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 quality management system (QMS) that doesn’t suck—or suck the life out of your MedTech team.

From the shift to FDA’s new QMSR aligned with ISO 13485:2016 to risk-based thinking, supplier controls, and right-sizing your documentation, this episode gives you actionable, real-world strategies to streamline your QMS without sacrificing compliance.

Whether you’re a three-person startup or a 20,000-person organization, you’ll learn how to avoid bloated SOPs, empower teams to own their processes, and build a culture where quality is a partner—not the “business prevention department.”

Includes horror-story “QMS Confessions” you won’t believe.

Be sure to like and subscribe for even more insights on medical device regulations, compliance, and quality systems (it will be fun and not painful, we promise).

Watch the video on YouTube: https://youtu.be/b947AW_N3nc
Visit us at https://leanraqa.com/ for evenmore regulatory goodness and to learn more about our services.
📩Got a question or a topic for a future session? Drop it in the comments below!
#FDA #RegulatoryAffairs #MedicalDevices #MedTech #Compliance #PreSub#QualitySystems #submissions #commercialization #startups #productlaunches#businessdevelopment

If you’re thinking about investing in medtech, congratulate yourself—you’ve chosen one of the most exciting, innovative, and occasionally stomach-churning sectors out there.

But between regulatory hurdles, clinical workflow quirks, and the fact that even great ideas can wither in the wild, medtech due diligence is…well, a sport.

In a recent webinar, industry veteran Renee Franz (Lean RAQA) teamed up with venture capitalist and serial entrepreneur Mudit Jain, PhD, (Treo Ventures) to walk investors through the realities of evaluating medical device opportunities.

With over 30 years of combined experience, plus unicorn exits, hundreds of cleared devices, and several cautionary tales under their belts, their conversation is a gold mine for investors entering this space.

Subscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense.

Watch the video on YouTube: https://youtu.be/Y_QojHiu4dQ

Visit us at https://leanraqa.com/ for even moreregulatory goodness and to learn more about our services.

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, Michelle Lott and Ti Benson break down one of the trickiest parts of the FDA clearance process: how to select a predicate that passes the “substantial equivalence” test without raising new questions of safety and efficacy.

You’ll learn how to build a strong predicate comparison table, what features FDA expects you to include, how to evaluate post-market data, and when older or newer devices make sense. Michelle and Ty also unpack the latest FDA thinking on predicate age, recalls, and draft guidances that are reshaping the regulatory landscape.

Whether you’re new to regulatory strategy or refining your next submission, this conversation offers practical insight—and a few laughs along the way—into making your predicate selection bulletproof.

Watch the video on YouTube: 

Be sure to subscribe to the Device & Conquer podcast for bold, insightful conversations that make medtech regulation make sense.

Visit us at  https://leanraqa.com/ for even more regulatory goodness and to learn more about our services.

📩Got a question or a topic for a future session? Drop it in the comments below!

#FDA #RegulatoryAffairs #MedicalDevices #MedTech #Compliance#PreSub#QualitySystems #submissions #commercialization #startups#productlaunches#businessdevelopment

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 & Conquer, Michelle Lott and Tianna Benson unpack what really goes into preparing an FDA 510(k) submission — from substantial equivalence and predicate devices to the eSTAR template, testing requirements, and why your submission is basically a regulatory novel.

They also cover the difference between traditional, special, and abbreviated 510(k) pathways, the myths around timelines, and why “just throw money at it” never works when you’re waiting on biocompatibility results.

In this episode, you’ll learn:

• How to structure your 510(k) as a cohesive “story”

• What FDA reviewers actually look for (and what confuses them)

• The role of risk management, human factors, and performance testing

• What the eSTAR template really does — and doesn’t — simplify

• When to use special vs. traditional 510(k) submissions

• How to avoid common rookie mistakes and review delays

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 Benson explain how to Pre-Sub like a pro.

