RAQA Today
Episodes
Building a Better Market Pathway: Aligning Regulatory, Reimbursement and Commercialization Teams
08 Dec 2025
Contributed by Lukas
Most medtech teams underestimate the work before FDA submission—and overestimate what happens after clearance. In this episode, regulatory expert Mi...
How to be the Regulatory Person Everyone Actually Likes | Device & Conquer | S2:E6
02 Dec 2025
Contributed by Lukas
A practical, lightly spicy guide to becoming the regulatory person teams actually respect—and want in the room.Learn how regulatory and quality prof...
How to Build a Quality System That Doesn't Suck | Device & Conquer | S2:E5
18 Nov 2025
Contributed by Lukas
Because your QMS should be a safety net—not a set of handcuffs.In this episode of Device and Conquer, Michelle and Ti break down how to build a qual...
Due Diligence for MedTech Investors: What You Really Need to Know Before Writing That Check
17 Nov 2025
Contributed by Lukas
If you’re thinking about investing in medtech, congratulate yourself—you’ve chosen one of the most exciting, innovative, and occasionally stomac...
Why Picking a Predicate Can Make or Break Your 510(k) | Device & Conquer | S2:E4
11 Nov 2025
Contributed by Lukas
Choosing a predicate device can make—or break—your 510(k) submission, so it's important to choose wisely.In this episode of Device and Conquer...
How to Build a 510(k) Without Losing Your Mind | Device & Conquer | S2:E3
03 Nov 2025
Contributed by Lukas
Building a 510(k) isn’t just about filling in forms — it’s about telling the FDA a story they can’t say no to.In this episode of Device & ...
How to Submit a Pre-Sub (like a Pro) | Device & Conquer | S2:E2
28 Oct 2025
Contributed by Lukas
The FDA pre-submission (Q-Sub) process can save you time — or sink your submission. In this episode of Device and Conquer, Michelle Lott and Tianna ...
FDA Strategy 2025: Policy, Pressures and the Path to Medtech Clearance | Part I | leanRAQA Today | S5:E6
22 Oct 2025
Contributed by Lukas
The FDA state of the union in 2025 - deregulation, QMSR, and a toilet paper shortage?Listen in as Michelle Lott and Tianna Benson tackle the wild worl...
How to Speak FDA (Without a Translator) | Device & Conquer | S2:E1
21 Oct 2025
Contributed by Lukas
Think you speak English? The FDA might disagree.In the Season 2 kickoff of Device &Conquer, hosts Michelle Lott and Tianna Benson break down the u...
Inside the FDA: Pre-Subs, Wellness Devices & Cybersecurity Challenges | leanRAQA Today | S5:E5
25 Sep 2025
Contributed by Lukas
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 blu...
Rise of the Regulatory Rebel
23 Sep 2025
Contributed by Lukas
In the Season 1 finale, Michelle and Ti challenge the traditional view of regulatory affairs as the “business prevention department.” Instead, the...
FDA 101: Audits, Classification Rules and EU MDR
15 Sep 2025
Contributed by Lukas
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. Fr...
FDA 101: Understanding the OTHER Regulatory Giant
08 Sep 2025
Contributed by Lukas
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 Administra...
EU MDR - More then Just Red Tape?
03 Sep 2025
Contributed by Lukas
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) —...
Wait, What - There are Rules?!?!?
26 Aug 2025
Contributed by Lukas
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 a...
QMSR, AI Reviewers and the Value of a Good FDA and Internal Audit | leanRAQA Today | S5:E4
27 Jun 2025
Contributed by Lukas
What if your quality system could audit itself — and tell you where you’re overcomplying, underperforming, or about to get caught in a regulatory ...
What You Need to Know About FDA Breakthrough Devices | leanRAQA Today | S5:E3
16 Jun 2025
Contributed by Lukas
Everyone wants that shiny FDA Breakthrough Device designation — but what does it really take to earn it, and does it actually make a difference?In t...
Medical Device Product Development: From Concept to Commercialization | leanRAQA Today | S5:E2
13 Mar 2025
Contributed by Lukas
Did you know that 60% of startups cannot survive beyond five years, and 75% will ultimately fail?Bringing a medical device to market is hard — but m...
