This technical report provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices— Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device software— Software life cycle processes. It does not add to, or otherwise change, the requirements of ISO 14971:2007 or IEC 62304:2006.This technical report is aimed at RISK MANAGEMENT practitioners who need to perform RISK MANAGEMENT when software is included in the MEDICAL DEVICE/SYSTEM, and at software engineers who need to understand how to fulfil the requirements for RISK MANAGEMENT addressed in ISO 14971
DS/IEC/TR 80002-1:2009 history
2009DS/IEC/TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software