Maps to
FDA QMSR (Part 820): §820.30(f)
ISO 13485: ISO 13485 §7.3.6
Requirement text
Design verification shall confirm that outputs meet input requirements. Results and follow-up actions shall be recorded.
Atomic constraints
- •Verification must confirm outputs meet inputs
- •Verification results must be recorded
- •Follow-up actions must be documented
- •Traceability to design inputs must exist
Evidence signals
- •
FILE_EXISTS
(Verification.*Report|Test.*Report|V.V|Design.*Verification)
- •
CONTENT_MATCH
Does this document describe design verification activities, test results, or traceability to design inputs?
Audit defense
Design verification for [your product] is documented in [your document ID]. All verification activities confirm outputs meet their corresponding design inputs, with results and follow-up actions formally recorded per QMSR 820.30(f).