Looking for an example of a medical device file

S

snoopy2017

Retired
#1
#1
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. :thanx:
 
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Ajit Basrur

Ajit Basrur

Staff member
Admin
#2
#2
The medical device file for each type or model of medical device referred to in ISO 13485:2016, clause 4.2.3 could be referred by different names, for example, technical file, design history file, device master record, device history file etc. and is up to the organization to define which of these documents constitutes their medical device file.

These are the exact requirements that were previously required per clause 4.2.1 in ISO 13485:2003 and EN ISO 13485:2012; and only explicitly described in the ISO 13485:2016 edition.

Thus your DMR or Technical File could serve as a Medical Device File.
 
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