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The creation of a DHF is the last step in the design controls process mandated by the FDA in 21 CFR Part 820. While the majority of the medical device compliance regulations enforce the establishment of policies and procedures for enforcing quality standards, the DHF is primarily an organizational tool meant to show that the design controls process was properly followed and documented throughout product development. Design controls are one of the core processes of the overall quality management system (QMS) mandate, and the presence, completeness, and accuracy of your DHF goes a long way towards helping you pass your next FDA audit.
The design history file requirements live in 21 CFR Part 820.30, which contains the regulations for the design controls process. You'll have to refer to subsection j) for the specific text on DHF, but we managed to squeeze it in below:
"j) Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part."
Here are some key interpretations of the DHF guidance that medical device companies should take note of:
Your DHF should contain all of the documentation created during the product development phase of your medical device. Following the mandated design controls process closely will help you understand what documents are required, as each step generates its own documentation. Below, we've listed the most important steps of the design controls process and what documents should be included with each step.
Greenlight QMS makes it easier than ever to compile your DHF just in time for an FDA or ISO audit. The DHF regulations allow medical device companies to present their DHF as a document that references the product development documentation for your medical device. Greenlight's QMS acts as a secure reference library that holds all of your product development documentation where you can quickly and easily link to it from your DHF. Instead of assembling, photocopying, and perpetually updating a physical file folder with hundreds of pages, medical device companies can produce and update one document for their DHF that references the documents in the QMS. With Greenlight QMS, creating and maintaining a DHF is so easy, it's practically done for you.
Looking for an all-in-one QMS solution to advance the success of your in-market devices and integrates your quality processes with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →