Podcasts about technolo

Support the show!! - https://www.patreon.com/chasedavisVideo - https://youtu.be/FJUG6gBZmkYGo to ionlayer.com and use code FPT to get $100 off your first kit. https://crwiley.com/X - https://x.com/crwiley1962Touchstone Magazine - https://www.touchstonemag.com/Theology Pugcast - https://crwiley.com/the-theology-pugcast/SummaryIn this episode of Full Proof Theology, Chase Davis and C.R. Wiley delve into the pressing issues of AI, transhumanism, and the implications of woke culture on society and the church. They explore the evolution of artificial intelligence, its infrastructure, and its applications in everyday life, while also discussing the ethical considerations and the need for a balance between digital and analog experiences. Wiley emphasizes the importance of understanding these technologies from a Christian perspective, advocating for discernment and a return to the analog world to maintain spiritual health. In this conversation, C. R. Wiley and Chase Davis explore the implications of transhumanism and artificial intelligence on the human body and Christian theology. They discuss the dangers of immersive technologies like VR, the ethical considerations of AI in pastoral care, and the theological challenges posed by the desire to enhance human capabilities through technology. The conversation emphasizes the importance of understanding our bodies as belonging to God and the potential consequences of surrendering our autonomy to technological advancements.Support the showSign up for the Patreon - https://www.patreon.com/chasedavisFollow Full Proof Theology on Instagram - https://www.instagram.com/fullprooftheology/Follow Full Proof Theology on Facebook - https://www.facebook.com/fullprooftheology/

The conversation discusses the potential Gun Alert, a technology that can notify gun owners if their firearm has been moved or removed from its usual environment. The technology aims to address issues such as suicide, domestic violence, and unauthorized access to firearms. It is well-received in various communities, including law enforcement and the firearms industry. The conversation emphasizes the importance of collective action and sensible solutions to reduce gun-related tragedies. The product is seen as a deterrent and an extra layer of security, especially for households with children or individuals going through mental health challenges. It is also seen as a tool for responsible gun ownership and can be used in scenarios such as temporary firearm storage or during times of crisis. The conversation highlights the need for a holistic approach to address the root causes of gun-related problems and the importance of education, technology, and collaboration among different stakeholders. Gun Alert is a new technology that aims to prevent accidental shootings and unauthorized access to firearms. The device is a sensor that attaches to a gun and sends an alert to the owner's smartphone if the gun is moved or tampered with. The goal is to promote responsible gun ownership and reduce gun-related accidents and tragedies. Gun Alert is currently focused on creating awareness and forming partnerships to get the product in the hands of those who need it the most, such as new gun owners, underserved communities, and veterans. The company's long-term vision is to make Gun Alert a standard accessory for gun owners, just like seat belts are for car owners.Patrick's LinkedInSend us a text

Omar Hernandez v. Illinois Institute of Technolo

We couldn't talk AI without chatting about Westworld - just in time, right before the season 4 premiere this weekend! In this episode, we share our thoughts on the show upon this re-watch compared to when the show first aired. We also compare Westworld and Ex_Machina, the movie we're watching this month, and discuss the similarities between both stories.Let us know what you think and chat with us on Twitter: https://twitter.com/WTF_WithUsCheck out our YouTube channel for extended conversations and outtakes: https://www.youtube.com/channel/UC1O6GFhumzrq8qNBYZuF_1QTheme Music Credit: Ultra Lights by Stefan Kartenberg (c) copyright 2020 Licensed under a Creative Commons Attribution Noncommercial  (3.0) license. http://dig.ccmixter.org/files/JeffSpeed68/61225 Ft: Javolenus

The EU MDR is changing a lot of things for medical devices, and even on Custom-made. The definition changes and has a huge impact on already marketed products. The manufacturers have to assess their portfolio to define again if their products are custom-made or not. In this episode, Erik Vollebregt will try to explain to you the rules you’ll need to follow. Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.” Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/ Axon Lawyers: https://www.axonlawyers.com/ Erik's blog: https://medicaldevicelegals.comMDCG 2021-3: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-3_en.pdf The post Which devices cannot be Custom-made? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

