Quality Management System Regulation (QMSR)

The clock is officially ticking!

We are in the midst of a significant regulatory shift for the medical device industry as the FDA’s Quality System Regulation (QSR) transitions to the Quality Management System Regulation (QMSR)! This announcement was officially made by the FDA on January 31st, 2024. The change introduces new expectations for quality systems by incorporating by reference the standards found in ISO 13485:2016. This means a comprehensive overhaul to FDA regulations aligning industry practices to international ISO standards.

What are the implications of the FDA’s change from QSR to QMSR for medical device manufacturers?

By February 2, 2026, medical device manufacturers must align their Quality Systems with the new QMSR requirements. This transition represents a considerable overhaul of existing practices, making early preparation crucial. Manufacturers will need a gap analysis to determine where their current quality system is lacking in light of what the new regulation demands. Once revisions to quality systems are made, then effective trainings about those revisions must be completed and documented. Last but not least, manufacturers must be ready to implement the changes at a fundamental and logistical level.

When do I need to act?

NOW! Don’t wait until this deadline is breathing down your neck; start to prepare for and execute this change immediately. Contact us to request a gap analysis, onsite internal audit, or support updating your quality system as your team embarks on this significant transition. DP Distribution & Consulting, LLC® has experts ready to walk you through the upheaval and help your company settle into the new expectations. We can be reached via the form or at 804-965-3981.

For more information on QMSR transition prep, click here.