Design History File (DHF)
Quick facts
| Category | Medical device design and development record compilation |
|---|---|
| Used by | Medical device manufacturing |
| Also called | DHF |
| Related standards | FDA 21 CFR Part 820, ISO 13485, QMSR |
| Related processes | Product design controls, risk assessment, device master record, device history record |
| Semantic match | Design History File, DHF, medical device design records, design and development file |
What is Design History File (DHF)?
A DHF tells the story of how a medical device was designed, compiling the records that demonstrate the design and development process followed an approved plan and met applicable requirements throughout. It typically includes design inputs, design outputs, design reviews, verification and validation records, and risk management documentation.
Each distinct device type or family requires its own DHF, since the design history of one device does not automatically apply to another, even if they share some common components or technology.
Under FDA's newer Quality Management System Regulation, effective February 2026, the specific term "Design History File" no longer appears in the regulation itself, with the underlying concept now aligning with ISO 13485:2016's Design and Development File requirements. Despite this shift, "DHF" remains widely used and understood terminology across the medical device industry.
Why is Design History File (DHF) important?
A complete, well-organized DHF gives manufacturers and regulators confidence that a device's design was developed thoughtfully and systematically, rather than assembled without adequate verification and validation.
During FDA inspections or Notified Body assessments, the DHF is often one of the first records reviewed, since it demonstrates whether design controls were genuinely followed throughout development rather than only documented after the fact.
Because the DHF connects directly to risk management and verification and validation activities, it also supports investigations into field issues, helping teams trace a reported problem back to specific design decisions or testing gaps.
How does Design History File (DHF) work?
A typical DHF compilation includes:
- Design plan. Document the intended design and development approach and phases.
- Design inputs. Capture the requirements the device must meet.
- Design outputs. Record specifications, drawings and other design deliverables.
- Design reviews. Document formal reviews conducted at defined development stages.
- Verification and validation. Record testing confirming outputs meet inputs and user needs.
- Risk management. Include risk analysis and mitigation activities tied to the design.
DHF vs. DMR vs. DHR
| Comparison | DHF | DMR | DHR |
|---|---|---|---|
| Documents | How the device was designed | How to build the device | Proof a specific unit was built as specified |
| Created | During design and development | After design is finalized | During and after production |
Real-world examples of Design History File (DHF)
A medical device company compiles its DHF throughout development, adding records as design reviews, verification testing and risk assessments are completed.
An FDA inspector requests a manufacturer's DHF for a specific device to confirm that design verification activities were completed and documented before the device advanced to production.
A company investigating a field complaint reviews the relevant DHF to determine whether the reported failure mode was previously identified and addressed during risk management activities.
Regulations and standards related to Design History File (DHF)
The DHF was historically required under FDA 21 CFR 820.30, with ISO 13485:2016 Clause 7.3.10 requiring an equivalent design and development file for each medical device type or family.
Under FDA's QMSR, effective February 2026, the specific DHF terminology has been replaced by alignment with ISO 13485's Design and Development File concept, though the underlying documentation expectations remain substantively similar.
Required by
How QT9 helps with Design History File (DHF)
QT9 QMS and ERP DHF capabilities
- Generate electronic Design History Records (eDHR) with single and multi-level support.
- Link design inputs, outputs, reviews and risk assessments in one connected file.
- Maintain complete, audit-ready design and development documentation.
- Support verification and validation record-keeping tied to design controls.
- Align documentation with both legacy DHF and current QMSR/ISO 13485 terminology.
- Provide instant access to design records during inspections or audits.
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Common mistakes with Design History File (DHF)
Common mistakes include compiling the DHF retroactively at the end of development rather than building it continuously as design activities occur, risking gaps or reconstructed records.
Other problems include confusing the DHF with the Device Master Record, mistakenly including manufacturing specifications rather than keeping the DHF focused specifically on the design and development history.
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