RAQA Today

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...

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 freez...

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,...

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 ...

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 understan...

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...

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 versio...

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 un...

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 i...

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 sur...

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...

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 int...

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 my...