Which document outlines a finished device’s design specifications?

The Design History File (DHF) is the document that outlines a finished device’s design specifications. It is a compilation of records that describes the design history of a finished device, including the design plans, design inputs and outputs, design review results, and verification and validation activities. This comprehensive file is essential for demonstrating that the device was developed in accordance with the applicable regulatory requirements and standards.

By detailing the design specifications, the DHF plays a critical role in ensuring that the manufacturer can produce the medical device according to the approved design and design changes are appropriately managed. The DHF not only supports compliance with regulatory bodies like the FDA but also provides an organized way to maintain documentation throughout the device’s lifecycle.

In contrast, the Device Master Record (DMR) contains the specifications for the device, including production procedures and quality assurance guidelines but does not include the detailed design specifications documented in the DHF. The Device History Record (DHR) focuses on the production history of a specific device batch, while the Drug Master File (DMF) is specific to drug products and does not pertain to finished medical devices. Thus, the DHF is the correct choice as it specifically addresses the design specifications of a finished device.