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DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact
Global Medical Device Podcast powered by Greenlight Guru
How to Document Your Design History File
If you start documenting early, you're just going to make it easy for yourself to assemble this design history file in the past. No, you don't need to make an official trace matrix if you're changing your design every two days until you get closer to that design freeze stage. All of those protocols or reports around how maybe you verified the design of your device all need to go into that DHF. There's two ways you can do that and I'm curious if you have an opinion on one where another.
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