Maps to
FDA QMSR (Part 820): §820.198
ISO 13485: ISO 13485 §8.2.1
Requirement text
The organization shall gather and monitor information on whether customer requirements have been met, including post-market surveillance.
Atomic constraints
- •Feedback collection process must be documented
- •Post-market surveillance plan must exist
- •Customer feedback must be analyzed for trends
- •Feedback must feed into CAPA and risk management
Evidence signals
- •
FILE_EXISTS
(Post.*Market|PMS.*Plan|PMCF|Customer.*Feedback|Surveillance|PMS)
- •
CONTENT_MATCH
Does this document describe post-market surveillance, customer feedback collection, or PMCF activities?
Audit defense
Post-market surveillance for [your product] is managed through [your document ID]. Our PMS plan defines data sources, collection methods, and analysis requirements. Feedback trends are systematically analyzed and feed into CAPA and risk management per ISO 13485 8.2.1.