GLOSSARYGlobal

Rework

Action taken on a nonconforming product so that it fulfills the specified requirements in the medical device file before it is released for distribution.

Where it is written: 21 CFR 820.3(b)

Avoid This Mistake

The Part 820 definition of rework supersedes the one in ISO 13485 and ties the target to the medical device file.

Related terms

Medical Device File Corrective Action

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