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


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 eBook will help you master the design history file by detailing: 

  • 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

    This eBook 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'.

Fill out the form to receive your free copy now.

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