Free download

Building your DHF with Cognidox

Download the guide for a deeper understanding of the design history file


This guide offers insight into:

The Design History File is a record of all the required design controls and how they were defined and implemented as your med tech product development progressed.

But it’s all too easy to misfile or lose the issues and drafts of all the documents you’ll generate during a long and complex development process. 

And those omissions can increase the risk of an incomplete DHF and a failed regulatory audit.

This guide will arm you with the knowledge to not only assemble a design history file, but make that process part of 'the way you do things'.

What information should be captured in your design history file

How to overcome the challenges of assembling a design history file 

How Cognidox helps you assemble your DHF

Defining the DHF requirement, with a look at FDA and ISO 13485 requirements

Download Now