EUDAMEDCommission implementing regulation 2021/2078: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2078EUDAMED webpage: https://ec.europa.eu/health/md_eudamed/udi_devices_registration_enEUDAMED Playground: https://webgate.training.ec.europa.eu/eudamed-play/landing-page#/UDI/Devices guidance: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed_udi-devices-user-guide_en.pdfInfographic EUDAMED: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-concept_en.pdfCategorization of devices: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-devices_en.pdfRegistration process: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-registration-process_en.pdfIVDR expert panelView in the context of the Performance Evaluation Consultation Procedure (PECP): https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000002-view_en.pdfFollowing MDCG 2021-22 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-22_en.pdfEU Reference laboratories (EURL)Feedback on Draft implementing regulation open until December 17th, 2021: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13272-EURL-fees_enGermany: Contact Persons for Medical Devices https://www.bfarm.de/EN/Medical-devices/Contact-persons/_artikel.html?nn=968830Ireland – HPRA: In-house Manufacturing of in vitro diagnostic medical devices – SurveyDue December 17th, 2021 http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/in-house-manufacturing-of-in-vitro-diagnostic-medical-devices-stakeholder-survey&id=07891026-9782-6eee-9b55-ff00008c97d0Ireland – HPRA: Update on the creation of Free Sale Certificate in Ireland: http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/applying-for-a-certificate-of-free-sale-updated-information&id=d4731026-9782-6eee-9b55-ff00008c97d0Annex XVI products – Finland – FIMEAhttps://www.fimea.fi/web/en/-/supervision-of-devices-referred-to-in-annex-xvi-of-the-medical-device-regulation-to-begin-in-autumn-2022CHRISTMAS BREAKMHRA Christmas period: Clinical Investigation: https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-deviceBelgium – FAMHP – Christmas period https://www.famhp.be/en/news/deadlines_for_the_submission_of_dossiers_during_end_of_year_periodSwitzerland: Registration of Economic Operators: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.htmlCH-RN Database: https://opendata.swiss/en/dataset/mep401-chnr-actorsHow to obtain the CHRN: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_11_001defi_fo-registrierungsantrag-einmalige-idnr-art55-mepv.pdf.download.pdf/BW630_11_001defi_FO_Antrag_Registrierung_CHRN.pdfSwitzerland – Procurement: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/beschaffung.htmlUK MHRA: Review launched into the health impact of potential bias in medical devices : https://www.gov.uk/government/news/review-launched-into-the-health-impact-of-potential-bias-in-medical-devicesWORLDUSA: Final rule for Medical Device De Novo Classification Processhttps://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-rule-medical-device-de-novo-classification-processPodcast episode 43 – How to register a Medical Device with FDA? (510k, PMA, DeNovo) How to register a Medical Device with FDA? (510k, PMA, de Novo…)USA: Draft Guidance 510K Device Software function SaMDWebinar Dec 16th, 2021 – Draft Guidance: Content of Premarket Submission for Device Software functions: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-draft-guidance-content-premarket-submissions-device-software-functions-12162021-12162021Draft guidance: https://www.fda.gov/media/153781/downloadUSA: Voluntary eSTAR Program: https://www.fda.gov/medical-devices/premarket-notification-510k/voluntary-estar-programNon-in vitro diagnostic eStar Version 1: https://www.fda.gov/media/154429/downloadIn Vitro Diagnostic eStar Version 1: https://www.fda.gov/media/154430/downloadSaudi Arabia: Borderline products https://www.sfda.gov.sa/sites/default/files/2021-11/GuidanceBorderlineProductsClassificationE.pdfNotified BodySGS Belgium: https://www.sgs.com/en/news/2021/11/sgs-belgium-nv-confirmed-as-a-notified-body-for-the-new-eu-medical-device-regulation-mdrMDR 25: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34IVDR 2017/746 6: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35EMDPodcastEpisode 153 – How to improve your QA RA Communication with Lesley Worthington: https://podcast.easymedicaldevice.com/153/Episode 154 – Is it possible to Private Label a Medical Device under MDR and IVDR with Erik Vollebregt: https://podcast.easymedicaldevice.com/154/Episode 155 – How to approach your Notified Bodies? With Dr Royth von Hahn https://podcast.easymedicaldevice.com/155/Episode 156 – Unleashing “MDR Classification surprises with Franck Matzek https://podcast.easymedicaldevice.com/156/LinkedIn LiveTalk Cybersecurity during MDR audit with Stefan Bolleininger:  https://www.youtube.com/watch?v=IK0DiXnISKE&t=4sIVDR 2017/746 – in-house devices: https://www.youtube.com/watch?v=AbwaA7DpbYI The post Medical Device News: December 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Here is the last Medical Device News for this year, I will cover all the updates that happen in the EU, UK, Switzerland,, US and Saudi Arabia. We will also review the situation for Notified Bodies. I hope you'll enjoy. The post Medical Device News: December 2021 Regulatory Update appeared first on Medical Device made Easy Podcast.

