FDA QMSR: What it Means for Your Quality Management System
Learn more about FDA QMSR: https://softwareconnect.com/go/fda-qm...
The FDA’s Quality Management System Regulation (QMSR) officially replaced the old 21 CFR Part 820 QSR on February 2, 2026. This incorporated ISO 13485 directly into U.S. regulation. For medical device manufacturers, this is the biggest shift in FDA quality requirements in nearly 30 years. In this video, we cover what changed, where companies are most exposed during inspections, and what the new rule means for your quality management system and QMS software.
QMS Platforms Mentioned:
Greenlight Guru: https://softwareconnect.com/go/greenl...
Qualio: https://softwareconnect.com/go/qualio...
Octave (EtQ) Reliance: https://softwareconnect.com/go/octave...
UniPoint: https://softwareconnect.com/go/unipoi...
QT9 QMS: https://softwareconnect.com/go/qt9-qm...
Get tailored QMS recommendations: https://softwareconnect.com/go/get-fr...
Compare medical device QMS: https://softwareconnect.com/go/medica...
Timestamps
0:00 – Intro
0:41 – What QMSR actually changes
1:09 – Terminology changes
2:03 – Major change #1: internal audit record visibility
2:40 – Major change #2: risk management across the QMS
3:20 – Major change #3: supplier risk evaluation
4:00 – Which manufacturers are most exposed
4:40 – What to look for in QMS software under QMSR
5:13 – QMS platforms supporting medical device compliance
5:43 – Final thoughts
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