ABSTRACT
The Austrian facility MedAustron is one of the most advanced centers for ion beam therapy and research in the world. The MedAustron Particle Therapy Accelerator (MAPTA) is a CE-certified Class IIb medical device. Safety is the core attribute to be achieved, assessed and maintained during the entire system lifecycle. This paper tells about the experience of certifying a large particle accelerator as a medical device, from the risk management point of view. Examples of the different risk management activities are given, in order to explain the way the risks have been analyzed, controlled and evaluated.
