IEC/ISO-62304, ISO-14971, IEC-80002 and the revised Medical Device Directive
The Medical Device Directive has emphasized the need for having an integrated SW Risk Management process when developing Medical Devices.
“For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.”
Synergus offers a 2-day hands-on to understand the process for Software Risk Management based on the IEC/ISO-62304, ISO-14971, IEC-62366 and IEC-80002.
The course will be held by Synergus experts in Risk management, Jonas Salomonson and Robert Ginsberg, who was one of the co-authors of IEC/ISO-62304.
Each occasion will be limited to 30 participants to allow for interaction during the course.