Design history file (DHF): what it is and how to maintain it
What a design history file contains, how it relates to the medical device file, 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 (DHF) is the set of records showing how a medical device was designed. Since 2 February 2026, the FDA QMSR requires it by incorporating ISO 13485:2016, whose clause 7.3.10 calls it the design and development file. DHF remains the common name, and the records it holds are much the same.
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, DMR and the medical device file
Under the old Part 820, the device master record (DMR) sat beside the DHF and described how the device is produced. The QMSR retires the DMR and DHR terms. That content now lives in the medical device file required by ISO 13485 clause 4.2.3: specifications, production, servicing and labelling.
The distinction still holds. The DHF is the design story, the medical device file 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 Traceable supports this for medical device teams.
Related guides
- DHF remediation for scaling medtechs
- PMA readiness: closing DHF gaps before the audit
- Design changes after launch: how to scope validation without starting over
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 set of records that shows how a medical device was designed. Since 2 February 2026 the FDA Quality Management System Regulation (QMSR) requires it through ISO 13485:2016, whose clause 7.3.10 calls it the design and development file. DHF remains the common name.
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.
What happened to the DMR?
The QMSR retired the device master record (DMR) and device history record (DHR) terms. What the DMR held, how the device is made, serviced and labelled, now sits in the medical device file required by ISO 13485 clause 4.2.3. The DHF is the design story, the medical device file is the recipe.
Keep your DHF assembling itself
Capture design inputs, outputs, and verification with traceability in one place.