Introduction to QMSR

Ready or not, QMSR is coming! - The FDA's new QMSR won't wait for you to catch up. Scared? Feeling Lost? That’s understandable. We are here to help ensure your Quality Management System is ready.

In February 2024, the FDA introduced new Quality Management System Regulations (QMSR) to incorporate ISO 13485:2016 by reference, creating significant changes in the compliance landscape by February 2026. If your QMS is primarily structured around the previous FDA regulations, or if you're a startup beginning to build your quality system, planning a smooth transition is crucial.