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Hi,
Being new to this arena would some kind person please explain the difference and what information would be included in each of the Following,
Device Master Record (DMR)
Device History Record (DHR)
Design History File (DHF)
Technical File
Are some of the above one and the same or all totally different as I have seen reference to all in my endeavour to determine what goes in each file. We are designing and intend to manufacture a medical device delivering energy to the patient over intact skin. Require CE mark etc.

Being new to this arena would some kind person please explain the difference and what information would be included in each of the Following,
Device Master Record (DMR)
Device History Record (DHR)
Design History File (DHF)
Technical File
Are some of the above one and the same or all totally different as I have seen reference to all in my endeavour to determine what goes in each file. We are designing and intend to manufacture a medical device delivering energy to the patient over intact skin. Require CE mark etc.
Thanks for the feedback, you are perfectly right.........I just wanted to pass to Damas a basic idea of the TF format
Thanks heaps Everyone for your very valuable information - I now understand what goes where as I was rather confused prior to my post. The sample Index, checklist and all the 'D' words being explained is excellent and is very much appreciated.