The MDR classification was hidding some surprises and I have asked Frank Matzek from Biotronik to tell us more about the products and rules we need to take care of. So Enjoy! The post Let’s unleash “MDR Classification surprises” [MDR 2017/745] appeared first on Medical Device made Easy Podcast.

Really great discussion with Dr Royth von Hahn from TÜV SÜD. He is providing some solutions on how to talk to your Notified Body. This would help Medical Device manufacturers. The post How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD] appeared first on Medical Device made Easy Podcast.

OEM OBL is really used a lot by Medical Device Manufacturers. But this is not possible anymore with EU MDR. So please listen to that as maybe you are doing it without knowing. The post Is it possible to Private Label a Medical Device under MDR & IVDR? appeared first on Medical Device made Easy Podcast.

Lesley Worthington is a career coach and will help you understand why improving your communication skills within QA RA can be a booster for you. We will talk about our experience as she also worked in QA RA. So don't miss this episode if you don't understand why your communication activities are not helping you. The post How to improve your QA RA Communication with Lesley Worthington? appeared first on Medical Device made Easy Podcast.

Latest update will focus on IVDR proposal, Artificial intelligence, Notified Bodies situation and MDCG guidances. Other elements will also be discussed. I hope you'll enjoy! The post Medical Device News – November 2021 latest update appeared first on Medical Device made Easy Podcast.

BREAKING NEWS: The EU Commission issued a proposal to delay some IVDR date of application but it is not a complete postponment so don't use this word. Listen the interpretation of Erik Vollebregt on that. The post How does the EU Commission plan to save IVDR 2017/746? appeared first on Medical Device made Easy Podcast.

Ana Luiza is my guest and we will explain to you how to be sure that your are compliant with CMR substances on your product. CMR will be reviewed during an audit and apparently there were a lot of mistakes. So let's help you to avoid that. The post How to comply with MDR when products contain CMR Substances? appeared first on Medical Device made Easy Podcast.

EUDAMED is the database that will provide all the information about your company and your devices. After the release of the Economic Operator module, now there is the release of the Device Registration and Certificate Module. So let's talk about that with Richard Houlihan from Eudamed.com The post EUDAMED Update: Should you register your medical devices now? appeared first on Medical Device made Easy Podcast.

Here is the Regulatory update for October 2021. We will talk of the Implementation of MDR and IVDR, MHRA, Swissmedic, FDA, AEMPS.. A new session of the Green Belt opens this month. The post Medical Device News – October 2021 Regulatory Update appeared first on Medical Device made Easy Podcast.

The MDR and IVDR has not finished to surprise us. On this episode we will talk about the article 16(4) where we see that in certain circumstances, an importer or Distributor will need to get certified by a Notified Body even if they are not doing a manufacturing activity. So don't miss that. The post Why does an Importer/Distributor need to appoint a Notified Body? appeared first on Medical Device made Easy Podcast.

Are you starting a clinical investigation or PMCF? Then are you using a Digital Solution to collect the data? Today we will explain to you what is The post How to collect Clinical Data within the 21st Century [Jon Bergsteinsson] appeared first on Medical Device made Easy Podcast.

We have passed the Date of application for MDR and this went well because a lot of manufacturers do have CE certificates that expire later. But for IVDR this is another story. So for the majority of the products, they should be compliant by the date of application. Let me explain that to you on this episode. The post How to manage the IVDR transition period? [IVDR 2017/745] appeared first on Medical Device made Easy Podcast.

Maybe some of dreamed of it, maybe this idea went through your mind but you haven't done it. Here we will talk with Erik Vollebregt of the consequences of opening a legal case with your Notified Body. The post Is it a good idea to sue my Notified Body? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast.

