FDA 21 CFR 820
The Quality System Regulation (QSR) is the applicable United States of America law for all economic partners involved in medical devices. The QSR consists of 15 Subparts, defined by letters from the alphabet. Find here the overview of the text and Expert explanations and opinions.
QSR
Subpart A - General provisions
Subpart B - Quality System Requirements
Subpart C - Design Controls
Subpart D - Document Controls
Subpart E - Purchasing Controls
Subpart F - Identification and Traceability
820.65
Traceability
Subpart G - Production and Process Controls
820.70
Production and process controls
820.72
Inspection, measuring, and test equipment
Subpart H -Acceptance Activities
820.86
Acceptance status
Subpart I -Nonconforming Product
Subpart J - Corrective and Preventive Action
Subpart K - Labelling and Packaging Control
820.120
Device labeling
Subpart L - Handling, Storage, Distribution, and Installation
Subpart M - Records
820.180
General requirements
820.181
Device master record (DMR)
820.184
Device hystory record (DHR)
820.198
Complaint files
Subpart N - Servicing
Subpart O - Statistical Techniques
