Best RAQA Today Podcast Podcasts (2025)

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Inside the FDA: Pre-Subs, Wellness Devices & Cybersecurity Challenges 46:42

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22h ago46:42

46:42

In this episode, Michelle and guests take a deep dive into what’s really happening inside the FDA in 2025. From pre-submission strategies to the blurred line between wellness and medical devices, this discussion uncovers the latest regulatory trends shaping medtech. What you’ll learn in this episode: How to structure effective FDA pre-submissions (…

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Rise of the Regulatory Rebel 39:46

16h ago39:46

39:46

In the Season 1 finale, Michelle and Ti challenge the traditional view of regulatory affairs as the “business prevention department.” Instead, they reframe regulators as strategic partners and proactive innovators who can drive compliance and competitive advantage. From shocking stories of last-minute compliance scrambles to major recalls that resh…

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FDA 101: Audits, Classification Rules and EU MDR 27:51

9d ago27:51

27:51

In this episode of Device and Conquer, we unpack the differences between the FDA’s inspection style and the EU’s notified body-driven approach. From classification rules and audit methodologies (QSR, ISO 13485, MDSAP) to unannounced FDA inspections versus Europe’s annual surveillance audits, we dig into what medical device companies really need to …

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FDA 101: Understanding the OTHER Regulatory Giant 23:44

16d ago23:44

23:44

Who really is the FDA and how do they regulate medical devices? In this episode of Device and Conquer, we break down the U.S. Food and Drug Administration’s role—from product classification and product codes to substantial equivalence, 510(k)s, de novos, and PMAs. Learn how the FDA oversees everything from tongue depressors to pacemakers and why re…

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EU MDR - More then Just Red Tape? 33:53

21d ago33:53

33:53

In this episode of the NEW Device and Conquer podcast, Michelle and co-host Ti dive deep into the European Union’s Medical Device Regulation (MDR) — and explain why it’s much more than just red tape. The conversation begins with a fun recap of their “Real or Ridiculous” game, where they fact-check quirky device ideas like smart spoons for Parkinson…

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Wait, What - There are Rules?!?!? 16:50

1M ago16:50

16:50

What exactly is a medical device — and why does it matter if it’s regulated? In this premiere episode of Device and Conquer, hosts Michelle Lott and Ti Benson unpack the surprisingly broad world of medical devices, from smart thermometers and glucose meters to fertility tech and connected implants. You’ll hear: The difference between drugs and devi…

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QMSR, AI Reviewers and the Value of a Good FDA and Internal Audit 36:30

3M ago36:30

36:30

In this episode Michelle and Adam Foresman from Ryden Solutions do a deep dive into right-sizing quality systems, lean regulatory practices, and the evolving landscape of AI-driven compliance tools in medtech. They reflect on personal pain points that sparked their ventures, swap audit war stories, and share insights into regulatory shifts like QMS…

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What You Need to Know About FDA Breakthrough Devices 23:03

3M ago23:03

23:03

The FDA Breakthrough Device Program offers a expedited path to market for medical devices that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. It allows for prioritized review and enhanced communication with the FDA to help bring innovative devices to market more quickly, but it's not for ev…

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Medical Device Product Development: From Concept to Commercialization 48:47

7M ago48:47

48:47

Did you know that 60% of startups cannot survive beyond five years, and 75% will ultimately fail?These failures frequently stem from late regulatory involvement, underestimation of remaining development work, and the compounding effect of early oversights. To mitigate these risks, a structured approach is essential, emphasizing early and continuous…

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EU Hot Takes: MDD vs MDR featuring Etienne Nichols and Karandeep Singh Badwal 45:12

8M ago45:12

45:12

Podcast of a July 2024 webinar event presented by Etienne Nichols and Greenlight Guru and featuring Karandeep Singh BadwalThe MDR is a comprehensive regulation that aims to improve patient safety and quality in the European Union, replacing the Medical Device Directive (MDD) and introducing more stringent requirements for manufacturers.LinkedIn: ht…

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Biocompatibility for MedTech Professionals 52:21

10M ago52:21

52:21

Everything you need to know about biocompatibility - in one podcast.From a webinar hosted by MedTech Leading Voice and featuring Michelle and Marina Daineko from Intrinsic Medical Group.LinkedIn: https://www.linkedin.com/in/michellelottraqaWebsite: https://leanraqa.com/YouTube: https://www.youtube.com/@leanRAQAInstagram: https://www.instagram.com/l…

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CE Certification vs FDA Submission Strategy: Which is Right for You? 49:45

12M ago49:45

49:45

Which market is best for your product - the EU or the US?The answer is not always straightforward, but Ronald Boumans, Nika Mendelev and I did our level best to answer your questions in this Master Class presentation.Michelle leads off with a review of FDA strategies and pathways.15:34 - Ronald dives into the particulars of MDR and dealing with not…

