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Design History File (DHF)
Eine Zusammenstellung von Aufzeichnungen, die die Designgeschichte eines fertigen Medizinprodukts beschreiben.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
The Design History File (DHF) applies to manufacturers who design medical devices under FDA quality system requirements (and analogous design-control frameworks). It is the compilation of records that demonstrate design was developed according to the approved design plan.
PROCESS / STEPS
- Maintain DHF as a living index of design inputs, outputs, reviews, verification, validation, and transfer records.
- Link each design change to risk management and, when required, regulatory submissions.
- Ensure DHF is inspection-ready: traceability from user needs → design inputs → outputs → V&V → DMR.
- Archive superseded revisions with controlled document numbers.
EXAMPLES
- An infusion pump DHF includes software requirements, cybersecurity threat models, biocompatibility reports, and design transfer checklists.
COMMON MISTAKES
- Treating DHF as a binder assembled only before audit rather than continuous design control evidence.
- Missing links between design changes and updated risk files or labeling.
RELATED GUIDES & TOOLS
SOURCES
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