QMSR, AI Reviewers and the Value of a Good FDA and Internal Audit | leanRAQA Today | S5:E4

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.