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DeviceTalks

DeviceTalks

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The DeviceTalks Podcast Network delivers news, insights and commentary from Medtech industry leaders. Our podcasts will inspire medtech professionals to create better medtech devices and companies. Explore the DeviceTalks Podcast Network, home to more than 8 podcasts: • AbbottTalks • AI Meets Life Sci • Boston Scientific Talks • DeviceTalks Weekly • IntuitiveTalks • MedtechWOMEN Talks • MedtronicTalks • Ortho Innovation Talks: Zimmer Biomet • StrykerTalks
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Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to li ...
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Medical Device Insights

Prof. Dr. Christian Johner

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Der Podcast "Medical Device Insights" des Johner Instituts wendet sich an Medizinproduktehersteller, Behörden und Benannte Stellen. Er liefert Praxistipps, um sichere und wirksame Medizinprodukte mit minimalem Aufwand zu entwickeln, zu prüfen, zuzulassen und im Markt zu überwachen. Damit hilft er Herstellern, Audits sicher zu bestehen und mit ihren Produkten im Markt erfolgreich zu sein. Mit diesem Podcast sind die Hörerinnen oder Hörer bestens informiert und diskutieren mit Behörden, Benann ...
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Left to Our Own Devices

Cybellum Technologies LTD

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We just announced Left to Our Own Devices: The Conference - the first virtual conference dedicated to product security, taking place on April 3rd, 2024. Save your spot for free at Cybellum.com/conference ------------------------------------- Introducing Left to Our Own Devices - the podcast dedicated to everything product security. Every other week, we will be talking with a different cybersecurity policymaker, engineer, or industry leader to hear their war stories and get their insider tips ...
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Poetic Devices: (Type) Writing Life

Kro, The Traveling Typist

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I make my living as an on-demand typewriter poet. I peddle surprise and delight. These are my stories, methods, and philosophies. My mission is to bring poetry to the people. Tune in for tales of typewriter theater, my stance on creative bravery, and to hear poetry from the streets.
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RQM+ industry-leading experts and often special guests discuss regulatory, quality, clinical, lab, and reimbursement challenges MedTech companies are facing. RQM+ is the world's leading MedTech service provider offering consulting, clinical trial, lab, and reimbursement services, as well as technology solutions to support the entire product lifecycle. With more former FDA, Medicines, and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ t ...
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A technology focused podcast where friends discuss emerging tech news, IT trends, and general technology related topics in a humorous and straight forward fashion. Find us wherever you listen to your favorite shows! https://linktr.ee/DeviceCastingCouch **Due to differing time zones and busy schedules, episodes are uploaded as we are able to record. We hope you understand.
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Device & Virtue

Chris Ridgeway & Adam Graber

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Chris & Adam argue the wrongs and rights of technology and faith in everyday life—from A.I. to Facebook to DNA tests—and how a Christian might live in the middle.
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Join us on DeviceAlliance's Podcast: MedTech Radio where we interview today's brightest minds in Southern California's medical device industry. Each episode deconstructs complex topics and provides the tactics, tools, and strategies to overcome tomorrow's challenges. DeviceAlliance strives to be the one-stop-shop at the center of the medical device ecosystem helping drive collaboration, innovation, and career development for all device professionals in Southern California.
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Device

KPBS Explore / Emily T. Griffiths

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Device is a monthly book discussion with a science-based twist. In each episode, we discuss a novel that uses science to drive the story’s action, and dissect the plot device for scientific plausibility.
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We help medical device professionals deepen their knowledge of customers, the industry, and their role. Our main objective is to help you become expert in your current position, and through a better understanding of others within your company and the best practices in others in the industry, enable you to fast-track your career.
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Plot Device

Plot Device

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In a world where movies exist, three men dare to plot movies that don’t. Every episode of this podcast Matt Rea, Reg Wiebe, and Neale Barnholden turn pitches by listeners like you into full stories. Along the way? We all learn a little something. Then you hear a trailer!
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“There’s A Device For That!” showcases the unprecedented device-based solutions changing the world around us and bringing experiences we once didn’t think possible to life. In each episode, our host, Sudhir Reddy, chats with an industry leader driving cutting-edge technology, such as line-busting devices, AI-enabled doorbells, and next-generation connectivity solutions, to explore what kind of impact they’re making and what’s in store for the future. Join us to uncover the progressive ideas ...
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Beyond Devices Podcast

