The IEC/TR 80002-1 and ISO 14971 Medical Devices Software Package specifies the process of identifying, controling and monitoring risk and hazards associated with medical device software. This package can be to implement a safety risk management process for all software in the healthcare environment independent of whether it is classified as a medical device. IEC/TR 80002-1 and ISO 14971 Medical Devices Software Package is aimed at risk management practitioners who need to perform risk management when software is included in the medical device/system and those who need to understand how to fulfil the requirements for risk management addressed in ISO 14971. It includes
ISO 14971:2007 and IEC/TR 80002-1 Ed. 1.0 en:2009.