FDA QMSR: What it Means for Your Quality Management System

Learn more about FDA QMSR: https://softwareconnect.com/go/fda-qmsr-69594 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/greenlight-guru-review-4d132 Qualio: https://softwareconnect.com/go/qualio-review-e19a4 Octave (EtQ) Reliance: https://softwareconnect.com/go/octave-review-16e7b UniPoint: https://softwareconnect.com/go/unipoint-review-6bf36 QT9 QMS: https://softwareconnect.com/go/qt9-qms-review-e64bc Get tailored QMS recommendations: https://softwareconnect.com/go/get-free-consult-c6f0a Compare medical device QMS: https://softwareconnect.com/go/medical-device-qms-software-03219 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 #MedicalDevice #ISO13485 #QMSSoftware #FDACompliance #QMSR #QualityManagementSystem #RegulatoryCompliance