Jan Dawson and Aaron Miller

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The Beyond Devices podcast is brought to you by Jan Dawson and Aaron Miller. Jan is the author of the Beyond Devices blog, as well as the owner and Chief Analyst at Jackdaw Research, a research and advisory firm focused on the consumer electronics market. Aaron is a business school professor, but in a past life ran one of the most popular iMovie blogs and co-authored several books in the iMovie: the Missing Manual series with David Pogue, and remains an avid follower of all things Apple. Jan ...
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The Medical Devices Group is the medical device industry hub that connects you with experts cherry-picked among our 350,000 members. • MedicalDevicesGroup.net – 1,000+ archived discussions + resources • medgroup.biz/premium – direct access to medical device experts • medgroup.biz/10x – in-person events • medgroup.biz/linkedin – legacy group • medgroup.biz/podcast – this podcast • medgroup.biz/eavesdrop – sister podcast Medical device work saves and transform lives, so we make our recordings, ...
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How can new technology help you to play a new musical instrument? The E-Sense research programme is experimenting with novel augmentation devices to explore sensory, bodily and cognitive extension. In this interdisciplinary research, philosophy and art combine with various flavours of computing: ubiquitous; wearable; and physical. We take a look at how E-Sense's speculative philosophical research experiments, built on the 1960's work of Paul Bach-Y-Rita's minimal tactile vision sensory subst ...
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3Eye Technologies and their channel partners explore everything in the world of mobile tech - topics range from product deep dives with industry experts, to leadership and business strategy discussions, to how to go to market effectively in a world that is relying more and more on mobile communication.
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Their Own Devices

Marc Groman and David Reitman

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No matter how tech savvy you are, your kids likely have you beat. Digital natives see the world in a fundamentally different way than all previous generations. This makes 21st century parenting an unprecedented challenge. Join Marc Groman, an Obama White House tech and privacy adviser, and David Reitman, an adolescent medical doctor, for candid discussions and helpful tips about screen time, social media, sexting, privacy, online gaming, and other challenges facing parents today. Marc and Da ...
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Devices and Desires

