Best Raqa Today Podcasts (2024)

1
eSTAR 5.0 - What You Must Know 32:58

7d 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
Episode 13: Updates on the IVDR 40:12

2d ago40:12

40:12

In this episode of the RAQA Café Podcast, our host engages with Warren Jameson (NAMSA’s Sr. Manager, Regulatory & Quality) and Christele Perrin-East (NAMSA’s Sr. Regulatory Consultant, IVD), to explore the extension of the EU IVDR deadline and its implications for the industry. Our experts highlight the importance of maintaining progress towards IV…

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

2M 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.By Michelle Lott

1
Episode 12: The Relationship among Risk Management, Clinical Evidence and Post Market Reports 43:16

2M ago43:16

43:16

Join us as we welcome two esteemed members of NAMSA’s Medical Writing team, Dr. Beatriz Rodriguez Grande and Dr. Sean Bird, for an insightful conversation on the intricate relationship between Risk Management, Clinical Evidence and Post-Market reports. Dr. Beatriz Rodriguez Grande, who began her career in the medical device industry as a Preclinica…

1
eSTAR 5.0 Q+A with Patrick Axtell from the FDA 33:52

2M 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

1
Fractional or Full Time Quality Support: Which is Right for You? 22:49

3M 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…

1
Effective Communication with your Notified Body 41:04

3M ago41:04

41:04

In this episode of NAMSA’s RAQA Café Podcast, we are excited to welcome back two esteemed members of the NAMSA team—Paul Risborough, B-Eng (Hons) (Principal Regulatory Consultant) and Matt Royle, PhD (Principal Regulatory Consultant)—to discuss aspects of effectively communicating with Notified Bodies. Both Paul and Matt bring a wealth of experienc…

1
Episode 10: Talking Risk with Dr. Naveen Agarwal - Part 2 19:34

5M ago19:34

19:34

In the tenth installment of NAMSA’s RAQA Café Podcast, our hosts continue their conversation from the previous episode, “Talking Risk with Dr. Naveen Agarwal – Part 1,” with guest speaker Dr. Naveen Agarwal (Principal and Founder of Creative Analytics Solutions, LLC). This episode focuses on how to maintain a Risk Management System and shares indus…

1
Medical Devices, Cloud Computing and Cybersecurity with Randy Horton 27:56

5M 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.…

1
Episode 9: Part 1: Talking Risk with Dr. Naveen Agarwal 42:01

5M ago42:01

42:01

Risk management is an essential requirement for all medical device organizations when developing, manufacturing, and commercially distributing medical products. In the ninth episode of NAMSA’s RAQA Café Podcast, our hosts sit down with guest speaker Dr. Naveen Agarwal (Principal and Founder of Creative Analytics Solutions, LLC) to discuss valuable …

1
Clinical Investigations: Collecting Proof that your Device is Safe and Effective 41:58

8M ago41:58

41:58

Clinical investigations play a crucial role in supporting regulatory submissions and must encompass the intended user and intended use environment. The U.S. Food and Drug Administration (FDA) refers to these pivotal studies as the definitive means of generating data that demonstrates the safety and effectiveness of a device for its intended use. Jo…

1
The Business Benefits of Quality 12:12

9M 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.By Michelle Lott

1
The Joy of Document Control 15:29

9M 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…

1
The EU IVDR: What do you need to know? 54:22

9M ago54:22

54:22

In the seventh episode of the NAMSA RAQA Café Podcast, our hosts sit down with Warren Jameson (NAMSA Senior Manager of Regulatory and Quality) and examine the European Union (EU) In Vitro Diagnostic Regulation (IVDR). IVDR 2017/746 was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually replac…

1
Make Quality Make $en$e: Management's Role in Quality 37:27

9M 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.…

1
Compliance Pitfalls (Animal Study) 33:00

10M ago33:00

33:00

In our sixth episode of the NAMSA RAQA Café Podcast, we sit down with guest speaker Jack Risdahl, NAMSA Principal Product Development Strategist and Doctor of Veterinary Medicine. During our discussion, Jack delves into common mistakes that are observed when conducting In Vivo studies, ways in which to mitigate these mistakes and variances pertaini…

1
RAQA Café Live! - RAPS EU Convergence and effective MDR-compliant Periodic Safety Update Reports 1:00:13

10M ago1:00:13

1:00:13

NAMSA and the Regulatory Affairs Professionals Society (RAPS) are delighted to host the first live edition of the RAQA Café! In this episode, our hosts will sit down with NAMSA UK-based Medical Device Regulation (MDR) experts, Matt Royle (Principal Regulatory Consultant) and Paul Risborough (Principal Regulatory Consultant) to discuss all things RA…

