Những podcast Medical Device hay nhất (2023)

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Medical Device made Easy Podcast

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How to create a Proactive Postmarketing Surveillance? [EU MDR]

17h ago

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The EU MDR is requiring more transparency and the PMS has a lot to play in it. In this episode, we will explain to you a difference that is visible for PMS which is Proactive Postmarketing Surveillance. We will explain what they mean by that and how some digital tools can help you. Who is Marcus Emne? Marcus Emne is the CEO & founder of Hoodin, the…

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Medical Device Insights

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2023-06: Tools für das Risikomanagement 19:15

4d ago19:15

19:15

Was Hersteller von Medizinprodukten bei der Einführung von Risikomanagement-Tools beachten sollten Wenden Sie sich bei weiteren Fragen an Christian Rosenzweig Senden Sie eine E-Mail Prof. Dr. Christian Johner (via Kontaktformular) Webseite: https://www.johner-institut.de/blog/medizinische-informatik/it-sicherheit-im-gesundheitswesen/…

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Global Medical Device Podcast powered by Greenlight Guru

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V&V Activities from a Verification Engineer POV - How Hard Could It Be? 32:15

6d ago32:15

32:15

What’s the difference between design verification and validation, and why are these activities so important? Today’s guest is Niki Price. Niki is a Medical Device Guru with 15 years of experience in medical devices who worked in production, quality, product development, and project manager. Today she discusses questions like what is being tested by…

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Mastering Medical Device

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Training with Virtual Reality – Accelerating Confidence, Competence and Experience with Richard Vincent 1:00:10

14d ago1:00:10

1:00:10

Richard Vincent is CEO and Co-founder of FundamentalVR, a company that is focused on improving patient outcomes by revolutionizing medical training through virtual learning platforms. Richard is experienced in building international businesses and has a keen interest in seeking out opportunities to disrupt markets through development and adoption o…

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Combinate Podcast - Quality in Pharma and Medical Devices

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076 - GMP Training, Competence, Human Error and Mentorship with Joanna Gallant 28:16

6d ago28:16

28:16

On this episode, I was joined by Joanna Gallant of JGTA. Joanna walks through: Training programs at companies that had consent decrees The difference between good training and bad GMP training Competence in knowledge work Human Error Joanna Gallant is an experienced, solutions-driven Quality and training professional who has spent more than 30 year…

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Medical Device made Easy Podcast

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What you should know about Vigilance Reporting for Medical Devices?

8d ago

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Vigilance Reporting is a process you should have but don’t want to use. In fact not having any vigilance reporting is a sign that your product is doing well. But having one means that maybe you need to improve your device. So in this episode, we will explain to you what is Vigilance Reporting and how you should build it. We will explain EU reportin…

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Medical Device Insights

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2023-05: Letzter Ausweg Sonderzulassungen 11:32

11d ago11:32

11:32

Wann Hersteller Sonderzulassungen, Sondergenehmigungen und den MDR Artikel 97 nutzen sollten Wenden Sie sich bei weiteren Fragen an Luca Salvatore Senden Sie eine E-Mail Prof. Dr. Christian Johner (via Kontaktformular) Webseite: https://www.johner-institut.de/blog/regulatory-affairs/sonderzulassungen/…

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Global Medical Device Podcast powered by Greenlight Guru

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Understanding the 'Compliance Manager' Role 21:15

13d ago21:15

21:15

What are the challenges in managing compliance and the difference between compliance and quality management positions? You’ll learn more by listening to today’s guest. In today’s episode, we spoke with Maryann Mitchell on the topic of Compliance Management. Maryann Mitchell is a Solutions Engineer at Greenlight Guru and is part of what we call our …

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Combinate Podcast - Quality in Pharma and Medical Devices

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075 - Shortages, Pricing, Mastering New Skills, and Building Deep Understanding with Ben Locwin 33:51

13d ago33:51

33:51

On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: - FDA Drug Shortages Report - Drug Shortages and Drug Pricing - How he approaches Mastering new skill sets and building deep understanding in new areas Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality a…

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Medical Device made Easy Podcast

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Medical Device News: March 2023 Regulatory Update

