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Subject = MDevSPICE;
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Displaying Results 1 - 2 of 2 on page 1 of 1
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A lightweight assessment method for medical device software processes
(2014)
McCaffery, Fergal; Clarke, Paul; Lepmets, Marion
A lightweight assessment method for medical device software processes
(2014)
McCaffery, Fergal; Clarke, Paul; Lepmets, Marion
Abstract:
This paper outlines the MDevSPICE-Adept process assessment method. MDevSPICE-Adept is a lightweight process assessment method that has been created for the MDevSPICE software process assessment model which is currently being developed for the medical device industry. MDevSPICE is a fully validated release of a medical device software process assessment model (formerly known as Medi SPICE), which was developed by the authors. While the MDevSPICE process assessment model is detailed and comprehensive, there is industry demand for a lightweight medical device software process assessment method. To address this requirement the MDevSPICE-Adept method has been developed. Details on how this has taken place and the procedures for implementing an MDevSPICE-Adept process assessment are presented. Information is also provided regarding how an MDevSPICE process assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this process assessment an...
http://doras.dcu.ie/21090/
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MDevSPICE - A comprehensive solution for manufacturers and assessors of safety-critical medical device software
(2014)
Clarke, Paul; Lepmets, Marion; McCaffery, Fergal; Finnegan, Anita
MDevSPICE - A comprehensive solution for manufacturers and assessors of safety-critical medical device software
(2014)
Clarke, Paul; Lepmets, Marion; McCaffery, Fergal; Finnegan, Anita
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.
http://doras.dcu.ie/21089/
Displaying Results 1 - 2 of 2 on page 1 of 1
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