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

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. DHRWhat’s involved with the design history fileRecommendations for retaining the design history fileThe difficulties of paper filesWhat device master records areMaking sense out of device history recordsWhat goes into the DHR per the FDAHow engineers can do a better job of the feedback processThe change control process to update the DMRLaura’s additional advice about documenting earlyMemorable 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 LinkedInDesign History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?Etienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru