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Design, Development, Training and Use of Medical Devices; with Practical Examples from Cardiovascular Medicine and Surgery Read chapter Read first chapter

2014 | OriginalPaper | Chapter

Risk Management Process in a Microwave Thermal Ablation System for CE Marking

Authors : E. Iadanza, C. Ignesti, G. Biffi Gentili

Published in: XIII Mediterranean Conference on Medical and Biological Engineering and Computing 2013

Publisher: Springer International Publishing

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Microwave thermal ablation (MWA) is a promising technique capable of achieving larger ablation zones quicker than other energy forms. The aim of this work is the risk management of a brand new microwave thermal ablation system, for the purpose of CE marking. The risk analysis will be driven by a multidimensional Failure Mode, Criticality and Effect analysis, which will take into account the effects on the patient, the operator and the hospital facility. All the principal mitigation interventions found will be described.

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previous chapter Effects of Combined Use of a Patient-Tracking System and a Smart Drug-Dispenser on the Overall Risk of the Diagnostic-Therapeutic Process
next chapter Medical Devices Recalls Analysis Focusing on Software Failures during the Last Decade
Metadata
Title
Risk Management Process in a Microwave Thermal Ablation System for CE Marking
Authors
E. Iadanza
C. Ignesti
G. Biffi Gentili
Copyright Year
2014
Book
XIII Mediterranean Conference on Medical and Biological Engineering and Computing 2013

Print ISBN: 978-3-319-00845-5

Electronic ISBN: 978-3-319-00846-2

Copyright Year: 2014

DOI
https://doi.org/10.1007/978-3-319-00846-2_290