14d ago

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Here is your Regulatory Update for the month of March 2023. Check all the links on Medboard Platform: https://www.medboard.com/reports/easy-medical-device-regulatory-update/2023/march/ – EU MDR 2017/745 extension has been voted: https://www.raps.org/news-and-articles/news-articles/2023/2/europeanparliament-votes-to-extend-mdr-transition -UK Impact …

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Medical Device Insights

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2023-04: IT-Sicherheit: Erwartungen der Benannte Stellen 14:10

15d ago14:10

14:10

Wie rasch sich die Erwartungshaltung zur IT-Security geändert hat Wenden Sie sich bei weiteren Fragen an Christian Rosenzweig Senden Sie eine E-Mail Prof. Dr. Christian Johner (via Kontaktformular) Webseite: https://www.johner-institut.de/blog/medizinische-informatik/it-sicherheit-im-gesundheitswesen/…

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Global Medical Device Podcast powered by Greenlight Guru

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DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact 27:53

20d ago27:53

27:53

DHF, DMR, and DHR are easy to mix up when you’re just using the abbreviations – they sound a lot alike! And they are connected. But it’s important to understand the differences between them as well as how they interact with each other. Medical Device Guru Laura Court joins the podcast today to discuss these three documents – what you need to know a…

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Combinate Podcast - Quality in Pharma and Medical Devices

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074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman 28:19

20d ago28:19

28:19

On this episode, I was joined by Christiana Hoffman, Executive Consultant & Business Development Manager at anteris medical GmbH. Christiana walks through: - Article 117 requirements for Combination Products in EU - Notified Body Opinions, Timelines, and Interactions\ -Reporting for Combination and when does Eudamed Apply Christiana is a medical de…

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Medical Device Insights

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2023-03: Änderung der MDR-Übergangsbestimmungen 26:34

22d ago26:34

26:34

Die neuen Übergangsbestimmungen, eine komplexe Materie Wenden Sie sich bei weiteren Fragen an Luca Salvatore (Senden Sie eine E-Mail ) Prof. Dr. Christian Johner (via Kontaktformular) Webseiten: Übergangsfristen der MDR Definition des Begriffs InverkehrbringungBởi Luca Salvatore, Prof. Dr. Christian Johner

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Medical Device made Easy Podcast

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Prepare your transition from Class I to Class Ir

22d ago

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The EU MDR is planning to be really challenging for Class I reusable Surgical Instruments as they will need to move to Class Ir. In this Episode, Tautvydas from Test Labs will explain to us what is expected from Medical Device Manufacturers. What they should prepare for being compliant with the new regulation? Who is Tautvydas Karitonas? Tautvydas …

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Global Medical Device Podcast powered by Greenlight Guru

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How Communication Affects the Outcomes of Quality Activities 48:16

27d ago48:16

48:16

Why do quality professionals struggle with clear communication in writing? What’s the problem with jargon? These are some of the questions explored in today’s podcast. Joining the show this episode is Lesley Worthington. Lesley has 20 years of quality and regulatory experience in medical devices, and she uses that experience to work with individual…

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Combinate Podcast - Quality in Pharma and Medical Devices

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073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal 19:05

27d ago19:05

19:05

On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal of Creative Analytics Solutions and ExceedQM. Naveen discusses: The Anatomy of a Hazard Hazard Source(HS), Initiating Mechanisms (IM) and Target-Threat Outcome (TTO) Clifton Ericcson How concepts/tools like these fit into the ISO14971 and ISO TR 2497…

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Mastering Medical Device

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Building a High Impact Customer Education Program with Lori Harada 54:36

28d ago54:36

54:36

Lori Harada is Senior Manager of Commercial Technical Excellence at Terumo Blood and Cell Technologies. Starting out as a nurse, Lori found that education was her passion and she’s been involved in it ever since. In this episode she shares the importance of education, what types of people are drawn to it and how to prepare them for success, conside…

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Medical Device Insights

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2022-14: Die drei Hürden, an denen die IVD-Herstelller scheitern 16:13

29d ago16:13

16:13

Vom Suchen der Benannten Stelle bis zum IVDR-Zertifikat Wenden Sie sich bei weiteren Fragen an Andreas Kalchschmid-Lehmann (Senden Sie eine E-Mail ) Prof. Dr. Christian Johner (via Kontaktformular) Webseite: IVDR Readiness-CheckBởi Andreas Kalchschmid-Lehmann, Prof. Dr. Christian Johner

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Medical Device made Easy Podcast

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SaMD international reach – What to consider?

