Artefact · Standards & Organisations
Design history file
The collection of records that shows how a medical device was designed: its plans, design inputs and outputs, reviews, verification, validation, risk management and design changes.
- Also known as
- DHF
- Type
- Artefact
- Domain
- Standards & Organisations, Compliance & regulation
Overview
The design history file is the evidence that a device was developed under design controls. It does not describe the device for sale; it shows that the agreed process was followed at each step, so that an auditor can trace any output back to the input and the review behind it.
How it works
It is opened when design planning starts and grows with each stage: the design and development plan, the approved design inputs, the architecture and design outputs, design review records, verification and validation reports, the risk management file, the usability engineering file and the record of each design change.
Each item is kept under document control, with versions and approvals, so the file shows what was known and decided at each point rather than a tidy summary written at the end.
The term is long established in US practice. ISO 13485 asks for the same evidence as a design and development file, and other markets expect it within the technical documentation and quality system records.
Examples
- Minutes of the design review that approved the design inputs.
- The chip verification report filed against the chip-level risk controls.
- The summative usability evaluation report.
- The impact assessment for a component change after release.
Why it matters
Quality systems managers own its structure, and every engineering team adds to it. Auditors and notified bodies sample it, and it must be kept for the period the regulations and the device life require, long after the last device is sold.
It matters most to: Configuration Management Engineer, Quality Systems Manager, Systems Engineer
Common confusions
- Not the same as Technical documentation
- Technical documentation shows a regulator that the device meets the rules; the design history file shows how the design was carried out.
- Not the same as Device master record
- The device master record says how to build and test the released device; the design history file records how it was designed.
Related standards
- ISO 13485 (quality management systems for medical devices)
Sources
- 21 CFR 820.30 Design controls (opens in a new tab), Legal Information Institute, Cornell Law School (US Code of Federal Regulations), 2026-11-10
- Quality Management System Regulation (QMSR) (opens in a new tab), US Food and Drug Administration, 2026-11-10
- ISO 13485:2016 Medical devices, Quality management systems, Requirements for regulatory purposes (opens in a new tab), Estonian Centre for Standardisation and Accreditation (EVS), for ISO, 2026-11-10
Related terms
Part of the Standards & Organisations glossary, with every term in the topic and the lifecycles, tools and standards that use them.
Where it appears on the Hub
Used on 6 pages of the Hub. In each group, the pages that mention it most come first.
Lifecycle stages and gates
- Design & Development Planning and Quality System Set-up (Medical lifecycle)
- Design plan approved (Medical lifecycle)
- Production release (Medical lifecycle)
- Regulatory Submission & Conformity Assessment (Medical lifecycle)
- Submission ready (Medical lifecycle)
- Design Transfer & Production Release (Medical lifecycle)
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Last reviewed . Written by The Semiconductor Hub editorial team. The full glossary