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Okay, i know this is the same song and dance as many other RM threats i searched out. This one has a slightly different tune tho...
So we are a contract manufacturer that produces prototype medical devices. We do not do implanables what so ever. we are a very new organization. we just started in april of 2009. so we are new to the game. had our first audit by a registrar and of course they found some nitpicky little things. The most major finding was our Risk Management procedure. It just failed outright.
Now, all we do are prototypes of medical devices as i said earlier. No implantables whatsoever. Our customer has done most of the Risk Management as they have done most the work but manufacturing the parts. So, not sure what it is i can implament the RM on. We do a LOT of one-offs. In fact, since we have started, i may have seen the same part 3 times. so i really dont have much in the way of "families" of parts to do a Risk Assessment on, which is what the auditor said we should do. Anyone have any info on how best to implement this?
As some quick background, i'm new to ISO 13485. Never done this before, so any and all help i can get would be awesome. Thanks.
So we are a contract manufacturer that produces prototype medical devices. We do not do implanables what so ever. we are a very new organization. we just started in april of 2009. so we are new to the game. had our first audit by a registrar and of course they found some nitpicky little things. The most major finding was our Risk Management procedure. It just failed outright.
Now, all we do are prototypes of medical devices as i said earlier. No implantables whatsoever. Our customer has done most of the Risk Management as they have done most the work but manufacturing the parts. So, not sure what it is i can implament the RM on. We do a LOT of one-offs. In fact, since we have started, i may have seen the same part 3 times. so i really dont have much in the way of "families" of parts to do a Risk Assessment on, which is what the auditor said we should do. Anyone have any info on how best to implement this?
As some quick background, i'm new to ISO 13485. Never done this before, so any and all help i can get would be awesome. Thanks.