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ASCA, CLAP, Fraudulent Biocompatibility Data and You 30:07

1y ago30:07

30:07

Biocompatibility testing is hot right now, in part because of the sharp increase in the number of FDA submissions containing fraudulent data. Some unethical third-party testing labs are sending their clients data mined from old 510(k) submissions - and passing it off as fresh data.So what's a medical device manufacturer to do? That was the topic of…

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A Conversation with Vistatec's Life Science In-Focus Podcast 21:22

1+ y ago21:22

21:22

The good folks at Vistatec invited me to participate in their Life Science In-Focus podcast last month, where host Karen Tkaczyk and I chatted about the intricacies of regulatory affairs within the life sciences.We also discussed just how I ended up in the field, and the many challenges companies face when choosing regulatory pathways in the United…

1
eSTAR 5.0 - What You Must Know 32:58

1+ y ago32:58

32:58

This is not last year's eSTAR - a LOT has changed, and there are things you need to know before you try to submit your 510k. In this episode, we'll guide you through the intricacies of the latest eSTAR 5.0 platform, crucial for those of you planning a 510k or PMA submission.We'll review the eSTAR 5.0 platform and what you need to know to use it eff…

1
The Benefits of 3rd Party FDA Reviewers 37:06

1+ y ago37:06

37:06

Why would you use a 3rd party reviewer for your submission? How does a 3rd party reviewer function? How is it different from working with the FDA?I sat down with my good friend Shawnnah Monterrey from Beanstock Ventures to answer all your pressing questions about using 3rd party reviewers.LinkedIn: https://www.linkedin.com/in/michellelottraqaWebsit…

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eSTAR 5.0 Q+A with Patrick Axtell from the FDA 33:52

1+ y ago33:52

33:52

Question, questions, everyone has questions about eSTAR 5.0, so I sat down with the FDA's Patrick Axtell to answer the most pressing ones I've received.From file size to eSTAR type to biocompatibility - we cover it all.By Michelle Lott

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Fractional or Full Time Quality Support: Which is Right for You? 22:49

1+ y ago22:49

22:49

When is it better for a medtech startup to hire a fractional quality professional, and when is it time to hire full-time? This is not necessarily an easy question to answer, and there can be a lot of factors impacting the decision. In this joint podcast with Mitch Robbins, we discuss the challenges and opportunities of today's topsy-turvy QA hiring…

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Medical Devices, Cloud Computing and Cybersecurity with Randy Horton 27:56

2y ago27:56

27:56

As medical devices become more connected, concerns about security increase, leaving manufacturers - and regulatory staff - uncertain as to the best path forward. Listen in as Michelle and guest Randy Horton discuss industry needs and what the FDA plans to do to ensure the safety of connected and AI-driven devices.LinkedIn: https://www.linkedin.com/…

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The Business Benefits of Quality 12:12

2y ago12:12

12:12

Many manufacturers see quality as a necessary evil, a box to be checked just to placate the FDA on the way to market launch. But it can be SO much more.In this episode, Ti Benson and I discuss how quality can actually be a business benefit and not simply something to be endured.LinkedIn: https://www.linkedin.com/in/michellelottraqaWebsite: https://…

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The Joy of Document Control 15:29

2y ago15:29

15:29

You may think document control is boring, but wait until you hear these stories:Red-lined post-it notes. Uncontrolled copies passed around during inspections. Master files stored on a desktop instead of in the eQMS system. Secret file cabinets in locked closets full of uncontrolled, red-lined specifications documents.Oh, the joy of document control…

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Make Quality Make $en$e: Management's Role in Quality 37:27

2y ago37:27

37:27

The best leaders know that quality is much more than a box to be checked, or a necessary evil to be endured along the road to FDA (or MDR) approval.This is the third in a series of conversations talking about quality and how it can actually benefit a company, and even give you an advantage over your competition.LinkedIn: https://www.linkedin.com/in…

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MDR By The Numbers: Leveraging New Data for Implementation Planning 1:18:00

2+ y ago1:18:00

1:18:00

MDR has been puzzling me for a few years now, and it's getting worse, not better. In this webinar hosted by Greenlight Guru, we look at the data gathered from recent MDCG guidance documents, industry and notified body surveys, and personal interviews with stakeholders (including notified bodies) who shared their first-hand experiences with implemen…

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EUDAMED Update: January 2023 51:47

2+ y ago51:47

51:47

Upload to EUDAMED is a requirement of MDR, but adoption has been slower than anticipated. Manufacturers are reluctant to invest in the time required to upload their product catalog, and the platform itself has been plagued with issues. Listen in as Richard Houlihan lifts the curtain on why industry has been reluctant to embrace EUDAMED and what the…

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From the Front Lines of EU Medical Device Regulation 1:00:55

