Select Page
nonconforming materials report

How Design Control Requirements have Changed with the New QMSR

The Quality Management System Regulation (QMSR) replaced the Quality System Regulation (QSR) on February 2, 2026. This update aligned 21 CFR 820 with ISO 13485:2016, therefore changing the standards for design control. 

To read more about how the QMSR changed design control requirements, download our FREE white paper! 

Get your FREE White Paper here!


* These fields are required.