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
