Design History File (DHF)

Design History File (DHF) is the FDA-mandated compilation of records that demonstrates a medical device’s design was developed in compliance with the approved design plan and 21 CFR 820.30 design controls. The DHF is the evidence chain: design inputs, outputs, reviews, verification, validation, transfer, and changes — kept across the full lifecycle of the device.

What it covers

• Design plan and updated design history.
• Design inputs — user needs, intended use, regulatory and standards requirements.
• Design outputs — drawings, specifications, software, and labeling.
• Design reviews, verification, and validation records.
• Design transfer to manufacturing and design changes with impact assessments.

Relationships (see sidebar)

• Conforms to 21 CFR Part 820 §820.30 and ISO 13485 §7.3.
• Supports Detailed Design, Regulatory Submission, and Quality Management.
• Implemented by medical-device PLM/QMS platforms including Aras Innovator (Aras Quality / Design Controls), PTC Arena (Arena QMS), and Dassault Medidata.
• Pairs with the Device Master Record and the Device History Record.