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Maintaining Technical Documentation under MDD and MDR

#1
Is it true that , when unpdating the techinical documentation under MDD (and soon MDR) all processes described in the technical documentation must be implemented in accordance with the applicable quality procedures in force? Of course risk managment and clinical evaluation must be periodically updated. But what if, for example, a device whas designed using a design control procedure that was later revised? Does it mean that all the DHF needs to be updated according to the new procedure?
 

indubioush

Quite Involved in Discussions
#2
Can you be more specific with your question. Your design history file is your technical documentation that will show how you meet the MDR requirements. This means you will need to update your documents or create new documents where needed to show compliance.
 
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