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Design Verification

Confirmation, by objective evidence, that the design outputs meet the design input requirements.

Where it is written: ISO 13485:2016 clause 7.3.6; definition as in 21 CFR 820.30(f) before February 2, 2026
Old rule: 21 CFR 820.3(aa) and 820.30(f), in Part 820 before February 2, 2026
Also called: design and development verification

Avoid This Mistake

Verification is not validation: it checks the design outputs against the design inputs, not the device against user needs.

Related terms

Design Validation Design Input Design Output

All Terms Run the Design Controls & V&V Completeness Diagnostic