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 and the risk of radiation exposure in a sun-filled hospital room.

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

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.

FDA Submission Pathways with EIT Health Alumni

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.

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

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 avoid them.

The FDA No Good Very Bad Day: Common Regulatory Mistakes

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 device to market in Europe.

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

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.

EUDAMED, MDR and Even More Madness with Richard Houlihan

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.

The Aftermath of MDR - Part I

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 more.

In this podcast, we dive into the whys and the hows of regulating digital health while still managing to bring products to market.

Digital Health: The Future of Medicine and Medical Devices

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 about state of the art, what it doesn't say, and how to determine your best path forward.

Is your State of Affairs for MDR State of the Art?

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.

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

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 all of the EU's problems, we did touch on some of the biggest challenges facing manufacturers.

From the Front Lines of EU Medical Device Regulation

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 future might hold for both sides.

EUDAMED Update: January 2023

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 implementation (spoiler alert: it ain't pretty).

MDR By The Numbers: Leveraging New Data for Implementation Planning

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/michellelottraqa

Website: https://leanraqa.com/

YouTube: https://www.youtube.com/@leanRAQA

Instagram: https://www.instagram.com/leanraqa

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

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!

LinkedIn: https://www.linkedin.com/in/michellelottraqa

Website: https://leanraqa.com/

YouTube: https://www.youtube.com/@leanRAQA

Instagram: https://www.instagram.com/leanraqa

The Joy of Document Control

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 market, and why many companies are opting for fractional QA professionals rather than full-time employees.

LinkedIn: https://www.linkedin.com/in/michellelottraqa

Website: https://leanraqa.com/

YouTube: https://www.youtube.com/@leanRAQA

Instagram: https://www.instagram.com/leanraqa

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

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.

eSTAR 5.0 Q+A with Patrick Axtell from the FDA

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/michellelottraqa

Website: https://leanraqa.com/

YouTube: https://www.youtube.com/@leanRAQA

Instagram: https://www.instagram.com/leanraqa

The Benefits of 3rd Party FDA Reviewers

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 effectively –the good, the bad, and the ugly.

The new features, including premarket approval content and updated cybersecurity documentation and dive into the simplified EMC questions, revised sterility section, and new biocompatibility testing options - we'll cover it all.

LinkedIn: https://www.linkedin.com/in/michellelottraqa

Website: https://leanraqa.com/

YouTube: https://www.youtube.com/@leanRAQA

Instagram: https://www.instagram.com/leanraqa

eSTAR 5.0 - What You Must Know

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 conversation this month when I chatted with Mike McGrew and Sandi Schaible from WuXi AppTech.

LinkedIn: https://www.linkedin.com/in/michellelottraqa

Website: https://leanraqa.com/

YouTube: https://www.youtube.com/@leanRAQA

Instagram: https://www.instagram.com/leanraqa

ASCA, CLAP, Fraudulent Biocompatibility Data and You

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 notified bodies.
27:15 - Nika Mendelev explains whether you really need to choose one or the other.
32:10 - the Q+A session begins.

Link to the full presentation on YouTube: https://youtu.be/4wyZzVibiAY

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

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/michellelottraqa

Website: https://leanraqa.com/

YouTube: https://www.youtube.com/@leanRAQA

Instagram: https://www.instagram.com/leanraqa

Biocompatibility for MedTech Professionals

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 regulatory engagement, meticulous documentation through a trace matrix to ensure cross-functional alignment, and a well-defined regulatory strategy that aligns with the chosen FDA pathway. Prototyping and manufacturing must be carefully managed, considering the impact of material and process changes, and prioritizing design for manufacturability.

 Finally, a strategic commercialization plan, including appropriate sales strategies, a clear understanding of the target market, robust intellectual property protection, and adequate funding, are crucial for navigating the complex medtech landscape and achieving sustainable success.

LinkedIn: https://www.linkedin.com/in/michellelottraqa

Website: https://leanraqa.com/

YouTube: https://www.youtube.com/@leanRAQA

Instagram: https://www.instagram.com/leanraqa

Medical Device Product Development: From Concept to Commercialization

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 everyone.

In this podcast, Michelle reviews the specifics of the program - the benefits, the requirements, the challenges - and talks about how you can decide if the program is right for you and your device.


LinkedIn: https://www.linkedin.com/in/michellelottraqa

Website: https://leanraqa.com/

YouTube: https://www.youtube.com/@leanRAQA

Instagram: https://www.instagram.com/leanraqa

What You Need to Know About FDA Breakthrough Devices

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 QMSR, MDR, and de-harmonization trends.

Highlights:

 - The hidden costs of over-documentation and duplicated audits
 - How AI can proactively identify compliance gaps — even across languages
 - The future of audits: less paper, more floor time, and higher impact
 - Why global harmonization is unraveling, and what that means for QA/RA teams
 - Real examples of FDA using AI to detect duplicated or fraudulent data
 
This episode is a must-listen for quality, regulatory, and compliance leaders, especially those working in startups, scaling medtech companies, and global manufacturers navigating complex, multi-jurisdictional requirements.

