Software Risk Management - for Medical Device and Digital Therapeutics Software
This immersive 3-day virtual programme on Software Risk Management for Medical Device and Digital Therapeutics Software follows the ISO 14971 process model and focuses on IEC 62304 and IEC/TR 80002-1 for insight into software risk management activities and documentation. The course promotes integration of software risk management into each activity of the software development lifecycle (SDLC) and creation of safety awareness among the entire product development organisation.
Other standards utilised during the 3-day course include IEC 82304, IEC 62366, cybersecurity (AAMI TIR 57, emerging IEC 81001-5-1), and upcoming IEC 62304 2nd edition impact to risk
Start Date: 7 September 2021