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  Article on the ISO 13485:2016 Medical Device File added to the Ombu Library

The Ombu Library, in the ISO 13485:2016 aisle, has an article on the Medical Device File from clause 4.2.3. The article explains the files requirements and includes the referenced MDSAP audit tasks and how the medical device File relates to the requirements in the MDD Annex II.

 

 

 
 
 
 
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