They explain when to use a pre-sub, how to structure your questions, and what to expect from FDA’s new eSTAR electronic template. Plus: insider tips on labeling, clinical protocols, and the art of “Does FDA concur?”

You’ll learn:

• How to use pre-subs to guide your FDA reviewer’s thinking

• What makes a strong vs. weak pre-sub question

• The difference between protocols and data (and why it matters)

• The risks of vague, open-ended questions

• Why IFUs and labeling now drive early FDA interpretation

• How FDA feedback lives forever — even from 10 years ago

Listen in and learn how to master the FDA pre-sub process and get insights that will help you move your device forward.

Watch the video on YouTube: https://youtu.be/XIJ2SAyAF9w

Be sure to subscribe to the Device and Conquer podcast for bold, insightful conversations that make medtech regulation make sense.

Visit us at https://leanraqa.com/ for evenmore regulatory goodness and to learn more about our services.
📩Got a question or a topic for a future session? Drop it in the comments below!
#FDA #RegulatoryAffairs #MedicalDevices #MedTech #Compliance #PreSub#QualitySystems #submissions #commercialization #startups #productlaunches#businessdevelopment

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.

Subscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense.

Watch the video on YouTube: https://youtu.be/5vQjrwYforY

Visit us at https://leanraqa.com/ for even more regulatory goodness and to learn more about our services.

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.

Watch the video on YouTube: https://youtu.be/lCICbNHgt4I

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 (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 to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense.

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

Visit us at https://leanraqa.com/ for even more regulatorygoodness and to learn more about our services.

Subscribe to the leanRAQA Today podcast for even more bold,insightful conversations that make medtech regulation make sense.

Watch the video on YouTube:

Visit us at https://leanraqa.com/ for even more regulatorygoodness and to learn more about our services.

📩Gota question or a topic for a future session? Drop it in the comments below!

Subscribe to the leanRAQA Today podcast for even more bold,insightful conversations that make medtech regulation make sense.

Watch the video on YouTube:

Visit us at https://leanraqa.com/ for even more regulatorygoodness and to learn more about our services.

📩Gota question or a topic for a future session? Drop it in the comments below!

Visit us at https://leanraqa.com/ for even more regulatorygoodness and to learn more about our services.
📩Got a question or a topic for a future session? Drop it in the comments below!

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 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!

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.

Watch the video version on YouTube: https://youtu.be/JbuFPVBuB-4

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.

Watch the video version on YouTube: https://youtu.be/nw9f7r5aWqE

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’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.

(MDR content starts at 7:06 if you don't want to listen to "Real or Ridiculous")

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.

Watch the video version on YouTube: https://youtu.be/lJIGfF4wECQ

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 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.

You can also watch the video version on YouTube: https://youtu.be/vBdgGz38Ewk

What if your quality system could audit itself — and tell you where you’re overcomplying, underperforming, or about to get caught in a regulatory trap?

In this episode of Lean RAQA Today, Michelle Lott sits down with Adam, founder of Ryden Solutions, to explore how AI-driven tools are changing the landscape of medical device quality management, audits, and regulatory compliance.

From navigating 225+ regulatory requirements to surviving 30 audits a year, Michelle and Adam share real-world lessons, laugh at regulatory absurdities, and imagine a future where AI helps—not hinders—compliance.

In this episode, you’ll learn:

• How AI and automation can streamline QMS maintenance and audits

• Why large medtech companies struggle with harmonizing multiple quality systems

• How Raiden Solutions is pioneering continuous gap analysis and compliance intelligence

• What the QMSR transition means for FDA inspections in 2026

• Why global “harmonization” is unraveling — and how Brexit, MDR, and AI are complicating things

• How regulators (and AI) are already scanning 510(k) data for fraud

• The line between useful automation and overengineering your processes

Subscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense.

Watch the video on YouTube: https://youtu.be/EICxX3h-7_UVisit us at https://leanraqa.com/ for even moreregulatory goodness and to learn more about our services.

