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MDevSPICE - A comprehensive solution for manufacturers and assessors of safety-critical medical device software

Clarke, Paul, Lepmets, Marion, McCaffery, Fergal and Finnegan, Anita (2014) MDevSPICE - A comprehensive solution for manufacturers and assessors of safety-critical medical device software. In: Software Process Improvement and Capability Determination. Communications in Computer and Information Science . Springer, pp. 274-278. ISBN 978-3-319-13036-1

Abstract
Software development is frequently challenged with quality concerns. One of the primary reasons for such issues is the very nature of the software development process. First, it can be difficult to accurately and completely identify the requirements for a software development product. Also, the implementation on various platforms and the need to integrate with sometimes unforeseeable additional systems adds complexity. For safety critical domains, such as the medical device and healthcare sectors, these hurdles are amplified. Whereas a failure in a desktop application may be resolved through a restart with no harm incurred, a failure in a medical device can have life threatening consequences. Our work in the Regulated Software Research Centre (RSRC) aims to support medical device producers in the production of safer medical device software. In this paper, we describe the MDevSPICE framework and how it addresses the safety concerns faced by medical device producers.
Metadata
Item Type:Book Section
Refereed:Yes
Uncontrolled Keywords:Medical Device Software; Software Process Improvement; Medical Device Software Process Assessment and Improvement; MDevSPICE
Subjects:Computer Science > Software engineering
DCU Faculties and Centres:Research Institutes and Centres > Lero: The Irish Software Engineering Research Centre
Publisher:Springer
Official URL:http://link.springer.com/chapter/10.1007/978-3-319...
Copyright Information:© 2014 Springer The oiriginal publication is available at www.springerlink.com
Use License:This item is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 3.0 License. View License
ID Code:21089
Deposited On:05 Feb 2016 09:57 by Fran Callaghan . Last Modified 04 Feb 2020 15:39
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