T
Heyo,
I have a friend jus audited and being throw a question by the auditor, " do you have any documented procedure for handling of returned used medical devices from hospital in the case where you need to carry out investigation on this non-conformance used medical device"?
They hav been told that this procedure shall cover the scope on handling of this non-conformance used medical device from returned from end user until the investigation have been conducted.
My friend need the experts here to advise them, is there any requirements stated in ISO 13485 and MDD?

Tiff.....
I have a friend jus audited and being throw a question by the auditor, " do you have any documented procedure for handling of returned used medical devices from hospital in the case where you need to carry out investigation on this non-conformance used medical device"?
They hav been told that this procedure shall cover the scope on handling of this non-conformance used medical device from returned from end user until the investigation have been conducted.
My friend need the experts here to advise them, is there any requirements stated in ISO 13485 and MDD?

Tiff.....
