DHF (design history file)

The design history file is the compilation of records showing that a device was developed according to the design plan and design controls.

Under the historical US Quality System Regulation, the design history file contained or referenced the records necessary to demonstrate that the design was developed in accordance with the design plan and the requirements of the regulation. ISO 13485 clause 7.3 requires design and development planning, inputs, outputs, review, verification, validation, transfer and change control. The DHF is the file that holds that evidence for a particular device.

FDA's QMSR aligns the US quality-system rule with ISO 13485, so teams increasingly describe this evidence in 13485 language while still keeping a file an investigator can follow. The file is not the technical documentation required by EU MDR Annex II, though the two overlap and should not contradict each other.

HAVGATE does not publish a standalone design-control authoring module. MDSAP Chapter 5 tasks are available in the audit checklist so you can audit an existing design project. The design records themselves remain your files unless you store controlled procedures about design in document control.