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.

Risk management process on a new microwave thermal ablation device: assessment and follow up / Iadanza, Ernesto; Ignesti, C.; Miniati, R.; Luschi, A.. - ELETTRONICO. - 57:(2016), pp. 1013-1017. (Intervento presentato al convegno 14th Mediterranean Conference on Medical and Biological Engineering and Computing, MEDICON 2016 tenutosi a cyp nel 2016) [10.1007/978-3-319-32703-7_199].

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

IADANZA, ERNESTO;MINIATI, ROBERTO;LUSCHI, ALESSIO
2016

Abstract

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.
2016
IFMBE Proceedings
14th Mediterranean Conference on Medical and Biological Engineering and Computing, MEDICON 2016
cyp
2016
Iadanza, Ernesto; Ignesti, C.; Miniati, R.; Luschi, A.
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Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/1061431
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