Overview of the Quality System Regulation

Sunday, June 2, 2024

Tag Archives: medical devices

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 [ad_2] Source link

Leave a comment 21 CFR 820, CDRH, Center for Devices and Radiological Health, CGMPs, Corrective and Preventive Action Subsystem (CAPA), FDA, medical devices, quality assurance, quality control, Quality System Regulation, radiation-emitting devices

Medical Devices Regulation Training

Shortcut Guy Regulation

MedTech Europe’s training on Medical Devices Regulation. [ad_2] Source link

4 comments medical devices, medtech, medtech europe, regulation, training