QSR | 21 CFR Part 820 AUDIT

QSR, or Quality System Regulation, refers to the set of regulations outlined in 21 CFR Part 820 by the United States Food and Drug Administration (FDA). These regulations specify requirements for the manufacturing of medical devices sold in the United States. Conducting an audit of a Quality System Regulation (QSR) according to 21 CFR Part 820 involves assessing a medical device manufacturer's compliance with these regulations.