![]() 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. Let’s begin.įor 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.Īs 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.įDA 21 CFR Part 820.30 has some requirements regarding the DHF: We’ve created this article to clarify the differences between DHF, DMR, and DHR. To make matters worse, these three aspects of design controls are quite closely related and share a lot of similarities. 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 for some time now, but the similarity of letters in each respective name is enough to cause ongoing confusion among medical device professionals. The medical device industry has a lot of acronyms.
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