EU Hot Takes: MDD vs MDR | leanRAQA Today | S5:E1
06 Feb 2025
Contributed by Lukas
The EU Medical Device Regulation (MDR) has reshaped the European regulatory landscape — bringing new rigor, new challenges, and plenty of confusion....
Biocompatibility for MedTech Professionals
06 Dec 2024
Contributed by Lukas
Everything you need to know about biocompatibility - in one podcast. From a webinar hosted by MedTech Leading Voice and featuring Michelle and Marina...
CE Certification vs FDA Submission Strategy: Which is Right for You?
01 Oct 2024
Contributed by Lukas
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 l...
ASCA, CLAP, Fraudulent Biocompatibility Data and You
24 Sep 2024
Contributed by Lukas
Biocompatibility testing is hot right now, in part because of the sharp increase in the number of FDA submissions containing fraudulent data. Some une...
A Conversation with Vistatec's Life Science In-Focus Podcast
13 May 2024
Contributed by Lukas
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 t...
eSTAR 5.0 - What You Must Know
19 Apr 2024
Contributed by Lukas
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 ...
The Benefits of 3rd Party FDA Reviewers
12 Mar 2024
Contributed by Lukas
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 ...
eSTAR 5.0 Q+A with Patrick Axtell from the FDA
20 Feb 2024
Contributed by Lukas
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 receive...
Fractional or Full Time Quality Support: Which is Right for You?
07 Feb 2024
Contributed by Lukas
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...
Medical Devices, Cloud Computing and Cybersecurity with Randy Horton
29 Nov 2023
Contributed by Lukas
As medical devices become more connected, concerns about security increase, leaving manufacturers - and regulatory staff - uncertain as to the best pa...
The Business Benefits of Quality
11 Aug 2023
Contributed by Lukas
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 mor...
The Joy of Document Control
09 Aug 2023
Contributed by Lukas
You may think document control is boring, but wait until you hear these stories: Red-lined post-it notes. Uncontrolled copies passed around during in...
Make Quality Make $en$e: Management's Role in Quality
31 Jul 2023
Contributed by Lukas
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. ...
MDR By The Numbers: Leveraging New Data for Implementation Planning
10 Mar 2023
Contributed by Lukas
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 gathe...
EUDAMED Update: January 2023
21 Feb 2023
Contributed by Lukas
Upload to EUDAMED is a requirement of MDR, but adoption has been slower than anticipated. Manufacturers are reluctant to invest in the time required t...
From the Front Lines of EU Medical Device Regulation
31 Jan 2023
Contributed by Lukas
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-we...
Risk Management - Beyond the Basics
13 Dec 2022
Contributed by Lukas
Risk management can be difficult to understand, even for seasoned quality and regulatory professionals, because there are SO. MANY. ACRONYMS. I mean,...
Trends in FDA Initiatives and the Impact on Orthopedic Devices
15 Nov 2022
Contributed by Lukas
Orthopedic devices may qualify as medical devices, but they have very different regulatory requirements. So different that the FDA created a new offic...
Free FDA Communications with the FDA? What you Need to Know
08 Nov 2022
Contributed by Lukas
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, Michell...
Split Personalities of QMS Audits for FDA, MDSAP and ISO 13485
31 Oct 2022
Contributed by Lukas
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 look...
Usability Testing and the FDA
25 Oct 2022
Contributed by Lukas
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 your State of Affairs for MDR State of the Art?
17 Oct 2022
Contributed by Lukas
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...
MDR, FDA and Other Regulatory Realities
22 Sep 2022
Contributed by Lukas
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...
Digital Health: The Future of Medicine and Medical Devices
13 Sep 2022
Contributed by Lukas
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. Digit...
The End of the COVID-Era EUAs
06 Sep 2022
Contributed by Lukas
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 th...
Crash Course in FDA Submissions
31 Aug 2022
Contributed by Lukas
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...
Five Steps to Bring a Medical Device to Market
23 Aug 2022
Contributed by Lukas
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...
