IEC/ISO-62304, ISO-14971, IEC-80002 and the revised Medical Device Directive
The Medical Device directive has with the new requirement for software in Medical Devices has created a need for many companies to introduce a process for SW Risk Management.
“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 on how to understand the process for Software Risk Management based on the IEC/ISO-62304, ISO-14971 and IEC-80002.
The course will be held by one of Synergus experts in Risk management together with 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.