Maps to
FDA QMSR (Part 820): §820.30(d)
ISO 13485: ISO 13485 §7.3.4
Requirement text
Design and development outputs shall be documented, verified against inputs, and include acceptance criteria and essential product characteristics.
Atomic constraints
- •Outputs must be documented
- •Outputs must be verified against inputs
- •Outputs must include acceptance criteria
- •Essential safety/performance characteristics must be identified
Evidence signals
- •
FILE_EXISTS
(Design.*Output|Specification|Drawing|Acceptance.*Criteria)
- •
CONTENT_MATCH
Does this document define design output specifications, acceptance criteria, or essential performance characteristics?
Audit defense
Design outputs for [your product] are documented in [your document ID]. Each output is verified against its corresponding design input and includes acceptance criteria and essential safety/performance characteristics per QMSR 820.30(d).