IEC 62304:2015 Medical Device Software Lifecycle Processes 4.4.2: 4.4.2 Risk management activities

For legacy software the manufacturer assesses feedback, including post-production information on incidents and near incidents from inside the organization and from users, and performs risk management activities on its continued use: its integration in the device architecture, the continuing validity of risk control measures it implements, the hazardous situations of its continued use, the potential causes of its contributing to them, and risk control measures for each cause.