Design history file (DHF): what it is and how to maintain it
What a design history file contains, how it differs from the device master record, and how to keep it audit-ready as a by-product of your work rather than a scramble at the end.
What a DHF is
A design history file is the compilation of records describing the design history of a finished medical device. FDA 21 CFR 820.30(j) requires manufacturers to establish and maintain a DHF for each type of device, showing that the design was developed in accordance with the approved design plan and the design control requirements.
What it contains
- The design and development plan.
- Design inputs and design outputs.
- Design review records.
- Design verification and validation results.
- Design transfer records.
- Design changes and their evaluation.
DHF versus DMR
The design history file records how the device was designed. The device master record describes how it is produced. One is the design story, the other is the production recipe, and they are maintained separately.
Keeping it audit-ready
A DHF becomes painful when its records are scattered across tools and drives, so assembling it is archaeology. If design inputs, outputs, reviews, verification, and changes are captured with traceability and controlled versions in one place, the DHF is an export rather than a project. See how design control software supports this for medical device teams.
This guide is educational and does not certify any product or organisation.
Common questions
What is a design history file?
A design history file (DHF) is the compilation of records that describes the design history of a finished medical device. FDA 21 CFR 820.30(j) requires each manufacturer to establish and maintain one for each device or device family.
What goes in a DHF?
The DHF demonstrates that the design was developed in accordance with the approved design plan and the design control requirements: design inputs and outputs, reviews, verification and validation, design transfer, and design changes.
How is a DHF different from a DMR?
The design history file records how the device was designed. The device master record (DMR) describes how it is produced. The DHF is the design story; the DMR is the recipe.
Keep your DHF assembling itself
Capture design inputs, outputs, and verification with traceability in one place.