2+ y ago1:00:55

1:00:55

What happens when two regulatory consultants sit down for a chat about MDR?A lot of distressed head shaking, for sure and an equal measure of what-were-they-thinking eye rolls, but we also dug into the meat of the proposed extension and what it might mean for industry.Monir El Azzouzi and I chatted last month about MDR, and while we didn't solve al…

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Risk Management - Beyond the Basics 54:31

3y ago54:31

54:31

Risk management can be difficult to understand, even for seasoned quality and regulatory professionals, because there are SO. MANY. ACRONYMS.I mean, there's FMEA, uFMEA, ISO, FDA, PMA to name a few.We discussed acronyms and more at the November meeting of the Dallas ASQ - Section 1402, so if you're ready to go beyond the basics and right into the v…

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Trends in FDA Initiatives and the Impact on Orthopedic Devices 38:14

3y ago38:14

38:14

Orthopedic devices may qualify as medical devices, but they have very different regulatory requirements. So different that the FDA created a new office to manage orthopedic devices - the Office of Science and Engineering Laboratories (OSEL) - and ensure their safety and efficacy. OSEL was created to accelerate patient access to innovative devices, …

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Free FDA Communications with the FDA? What you Need to Know 50:09

3y ago50:09

50:09

There's the pre-submission, of course, but did you know there are other ways to get FDA feedback without breaking the budget? In this episode, Michelle reviews three pathways that can help startups save some cash while working their way through the commercialization process.By Michelle Lott

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Split Personalities of QMS Audits for FDA, MDSAP and ISO 13485 50:51

3y ago50:51

50:51

Similar but different is a good way to describe how FDA inspections and MDSAP and notified body audits compare. On the surface, they appear to be looking at the same things, but dig a little deeper and the differences in agenda - and outcome - become plain.By Michelle Lott

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Usability Testing and the FDA 32:35

3y ago32:35

32:35

Do you know how your end users will use your device? Are you sure?Do you know how end use will differ between demographic groups? Do you know why this is important, and how usability testing fits into your risk assessment?Shannon Clark has been doing human factors/usability testing for some time, and she can tell you exactly why usability testing i…

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Is your State of Affairs for MDR State of the Art? 1:03:11

3y ago1:03:11

1:03:11

If you're struggling to determine whether your devices qualify as state of the art - and how that can impact your submission strategy - then check out this presentation I did with my friends at Greenlight Guru in August.Etienne Nichols and I sort through all the acronyms - SOTA, SOC, MDR, MEDDEV, IVDR - and try to shed some light on what MDR says a…

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MDR, FDA and Other Regulatory Realities 35:41

3y ago35:41

35:41

When submitting a medical device for regulatory approval, it's always better to just dive in, accepting the fact that it's going to take a lot of work and require a lot of patience before you feel the glow of market clearance or approval.There are just SO MANY things to consider, and remember, and document, and SO MANY regulations to refer to on bo…

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Digital Health: The Future of Medicine and Medical Devices 43:14

3y ago43:14

43:14

Digital health technologies are exactly new, but they did get a huge boost from COVID and will define how we deliver healthcare in the future. Digital health includes telemedicine, software functions that allow providers to monitor patients remotely, apps that track medication use and provide user-configured reminders for improved compliance - and …

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The End of the COVID-Era EUAs 42:09

3y ago42:09

42:09

The end of the COVID-era emergency use authorization (EUA) is rapidly approaching - do you know what's next?Earlier in the year, the FDA laid out their proposed plans for transitioning devices marketed under and EUA or FDA enforcement policy - then went radio silent.They still haven't released their final guidance, so what's a manufacturer to do?In…

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Crash Course in FDA Submissions 25:10

3y ago25:10

25:10

So - you have a product, and you have a submission ready to go to the FDA. You're all set, right? You know how the e-Submitter works, you know exactly what FDA Form 3514 is for, and you know the best questions to ask the FDA during your pre-sub?If you've answered NO to any of these, then listen in as Michelle explains what you need to do to help yo…

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Five Steps to Bring a Medical Device to Market 29:22

3y ago29:22

29:22

So - you're a hot new startup with a snappy new medical device. Now what? Do you have an intended use statement? Do you have the 𝘳𝘪𝘨𝘩𝘵 intended use statement? Do you know for sure that your product qualifies as a medical device? What about your predicate device?There are a lot of potholes along the road to market clearance or approval, so come alon…

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Design Controls and Risk Management 1:19:43

3y ago1:19:43

1:19:43

Which comes first - design controls or risk management? Both - because the two are inextricably linked. In this podcast, we'll take an in-depth look at both design controls and risk management, the waterfall design process, how/where risk management fits into that process - and vice versa - as well as discuss the ISO and 21 CFR 820 requirements for…

