FDA QMSR Explained: How the QMSR Replaces the QSR
Duration: 60 Minutes
The FDA Quality Management System Regulation (QMSR) took effect in February 2026, replacing the Quality System Regulation (QSR). This 60-minute FDA QMSR training explains how ISO 13485 has been incorporated into 21 CFR Part 820 and what that means for your quality system.
The QMSR is more than a revision. It aligns FDA requirements with ISO 13485 while keeping many QSR requirements, and it expects risk to be applied to quality system processes. Because the regulation doesn't say how to do that, the session explains the hazard analysis process under ISO 14971 and how to apply it to those processes.
You'll also learn what FDA now expects from top management, how supplier oversight is strengthened and risk based, and what this means for FDA inspections.
- Build a quality system that conforms to the QMSR
- Explain how ISO 13485 is incorporated into 21 CFR Part 820
- Identify the QSR requirements the QMSR retains
- Apply ISO 14971 hazard analysis to quality system processes
- Describe FDA expectations for top management and supplier oversight
- ISO 13485
- QMSR requirements
- Sections of 21 CFR 820 that are retained
- Hazard analysis procedure
- Applying risk analysis to quality system processes
- Top management involvement and FDA expectations
- Risk-based supplier oversight
- FDA inspections
Device manufacturers now face stricter requirements. Documents that prove product quality are no longer enough, and neither is conformance to ISO 13485 on its own. Quality is the process that controls the documents, and those processes, including supplier control, CAPA, change control and training, must be risk based.
The session suits engineering staff, software and development engineers, production management, QA and QC personnel, and management.
- Engineering personnel
- Software developers
- Development Engineers
- Production Management
- QA/ QC personnel
- Management
Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
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