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.

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

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.”

Links:

Laura Court LinkedIn

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

Etienne Nichols LinkedIn

Greenlight Guru Academy

MedTech Excellence Community

Greenlight Guru

Episode 38: Me, Me, Me