Maps to
FDA QMSR (Part 820): §820.30(g)
ISO 13485: ISO 13485 §7.3.7
Requirement text
Design validation shall confirm the resulting product meets requirements for the specified application or intended use.
Atomic constraints
- •Validation must be performed under defined operating conditions
- •Validation must confirm product meets intended use
- •Clinical evaluation or usability testing must be included where applicable
- •Validation results must be recorded
Evidence signals
- •
FILE_EXISTS
(Validation.*Protocol|Validation.*Report|Clinical.*Evaluation|Usability)
- •
CONTENT_MATCH
Does this document describe design validation activities, clinical evaluation, or usability testing for intended use?
Audit defense
Design validation for [your product] is documented in [your document ID]. Validation was performed under defined operating conditions to confirm the device meets its intended use, with clinical evaluation and usability testing included per QMSR 820.30(g).