{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fbe138bab-4542-48ab-9179-8ddfcbac0297","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"<iframe style=\"width: 100%; height: 200px;\" title=\"DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/be138bab-4542-48ab-9179-8ddfcbac0297\"></iframe>","title":"DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact","description":"<p>DHF, DMR, and DHR are easy to mix up when you\u2019re just using the abbreviations \u2013 they sound a lot alike! And they are connected. But it\u2019s important to understand the differences between them as well as how they interact with each other.</p><p>Medical Device Guru Laura Court joins the podcast today to discuss these three documents \u2013 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.</p><h3>Some of the highlights of this episode include:</h3><ul><li>DHF vs. DMR vs. DHR</li><li>What\u2019s involved with the design history file</li><li>Recommendations for retaining the design history file</li><li>The difficulties of paper files</li><li>What device master records are</li><li>Making sense out of device history records</li><li>What goes into the DHR per the FDA</li><li>How engineers can do a better job of the feedback process</li><li>The change control process to update the DMR</li><li>Laura\u2019s additional advice about documenting early</li></ul><h3>Memorable quotes from Laura Court:</h3><p><em>\u201cI am on the onboarding and implementation side of our team for the gurus here, so I help get our customers started in the software.\u201d</em></p><p><em>\u201cYour design history file is truly the history of how your product was developed.\u201d</em></p><p><em>&nbsp;\u201cDon\u2019t assume that you know everything. Even if you\u2019ve been reading your DHF, you\u2019re not going to know everything.\u201d</em></p><p><em>\u201cEverything should go through document control.\u201d</em></p><h3>Links:</h3><p><a href=\"https://www.linkedin.com/in/laura-court-9a014791/\" rel=\"noopener noreferrer\" target=\"_blank\">Laura Court LinkedIn</a></p><p><a href=\"https://www.greenlight.guru/blog/design-history-file-dhf-device-master-record-dmr-device-history-record-dhr\" rel=\"noopener noreferrer\" target=\"_blank\">Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?</a></p><p><a href=\"https://www.linkedin.com/in/etiennenichols/\" rel=\"noopener noreferrer\" target=\"_blank\">Etienne Nichols LinkedIn</a></p><p><a href=\"https://www.greenlight.guru/academy\" rel=\"noopener noreferrer\" target=\"_blank\">Greenlight Guru Academy</a></p><p><a href=\"https://community.greenlight.guru/\" rel=\"noopener noreferrer\" target=\"_blank\">MedTech Excellence Community</a></p><p><a href=\"https://www.greenlight.guru/\" rel=\"noopener noreferrer\" target=\"_blank\">Greenlight Guru</a></p><p><br></p>","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/9bfc0441-c046-4e2c-8552-1d8bd754f164/b29c630a-daf3-43f6-b0af-54f0fbc4bba1.png"}