Risk management process on a new microwave thermal ablation device: assessment and follow up

Despite representing a new and promising technique for the minimally invasive cure of cancer, there are still few available microwave thermal ablation devices ready for clinical use. Safety for patients and users has therefore to be guaranteed for every new thermal ablative device with an indepth risk management process. This paper describes the feedback of the proactive risk management study on a new microwave thermal ablation device, started in 2013, and the follow-up of the risk management process which allowed the realization of the first working prototype of the device and, eventually, will lead to its CE marking.