29d ago

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We are in a global world, so normally what is good for the EU can be also good for other countries. But here the only barrier is local law. This is mainly what we will discuss on this Podcast. We will use the example of SaMD or Software as a Medical device for it and share with you the experience that we have but this is applicable to nearly all me…

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Global Medical Device Podcast powered by Greenlight Guru

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Part 2: The Theranos Loophole & Lab Developed Tests 43:16

1M ago43:16

43:16

In a continuation of the previous episode, Mike Drues joins the podcast to further discuss LDTs, IVDs, and how those related to the ongoing Theranos situation. Mike is the president of Vascular Sciences, has a Ph.D. in biomedical engineering, and has extensive experience with Regulatory Strategy. In today’s episode, he begins by reviewing some of t…

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Combinate Podcast - Quality in Pharma and Medical Devices

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072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa 53:56

1M ago53:56

53:56

On this episode, I was joined by Dan Formosa, legendary designer and founder of ThinkActHuman. On this episode, Dan walks through:- Eliminating the need for instruction through good design- Drug/Device Combination Product Usability- Collaborating with OXO on a Pre-Filled Syringe- Creating the worlds first toothbrush designed for children- Usability…

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Medical Device made Easy Podcast

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Biological Evaluation: Top Big mistakes

1M ago

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In this podcast episode, Laura and Paul will share with us the big mistakes done by some Medical Device manufacturers when they are considering Biological Evaluation for their products. You may need to take some notes as Laura and Paul are really knowledgeable on this process as they are onboarding some of their customers at ICARE Group and they wi…

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Global Medical Device Podcast powered by Greenlight Guru

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Part 1: The Theranos Loophole & Lab Developed Tests 37:33

1M ago37:33

37:33

What’s the difference between an LDT and an IVD and what does that have to do with the Theranos case? In this episode, we dig deep into this topic. Mike Drues, a frequent returning guest to the Global Medical Device podcast is the president of Vascular Sciences. He has a Ph.D. in biomedical engineering and extensive experience with Regulatory Strat…

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Combinate Podcast - Quality in Pharma and Medical Devices

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071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols 59:19

1M ago59:19

59:19

On this episode, I was joined by Etienne Nichols, who is a Medical Device Guru and Host of the Global Medical Device Podcast. Etienne Discusses: -Translating lessons from the Steel Industry into MedTech -His experience on combination products - What is the most important quality system element? Etienne Nichols is a Medical Device Guru and Mechanica…

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Medical Device Insights

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2023-02: Weshalb Tierversuche fast immer unnötig sind 14:14

1M ago14:14

14:14

Biokompatibilität von Medizinprodukten auch ohne Tierversuche nachweisen Wenden Sie sich bei weiteren Fragen an Sarah Gruber (Senden Sie eine E-Mail) Prof. Dr. Christian Johner (via Kontaktformular)Bởi Sarah Gruber , Prof. Dr. Christian Johner

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Medical Device made Easy Podcast

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Medical Device News: February 2023 Regulatory Update

1M ago

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Here is your Regulatory Update for the month of February 2023. Check all the links below – EU amendment of the EU MDR and IVDR: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en – Proposal for extension consultation: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Medical-devices-transition-period…

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Global Medical Device Podcast powered by Greenlight Guru

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Implementing an eQMS after Switching from Paper 31:01

2M ago31:01

31:01

What’s involved in switching from a paper-based QMS to an eQMS? What kinds of difficulties do companies experience when making that change? Today’s guest will explain her experiences with making that switch. In today’s episode, you’ll hear a conversation with Kendyl Williams on the topic of Implementing an eQMS. Kendyl is a Medical Device Guru at G…

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Combinate Podcast - Quality in Pharma and Medical Devices

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070 - The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen 50:31

2M ago50:31

50:31

On this episode, I was joined by Paul Jansen, who's a drug/device consultant, advisor, and board member in the combination products space. Paul discusses: - His experience leading combination product focused organizations at Eli Lilly & Sanofi - The first autoinjectors and the history surrounding ISO 11608 - Managing a product line, owning P&L and …

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Mastering Medical Device

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Working With Health Plans to Deliver Value with David Smith 56:42

2M ago56:42

56:42

David Smith is President and Chief Revenue Officer of Ilumivu, a company that is taking data from common smartwatches and using AI and machine learning to gain insights into the early detection of certain medical conditions. In this episode he shares how health plans are evolving, how physician perceptions of the plans are changing, how well care a…

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Medical Device made Easy Podcast

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How to do Post-Marketing Surveillance in the US (vs EU)?

