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GLOSSARYGlobal

Design Validation

Establishing by objective evidence that the finished device meets user needs and its intended use.

Where it is written: ISO 13485:2016 clause 7.3.7; definition as in 21 CFR 820.3(z)(2) before February 2, 2026
Old rule: 21 CFR 820.3(z)(2) and 820.30(g), in Part 820 before February 2, 2026
Also called: design and development validation

Avoid This Mistake

Validation under clause 7.3.7 includes clinical or performance evaluations as the applicable regulatory requirements call for.

Related terms

Design Verification Design Controls

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