On this September 2021 update we will talk about FDA, MHRA, Swissmedic, ANSM, Fimea, MDCG guidances, New Notified Bodies... A lot to talk about so don't miss this update. If you are not willing to read the guidances, let me summarize it for you. The post Medical Device News – September 2021 Latest Updates appeared first on Medical Device made Easy Podcast.

There are a lot of questions about Software as Medical Devices. So I have invited Dr. Abtin Rad from TÜV SÜD to give us more information about how to consider SaMD with the EU MDR 2017/745 The post How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD) appeared first on Medical Device made Easy Podcast.

This is a question I asked myself when I started my career. I am now an independant consultant but I started as a Full-time employee. So Smahan will help us understand which option can be the best for you. The post Better to be a Consultant or a Full-time employee? [Lifescience industry] appeared first on Medical Device made Easy Podcast.

We talked a lot about MDR and tried to teach most of its requirements. And today we will continue by providing you with the Most Common Mistakes that are discovered by Notified Bodies. Martin Witte from TÜV SÜD will share with us the issues that are discovered by its team. Let's learn from it. The post What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD] appeared first on Medical Device made Easy Podcast.

This is already Mi-Year with the summer holiday. But EU Commission didn't sleep as there was a lot of MDCG guidance released. Let's review the agenda for this month and don't miss all the links. The post Medical Device News – August 2021 Regulatory Update [MDR & IVDR] appeared first on Medical Device made Easy Podcast.

Vigilance Reporting is an important system to have within your quality management system. Even if you are still MDD, you need to comply to the MDR requirements for it. So I will help you for that. The post How to implement Vigilance Reporting for MDR and IVDR? appeared first on Medical Device made Easy Podcast.

Technolo-gee.....is it good or bad?Do you agree technology can be a double-edged sword? Advancements in technology have improved our everyday lives as well as caused arguments and heartache. As with every great peak, there is definitely a valley. I'm going to hike that mountain (with Tito's in hand) and share some laughs along the way. Produced By:  Fadi GattoussiPlease follow Boobs, Booze and Other Stuff on.....SpotifyApple PodcastsInstagramTik TokYouTubeiHeart

After receiving a lot of questions on System and Procedure pack we have decided to have a second episode on it with Erik Vollebregt. So let's review some special cases and also some feedback from the authorities. The post System and Procedure Pack the RETURN with Erik Vollebregt appeared first on Medical Device made Easy Podcast.

Bassil Akra will help use interpret this first Expert Panel Opinion. Bassil already helped on a previous episode where we discussed about the creation of this Expert Panel. Let's review this first outcome and see the consequence of it for the industry. The post How to interpret the first Expert Panel Opinion? [Bassil Akra] appeared first on Medical Device made Easy Podcast.

We will update you on all what happened within the Medical Device regulation. All new The post Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA] appeared first on Medical Device made Easy Podcast.

The State-of-the Art is one of the component that can make you win or make you lose. If this research is not done correctly, it can ruin your Clinical Evaluation Report or Performance Evaluation Report. Hakan Inan from Requalite will explain to us why this is important. The post How to build your State-of-the-art for your Medical Devices? appeared first on Medical Device made Easy Podcast.

In the case you are placing your brand trademark on a product, or if you buy a product designed by another company... then you need to understand the rules related to Intellectual properties. This episode with Stephen Carter will be a masterclass about Intellectual Property. The post How Intellectual Property is linked to the Medical Device Regulation? appeared first on Medical Device made Easy Podcast.

Clinical Investigation is not really an easy process. So it can be important for your to understand what are the requirements and get some details about time and cost. Helene Quie from Qmed Consulting which is also a CRO will help us learn more about this process required by EU MDR. The post How to perform a good Clinical Investigation with Helene Quie appeared first on Medical Device made Easy Podcast.

This podcast episode is really important as this answers some of the questions that a lot of my customers are asking. So I hope this will help you to understand why this is important to perform a Biological Evaluation or Biocompatibility for your finished product. The post How to perform a Biological Evaluation for your Medical Device? appeared first on Medical Device made Easy Podcast.

Medical Device News June 2021 Update is providing you all the last updates. This IS the episode of the EU MDR date of application. A lot of news provided. The post Medical Device News – June 2021 Update [EU MDR Date of Application] appeared first on Medical Device made Easy Podcast.