2M ago

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We talk a lot about Post Marketing Surveillance in Europe with EU MDR, MDCG, and all the rules to follow. But when you hear about how this is done in the US you will see that this is really completely different. For that, I have invited Robert Packard to help us understand the rules behind it and also talk about an IT application that can help you …

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Global Medical Device Podcast powered by Greenlight Guru

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Essentials of Sterilization for Med Device Professionals 36:57

2M ago36:57

36:57

What tools do sterilization engineers need the most? What’s the difference between sterilization modalities? Those are some of the points that our guest will be talking about in today’s conversation. Laura Maher previously appeared on the podcast to talk about UDI, and now she’s here to talk more about sterilization. Laura is a Medical Device Guru …

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Combinate Podcast - Quality in Pharma and Medical Devices

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069 - EU MDR Extension with Michelle Lott 17:45

2M ago17:45

17:45

On this episode, Michelle Lott discusses the EU MDR Extension that was formalized by the European Commission and what it means for industry. If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Regulatory Grief" and checkout Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today.Michelle Lott is the founder and…

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Medical Device Insights

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2023-01: Krankenbetten für Ghana 18:10

2M ago18:10

18:10

Helfen Sie mit Ihrer Spende, die Krankenversorgung zu verbessern! Bitte helfen Sie mit einer Spende über diese Webseite! Wenden Sie sich bei weiteren Fragen an Thomas Erkert thomas.erkert@t-online.deBởi Thomas Erkert, Prof. Dr. Christian Johner

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Medical Device made Easy Podcast

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How to evaluate Benefit-Risk Ratio for Medical Devices?

2M ago

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The evaluation of the Risk-Benefit ratio is key for Risk Management Files per ISO 14971 or when you build your Clinical Evaluation Report or when you need to define the risk of using a particular technology against another. I mean that risk-benefit evaluation is mainly what helps us to decide that our product is safe and performant. So on this epis…

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Global Medical Device Podcast powered by Greenlight Guru

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UDI: 101 33:23

2M ago33:23

33:23

What is UDI? Why is it important, and what does the implementation of UDI look like? If you don’t know, you probably should start learning, and in today’s episode, you’ll hear from two guests with UDI experience. You’ll learn a lot about UDI and learn where to find some fantastic resources that can increase your knowledge. Laura Maher and Brittani …

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Global Medical Device Podcast powered by Greenlight Guru

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Quality Myths and Lessons Learned 45:47

2M ago45:47

45:47

What words cause the most problems in MedTech, and what situations should you be ready to handle when you work in Quality? Today’s guest wrote about these issues in his book and will be talking more about them in today’s interview. Kevin Becker has a bachelor’s degree in Mechanical Engineering from the University of Minnesota and a Master's degree …

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Combinate Podcast - Quality in Pharma and Medical Devices

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068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge 47:19

2M ago47:19

47:19

On this episode I was joined by David Rutledge, author of Mythical Medical and CEO of Global Strategic Solutions. David Discusses: · His book Mythical Medical · Benefit (As part of Benefit/Risk) · PRRC Role and EU MDR David R Rutledge, Pharm.D., FCCP, FAHA is a results-oriented consultant for clinical evaluation and investigation, clinical risk man…

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Medical Device made Easy Podcast

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Breaking News: EU MDR Extension Proposal is out for consultation

2M ago

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Finally, a proposal is now available, and we wanted to discuss it and identify if there are any surprises. Erik Vollebregt from Axon Lawyer is helping us understand all this. This proposal is also under consultation until January 18th, 2023. So don’t miss that as this is tomorrow for those seeing the episode today. To conclude, this is only a propo…

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Global Medical Device Podcast powered by Greenlight Guru

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Determining User Needs for Your Medical Device 42:18

2M ago42:18

42:18

What is a user need, and when should you start working on them? How can you figure out what the user truly needs – and by the way, do you know who the user is? These are some of the topics you’ll hear about in today’s episode. Jesseca Lyons joins the podcast today to share more information about user needs. Jesseca is a Mechanical Engineer who’s sp…

