LTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning
From Let's Talk Risk! with Dr. Naveen Agarwal by Casual and informal conversations about practical aspects of medical device risk management.
February 27, 2026 · 28 min
About this episode
Holly Cotter discusses the transition from QSR to QMSR and its implications for MedTech manufacturers.
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…
People in this episode
Host: Naveen Agarwal
Guest: Holly Cotter
Topics covered
- Quality Management System Regulation
- FDA inspection
- MedTech industry
- ISO 13485 certification
- regulatory changes
- quality planning
Keywords
- QMSR
- FDA
- MedTech
- ISO 13485
- MDSAP
- regulatory compliance
- quality planning
- risk management
Mentioned in this episode
Organizations: FDA, ISO 13485, MDSAP, indieMedTech
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