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Global Medical Device Podcast powered by Greenlight Guru

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Global Medical Device Podcast powered by Greenlight Guru

Greenlight Guru + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory

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The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
 
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 ...
 
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.
 
Welcome to the Combinate Podcast, a show that brings you closer to what makes MedTech and BioTech incredible, the people behind the scenes. I’ve worked on product development teams in the Medical Device and Pharmaceutical industries for the last decade of my life and my aim with this podcast is to understand. Each week, I sit down with leaders to examine the roadblocks in development and access we face and bring to light concepts and tools from our industry and others that will help address ...
 
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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show series
 
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…
 
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…
 
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…
 
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 …
 
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 …
 
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…
 
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…
 
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 …
 
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 …
 
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…
 
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…
 
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…
 
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…
 
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…
 
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…
 
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…
 
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 …
 
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…
 
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):…
 
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…
 
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…
 
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 …
 
What are the proposed CRDH guidelines for the 2023 fiscal year, and why do they matter? How should you be thinking about them? Today’s episode covers the newly-released guidelines and addresses important questions about these guidelines specifically and about the practice of releasing these guidelines in general. Today’s conversation is with regula…
 
On this episode, I was joined again by Skip Creveling. During the last episode, Skip walked through Design for Six Sigma(DFSS), and finding/measuring what's important(critical parameters and tolerancing). In this episode, he discusses: Design and Development processes in Pharma and MedTech How DFSS can be integrated into lifecycle management Design…
 
On December 9th, 2022, the EU Commission made a proposal to extend the transition period of the EU MDR 2017/745. But some people think this is already done which is not the case. There was also at the exact moment the publication of the MDCG 2022-18 on Article 97 used to continue placing devices on the market. To clarify all that I have invited Eri…
 
EUAs were less known before COVID than they are now. Between COVID and now Monkeypox, what has been learned about EUA, and where is it going as we move forward? Those are important aspects of today’s discussion with guest, Mike Drues. Mike Drues is President of Vascular Sciences, an education, training, and consulting company that offers many servi…
 
On this episode, I was joined by Niedre Heckman, MPH, PhD, FRAPS, Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda.Niedre discusses:- Challenges with global regulatory strategies for combination products- Impact of regulatory strategies on patients and product adoption- Becoming an FRAPS, and building wi…
 
Dr. Laura Cazier is a Board Certified emergency medicine physician who is also helping other doctors deal with burnout and other challenges through life skills coaching. She co-founded The Whole Physician with two other board-certified ED doctors, providing mindset and wellness coaching for physicians, by physicians. In this episode Dr. Cazier shar…
 
Imagine that you have a question to ask the EU Commission, your Notified Body, or any association about being a PRRC. Then this is the episode to listen to. During the Team-PRRC event on November 3 and 4 2022, I was able to record some of the sessions and propose them to you know. Here are the people that were on the panel: Bassil Akra, Board Membe…
 
What kinds of possibilities exist in the future for healthcare? How can medical devices reach across different fields of medicine and provide a holistic patient experience in collaboration with each other? These are some of the ideas you’ll hear about in today’s conversation with Daniel Kraft about the future of healthcare. Daniel Kraft is a Stanfo…
 
I love talking to fellow podcasters and on this episode, I was joined by Dr. Stefan Walzer, the CEO of MArS Market Access & Pricing Strategy. Stefan discusses: Discounts, Rebates, and how Co-Payment is different in Europe How data is presented to payers in Europe and European Reimbursement Germany/AMNOG Process Negotiation Dr. Stefan Walzer is a he…
 
Ohad Arazi is President & CEO of Clarius, a company that provides a high-definition wireless ultrasound system that includes AI to help reduce the complexity of ultrasound. In this episode he shares about his time in the Israeli military and the surprising environment that encourages entrepreneurship, what you can learn while working in large and s…
 
HOT TOPICS Europe Common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 https://webgate.ec.europa.eu/regdel/#/implementingActs/7377?lang=en https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R2346 Reclassification of groups of certain active products without …
 
