As of February 2, 2026, the transition period for the Quality Management System Regulation (QMSR) has officially ended. The FDA now expects full compliance with this new framework, guaranteeing that FDA 21 CFR part 820 and ISO 13485 operate as one.
As of February 2, 2026, the transition period for the Quality Management System Regulation (QMSR) has officially ended. The FDA now expects full compliance with this new framework, guaranteeing that FDA 21 CFR part 820 and ISO 13485 operate as one.