DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact

March 1, 2023

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DHF, DMR, and DHR are easy to mix up when you’re just using the abbreviations – they sound a lot alike! And they are connected. But it’s important to understand the differences between them as well as how they interact with each other.

Medical Device Guru Laura Court joins the podcast today to discuss these three documents – what you need to know about them, what to do with them, and why it matters.

Listen to the episode to learn how Laura thinks about best practices, what companies get wrong, and how to improve when dealing with these three different kinds of documentation.

Listen now:

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Some of the highlights of this episode include:

  • DHF vs. DMR vs. DHR

  • What’s involved with the design history file

  • Recommendations for retaining the design history file

  • The difficulties of paper files

  • What device master records are

  • Making sense out of device history records

  • What goes into the DHR per the FDA

  • How engineers can do a better job of the feedback process

  • The change control process to update the DMR

  • Laura’s additional advice about documenting early


Laura Court LinkedIn

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

Etienne Nichols LinkedIn

MedTech Excellence Community

Greenlight Guru Academy

Greenlight Guru

Memorable quotes from Laura Court:

“I am on the onboarding and implementation side of our team for the gurus here, so I help get our customers started in the software.”

“Your design history file is truly the history of how your product was developed.”

 “Don’t assume that you know everything. Even if you’ve been reading your DHF, you’re not going to know everything.”

“Everything should go through document control.”

About the Global Medical Device Podcast:


The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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