Overview of the Quality System Regulation

This CDRH Learn module discusses the background, broad regulatory requirements and history of the FDA Quality System Regulation, 21 CFR 820 for medical devices. The module defines key terminology used in the QS regulation, explains the purpose of a quality system, and explains the 7 major sub-systems approach. To view more medical device educational resources please visit https://www.fda.gov/training-and-continuing-education/cdrh-learn

FDACDRHCenter for Devices and Radiological Health