QMSR Unpacked: The New FDA Playbook for Quality System Readiness

QMSR is not just a terminology update from QSR to ISO 13485. It changes how FDA inspectors evaluate quality systems, risk-based decision-making, management responsibility, CAPA, complaints, design controls, and quality culture. In this Friday In-Focus session, Michelle Lott, RAC, and Dawn Balazs-Metz unpack what FDA now expects under QMSR, how those expectations compare with ISO 13485 and EU MDR practice, and what RA/QA teams should do now to prepare for inspections. You will learn: • Why FDA is putting more emphasis on risk-based quality management and quality culture • How QMSR changes inspection focus across CAPA, complaints, supplier controls, product realization, and risk management • Why top management accountability matters more under the new inspection model • What design control teams need to know about risk integration, DHF, DMR, and Medical Device File expectations • How management review records need to show clear inputs, outputs, decisions, and follow-through • Why CAPA must better separate corrections, corrective actions, and preventive actions • How complaints and broader feedback now connect into PMS, risk management, recalls, and lifecycle improvement • What resources and training can help teams prepare for QMSR readiness Speakers: • Michelle Lott, RAC — Principal and Founder, leanRAQA • Dawn Balazs-Metz — Principal Consultant and Founder, Balazs-Metz Consulting, LLC Replay and chapters below. 00:05 – Welcome and speaker introductions 02:00 – Session agenda and how to submit questions 03:00 – Are you ready for FDA’s new inspection methodology? 04:01 – Why historic 483 trends matter under QMSR 04:52 – EU notified body framing: same questions, different auditors 05:17 – Early QMSR 483 metrics and new inspection categories 06:35 – Risk-based QMS decisions, quality culture, and top management accountability 07:30 – EU vs FDA experience with ISO 13485 expectations 09:31 – Layered expectations: QMSR, ISO 13485, QSR preamble, and supporting guidance 11:23 – Amy White resources and practical QMSR interpretation 13:32 – Integrated risk management across the QMS 18:30 – Design controls, recalls, and safety-by-design expectations 22:55 – EU technical documentation as a living file 23:42 – Independent design reviewers and practical best practices 25:45 – Risk management integration across user needs, design inputs, and lifecycle controls 31:00 – Management review requirements: inspectable inputs and outputs 35:45 – CAPA under QMSR: corrective vs preventive actions and risk-based triggers 37:30 – Corrections, field actions, and reporting responsibilities 39:30 – New data inputs feeding CAPA and trending 41:10 – Complaint procedures under QMSR, ISO 13485, and 21 CFR 820.35 42:20 – Feedback beyond complaints: positive input, surveys, and social listening 43:00 – EU MDR post-market surveillance: proactive and reactive data streams 44:15 – Complaint links to reporting, UDI tracking, recalls, and labeling controls 45:50 – Practical resources for QMSR and ISO 13485 readiness 46:25 – FDA’s new one-day inspection method and early adoption signals 47:55 – QMSR training options and implementation support 48:50 – EU regulatory outlook: MDR 2.0, UDI rollout, and notified body bottlenecks 53:18 – Follow-up resources, slides, Q&A summary, and closing