Fr. Bryan Wandel, Fr. Andrew Thebeau, James Kibby

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We're taking a deeper dive into the culture we live in. We'll need three things: (1) An understanding of the culture we find ourselves in. (2) A sharp analysis of the cracks in the smooth, seemingly solid narrative that our culture tells us about what it means to live a good life. (3) A new imagination of what it looks like for the gospel of Christ to open up and thrive from within the cracks of our culture. This podcast comes from clergy and laypeople at Church of the Atonement in Buffalo, ...
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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. 🧪 With a fascinating career spanning drug development with GSK to addressing ESPN's water issues, RQM+ / Jordi Labs Senior Stu…
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Since EU MDR and IVDR launched, there is a phenomenon that raised which is the use of surveys to gather clinical data. So we wanted to share with you how to do this right and what you should be careful on. So listen to Cesare Magri from 4BetterDevices who will tell us more about surveys in the Medical Device field. Who is Cesare Magri? Cesare has a…
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Eine erste Einordnung der neuen EU-Verordnung mit Dr. Till Klein Anfang März 2024 hat die EU den AI Act, die Verordnung zu Produkten mit künstlicher Intelligenz, veröffentlicht. In dieser Podcast-Episode geht der AI-Act-Experte Dr. Till Klein im Gespräch mit Prof. Johner Fragen nach wie: Was ist das Ziel des AI Acts? Welche konkreten Anforderungen …
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Multiple streams of revenue are the future in our industry for reps AND surgeons. What if one of those streams was....YOU? Pitchsink is where ideas meet talent, so if you have a device idea you want commercialized, if you have a talent to serve our community, monetization could very well be in your future!! Steven Flutie has such an incredible stor…
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M West trade show in Anaheim, California, to discuss the pivotal Voluntary Improvement Program (VIP). This conversation sheds light on how the program, stemming from FDA’s Case for Quality initiative, utilizes the Capability Mat…
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In the latest episode of MedtechWOMEN Talks, Rebecca Whitney, SVP, Global Spine President, ZimVie dives deep into what it takes to bring innovative medical solutions to market in a large medtech OEM, weighing the benefits of internal product development against strategic external partnerships.​The episode shines a light on the diligent process behi…
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On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, expect to learn from Alan about how reliability engineering concepts can be used for single use combination products. Why infusion pumps are susceptible to recalls. Why people call Allen captain Allen Stevens. A…
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Dungeons and Devices is a podcast about role playing games, computer games, hardware, software and technology. We publish 30-60 minute episodes every second Thursday. Expect the first episodes to be published on 4th of April. Disclaimer: 'Dungeons and Devices' is an independent podcast created for entertainment and informational purposes. This podc…
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In this week’s DeviceTalks Weekly Podcast, Bridget C. Bagnato, worldwide president of specimen management at BD, gives us a glimpse of phlebotomy’s future – the BD MiniDraw, a blood testing system that can run a wide array of diagnostic tests on the blood drawn from a fingertip. How might this change how and where blood is drawn in the future.Thank…
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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. Our newest Excellence Spotlight interview is with Noel Keegan, a central figure in RQM+ clinical trial services. Noel is Sr. D…
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On this episode, I was joined by Former FDA Investigator and Managing Consultant of Practical Compliance Results, Vin Cafiso. Vin discusses: 01:35 Journey from Premed to FDA Investigator: VIN's Story 07:25 Understanding the Impact of QMSR on Industry 16:24 The FDA's Approach to Inspections and Compliance 27:45 The Shift Towards Quality Culture in F…
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The EU MDR and IVDR is a bit more demanding on Postmarketing Surveillance. In this episode we will explain to you from the eye of an auditor what they want to see and how you can avoid some mistakes that are always identified. Who is Steve Curran? Dr Steve Curran has over 20 years experience in the medical device industry both as an engineer and le…
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Hilfestellung für die FDA-Zulassung von Medizinprodukten Der US-Markt wird für europäische Hersteller immer attraktiver. Denn zum einen gelingt es den Herstellern, schneller und einfacher die regulatorischen Anforderungen zu erfüllen und ihre Produkte in den Markt zu bringen. Zum anderen ist der US-Markt sehr groß und teilweise homogener als der eu…
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In this episode of DeviceTalks Weekly Co-Hosts Tom Salemi and Chris Newmarker pay a visit to the Wizard, Joe Mullings of The Mullings Group, to get his take on the disruptive force that is Intuitive’s da Vinci 5. What does this mean to the surgical robotics competitors both big and small?Then Tom Salemi talks with Murali Srivathsa, CEO of Akura Med…
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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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. 🔬 Kaitlin Lerner is "that chemist" with a Gibbs free energy tattoo. As Director of Operations, she's also one of the most bril…
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On this episode I was joined by Naveen Aggarwal founder of Creative Analytic Solutions and host of "Let's talk risk". In this episode, Naveen walks through the big changes to risk management with the QMSR, and risk beyond safety. The episode covers the confusion surrounding the mandatory nature of risk management in particular and we spend the seco…
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In the latest episode of AbbottTalks, Abbott Cardiovascular's leaders, Christopher Piorkowski, MD, DVP and Chief Medical Officer of Electrophysiology, and Dan Kaiser, Divisional VP Product Development, Electrophysiology, delve into the vast landscape of electrophysiology and the comprehensive approach Abbott is taking towards atrial fibrillation (A…
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We sat down with the VP of Research at Cybellum, aka "Roman Explains" to learn from his vast experience in embedded device security research and get practical insights into how to use AI in product security, following the release of his new "Ask Roman" product feature for product security professionals.…
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The FDA announced the alignment of QMSR to the ISO 13485 standard. So now the question is: What does it change for me? Do you need to update your full QMS? Will you need to go through another audit or inspection? Is this really a revolution? Naveen Agarwal from Exceed will answer this question. So don’t miss this episode to know more about QMSR. Wh…
