Medical   -   ISO/IEC 80002-1:2009 Risk Assessment for Medical Device

IEC/TR 80002-1:2009 provides guidance for risk assessment as per  ISO 14971:2007,  

It does not adds or  change the requirements of ISO 14971:2007 or IEC 62304:2006.

Eurotech assess the Risk Assessment doneby you as per this standards and  gives compliance certification against these standard besides providing training for Risk Assessment for medical devices such as implants, eletromedical and medical software 

 

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