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This is my first posting. I did a search and couldn't find this question already, and I hope I have put it in the correct forum.
During the ISO audit (9001 and 13485) our auditor recommended checking the FDA site on a monthly basis to see if our device had any MDRs. He said that we could print a copy of the search each month and put in a file folder so that if future auditors requested if we had any MDRs we could prove that we did not.
I've not been able to find anything on the FDA site or within the ISO standards that make this a requirement. We didn't get any nonconformance for it but it still is an open question for me as to why he would have recommended something that seems like "busy work".
Our device is Class II 510k cleared. Has anyone ever encountered this recommendation before or was this auditor off base. Please note that I am pretty new to the medical device industry and this was my first ISO audit.
During the ISO audit (9001 and 13485) our auditor recommended checking the FDA site on a monthly basis to see if our device had any MDRs. He said that we could print a copy of the search each month and put in a file folder so that if future auditors requested if we had any MDRs we could prove that we did not.
I've not been able to find anything on the FDA site or within the ISO standards that make this a requirement. We didn't get any nonconformance for it but it still is an open question for me as to why he would have recommended something that seems like "busy work".
Our device is Class II 510k cleared. Has anyone ever encountered this recommendation before or was this auditor off base. Please note that I am pretty new to the medical device industry and this was my first ISO audit.