Maps to
FDA QMSR (Part 820): §820.198
ISO 13485: ISO 13485 §8.2.2
Requirement text
The organization shall establish documented procedures for receiving, reviewing, and evaluating complaints. FDA-Plus: Each complaint must be evaluated to determine whether it constitutes a reportable event under 21 CFR Part 803 (MDR). Complaint investigation must determine if CAPA is needed. Records must be maintained and accessible for FDA inspection.
Atomic constraints
- •Documented complaint handling procedures must exist.
- •All complaints must be received, logged, and evaluated in a timely manner.
- •Each complaint must be assessed for MDR reportability (FDA requirement).
- •Investigation must determine root cause and whether CAPA is needed.
- •Complaint trending must be performed to identify systemic issues.
- •Complaint records must be maintained and retrievable.
Evidence signals
- •
FILE_EXISTS
(Complaint|CMPL|Customer.*Feedback|MDR.*Evaluation)
- •
CONTENT_MATCH
Does this document describe procedures for receiving, investigating, and evaluating complaints including MDR reportability assessment and trending?
Audit defense
Complaint handling for [your product] is managed through [your document ID]. Every complaint is logged, investigated, and evaluated for MDR reportability. Quarterly trending analysis feeds our CAPA system, ensuring systemic issues are identified and addressed proactively.