A New Chapter in Quality Regulation, for nearly three decades, the Quality System Regulation (QSR) under 21 CFR Part 820 has defined how medical-device manufacturers in the United States ensure their products are safe, effective, and consistently produced.
Now, for the first time since 1996, the FDA is rewriting that foundation. On February 2, 2026, QSR will officially give way to the Quality Management System Regulation (QMSR) — a modernized framework aligned with the global standard ISO 13485:2016.
This isn’t just a new acronym. It’s a strategic shift toward global harmonization, risk-based thinking, and evidence-driven compliance.
Why This Shift Matters
The FDA recognized what manufacturers have been saying for years: Maintaining two separate quality frameworks — QSR for the U.S. and ISO 13485 for international markets — creates redundant work without improving patient safety.
By aligning with ISO 13485, the new QMSR allows for:
- Global consistency: One system can satisfy both U.S. and international markets.
- Reduced duplication: Fewer parallel procedures and records.
- Better supplier oversight: Standardized expectations worldwide.
- Improved risk control: Risk management applies across the entire product lifecycle.
The goal isn’t to make compliance easier — it’s to make it smarter.
From QSR to QMSR: What’s Really Changing
Documentation Structure
- Manufacturers must now maintain a Quality Manual and a Medical Device File for each product family.
This ISO-style structure replaces the patchwork of DMRs, DHRs, and DHFs. The new format emphasizes clarity and traceability — from design input to post-market feedback. - Risk Integration
Risk is no longer a chapter in your design procedure; it’s the thread that runs through every process.
Supplier qualification, CAPA, change control, and management review must all document how risk was evaluated and mitigated. - Transparency of Records
Under QSR, certain internal documents were often considered off-limits to FDA inspectors. That has changed.
Management reviews, supplier audits, and internal audit reports will now be within the FDA’s inspection scope. - Supplier Controls
Expect to see risk-based qualification and re-evaluation programs with formal quality agreements for critical suppliers.
What Isn’t Changing
The core pillars of QSR remain relevant: Design controls, CAPA, process validation, and complaint handling still apply.
The difference is that now they must be documented and analyzed through a global lens.
How to Prepare Now
- Perform a Gap Assessment — Map existing procedures against ISO 13485 and QMSR.
- Create a Transition Plan — Prioritize high-risk gaps first (e.g., supplier oversight).
- Train Your Teams — Focus on competence and ownership, not checkbox training.
- Test Your System — Conduct a mock inspection to confirm readiness.
The Compliance Insight Advantage
Since 2000, Compliance Insight has guided manufacturers through every major FDA change.
Our consultants combine hands-on experience with regulatory expertise to make your transition smooth, structured, and inspection ready.
Contact us today to schedule a QMSR readiness assessment and turn regulatory change into a strategic advantage.