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Global Medical Device Podcast powered by Greenlight Guru

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Fraud in the Healthcare Industry & the Role of Whistleblowers 52:43

2M ago52:43

52:43

What does the False Claims Act do, and when does it involve medical devices? In today’s episode, you’ll hear from Jonathon Tycko, an attorney who represents whistleblowers. Jonathan is a founding Partner with Tycko & Zavareei LLP, a law firm with offices in Washington, D.C., and California. His practice represents whistleblowers under the False Cla…

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Combinate Podcast - Quality in Pharma and Medical Devices

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067 - mRNA, Flu Vaccines, Good Presentations, and Non-Linear Career Paths with Jane M. True 47:34

2M ago47:34

47:34

On this episode I was joined by Jane M. True, VP, mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead at Pfizer. • Following career tracks, "experience", and non-linear career progression • Practical tips for presenting and nerves • Storyboarding and the Minto Principle • How Flu Vaccines are developed globally • mRNA and what i…

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Medical Device made Easy Podcast

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How to improve the relationship between QA – RA and Marketing?

2M ago

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In the Medical Device world, you need to work as a team. Sometimes it is really difficult and we will discuss that with Omar M. Khateeb. The relationship between Marketing and QA RA is one of those examples. One is willing to sell creatively and the other is trying to avoid any legal issues. So how should this be balanced? Don’t miss this episode t…

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Global Medical Device Podcast powered by Greenlight Guru

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Auditing the Auditor 41:05

2M ago41:05

41:05

For some people, audits are terrifying. But today’s guest says you need to learn to love the audit process, and she shares information that can help you do that. Sara Adams is a Medical Device Guru at Greenlight Guru. Medical Device Gurus are part of Greenlight Guru’s “Guru Edge.” Medical Device Guru’s help customers onboard to their new software a…

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Global Medical Device Podcast powered by Greenlight Guru

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What is MedTech Lifecycle Excellence? 45:09

2M ago45:09

45:09

Why is the state of MedTech culture and tools the way it is? How should the industry be thinking about moving away from generic compliance and toward MedTech Lifecycle Excellence? Jon Bergsteinsson, co-founder of SMART-TRIAL by Greenlight Guru, is a MedTech professional and clinical affairs expert. Jon is also involved in educating and helping the …

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Combinate Podcast - Quality in Pharma and Medical Devices

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066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio 55:34

3M ago55:34

55:34

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions. Fran and I discuss: Her career at West Pharmaceuticals starting in the lab and retiring as Chief Scientific Officer Becoming experienced in Marketing, QA and RA What the C-Suit expects from individual contributors How to recognize opp…

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Medical Device made Easy Podcast

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Medical Device News: January 2023 Regulatory Update

3M ago

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EU MDR extension Implementation of the Medical Device Regulation https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf Provisional Agenda 9th Meeting – Implementation of the Medical Device Regulation (MDR) https://data.consilium.europa.eu/doc/document/ST-15453-2022-INIT/en/pdf Implementation of the Medical Device Regulation (MDR):…

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Global Medical Device Podcast powered by Greenlight Guru

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The Best of Jon & Mike Through the Years 50:39

3M ago50:39

50:39

Today’s episode is a little different than usual. This will be Jon Speer’s last podcast for Greenlight Guru, as he’ll be moving on to future ventures as of December 31st. In honor of many podcast episodes featuring Jon and Mike Drues, this episode is a tribute to some of the best episode topics that the two of them have tackled. They review some of…

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Combinate Podcast - Quality in Pharma and Medical Devices

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065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh 29:03

3M ago29:03

29:03

This solo episode walks through 8 of the quality lessons I learned by losing 100lbs over the last 10 years. They are: Change takes time Change starts from a small decision More pain does not equal more pain/Quality is free. Prevention is part of performance Environment is as critical as habit Managing constraint changes as the quality journey evolv…

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Medical Device made Easy Podcast

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Grow your LinkedIn Profile with Karandeep Badwal

3M ago

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Getting some visibility is the key to growing your LinkedIn Profile. And on this episode, we tell you how to be more visible or help build a community. As always you cannot do that alone so we propose you a challenge at the end. Who is Karandeep Badwal? Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices …

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