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Breakthrough, de novo, or PMA? FDA Submission Pathways for Novel Devices 47:59

3y ago47:59

47:59

You've developed a novel technology and want to bring it to market in the US. Now what? Can you submit as a breakthrough device, or is the de novo route a better choice? How are they different? How are they similar? Breathe - and listen in as Michelle walks you through the options.By Michelle Lott

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The Aftermath Of MDR - Part III 20:32

3+ y ago20:32

20:32

In this final segment from 𝗧𝗵𝗲 𝗔𝗳𝘁𝗲𝗿𝗺𝗮𝘁𝗵 𝗼𝗳 𝗠𝗗𝗥 webinar, we discuss what you should and should not do when preparing for your certification, then segue into what you need to consider when building the business case for (or against) pursuing certification.This one runs a bit longer than 15 minutes because it includes most of the Q+A session, and tha…

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The Aftermath of MDR - Part II 15:23

3+ y ago15:23

15:23

Six months into MDR and manufacturers and notified bodies are clashing over differences in opinion and fighting over their respective interpretation of the standards in pursuit of product certification.In this second installment of a series, I share three real-world examples of what actual clients faced when going through the MDR certification proc…

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The Aftermath of MDR - Part I 15:40

4y ago15:40

15:40

It's no longer a secret that MDR has morphed into an unmitigated disaster for the medical device industry - and Michelle has the goods to prove it. In this first in a series, she spills the beans on notified body readiness, the roadblocks that have been causing the most trouble, and the FDA's long-term plan to become the easier pathway to market.…

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EUDAMED, MDR and Even More Madness with Richard Houlihan 20:55

4y ago20:55

20:55

This is the second part of my conversation with Richard Houlihan, where we delve into the current status of the EUDAMED database, the intricacies of the data entry process, and why the EU competent authorities are not your friends.By Michelle Lott

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EUDAMED, MDR and Other Madness with Richard Houlihan - Part I 16:33

4y ago16:33

16:33

We all knew that MDR would change the medical device industry forever, hopefully for the better. But as manufacturers grapple with redundant requirements and notified bodies struggle to attract and retain the qualified staff mandated by the new regulation, it becomes clear that MDR is not just changing the medical device industry - it's requiring a…

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The MDR No Good Very Bad Day: Go To Market Challenges in the EU 12:14

4y ago12:14

12:14

It used to be that Europe was the first choice when bringing a product to market. Relaxed regulation meant a quick approval and the chance to earn some money while waiting for FDA approval. That's not the case anymore, and thanks to MDR, there are new challenges and roadblocks - not to mention a LOT more expense - involved in bringing a medical dev…

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The FDA No Good Very Bad Day: Common Regulatory Mistakes 14:51

4y ago14:51

14:51

Whether you are an investor or inventor/founder, there are some things you need to avoid if you want your FDA submission to succeed, some common regulatory mistakes that a lot of startups make. These common misconceptions about the FDA submission process can cost you time and money and extend your go-to-market timeline, so it's worth knowing how to…

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Empowering Female Entrepreneurs and Investors with Faz Bashi 27:48

4y ago27:48

27:48

More and more women are investing in medtech startups as the next phase of their professional development. It's a key career move that can fuel further business growth while establishing women entrepreneurs as experts and investors to be taken seriously.But all investors need to know what to look for when gauging a pitch from a startup, because it'…

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How A Strong Regulatory Strategy Can Boost Your Business with Stephanie Schull 19:32

4+ y ago19:32

19:32

Does regulatory strategy really impact your business strategy? Yes! Stephanie Schull, founder of kegelbell, explains how defining the regulatory strategy for her fledgling business early on helped promote her product both to investors and distributors around the globe.By Michelle Lott

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FDA Submission Pathways with EIT Health Alumni 1:17:43

4+ y ago1:17:43

1:17:43

Determining which FDA submission pathway best applies to your medical device or product can be daunting. Listen in as Michelle explains how to decide if your product qualifies for a 510(k), PMA, de novo or 510(k) exempt submission - as well as the basic requirements for each.By Michelle Lott

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All You Ever Wanted to Know About Risk Management with Edwin Bills 44:02

4+ y ago44:02

44:02

No matter the risk management question, Edwin Bills will likely have the answer. He's been involved in the medical device quality and regulatory space for many, many years. Give him a tricky compliance situation or example, and chances are he has been there and done that, maybe more than once.Ed sat down with Michelle to talk about ISO 24971, MDR a…

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Regulatory and Reimbursement - Similar but Different 38:54

4+ y ago38:54

38:54

Are regulatory and reimbursement at all related? Does one influence the other? Or are they more like oil and water, both necessary but not really something you should mix?Michelle and Nic Anderson answer questions about how regulatory and reimbursement issues can impact a product's go-to-market strategy, and how these two seemingly disparate areas …