W
Re: AIAG's FMEA Manual 4th Edition
...a bit of a sidetrack here (forgiveness requested):
Is the AIAG FMEA Manual 4th Ed. the best choice for a medical device manufacturer looking to implement FMEA? We already use ISO 14971 to create our Hazard Analysis, but I want a tool specifically for medical device FMEA. Could be that the AIAG guide is completely appropriate, but I don't want to implement a system based on this and then find out we should have used ISO/EN something-or-other! I'm also going to raise this question in the Medical Device Forum just to be safe...
...a bit of a sidetrack here (forgiveness requested):
Is the AIAG FMEA Manual 4th Ed. the best choice for a medical device manufacturer looking to implement FMEA? We already use ISO 14971 to create our Hazard Analysis, but I want a tool specifically for medical device FMEA. Could be that the AIAG guide is completely appropriate, but I don't want to implement a system based on this and then find out we should have used ISO/EN something-or-other! I'm also going to raise this question in the Medical Device Forum just to be safe...
