Design History File (DHF) Index Template
A design history file collects the evidence that a device was designed under control. This worksheet gives you an index to build and maintain, so any reviewer can see which records exist, who owns them and whether they are approved.
| DHF section | Document number | Document title | Revision | Owner | Status | Approval date | Pages | |
|---|---|---|---|---|---|---|---|---|
Extend the rows for every record in your design project. Under ISO 13485 the equivalent term is the design and development file. Keep the index current as records are revised, and confirm what your quality system procedures require in the file.
Reconcile your DHF index with PLM and ERP
Optional: a short review of how drawing, BOM and change data could be matched against your DHF index.
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How to use this worksheet
Add one row per record in the design project. Pick the DHF section, enter the document number, title, revision, owner and status, and add the approval date. The total pages and document count at the bottom help you spot gaps. Export to Excel and keep the index as the first page of the file or in your document management system. Update it each time a record is revised or superseded.
- Index by section so gaps in a design stage are visible
- Reference the current approved revision of each record
- Mark old versions as superseded instead of deleting rows
- Link each requirement to its verification and validation record
What belongs in the file
The old FDA design control requirement in 21 CFR 820.30 expected a file that demonstrates the design was developed according to the approved plan. ISO 13485 clause 7.3 asks for a design and development file covering the plan, inputs, outputs, review, verification, validation, transfer and changes. Together they point to the same content: the plan, input requirements, outputs such as drawings and specifications, design reviews, verification and validation results, transfer to production, and a history of changes and the risk management file.
DHF, DMR and DHR
People often mix these up. The DHF shows how the design was developed. The device master record, or medical device file, holds the instructions and specifications needed to manufacture and release the device. The device history record shows how one lot or serial number was actually built. The DHF feeds the DMR at design transfer, and the DMR is what each DHR proves was followed.
Common mistakes
Frequent problems are inputs with no matching verification, a design review held without independent attendees, outputs that do not state acceptance criteria, and a file assembled at the end of the project from memory. Build the index from day one and review it at each design gate, so missing records are noticed when they can still be produced properly.
Frequently Asked Questions
What is a design history file?
It is the compiled record showing a medical device was designed according to an approved plan and the design control process. It holds plans, requirements, outputs, reviews, verification, validation, transfer and change records.
Do I need a separate DHF for each device?
Generally yes, one per device type or family, as defined in your procedure. Variants that share design records can reference the same documents, as long as the file clearly shows what applies to which model.
Does the DHF have to be one physical binder?
No. It can be an index that points to records in different systems, provided each record is controlled, retrievable and the index is current. Many teams keep the index in a spreadsheet or document control tool.
When should the DHF be closed?
The file stays open for the life of the product because design changes keep adding records. Many firms baseline it at design transfer and release, and then add later changes through change control.
If your drawings, BOMs and change orders live in PLM or ERP, Netray can help reconcile them with the DHF index on your own infrastructure.
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