Establishing the Design History File
The Design History File (DHF) is a compilation of documents that demonstrates that a logical and controlled process was followed during development of a particular medical device. (If more than one medical device is being developed, more than one DHF will need to be prepared: each device needs its own DHF and each DHF should be named for the design it will contain.)
The DHF contains or references all the records necessary to establish compliance with the design plan and regulation. The DHF is necessary so that manufacturers can exercise control over and be accountable for the design process, ensuring that the finished design conforms to the design specifications
The design control procedures, or quality management system processes, should also be included in the DHF. The DHF needs to address the development of the device, accessories, major components, labeling, and packaging through design validation along with what decisions were made and when.
Contents of the DHF include the Design Plan, Use Cases, Design Inputs, Design Outputs (including labeling), Verification Protocols and Reports, Validation Protocols and Reports, Design Review Reports, Design Requirements Trace Matrix, and the Risk Management File. Regulatory holds clinical data and regulatory applications separately in their control.
With transfer to manufacturing, the Device Master Record (DMR) takes over. The documents in the DHF, or DHF output, serve as the basis for the Device Master Record.