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.