1
IVD Special - Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations 35:33

11M ago35:33

35:33

In our fourth episode of NAMSA's RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Sonia Lecce (Principal IVD Regulatory Consultant) and Duan Threats (Senior IVD Regulatory Consultant). During the discussion, Sonia and Duan delve into the differences between SiMD and SaMD for In Vitro Diagnostics (IVD), as well as FDA criteria deemed…

1
The Role of Software in Healthcare - Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations 35:30

12M ago35:30

35:30

What are the differences between Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD)? In this third episode of NAMSA's RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Lezlie Hynes (Principal Quality Consultant) and Monica R. Montanez (Principal Product Development Strategist). During the discussion, they del…

1
Refuse to Accept Policy and the Future of FDA Submissions 31:44

1y ago31:44

31:44

What is the FDA’s Refuse to Accept Policy? In this second episode of NAMSA's RAQA Café Podcast, we are joined by NAMSA’s Principal Product Development Strategist, Angela Mallery, to examine the procedures and criteria FDA use in assessing whether a premarket notification 510(k) submission meets a minimum threshold of acceptability, and if it should…

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

1y 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…

1
Choosing the Right Consultant 36:28

1y ago36:28

36:28

Finding the right consultant is crucial to the success of your project. In this first episode of NAMSA’s RAQA Café Podcast, our hosts, joined by two guest speakers, delve into the many aspects that must be considered when choosing the best consultant for your product development needs. Providing perspectives from both large-scale manufacturers and …

1
EUDAMED Update: January 2023 51:47

1y 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…

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

1y 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…

1
Risk Management - Beyond the Basics 54:31

1+ y 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…

1
Trends in FDA Initiatives and the Impact on Orthopedic Devices 38:14

1+ y 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, …

1
Free FDA Communications with the FDA? What you Need to Know 50:09

1+ y 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

1
Split Personalities of QMS Audits for FDA, MDSAP and ISO 13485 50:51

1+ y 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

1
Usability Testing and the FDA 32:35

1+ y 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…

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

1+ y 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…

1
MDR, FDA and Other Regulatory Realities 35:41

1+ y 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…

1
Digital Health: The Future of Medicine and Medical Devices 43:14

1+ y 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 …

1
The End of the COVID-Era EUAs 42:09

1+ y 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…

1
Crash Course in FDA Submissions 25:10

1+ y 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…

1
Five Steps to Bring a Medical Device to Market 29:22

1+ y 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…

1
Design Controls and Risk Management 1:19:43

1+ y 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…

1
Breakthrough, de novo, or PMA? FDA Submission Pathways for Novel Devices 47:59

1+ y 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

1
The Aftermath Of MDR - Part III 20:32

2+ 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…

1
The Aftermath of MDR - Part II 15:23

2+ 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…

1
The Aftermath of MDR - Part I 15:40

2+ y 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.…

1
EUDAMED, MDR and Even More Madness with Richard Houlihan 20:04

2+ y ago20:04

20:04

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

1
EUDAMED, MDR and Other Madness with Richard Houlihan - Part I 16:33

2+ y 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…

1
The MDR No Good Very Bad Day: Go To Market Challenges in the EU 12:14

2+ y 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…

1
The FDA No Good Very Bad Day: Common Regulatory Mistakes 14:51

2+ y 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…

1
Empowering Female Entrepreneurs and Investors with Faz Bashi 27:48

3y 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'…

1
How A Strong Regulatory Strategy Can Boost Your Business with Stephanie Schull 19:56

3y ago19:56

19:56

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

1
FDA Submission Pathways with EIT Health Alumni 32:35

3y ago32:35

32:35

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

1
All You Ever Wanted to Know About Risk Management with Edwin Bills 44:02

3y 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…

1
Regulatory and Reimbursement - Similar but Different 39:16

3y ago39:16

39:16

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 …

1
FDA Device Downclassification - This is Not Good News 26:54

3y ago26:54

26:54

The recent FDA device downclassification decision is not good news - for industry or for patients. Several devices on this list - namely ventilators - have benefitted from close FDA scrutiny during the 510(k) submission process. They are safe precisely because they have been so closely regulated, not because they are simple to use and present limit…

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