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View Full Version : Risk Management Software suggestions?


jscholen
15th January 2008, 10:22 AM
Does anyone have suggestions for software to ensure ISO 14971-Risk Management within the framework of product(medical devices) life cyle is compliant?

mmantunes
15th January 2008, 11:20 AM
Does anyone have suggestions for software to ensure ISO 14971-Risk Management within the framework of product(medical devices) life cyle is compliant?

The only software that i know that is specifical to the medical devices industry is Fmea for Medical Devices from Dyadem - http://www.dyadem.com/. The problem with this software is that itīs focused on FMEA (altough it can be "extended" in some ways).

Nowadays i would recomend a PLM (product lifecycle management) software with a risk management module tailored to ISo 14971. I donīt know if this solution is available commercially.