Does the DoC require a technical documentation version?

D

DannyVerbiest

Starting to get Involved
#1
#1
Hi all,
I have 2 questions on which I'd love to get some insight.

1) does a medical device's technical file (TF) needs to have an overal version number? If so, should one update this version everytime one of the documents in this TF is being updated?
2) does the declaration of conformity need to mention the TF version? I presume not, otherwise each update will trigger a new DoC version

thanks in advance for your feedback!
Rob
 
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