# LTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations

Page: https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-138-michelle-lott-on-qmsr-readiness-risk-based-assurance-and-fda-expectations
Text version: https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/ltr-138-michelle-lott-on-qmsr-readiness-risk-based-assurance-and-fda-expectations.md
Podcast: [Let's Talk Risk! Podcast](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844)
Published: 2026-01-09T13:00:00+00:00
Episode link: https://naveenagarwalphd.substack.com/p/lltr138-michelle-lott-on-qmsr-readiness-risk-based-assurance-and-fda-expectations
Audio file: https://api.substack.com/feed/podcast/182964747/61cb959bc014ac9018fc3a8edd018016.mp3
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Duration seconds: 1783

## Resource

Summary “The industry is aware of QMSR, but they’re not moving. Many are still holding their breath, hoping something will change.” In this episode of the Let's Talk Risk Podcast , host Naveen Agarwal is joined by Michelle Lott for a deep and practical discussion on QMSR readiness as FDA’s February 2026 deadline rapidly approaches. Michelle shares a sobering view of where the medical device industry truly stands, highlighting a dangerous gap between awareness and action. The conversation explores how FDA is signaling its expectations well before inspections begin, particularly through new draft guidance for pre-market submissions. Together, Naveen and Michelle unpack what “risk-based approach” really means under QMSR, not just for design and development, but across supplier controls, CAPA, complaints, data analysis, and management review. They also examine one of the most consequential shifts under QMSR: FDA’s expanded authority to review management responsibility and system-level effectiveness. The episode closes on a forward-looking note, emphasizing the opportunity for QA/RA leaders to reposition themselves, not as compliance enforcers, but as strategic partners in prevention, assurance, and sustainable patient safety. Chapters 00:00 Why QMSR readiness matters now 01:00 Industry complacency and false hope for delays 05:00 FDA signals through pre-market guidance 09:00 Compliance vs. assurance: what FDA really wants 11:00 What “risk-based” means beyond ISO 14971 14:00 Where companies should prioritize immediately 17:00 Management review and executive accountability 26:00 The opportunity for QA/RA leadership under QMSR Suggested links: * LTR: Risk, CAPA and FDA Inspections under QMSR . * Lean RAQA: RAQA Services, Resources and Courses . * FDA: Voluntary Improvement Pro…

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