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Old 15th January 2008, 10:22 AM
jscholen jscholen is offline
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Default Risk Management Software suggestions?
Does anyone have suggestions for software to ensure ISO 14971-Risk Management within the framework of product(medical devices) life cyle is compliant?
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Old 15th January 2008, 11:20 AM
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Default Re: Risk Management Software suggestions?
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Originally Posted by jscholen View Post

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 it´s 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 don´t know if this solution is available commercially.
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