MENU menu

Design File Compilation


What is a Design File for a medical device?


Design files are crucial documents that need to be submitted by the manufacturer to a Notified Body for approval. There are regulatory and legal requirements for submitting these files. One of the essential elements of the design file is - A Design History File (DHF). DHF stores all documentation related to design controls. It indicates the design history of a medical device and provides evidence that all design control procedures were implemented correctly and followed by the manufacturer. This is a mandatory requirement for regulatory agencies (FDA 21 CFR 820 and ISO 13486).


Here is a list of all the documentation that should be included in your Design History File:




Are your files ready?

Or are you wondering where to start from?


Your first step should be contacting our Regulatory Experts!

We are here to be your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health!


Our experts have robust experience of cutting through the maze and navigating regulatory affairs for your medical innovation.

Send us an email at and get a FREE 30 Minute Consultation with our experts!




Get access to the Med-Di-Dia’s newsletter, where industry experts help you to stay on top of shifting global markets.

Stay updated with the latest Trends in the world of Medical Devices!


* indicates required