Quality Management System Regulation (QMSR)

The FDA’s Quality Management System Regulation (QMSR) became effective on February 2, 2026, amending the medical device current good manufacturing practice requirements in 21 CFR Part 820. Medical device manufacturers must now evaluate their quality systems against the requirements currently in effect.

QMSR incorporates ISO 13485:2016 by reference while retaining FDA-specific requirements. Compliance Insight helps manufacturers assess gaps, update procedures and records, and prepare their teams for FDA inspections under the current framework.

Key Changes Under QMSR

QMSR incorporates ISO 13485:2016 while retaining FDA-specific requirements. Key areas to assess include:

• Risk-Based Quality Processes – Evaluate how your procedures apply risk-based controls across the quality management system.
• Quality Documentation – Review your quality manual, medical device files, and supporting procedures against applicable requirements. Map existing DMR, DHR, and DHF documentation to the current framework rather than simply renaming files.
• Inspection Access to Records – Prepare management review, internal audit, and supplier audit records for FDA review. QMSR does not retain the former inspection exemption for these records.
• Supplier Controls – Review supplier selection, monitoring, and purchasing controls based on supplier performance and the risks associated with purchased products and services.
• CAPA and Data Analysis – Assess how complaints, nonconformities, audit findings, and quality trends inform corrective and preventive actions. Document effectiveness checks.
• Design and Development – Where applicable, verify that design procedures and records meet ISO 13485 requirements and FDA-specific provisions.
• Complaint and Identification Records – Verify that complaint, servicing, and device records contain the identification information required by 21 CFR 820.35, including applicable UDI information.

Why It Matters

QMSR is now in effect. Manufacturers should be able to demonstrate that their quality systems meet both the incorporated ISO 13485 requirements and applicable FDA requirements. ISO 13485 certification alone does not establish QMSR compliance or exempt a manufacturer from FDA inspection.

Compliance Insight helps medical device manufacturers assess QMSR gaps, strengthen documentation, and prepare for FDA inspections.

How Compliance Insight Can Help

Compliance Insight helps medical device manufacturers assess and strengthen their quality systems under QMSR. Our consultants can:

• Conduct gap assessments against applicable QMSR and ISO 13485:2016 requirements.
• Update quality procedures, forms, and records.
• Train teams on risk-based quality processes, CAPA, and FDA inspection readiness.
• Assess supplier qualification, monitoring, and purchasing controls.
• Support remediation planning and verification of corrective action effectiveness.

Whether you need a focused assessment or ongoing quality support, we help turn identified gaps into practical, prioritized actions.