Quality Assurance
FDA QMSR Transition (21 CFR 820 → ISO 13485)
Align your quality system to FDA’s Quality Management System Regulation, in effect since February 2, 2026.
What It Is
FDA quality system requirements have changed. Is your business ready?
The FDA’s Quality Management System Regulation (QMSR) took effect February 2, 2026, bringing U.S. medical device quality requirements into closer alignment with ISO 13485:2016.
For your business, this means your existing quality processes, documentation, and procedures may need updates to meet the new requirements.
Whether you’re already ISO 13485 certified or operating under the previous FDA Quality System Regulation (QSR), understanding what’s changed is essential to maintaining compliance and staying prepared for FDA inspections.
When You Need It
If you manufacture or distribute medical devices subject to FDA quality system requirements, it’s time to make sure your quality system is aligned.
You may need support if you’re:
- Unsure whether your current quality system meets QMSR requirements.
- Already ISO 13485 certified but need to address remaining FDA-specific requirements.
- Transitioning from the previous 21 CFR Part 820 requirements.
- Concerned about documentation gaps, inspection readiness, or the time required to update your processes.
- Looking for expert guidance without overwhelming your internal team.
Even if your quality system is well established, a targeted review can help identify gaps before they become compliance issues.
What We Do
We take the complexity out of QMSR compliance so you can focus on running your business.
Our team helps you understand exactly what needs to change, what can stay the same, and how to move forward with confidence.
We assess your existing quality system, identify compliance gaps, and develop a practical action plan tailored to your organization.
From updating procedures and documentation to training your team and preparing for FDA inspections, we provide hands-on support throughout the process.
Already ISO 13485 certified? We focus on the FDA-specific gaps, helping you avoid unnecessary work.
Still operating under the previous QSR? We guide you through the full transition.
The result: A quality system aligned with current FDA requirements, a team that understands its responsibilities, and greater confidence heading into your next inspection.
We Live It, Not Just Advise It
Our own family quality system is making this exact transition, on the same deadline, across manufacturing and sterilization operations that FDA can inspect. We are not interpreting QMSR from the outside — we are implementing it inside an FDA-registered establishment in real time, and bringing that working knowledge directly to your transition.
How AuditIQ Helps
AuditIQ maps your existing QMS against the QMSR and ISO 13485 reference, producing a gap list and a prioritized transition punch list so you focus effort where it actually matters and close gaps before your next FDA inspection.
Learn more about AuditIQ →Frequently Asked Questions
When did the FDA QMSR take effect?
The QMSR took effect February 2, 2026. Since that date, FDA quality system requirements incorporate ISO 13485:2016 by reference, replacing the prior 21 CFR 820 Quality System Regulation structure.
I am already ISO 13485 certified — do I still need to do anything?
Usually yes, but less. QMSR incorporates ISO 13485 but retains certain FDA-specific requirements (for example around records, labeling, and UDI) and changes how FDA inspects. We reconcile your certified system with those FDA-specific deltas so you are clean on inspection.
What happens to the DMR and DHR?
The QMSR moves away from the specific Device Master Record and Device History Record constructs of the old QSR toward ISO 13485’s medical device file and records structure. We update your terminology, documentation map, and procedures accordingly.
Ready to Talk Through Your QMSR Transition Project?
Tell us where you are in the process. We respond within one business day.
Request a ConsultThe Boulder BioMed Family
One campus, one quality system. We manufacture, sterilize, and test medical devices in-house — so our regulatory and quality work is grounded in operations, not theory.