heading up the discussion on the October 10 WIHI: New Staffing Models for Primary Care. Dr. Wagner developed the Chronic Care Model, which was groundbreaking for office practices in the late 1990s and remains foundational to the creation of patient-centered medical homes today. Changing how providers and staff both divide up the work and share responsibility for every patient is a critical part of this transformation, and Drs. Kirsten Meisinger and Thad Schilling will use their time on this WIHI to share what they’ve been doing that’s earning their sites accolades and, most importantly, achieving better results.IHI’s Trissa Torres is no stranger to primary care transformation. Prior to joining IHI, Dr. Torres helped pioneer new care models for the Genesys Health System in Michigan and developed the concept and role of “Health Navigators” to help patients build upon an office visit and identify further support in the community. We hope you will listen!

Welcome Back, Hajar's Hair!!!! We return to the core crew this week for our discussion of the latest episode of Serial. Who is a super spy? Who is a double agent? What is INTERPOL? A fantastic rock band, or something more sinister? Why is the paper yellow? Who is the real sausage king of the US? Some of this and more may or may not be discussed during this week's thrilling episode!

Welcome Back, Hajar's Hair!!!! We return to the core crew this week for our discussion of the latest episode of Serial. Who is a super spy? Who is a double agent? What is INTERPOL? A fantastic rock band, or something more sinister? Why is the paper yellow? Who is the real sausage king of the US? Some of this and more may or may not be discussed during this week's thrilling episode!