M
Microbe
I wonder if it is possible for someone to give me some advice. We are a small medical device company, primarily selling with the EU - so we have technical files/design history files for our products.
We also sell a small amount to the US, but have plans to expand. It is likely that at some stage we will be audited by the FDA. We have in place a DMR within our QMS for each of our products, but it does appear to be a useless and redundant document, as all the information is held elsewhere within our system.
I am fundamentally against having un-necessary documentation, and would ideally like to be able to use the information that we already have ie the technical faile and design history file. If this is not possible, what is the best way to structure the DMR, giving maximum benefit for minimum hassle. Are there any templates out there?
Many thanks for any help/advice offered
Microbe
We also sell a small amount to the US, but have plans to expand. It is likely that at some stage we will be audited by the FDA. We have in place a DMR within our QMS for each of our products, but it does appear to be a useless and redundant document, as all the information is held elsewhere within our system.
I am fundamentally against having un-necessary documentation, and would ideally like to be able to use the information that we already have ie the technical faile and design history file. If this is not possible, what is the best way to structure the DMR, giving maximum benefit for minimum hassle. Are there any templates out there?
Many thanks for any help/advice offered
Microbe