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Hi everyone,
I know this topic has been discussed previous. Does anyone have a sample medical device file? My understanding is that it's not exactly like the DMR, but it is a file that references or points to where the relevant documents are kept. Please confirm if this is similar to an EU Technical File.
Thank you.
I know this topic has been discussed previous. Does anyone have a sample medical device file? My understanding is that it's not exactly like the DMR, but it is a file that references or points to where the relevant documents are kept. Please confirm if this is similar to an EU Technical File.
Thank you.