How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a device is classed? This is the focus of today’s episode with recurring guest Mike Drues, in a conversation with host Jon Speer, founder of Greenlight Guru. Mike is President of Vascula…
 
On this episode, I was joined by Skip Creveling, President and Founder of PDSS Inc. Skip walks through: Learning from Genichi Taguchi and Stuart Pugh The 7 Steps to Robust Design Design for Six Sigma(DFSS) Six Sigma in Marketing Tolerancing and Critical Parameters Clyde "Skip" Creveling is the President & Founder of PDSS Inc. Skip has led the DFSS …
 
David Albert is a physician, inventor, and serial entrepreneur. He is the Founder and Chief Medical Officer of Alivecor, the leading company in personal ECG technology. He has founded 5 companies, and sold two – one to Arrhythmia Research Technology and one to GE which he joined as Chief Scientist of GE Cardiology. David has 32 issued US patents an…
 
Sterilization for medical devices is a critical topic. Now when you are developing your Medical Device, you should start by asking which sterilization process you should follow for your devices because this will lead to the question of which material you should use to build your device… So to help us have a clear understanding of how Sterilization …
 
What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike Drues, discusses as he begins his conversation with host John Speer, founder of Greenlight Guru. Mike is President of Vascular Sciences, an education, training, and consulting compan…
 
Elena Kyria, CEO of Elemed joins the podcast and discusses:- Why People stay in roles and why they leave-Starting Elemed-The trusted advisory role that recruiters play-Community work on EU MDR and RAPSElena Kyria is an award-winning talent acquisition specialist in the Medtech industry. She is the CEO of Elemed and in charge of executive placements…
 
Risk Management is a discipline of its own within the Medical Device field. In ISO 13485, EU MDR 2017/745, IVDR 2017/746, FDA QSR, MDSAP… All of them talk about Risk Management. You should manage your risks. But why is this so important or even critical? This is what we will discuss with Kailash Kalidoss who is a Medical Device Engineer and also a …
 
What are ISO 9001 and ISO 27001? Once you have them, what can you do with them? These are the questions you’ll hear Mark Alpert answer in today’s episode. Mark Alpert is the Director of Quality at Greenlight Guru and has a background working for a Notified Body, and was most recently the Vice President of Business Assurance Division for TUV SUD Ame…
 
On this episode, I was joined by Ethan Drower, of Citemed. Ethan is a prolem-driven, software engineer and fellow Chicagoan who's focused on making literature review for EU MDR Clinical Evaluation Reports(CER) more efficient, traceable and robust. Ethan and I discuss: - A problem-driven career - Challenges with EU MDR Clinical Evaluation Reports(CE…
 
You maybe ask yourself how to get to distribute your Medical Device in the US? Then listen to the story of MysteryVibe with their devices. He will answer questions such as: – Why the US market and not the EU? – What was the interaction with consultants for the Quality and Regulatory aspects? – How is it to work with a Quality Management System? – H…
 
What’s accelerated the growth of online healthcare device sales, and what’s the future of regulation regarding selling used medical devices? In today’s episode, we spoke with Scott Carson on the future of buying and selling used medical devices. Scott has been in healthcare marketing, business development, sales, and management experience for more …
 
On this episode, I was joined again by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss: - PMSR and Risk Management - Patient Safety, Pharmacovigilance, Medical Affairs, Clinical Affairs in Medical Device and Pharma companies. - PMSR Regulatory Landscape Globally (Outside of the US) D…
 
In this episode, Cesare Magri from 4BetterDevices will explain to us why medical device manufacturers are making mistakes when they try to gather Clinical Evidence for their Software or IVD devices. You may have made also this mistake and it would be better to know that before your Notified Body rejects your application. You will understand how to …
 
The importance of cervical cancer screening in the U.S.Why is cervical screening so important in the U.S. and globally? And how has the pandemic affected that screening? Today’s episode features Chris Beddard, VP of US Marketing at BD. She joins the podcast today to discuss a product she and her team have been working on to improve the lives of wom…
 
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