Which FMEA tool would you suggest for medical device segment? Relex Reliability Studio, Isograph Reliability Workbench, XFMEA, IFS RCM Toolkit or any other?
Dear Murali
I have seen and used in-house FMEA tools a lot for Medical Device Industry... But the focus has to be split into 3 areas... In my Experience with GE and Coronary stents, we use
SFMEA - Safety FMEA,- more focused towards patient safety, Operator Safety, regulator safety etc... Risk & Risk Mitigation Strategy
DFMEA - Design FMEA - More focussed towards design at system, sub-system and component level of designs, their failure modes, preventions
PFMEA - Process FMEA - More focussed towards preventions of mistakes in manufacturing assembly, manufacturing process etc.
If I can be of any further help, pl. do let me know
Kindest Regards
LR
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