$297 — Standard Tier

Design History File (DHF) Toolkit: FDA 21 CFR 820.30 Templates

Design History File Toolkit — DHF index, design review template, design input requirements, V&V plan, design transfer checklist, and DHF closure authorization form.

Get the Toolkit — $297

7-day money-back guarantee • One-time purchase • Instant download

What's Included

Design History File (DHF) Index Template (21 CFR 820.30(j))
Design Review Meeting Agenda and Minutes Template
Design Input Requirements Specification Template
Design Verification and Validation Plan (V&V Plan)
Design Transfer Checklist (21 CFR 820.30(h))
DHF Closure and Design Freeze Authorization Form

Benefits

DHF index structured the way FDA investigators read it for completeness
Design input template includes traceability matrix backbone linking inputs to outputs and V&V
V&V plan satisfies FDA reviewer expectations during 510k review and inspection
Design transfer checklist closes the loop from development to manufacturing

Is This For You?

This toolkit is designed for teams facing these challenges:

FDA 483 citing incomplete DHF or missing design control records
Design input to output traceability not documented
V&V plan missing acceptance criteria or sample size rationale
Design transfer to manufacturing not formally documented

Who This Is For

Design engineers responsible for DHF maintenanceRA leads supporting design control complianceQA directors preparing for FDA design control inspectionsStartups building first ISO 13485 compliant design system

Frequently Asked Questions

What is the DHF and why does FDA care about it?

The Design History File proves your device was designed using design controls per 21 CFR 820.30. FDA investigators review the DHF to confirm design reviews occurred, inputs were documented, and V&V was performed before transfer to manufacturing.

Does ISO 13485 require a DHF?

ISO 13485 Section 7.3 requires a design and development file equivalent to the FDA DHF. These templates satisfy both FDA 21 CFR 820.30 and ISO 13485:2016 Section 7.3 requirements.

Related Toolkits

Design Controls

$247

DMR and DHR Toolkit

$247

ISO 14971 Risk Management

$247

Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $297

7-day money-back guarantee