IEC/TR 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 add to or change the requirements of ISO 14971:2007 or IEC 62304:2006. IEC/TR 80002-1:2009 aims at risk management practitioners who perform risk management when software is included in medical device or system. It is also aimed towards software engineers who require to understand how to fulfill the requirements of risk management addressed in ISO 14971. ISO 14971 is acknowledged as a principle standard to use while performing medical device risk management.

IEC/TR 80002-1:2009 is not intended to be used as a basis of regulatory certification or inspection assessment activities.

Eurotech assess the Risk Assessment done by you as per this standards and  gives compliance certification against these standard besides providing training for Risk Assessment for medical devices such as implants, electro-medical and medical software.