{"id":601512,"date":"2024-05-29T14:30:00","date_gmt":"2024-05-29T18:30:00","guid":{"rendered":"https:\/\/platohealth.ai\/design-history-file-dhf-vs-device-master-record-dmr-vs-device-history-record-dhr-whats-the-difference\/"},"modified":"2024-05-29T23:08:49","modified_gmt":"2024-05-30T03:08:49","slug":"design-history-file-dhf-vs-device-master-record-dmr-vs-device-history-record-dhr-whats-the-difference","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/design-history-file-dhf-vs-device-master-record-dmr-vs-device-history-record-dhr-whats-the-difference\/","title":{"rendered":"Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What’s the Difference?","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"

\"Design<\/h2>\n

The medical device industry has a lot of acronyms. <\/p>\n

The terms DHF, DMR, and DHR (which stand for Design History File, Device Master Record, and Device History Record, respectively) have had associations with design controls<\/a> for some time now, but the similarity of letters in each respective name is enough to cause ongoing confusion among medical device professionals. <\/p>\n

To make matters worse, these three aspects of design controls are quite closely related and share a lot of similarities. We\u2019ve created this article to clarify the differences between DHF, DMR, and DHR. Let\u2019s begin.<\/p>\n\n\n\n
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For two year’s and counting, Greenlight Guru has been named a quality management software Leader according to G2 Crowd, based on high customer satisfaction scores and its large market presence.<\/em><\/p>\n

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DHF \u2013 Design History File<\/strong><\/h2>\n

DHF is the design history file.<\/p>\n

As you go through the design and development process for your medical device, the documentation that you create will be contained in your design history file, commonly abbreviated as DHF. <\/p>\n

FDA 21 CFR Part 820.30<\/em><\/a> has some requirements regarding the DHF:
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The design history file shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.<\/i><\/p>\n

This means that any material proving your device is compliant should be included in your DHF. Auditors and inspectors will check your DHF to verify compliance, so keeping your design history files well organized in an industry-specific medical device QMS<\/a> is essential.<\/p>\n

As a device maker, you\u2019ll need to maintain a separate design history file for each type of device you develop. While this is straightforward in theory, things can get messy if you don\u2019t consolidate and organize as you work. <\/p>\n

Trying to build out your DHF after the fact makes organizing your documents harder. Instead, treat your DHF as a living document that you update throughout the design and development process of your device. <\/p>\n

You need to include or provide a reference to all of the records related to the activities that took place during design and development.<\/p>\n

What Belongs in the DHF?<\/h3>\n

Here are the specific documents that you should include in your DHF:
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