Requirements for Updating a Medical Device Technical File

Nancylove

Starting to get Involved
#11
What does the technical file has to do with auditing? The technical file should be reviewed whenever the information it contains change. This is to demonstrate the "product safety and effectiveness" aspect of the regulations, and this has always have to be up-to-date (not waiting an audit, which is related to the QMS aspect of the regulations).
But, doesn't a company's technical files need to be part of it's internal audit program?
 
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Marcelo

Inactive Registered Visitor
#12
But, doesn't a company's technical files need to be part of it's internal audit program?
You can include anything in an audit, however, the need to update a technical file is not linked to the audit. It's linked to the requirement that the technical information is always up-to-date.
 
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