The US FDA QMSR Transition - 21 CFR 820 and ISO 13485

This course turns the FDA’s QMSR transition into a clear, actionable roadmap — showing how ISO 13485 becomes federal law, how risk management expands under ISO 14971, and what shifts inside the new Part 820 demand immediate attention. It helps you understand the rule the way FDA expects industry to understand it.

The FDA is pushing one of the biggest shifts the medical device world has seen in decades: replacing the long-standing QSR with a new Quality Management System Regulation aligned directly with ISO 13485. This isn’t a cosmetic rewrite. It changes how companies think about risk, documentation, inspection readiness, design control, and the overall culture of quality. If your organization makes devices, combination products, or supports compliance activities, this transition will reshape your daily work.

The new rule strengthens risk management expectations using ISO 14971, tightens traceability requirements, updates design control expectations for Class II and III devices, and redefines what senior management accountability should look like. It also brings “incorporation by reference” into the spotlight — which means ISO 13485 becomes part of federal regulation, not just a best practice. Companies that treat this lightly will struggle during inspections, while those who prepare now will operate with far more clarity and confidence.

This session breaks down what the QMSR actually demands, what’s changing inside the new Part 820, and where manufacturers often underestimate the effort required. If you want a clear, practical understanding of the new rule — without drowning in regulatory jargon — this course delivers the direction and industry context you need to prepare your teams for the one-year transition window.

WHAT WILL YOU GAIN

• A detailed breakdown of QMSR expectations vs. existing 21 CFR 820 requirements
• Insight on how risk management under ISO 14971 must now shape your QMS
• Guidance to handle the one-year transition without disrupting operations

WHY TAKE THIS COURSE

• Eliminate ambiguity between ISO and FDA quality expectations
• Learn where current processes fall short of QMSR and how to fix them
• Build team alignment before the transition window closes

KEY AREAS COVERED

• The structure and intent of the new Quality Management System Regulation (QMSR)
• How “incorporation by reference” pulls ISO 13485 into 21 CFR 820
• Expanded risk management expectations tied to ISO 14971
• Key changes to design control, traceability, and customer focus
• Impacts on Class I, II, and III devices—plus combination products
• Phase-in timeline and what to prioritize during the transition