EU MDR is starting tomorrow and we wanted to check the situation for Economic Operators. We had already interviewed Catherine on the previous survey release. This time we do a follow-up The post EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson] appeared first on Medical Device made Easy Podcast.

1 week to the EU MDR and we hope that you are ready. If not, then you can maybe listen to this episode as we are answering some last minute questions. The post MDR is coming so brace yourself with Erik Vollebregt appeared first on Medical Device made Easy Podcast.

This process called EUA was really famous last year when everyone wanted to register its face mask or respirator or covid-19 test in the USA. After 1 year let's see the conclusion of Michelle Lott on it. The post FDA: Is the Emergency Use Authorization worth it? (EUA) appeared first on Medical Device made Easy Podcast.

This is the last month before the EU MDR 2017/745 Date of Application. We will talk about that and about all the updates The post Medical Device News – May 2021 Update [EU MDR 2017/745] appeared first on Medical Device made Easy Podcast.

It is Day -30 for the EU MDR date of application. So let's summarize what should be ready for you and also what is not mandatory. The post Checklist – What is important before the EU MDR Date of Application? appeared first on Medical Device made Easy Podcast.

Merger and Acquisition is an important topic to understand as people think this is a fiance activity. But when you'll listen to this episode, you will not think that anymore. The post How to perform correctly a Merger & Acquisition during the MDR transition? appeared first on Medical Device made Easy Podcast.

IVDR is planned for May 26th, 2022 but why it will be more difficult for IVD manufacturers than for MDR manufacturers? Listen to this episode to have a better understanding The post Will it be really difficult for IVD manufacturers? [IVDR 2017/746] appeared first on Medical Device made Easy Podcast.

During the Greenlight Guru summit on EU MDR & IVDR I have presented the way to create a label. And following the session there was so many questions that I decided to answer to some of them within the Podcast so everyone can benefit from it. So I hope this will help. The post How to create a Label under MDR? (Questions & Answers) appeared first on Medical Device made Easy Podcast.

The system and procedure pack within EU MDR is still a mystery for a lot of people and Erik Vollebregt accepted to help us have a better understanding of this specific cases. We will explain to you what it is and who can use it. The post How System and Procedure Pack are regulated under EU MDR? appeared first on Medical Device made Easy Podcast.

In this episode, Edgar Kasteel will help us understand the role of an importer and will also tell us more about the model of independent importers. The post How to import your Medical Devices with an Independent Importer? appeared first on Medical Device made Easy Podcast.

In this monthly episode we will review what happened within the Medical Device industry. EUDAMED, Covid19, Notified Bodies... The post What is the Medical Device News? [March 2021 update] appeared first on Medical Device made Easy Podcast.

Waterfall or Agile? Jon Speer from Greenlight Guru will help to understand what is the best methodology that can be used to develop your medicaldevices. The post The best design methods for successful development? [Jon Speer] appeared first on Medical Device made Easy Podcast.

How to find a job in the QA RA world for Medical Devices? This is what we will discuss with Karandeep Badwal. We will provide our tips and also the platforms to visit. The post How to find a QA RA job for Medical Devices? [Karandeep Badwal] appeared first on Medical Device made Easy Podcast.

If you are thinking that you are the only one that has issues as QA RA, then listen to this episode. I hope this will help you to understand that there is a certain mindset to have when you do this type of job. The post What is the QA RA Mindset with Michelle Lott appeared first on Medical Device made Easy Podcast.

What do trees need computers for? Well, the people working to preserve them do. Our team of IT professionals manages technology that supports hundreds of staff across Lake County. Not only desktop computers, but smartphones, servers, databases, laptops, projectors, and more. Debbie Boness, Information Technology Officer, and Rian Crowley, Database Developer, discuss how we turn technology into technolo-tree. Season 2 runs now through November 17, 2020. Learn more: www.LCFPD.org Music: Coffee Stains by Riot Swoop by The Mini Vandals There Are Chirping Birdies In My Soul by Reed Mathis Trail of Breadcrumbs by Lyle Workman Got an idea or a question for our podcast team? Email us at WordsOfTheWoods@LCFPD.org. Words of the Woods is a production of the Lake County Forest Preserves in Libertyville, Illinois.