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.

Rise of the Regulatory Rebel

RAQA Today

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