D
Hello,
I was wondering if I could get some ideas from anyone who has already or is soon to be implementing ISO 13485:2003 in regards to Advisory Notices. I may not be looking into it far enough, but in 8.5.1 states the requirement for a procedure(s) for the issue and implementation of advisory notices. Following the definition of Advisory Notice, would it be wise to add an additional process in the Recall Procedure, where it would document the notification to customer(s) as an Advisory Notice (use of, modification of, return of, or destruction of) in regards to the medical device? I was thinking of also adding a "yes/no", in the Engineering Change approval process to ensure if an Advisory Notice is needed.
Let me know your thoughts.
Thanks,
Dan
I was wondering if I could get some ideas from anyone who has already or is soon to be implementing ISO 13485:2003 in regards to Advisory Notices. I may not be looking into it far enough, but in 8.5.1 states the requirement for a procedure(s) for the issue and implementation of advisory notices. Following the definition of Advisory Notice, would it be wise to add an additional process in the Recall Procedure, where it would document the notification to customer(s) as an Advisory Notice (use of, modification of, return of, or destruction of) in regards to the medical device? I was thinking of also adding a "yes/no", in the Engineering Change approval process to ensure if an Advisory Notice is needed.
Let me know your thoughts.
Thanks,
Dan
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