GLOSSARYGlobal

Design Output

The results of design work at each phase and at its end, which must meet the design input requirements. The finished design output is the basis for the medical device file.

Where it is written: ISO 13485:2016 clause 7.3.4; definition as in 21 CFR 820.3(g) before February 2, 2026
Old rule: 21 CFR 820.3(g) and 820.30(d), in Part 820 before February 2, 2026
Also called: design and development outputs

Avoid This Mistake

The finished design output is the starting point for the medical device file, which replaced the device master record.

Related terms

Design Input Design Verification Medical Device File

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