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

What exactly is a medical device — and why does it matter if it’s regulated? In this episode of Device and Conquer, hosts Michelle (regulatory specialist) and Ty (your curious co-navigator) 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 devices

Real-life horror stories of unregulated (and unsafe) products that changed the industry

How the FDA, EU, and other regulators define and oversee devices differently

Why regulations aren’t just “red tape” — they protect patients and level the playing field for innovators

Plus: a rapid-fire game of Real or Ridiculous — can you guess which products are actual medical devices and which ones we made up?

Subscribe to Device and Conquer and join us each week as we untangle the messy, fascinating, and sometimes ridiculous world of medtech regulation.

Wait... There are Rules_!

In this episode of Device and Conquer, Michelle and Ti dive deep into the European Union’s Medical Device Regulation (MDR) — and talk about 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’s, mood rings that claim to detect cancer, and next-gen implants. From there, they unpack the real-world implications of MDR, explaining what the regulation means for companies, innovators, and ultimately, patients.

(You can skip "Real or Ridiculous" and go right to the good stuff, which starts at roughly 7:06)

Key highlights include:

The challenges and importance of achieving a CE mark under MDR

How MDR impacts both startups and established medtech companies

The balance between innovation and compliance in Europe’s regulatory landscape

Practical insights on how companies can prepare for MDR scrutiny

The ripple effect on global markets, investors, and patient safety

Whether you’re a regulatory affairs professional, a medical device startup, or just curious about how Europe is shaping the future of healthcare innovation, this episode breaks down complex regulations into an engaging and accessible conversation.

Tune in to learn why MDR is reshaping the medtech industry — and how you can stay ahead.

EU MDR - More than Just Red Tape?

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 regulatory strategy can make or break your product’s success.

FDA 101: Understanding the OTHER Regulatory Giant

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 know before entering either market.

Whether you’re a startup navigating your first clearance or a seasoned RA/QA pro, this is your crash course on how regulators (and auditors) think—and why it matters for your compliance strategy.

FDA 101 Part 2: Audits, Classification Rules and EU MDR

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.

Catch the video version on YouTube: https://youtu.be/K8hZ9P2_oIU

From shocking stories of last-minute compliance scrambles to major recalls that reshaped the industry, this episode reveals why being a “regulatory rebel” means understanding intent over letter, pushing back when it matters, and building trust across teams.

Key takeaways:

How proactive vs. reactive compliance impacts company culture and patient safety

Why draft guidance matters (and how to use it to influence FDA thinking)

The ethical and strategic case for regulatory professionals as innovators

What Michelle and Ti would change if they ruled the FDA for a day

Perfect for regulatory pros, quality leaders, and anyone ready to challenge the status quo in medtech.

Season 2 coming soon!

Rise of the Regulatory Rebel

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.

Watch the video version on YouTube: https://youtu.be/R0K9UsbxfLw

What you’ll learn in this episode:

How to structure effective FDA pre-submissions (Q-subs) for better feedback

Why the FDA’s focus on “inherent use” claims is shaking up wellness and digital health products

Real-world examples of recalls, labeling risks, and social media missteps

Why startups and Fortune 500s alike struggle with regulatory strategy

The rising demand for cybersecurity policies in medtech and service providers

When (and how) to push back on FDA reviewers with evidence

If you’re in medical device development, regulatory affairs, or quality management, this episode gives you actionable insights to avoid costly mistakes and stay ahead of FDA expectations.

👉 Subscribe and never miss an update on FDA regulations, compliance trends, and medtech innovation.

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

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 unique language of the U.S. Food and Drug Administration — a dialect every medtech professional needs to understand to survive regulatory conversations.

From decoding words like “should,” “non-binding,” and “substantial equivalence” to navigating claims, AI buzzwords, and “inherent use,” this episode reveals why context, punctuation, and phrasing can make or break your FDA submission.

You’ll learn:

Why “should” really means “shall” in FDA guidance
How to argue (and win) your case using the right regulatory language
What “substantial equivalence” actually means (and doesn’t)
Why saying your product uses “AI” might double your review time
The hidden meaning of “general wellness” and “inherent use”
How punctuation can change compliance outcomes

Whether you’re a startup founder or seasoned QA/RA pro, this is your crash course in how to speak FDA — without a translator.

Listen, laugh, and learn as Michelle and Tianna pour a cocktail and translate regulatory jargon into plain English.

How to Speak FDA (Without a Translator)

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 world of FDA policy shifts and what they mean for medical device manufacturers. From the administration’s sweeping deregulation mandates to the long-awaited transition from QSR to QMSR, they connect the dots between chaos, comedy, and compliance.

You’ll hear:

How the FDA’s current freeze on new regulations is reshaping device approval pathways
What the shift from QSR to QMSR really means for your quality system
Why de novo submissions are both a blessing and a black box right now
And yes… how a literal shortage of office supplies at FDA HQ ties into all of this

Whether you’re a regulatory pro, a QA lead, or just someone who enjoys watching bureaucracy unfold in real time, this episode will help you decode what’s happening at the FDA — and how to stay one step ahead.

FDA Strategy 2025: Policy, Pressures, and the Path to Medtech Clearance | Part I

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 limited risk to the patient.

This podcast combines three different interviews into one narrative about the FDA decision, the reasoning behind it, and the action we need to take to keep ventilators and other devices under the careful watch of federal regulations.

Link to the original post and instructions for submitting your comments to the Federal Register: https://leanraqa.com/regulatory-quality/fda-down-classified-classification/

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