Design Controls and Risk Management
17 Aug 2022
Contributed by Lukas
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 a...
Breakthrough, de novo, or PMA? FDA Submission Pathways for Novel Devices
09 Aug 2022
Contributed by Lukas
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 rou...
The Aftermath Of MDR - Part III
25 Jan 2022
Contributed by Lukas
In this final segment from 𝗧𝗵𝗲 𝗔𝗳𝘁𝗲𝗿𝗺𝗮𝘁𝗵 𝗼𝗳 𝗠𝗗𝗥 webinar, we discuss what you should and should not ...
The Aftermath of MDR - Part II
06 Jan 2022
Contributed by Lukas
Six months into MDR and manufacturers and notified bodies are clashing over differences in opinion and fighting over their respective interpretation o...
The Aftermath of MDR - Part I
16 Dec 2021
Contributed by Lukas
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...
EUDAMED, MDR and Even More Madness with Richard Houlihan
23 Nov 2021
Contributed by Lukas
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 t...
EUDAMED, MDR and Other Madness with Richard Houlihan - Part I
03 Nov 2021
Contributed by Lukas
We all knew that MDR would change the medical device industry forever, hopefully for the better. But as manufacturers grapple with redundant requireme...
The MDR No Good Very Bad Day: Go To Market Challenges in the EU
15 Oct 2021
Contributed by Lukas
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 som...
The FDA No Good Very Bad Day: Common Regulatory Mistakes
29 Sep 2021
Contributed by Lukas
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 regul...
Empowering Female Entrepreneurs and Investors with Faz Bashi
13 Jul 2021
Contributed by Lukas
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 furt...
How A Strong Regulatory Strategy Can Boost Your Business with Stephanie Schull
18 May 2021
Contributed by Lukas
Does regulatory strategy really impact your business strategy? Yes! Stephanie Schull, founder of kegelbell, explains how defining the regulatory strat...
FDA Submission Pathways with EIT Health Alumni
01 Apr 2021
Contributed by Lukas
Determining which FDA submission pathway best applies to your medical device or product can be daunting. Listen in as Michelle explains how to decide ...
All You Ever Wanted to Know About Risk Management with Edwin Bills
12 Mar 2021
Contributed by Lukas
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...
Regulatory and Reimbursement - Similar but Different
04 Mar 2021
Contributed by Lukas
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 some...
FDA Device Downclassification - This is Not Good News
25 Feb 2021
Contributed by Lukas
The recent FDA device downclassification decision is not good news - for industry or for patients. Several devices on this list - namely ventilators -...
Inside a Notified Body with Robert Dostert
17 Feb 2021
Contributed by Lukas
Robert has years of experience working for notified bodies, and provides a peek behind the curtain at the North American division of Norway's DNV GL P...
Entrepreneurial Roundtable with Elena Kyria
11 Feb 2021
Contributed by Lukas
In this clip from Elemed's Entrepreneurial Roundtable series, Michelle sits down with Monir El Azzouzi, Stefan Boelleininger and Elena Kyria to talk a...
Ventilators, Components and Accessories - Choosing the Right FDA Pathway for Your Product
03 Feb 2021
Contributed by Lukas
Have you ever struggled to understand the regulatory difference between a product, an accessory and a component? Have you ever driven yourself slight...
PPE, Masks and FDA Regulations in the Age of Coronavirus
29 Jan 2021
Contributed by Lukas
Protective gear is still in high demand, and absolutely everyone is making masks. In this April 2020 clip from Joe Hage’s weekly COVID-19 call, I di...
Regulatory Requirements and the "Simple" Surgical Mask
22 Jan 2021
Contributed by Lukas
You have a raw material supplier. You have a marketing strategy. You have a sales funnel. But what you don't have is a clear understanding of the regu...
RAQA Today Becomes leanRAQA Today: What's Next?
13 Jan 2021
Contributed by Lukas
Mitch Robbins is moving on, and Michelle Lott of lean RAQA will be taking over the podcast! Mitch and Michelle chat about transitioning the podcast, w...