FDA QMSR Explained: How the QMSR Replaces the QSR
Duration: 60 Minutes
This course will explain the FDA QMSR that is effective February 2026, replacing the QSR.
The integration of ISO 13485 into 21 CFR Part 820 to form the QMSR will be explained. The QMSR isn’t only a revision. It changes the approach to a Quality System. It aligns FDA requirements with ISO 13485 while retaining many of the FDA QSR requirements. Emphasis is on applying risk to the processes of the Quality System. Compliance is more than creating documents , it is creating risk based integrated processes.
An important part of the QMSR is applying risk evaluation to QS processes. However, it does not describe how to do this. We will explain the Hazard Analysis process, following ISO 14971, and how to apply it to the Quality System processes.
Top management must now be very involved in the QS. We will describe the FDA expectations for top management.
Supplier oversight is risk based and is strengthened.
- How to create a quality system that conforms to the QMSR
- ISO 13485
- QMSR requirements
- Retained sections of 21 CFR 820
- Hazard analysis procedure
- How to apply risk analysis to QS processes
- FDA inspections
Device manufacturers will face new and stricter requirements than before. The emphasis is on controlling quality of the processes involved in the Quality System. Creating documents that prove product quality is not sufficient. Quality is no longer documents. Quality is the process that controls the documents. Conforming to ISO 13485 is not sufficient. Having risk based quality processes is necessary. These processes include supplier control, CAPA, change control, and training. Handouts are pre release change control form, post release change control form,
- 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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