Global Medical Device Podcast powered by Greenlight Guru

What’s involved in a systematic literature review for the EU MDR, and how should companies handle those steps?  In today’s episode, you’ll hear from Co-Founder and Operating Partner of CiteMed, Ethan Drower, on the topic of Systematic Literature Reviews for EU MDR Clinical Evaluation Reporting. In today’s conversation, we covered topics like where information for the literature review comes f...

What do engineers need to understand about manufacturing? How can you apply that knowledge to design controls? On today’s episode, our guest Tom Rish covers the topic of Design Controls. Tom is the Director of Guru Services at Greenlight Guru and a Product Development Engineer in Orthopedics. Listen as we talk about the differences between user needs and design inputs and the pitfalls companies ge...

Why do the same types of problems show up again and again in FDA medical device inspections? In today’s episode, Mike Drues joins the podcast to talk about the FDA's Fiscal Year Report for 2022 Inspections and discusses the most common problems found during these inspections. Recurring guest Mike Drues is the President of Vascular Sciences where he works to educate the industry and offers help to...

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 design verification and what is being tested by d...

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 Guru Edge. She has more than 15 years of experienc...

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 about them, what to do with them, and why it matter...

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 individuals and teams to fine-tune their quality conversatio...

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 the information in Part 1 of this discussion. He d...

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 Strategy, the FDA, and the history behind most of the...

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 Greenlight Guru. When it comes to implementing an e...

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 at Greenlight Guru and is a self-proclaimed steril...

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 Smith are both Medical Device Gurus and Greenlight...

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 in Reliability Engineering from the University of...

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 spent most of her career gathering and defining requ...

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 Claims Act, along with similar statutes. Jonathon...

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 and guide them through the various regulatory requi...

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 MedTech industry get safe and effective devices to...

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 their favorite episodes and throughlines of their...

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 regular guest Mike Drues. Mike is President of Vascular...

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 services to medical device, pharmaceutical, and biotech...

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 Stanford and Harvard-trained Physician-Scientist i...

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 Vascular Sciences, an education, training, and consulting...

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 company that offers many services to medical device, pha...

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 America. Listen to the episode to hear what Mark has...

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 than 30 years. He was on the team that built the e...