Assembling a Design History File (DHF) for your medical device

Download our Design History File (DHF) guide to:

  • Understand what a DHF is and how it fits into your medical device quality management activities

  • The components you need to include in your DHF

  • How your DHF interacts with other key medical device documentation, such as your Device Master Record

 
Complete the form to the right to get started!
 
 
What you'll get:
 

1. DHF ingredient breakdown

From design plans and user needs to inputs and outputs, understand every component of a compliant DHF and where to start building them
 
2. Compliance requirements

Dive into the documentation your business will need to assemble for compliance with FDA 21 CFR 820 and ISO 13485
 
3. Preparation tips

Understand everything you need to do to satisfy your FDA or ISO auditors. Know your DHF from your DHR and tackle your medical device design control responsibilities with confidence
 
 
Design History File medical device design controls guide