Design history file (DHF) is a mandatory documentation you create throughout the medical device design and development process. It is mandatory for each device class. DHF should contain all the records necessary to validate that the device design was developed according to the accepted design plan. In case if it does not contain similar information, then it must provide a reference to that information. It must contain all the records starting from the user needs, design input, design output, design changes, verification & validation methods & reports, design review and design transfer information.