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In this episode of the DeviceTalks Weekly podcast, John Murphy, CEO of Virtual Incision, highlights the headline-grabbing surgical robotics start-up. Virtual Incision followed up a trip to the ISS for a nod from the FDA. What’s next? He talks to Editorial Director, Tom Salemi.But first Shriya Srinivasan, Ph.d, assistant professor at Harvard’s Schoo…
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This week's episode features Darren Adams. Darren joined the course as a GEO Scientist and has been hired medical device sales. Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevice…
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In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Gary Saner, a seasoned expert in medical device Unique Device Identification (UDI) and regulatory compliance. They embark on a comprehensive exploration of the ever-evolving landscape of UDI requirements, shedding light on crucial deadlines, common pitfalls, and…
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In this episode of Ortho Innovation Talks, Nitin Goyal, MD, chief science, technology and innovation officer at Zimmer Biomet (ZB) shares his journey from the OR to the medtech industry.Dr. Goyal oversees ZB’s global innovation, medical education, clinical affairs, and reimbursement strategy. He tells host Tom Salemi about his passion for building …
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On this episode I was joined by Mat Straton, Founder of Coalition Ltd. In this episode, Mat discusses: 01:02 Venturing into Combination Products 02:46 Andy's Journey into Healthcare Space 04:48 Challenges in Deep Brain Stimulation 08:55 The Impact of working with Andy Grove 10:42 The Struggle with Parkinson's Disease 13:20 The Speed of Product Deve…
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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_…
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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. Yesterday, we published a clip of RQM+ Senior Consultant Anastassia Young, MS discussing our recent conversation with the FDA …
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Are you navigating adverse event (AE) reporting in post-market clinical follow-up (PMCF) studies? In a recent discussion with the FDA, we've uncovered valuable insights into exemptions and variances for AE reporting that could significantly reduce your reporting burden. This collaboration between RQM+ and the FDA paves the way for a more efficient …
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How can participatory art show us a vision of the world we want to live in? How can the act of play connect us, and bind political and cultural movements together? How the heck does this relate to mushrooms and typewriters??? Tune in and find out the answers to these and other bizarre and beautiful questions.…
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In this episode of the DeviceTalks Weekly podcast, we meet the 13 finalists for the MedTech Color Pitch Competition, both general and pediatric categories.Editorial Director Tom Salemi and Managing Editor Kayleen Brown ask each entrepreneur about the problems they’re trying to solve and the solutions they’ve developed. Tom and Kayleen also intervie…
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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This show was recorded 22 February 2024. We encourage you to download the supplemental PDF content for 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. Th…
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On this episode, I do an active reading to begin to unpack the Quality Management System Regulations(QMSR) Final Rule that was issued by FDA in early February 2024. 0:00 Introduction 05:09 Initial Reactions to the idea of the QMSR 06:57 History of the Device cGMP's, QSR, and QMSR 11:52 What's changing in 21 CFR 820? 24:59 What's changing in 21 CFR …
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In this episode of MedtechWOMEN Talks, Christina Hawley, Sr. Director, of Clinical Operations at May Health helps to unravel the clinical trial process for medical devices, emphasizing the non-linear path from early feasibility to pivotal trials and post-market studies; and delves into the meticulous process of gaining FDA approval and even the nua…
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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. 🌌 Meet the supremely talented Song Seto, PhD, RAC in our latest Excellence Spotlight interview. Song is a Principal in our RA/…
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In January 29th, 2024, the EU Commission issued a Proposal that discuss mainly the shortage of Medical Devices, the EUDAMED availability and the IVDR transition periods. So apparently this is urgent and needed to avoid shortage. Let’s ask Erik Vollebregt what he thinks about it. Will this really help and when will this become a law as it is only a …
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Wer wann wofür bei Medizinprodukten haftet Die EU bereitet eine neue Produkthaftungsrichtlinie vor, die insbesondere Medizinproduktehersteller betrifft, explizit auch solche, deren Produkte Verfahren der künstlichen Intelligenz (KI) verwenden. Prof. Johner klärt im Gespräch mit dem auf Medizinprodukte und Produkthaftung spezialisierten Rechtsanwalt…
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In this episode of the DeviceTalks Weekly Podcast, Co-hosts Tom Salemi and Chris Newmarker interview Brad Estes, CEO of CytexOrtho, the winner of a pitch contest staged by AAOS. The company is developing implants that could serve as an alternative therapy to total hip replacement.In our main interview, Tom interviews David Wilson, CEO of InnovHeart…
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the world of medical device quality and reliability with expert guest Kevin Becker. They explore the nuanced challenges of ethical decision-making in the MedTech industry, the complexities of accelerated testing, and the continuous quest for quality improvement. …
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On this episode, I was joined by Andy Robertson, founder of CQE Academy. In this episode, Andy outlines 5 steps to becoming an exceptional quality engineer, such as seeking mentorship, taking on challenging assignments, and being a lifelong learner. Andy stresses the importance of honing soft skills for effective leadership and suggest stepping out…
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💬 Show NotesIn this tech-packed episode of The Device Casting Couch, Ryan and John return from a hiatus with a treasure trove of topics, from the groundbreaking to the downright concerning. They kick off with a deep dive into the promise of portable nuclear batteries, exploring BetaVolt Technologies' claim of a 50-year charge from a hand-held devic…
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Summary This discussion provides a high-level overview of the current state of artificial intelligence (AI) in in vitro diagnostics (IVDs). The conversation between Director of IVD Intelligence and Innovation, Margot Borgel, and Principal Regulatory Scientist, Bethany Chung, Ph.D., RAC, covers several aspects of AI in IVDs, including its use in dia…
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