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reshamn replied to the topic Discussion Topic: Is the DHF a living document? in the forum The Design History File 7 years, 2 months ago
A follow-up question from Dr. Simon’s post:
As I mentioned earlier, once the DHF is sealed any ongoing changes should be added to the DMR seems more logical to me.
For those of you who are currently working in the medical device industry or have had previous experience with this, which of those two thoughts does your company follow? Is one preferred over the other or does it change for specific cases?