Episode
LTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning
- Podcast
- Let's Talk Risk! Podcast
- Published
- Feb 27, 2026
- Duration seconds
- 1701
- Processing state
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Summary
Summary “You don’t want to be implementing QMSR while the FDA is waiting in the lobby.” As the FDA transitions from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), confusion persists across the MedTech industry. Is ISO 13485 certification enough? Does MDSAP cover everything? What exactly will FDA inspectors expect? In this episode of the Let’s Talk Risk Podcast , host Naveen Agarwal sits down with Holly Cotter to talk about what this transition really means for manufacturers, especially startups and U.S.-only companies. Holly brings a rare perspective: biomedical engineer, hands-on clinical experience, global regulatory consultant, and community builder. Together, we unpack not just regulatory changes — but the leadership opportunity QMSR presents for quality and regulatory professionals. Chapters 00:00 Introduction and QMSR transition 02:25 Explicit vs. implied changes under QMSR 06:00 Risk beyond design validation: FDA’s broader lens 09:30 Inspection uncertainty: Q-SIT, guidance gaps, and readiness 11:35 MDSAP alignment: what it covers — and what it doesn’t 14:00 The Quality Plan: your most practical readiness tool 20:10 Dangerous assumptions about ISO 13485 certification 25:40 indieMedTech: building community in MedTech If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter . Suggested links: * LTR: QMSR Readiness, Risk-Based Assurance and FDA Expectations . * LTR: 90-Day QMSR Readiness Action Pan for Leaders . * LTR: FDA Readiness for QMSR . Key Takeaways * ISO 13485 certification ≠ automatic QMSR compliance * Risk-based thinking must extend across the entire quality system * Internal audits and management reviews will face deeper FDA scrutiny * MDSAP is helpful, but not sufficient * A simple…