Final answer:
Re-testing and re-evaluation of nonconforming devices after rework must be documented in the Device History Record, which tracks the production history and ensures compliance and traceability of the finished device.
Step-by-step explanation:
According to the Quality System Regulations, re-testing and re-evaluation of nonconforming devices after rework activities must be documented in the Device History Record (DHR).
The DHR is a compilation of records containing the production history of a finished device.
It ensures that each device was manufactured according to the Device Master Record (DMR) and met all the necessary requirements and specifications. When a nonconforming device undergoes rework, the re-testing and re-evaluation must be captured in the DHR along with a description of the rework, to show compliance and traceability.