Re-testing and re-evaluation of nonconforming devices must be documented in which record?

The correct choice is the device history record, which serves as a comprehensive account of the manufacturing history of a specific batch or unit of a medical device. It includes all relevant documentation, including records of quality control activities, production, and any deviations or nonconformances that have occurred during the device's lifecycle.

When a nonconforming device is identified, it is essential to document the re-testing and re-evaluation processes to ensure compliance with regulatory requirements and to maintain traceability. This documentation provides valuable information about how the device was assessed and what actions were taken to address any quality issues, thus supporting the overall quality management system of the manufacturer.

The other records mentioned have different purposes: the device master record includes the specifications and manufacturing information for a device, the quality manual outlines the company’s quality management system policies, and the design history file contains documentation about the design and development of a device. None of these would be appropriate for detailing the specifics of re-testing and re-evaluation of nonconforming devices as effectively as the device history record does.