Guide
Design history file (DHF): what it is and how to build one
The design history file is the record that shows your device was developed the way design controls require: each design activity documented, reviewed and linked. It is not a single binder you assemble at the end — it is the organised result of doing design controls properly from day one.
The essentials
What goes in a DHF
Design plans and reviews
The design and development plan, and the records of each formal design review — who attended, what was assessed, and what was decided.
Inputs, outputs and traceability
Design inputs (the requirements), design outputs (drawings, specifications, software) and the traceability that connects each output to the input it satisfies and the verification that proved it.
Verification and validation
Test protocols, results and conclusions for design verification, and validation evidence including usability and clinical evaluation where applicable.
Changes and transfer
Design change records and the design transfer activities that handed the design to production — the final proof the history is complete.
DHFs and their neighbours
DHF vs DMR vs DHR
- 1The DHF is about the design: it contains or references the records of development under design controls.
- 2The device master record (DMR) is about production: the specifications and procedures needed to build the finished device.
- 3The device history record (DHR) is about each batch or unit: the production, test and release records showing the device was built to the DMR.
- 4In the FDA QMSR and ISO 13485 the vocabulary shifts to 'design and development records' and 'production records', but the three ideas remain.
- 5Keep the links between them explicit — a change in the DHF should visibly trigger updates in the DMR.
Where Qevatrix fits
A design history that assembles itself
QualityOS records each design activity as it happens — plans, inputs, outputs, reviews, verification, validation, transfer and changes — linked in one traceable history, so the DHF exists as evidence rather than an end-of-project archaeology exercise.
More guides
See all guidesQualityOS
FDA QMSR transition guide
What changes as 21 CFR Part 820 aligns with ISO 13485:2016, and how to prepare your quality system.
QualityOS
ISO 13485 in 2026
What is being worked on in the standard, what stays the same, and what to plan for.
QualityOS
Medical device quality management system
The processes a device QMS needs, how they connect, and a practical order to build them in.
This guide is an orientation, not regulatory advice. Confirm requirements against the FDA QMSR, ISO 13485:2016 clause 7.3 and the regulations of each market you sell in.