On February 2, 2026, the FDA will officially replace its long-standing Quality System Regulation (QSR, 21 CFR Part 820) with the Quality Management System Regulation (QMSR). This is the most significant update to U.S. medical device quality requirements in decades.

The QMSR aligns U.S. regulations with ISO 13485:2016, the internationally recognized quality standard for medical devices. For manufacturers, this means fewer duplicative systems, better global harmonization, and clearer expectations during inspections.

Key Changes Under QMSR

Compared to QSR, the new QMSR introduces important shifts:

• Risk Management Everywhere – Risk-based thinking must be integrated throughout the quality system, not just in design validation.
• Document & Record Control – Terms like DMR, DHR, DHF give way to ISO’s “Medical Device File,” and a Quality Manual is now required. All QMS records (including management reviews and internal audits) are subject to FDA inspection.
• Supplier Oversight – Stronger, risk-based supplier controls and documented quality agreements are expected.
• CAPA & Data Analysis – Trend analysis of quality data and proactive, risk-based corrective and preventive actions are emphasized.
• Design Controls – Enhanced traceability between design inputs, outputs, verification, and validation is required.
• Complaint Handling – Complaint records must now include device identifiers such as UDI, ensuring tighter post-market traceability.

Why It Matters

FDA’s QMSR harmonization with ISO 13485 reduces compliance burdens for companies selling globally, but it also raises the bar for inspection readiness. The FDA will expect clear evidence of risk-based processes, updated documentation, and full record transparency.

How Compliance Insight Can Help

At Compliance Insight, we’ve guided medical device manufacturers through FDA transitions for over 25 years. Our experts are ready to:

• Conduct QMSR gap assessments against your current QSR-based system.
• Update procedures, forms, and records to meet ISO 13485 and QMSR requirements.
• Train your team on risk management, CAPA, and QMSR inspection readiness.
• Support supplier qualification and quality agreement updates.

With our experience in FDA-regulated industries, we make the complex transition to QMSR straightforward, compliant, and inspection-ready.