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

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conversation explores how FDA is signaling its expectations well before inspections begin, particularly through new draft guidance for pre-market submissions.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.Chapters00:00 Why QMSR readiness matters now01:00 Industry complacency and false hope for delays05:00 FDA signals through pre-market guidance09:00 Compliance vs. assurance: what FDA really wants11:00 What “risk-based” means beyond ISO 1497114:00 Where companies should prioritize immediately17:00 Management review and executive accountability26:00 The opportunity for QA/RA leadership under QMSRSuggested links:* LTR: Risk, CAPA and FDA Inspections under QMSR. * Lean RAQA: RAQA Services, Resources and Courses. * FDA: Voluntary Improvement Program (VIP).Key Takeaways* Many companies are aware of QMSR, but are still not acting with urgency.* ISO 13485 alignment significantly reduces compliance risk, but does not eliminate it.* FDA has already committed to inspecting against QMSR beginning February 3, 2026 and there is no grace period coming.* New PMA draft guidance signals FDA’s shift from compliance evidence to assurance of sustained safety and effectiveness.* “Risk-based approach” under QMSR applies across the entire QMS, not just ISO 14971 hazard analyses.* Management review is no longer protected territory; FDA can now assess how leadership identifies and responds to systemic risk.* The five chronic FDA pain points: CAPA, complaints, design controls, supplier controls, and nonconforming product, will matter even more under QMSR.* Strong QA/RA leaders can use QMSR as a platform to become prevention partners, not procedural gatekeepers.KeywordsQMSR readiness, FDA QMSR, ISO 13485, risk-based approach, risk-based assurance, compliance vs assurance, FDA inspections, management review accountability, CAPA effectiveness, supplier controls, quality system maturity, QA/RA leadershipAbout Michelle LottMichelle Lott is the founder of Lean RAQA, where she provides fractional RA/QA leadership, audit prep, quality system design, and regulatory strategy for MedTech startups and small companies. With 20+ years of experience and an RAC certification, Michelle has helped hundreds of firms navigate FDA submissions and ISO compliance, bringing clarity and efficiency to even the most complex regulatory challenges. DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe