Maps to
FDA QMSR (Part 820): §820.30(h)
ISO 13485: ISO 13485 §7.3.9
Requirement text
Design transfer activities shall ensure design outputs are verified as suitable for manufacturing before becoming final production specifications.
Atomic constraints
- •Transfer procedures must be documented
- •Design outputs must be verified as suitable for manufacturing
- •Production specifications must be established
Evidence signals
- •
FILE_EXISTS
(Design.*Transfer|Manufacturing.*Transfer|Production.*Spec)
- •
CONTENT_MATCH
Does this document describe design transfer to manufacturing, production specifications, or manufacturing readiness?
Audit defense
Design transfer for [your product] is documented in [your document ID]. All design outputs were verified as suitable for manufacturing using a formal transfer checklist before establishing final production specifications per QMSR 820.30(h).