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 this episode, Michelle Lott joins Monir El Azzouzi on the Medical Device Made Easy podcast to unpack the truth behind the Breakthrough Devices Program — from eligibility and benefits to the myths, statistics, and reality checks every medtech company needs before applying.

They discuss how this program — and its sibling, the Safer Technologies Program (STEP) — fits into the FDA’s pre-submission framework, the most common reasons applications are rejected, and why only a fraction of “breakthrough” devices ever make it to market.

Here's what else you’ll learn:

• What the FDA Breakthrough Device Program is — and what it’s not

• Key differences between Breakthrough and Safer Technologies (STEP) programs

• How to prove your device treats a life-threatening or permanently debilitating condition

• Why early data, prototypes, and patient advocacy are essential for success

• What the real benefits (and limits) of designation are

• Hard stats: only ~12% of devices reach market authorization

• How to make your submission persuasive — and avoid the “rose-colored glasses” trap

Whether you’re an early-stage startup or an experienced RAQA professional, this conversation demystifies one of FDA’s most talked-about programs — and shows you how to navigate it strategically.

Subscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense.

Visit us at https://leanraqa.com/ for even moreregulatory goodness and to learn more about our services.

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 most startups make it much harder than it has to be.

In this episode of Lean RAQA Today, Michelle Lott and Renae Franz reveal the most common mistakes medtech startups make from concept through commercialization — and how to avoid the “butterfly effect” that can turn a minor oversight into a million-dollar failure.

From creating a traceability matrix that actually prevents design disasters to aligning your regulatory, quality, and business strategy, Michelle and Renae share practical frameworks, real-world cautionary tales, and actionable advice to help startups save time, money, and credibility on the path to FDA clearance and market success.

In this episode, you’ll learn:

• Why most startups are only 20% done when they think they’re 80% ready for FDA

• How to use a trace matrix to prevent downstream compliance failures

• Real-world horror stories: cold-weather power cords, overdrawing donors, and untested adhesives

• How early regulatory strategy affects design, documentation, and market selection

• How to avoid the “Porsche vs. Ford Focus” problem in medical device design

• What to know about 510(k), de novo, and PMA pathways (and what each really costs)

• Why unsubstantiated marketing claims can derail your entire launch

• Commercialization strategy 101: distribution, sales models, and hospital adoption

• Protecting your IP and product cost structure before it’s too late

If you’ve ever thought “we’ll deal with regulatory later,” this episode will convince you otherwise — with humor, humility, and decades of hard-earned insight.

Subscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense.

Watch the video on YouTube: https://youtu.be/94gm5sP0EDUVisit us at https://leanraqa.com/ for even moreregulatory goodness and to learn more about our services.

The EU Medical Device Regulation (MDR) has reshaped the European regulatory landscape — bringing new rigor, new challenges, and plenty of confusion.

In this episode, Michelle Lott joins Etienne Nichols (Greenlight Guru) and Karandeep Singh Badwal to debate the real-world impact of MDR on medtech innovation, market access, and patient safety.

From notified body bottlenecks to language barriers, inconsistent interpretations, and the myth of increased safety, the trio unpacks what MDR is really doing to the industry — and what manufacturers can do to survive (and thrive) under it.

Here's what you’ll learn:

• How MDR differs from MDD — and why it’s not a total overhaul

• Why software, AI, and post-market surveillance have become regulatory pain points

• The 12–18 month reality of CE marking under MDR

• How to select the right notified body (and why language matters)

• Why documentation ≠ device safety — and integrity still matters most

• The “significant change” rule: what triggers recertification

• Why smaller companies are struggling to stay in the EU market

• Practical steps to build a quality culture and navigate MDR effectively

Subscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense.

Watch the video on YouTube: https://youtu.be/Kgbmh0neJpE

Visit us at https://leanraqa.com/ for even moreregulatory goodness and to learn more about our services.