Medical devices · Training guide

Design History File

Write the design history file summary and traceability matrix: user needs to design inputs, outputs, verification and validation, with risk controls, design reviews and transfer checked.

Writes: DHF Design controls
Product type: Medical devices
Guidance it follows: 21 CFR Part 820 (QMSR, incorporating ISO 13485:2016 by reference, effective 2 February 2026); ISO 13485:2016 clause 7.3; FDA Design Control Guidance for Medical Device Manufacturers (1997); ISO 14971:2019; IEC 62304; EU MDR 2017/745 Annex II
Time to learn: About 20 minutes with the example

Open the tool at https://app.cmcfy.com/app/design-history-file.html. This guide is also online at https://cmcfy.com/guides/design-history-file.html

1. What this module does

You list the user needs with their validation, the design inputs with their outputs, verification and linked hazard, and the design reviews.

The tool builds the traceability matrix, flags needs without inputs, inputs without outputs, open or failed verification and validation, risk controls that are not verified, and reviews without an independent reviewer.

What you get

A Word or PDF file: design history file summary and traceability matrix.

2. Before you start

Have these ready. You can still start with the example data and replace it piece by piece.

User needs and design inputs with their IDs.
Verification and validation reports.
Design review minutes.

Your data stays on your computer. The bar under the title counts every network request the page makes; it stays at 0 because your data never leaves your computer. Download offline copy saves a single file that opens from your own computer with all network access blocked, for air-gapped PCs.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/design-history-file.html. The example is loaded when the page opens, so every panel already has realistic data. Follow the steps to see how it works, then replace the example with your own data.

Describe the project
Give the device, design project, classification, design reviews and the device master record.
Enter the trace
One row per design input, with the user need it comes from, its output, verification and any hazard ID.
Read the result
The headline gives the outcome, for example "1 critical gap in the design history file".
Traceability matrix.
Resolve alerts and download
Failed verification or validation, an unverified risk control and no design reviews are critical. Open items and missing outputs are flagged. Then preview and download.

4. Field reference

Every input in the tool, panel by panel. Tables accept rows pasted straight from Excel, comma-separated text, or a loaded file; check the columns after loading a file. Fields marked “when it applies” appear only for the choices that need them.

1 · Device and project

Field	What to enter
Device	Type it in.
Design project	Type it in.
Class (US) and risk class (EU)	Type it in.
Design reviews held	A table. Columns: Phase \| Date \| Independent reviewer present (yes/no). Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan).
Design transfer to production complete	Tick the box if it applies.
Device master record (medical device file) reference	Type it in.

2 · Traceability

One row per design input. Result: pass or fail. Risk ID links the input to a hazard in the risk management file.

Field	What to enter
User needs	A table. Columns: User need ID \| User need \| Validation ID \| Validation result. Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan).
Design inputs	Write Pass or Fail in the result, or leave it empty while verification is open. A table. Columns: Input ID \| User need ID \| Requirement \| Design output \| Verification ID \| Verification result \| Risk ID. Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan).

5. Checks and alerts

Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:

Every need traced to inputs, outputs, verification and validation.
Risk controls verified.
Design reviews, transfer and DMR.

How to resolve alerts

Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record.
Major alerts block the download until you fix them or type a justification and press Accept justification.
Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
Some alerts have an Apply fix button that makes the change for you. Reopen undoes a justification.

Narratives

This module writes: Design history summary. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.

6. Preview, gap review and download

Press Preview next to a section, or Preview and download all. The document opens in a preview window, exactly as the Word file will read.
The left side lists the review, run on your device: gaps in the data (missing values, open alerts), gaps in the report (missing content the guidance expects, placeholders such as [site] or TBD left in the text) and, if you load the approved protocol under Compare with the protocol, differences from the protocol (requirements, criteria, batches or time points it plans that the report does not show).
Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
Optional AI review: a second read for contradictions, claims without data and vague wording. The report text is sent to Claude only when you press it, and only where your plan includes AI. Check every AI finding; AI can be wrong.
Press Download Word (.docx) or Download PDF. With several documents open, All as Word (.zip) and All as PDF (.zip) download the set. The download buttons stay disabled while a blocking alert is open; the preview still works.

Documents this module produces

Section	Document
DHF	Design history file summary and traceability matrix

Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.

7. US and EU submissions

US: 21 CFR 820 (QMSR, incorporating ISO 13485:2016). EU: ISO 13485:2016 and EU MDR Annex II.

8. Working with other modules

Hazard IDs come from the Risk Management Report; the summary supports the Device Submission (510(k), De Novo, PMA).

9. Common pitfalls

Validating on prototypes instead of production-equivalent units.
Risk controls left unverified at release.

10. Practice exercises

Each exercise starts from the example (press Load example to reset). We run these on every update of this guide, so the result you see should match.

Close the cybersecurity verification
Enter Pass for VER-21.
Expected resultNo critical gap remains.