FDA QSMR Awareness and Gap Assessment Checklist

Is your QMS ready for the FDA’s QMSR deadline on February 2, 2026?

If you manufacture or distribute medical devices in the U.S., the FDA's harmonization of 21 CFR Part 820 with ISO 13485:2016 known as the Quality Management System Regulation (QMSR) is a game-changer. This transformation will streamline compliance globally, but only if your systems are aligned.

Our FDA QSMR Gap Assessment Checklist is your essential toolkit to assess readiness, identify process gaps, and plan upgrades before it’s too late.

Download the Checklist Now and:

• Evaluate compliance with both ISO 13485:2016 and FDA QMSR
• Conduct a structured gap assessment across quality, regulatory, and manufacturing teams
• Assess what needs to be done for QMSR compliance ahead of the February 2026 deadline
• Create a timeline for remediation to stay ahead of audits
• Prioritize high-risk areas

This comprehensive, easy-to-use checklist provides a side-by-side comparison of ISO 13485 clauses and corresponding FDA QMSR (21 CFR) requirements.

With audit-readiness at stake, this checklist offers a practical, fast-start solution to benchmark your current state and initiate cross-functional improvement projects.

Download the Checklist