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

 

A DHF is a vital component of your medical device's quality and regulatory activity.

Learn how to build yours here.

Instant access. No email required.

 

Download our Design History File (DHF) guide to:

 

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

  • Unpick the components you need to include in your DHF

  • Learn 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:
 
  • Subttasks-bgDHF 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
 
 
  • Check-bgCompliance requirements

Dive into the documentation your business will need to assemble for compliance with FDA 21 CFR 820 and ISO 13485
 
 
  • Happy-bgPreparation 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