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Safety critical software process assessment: how MDevSPICE® addresses the challenge of integrating compliance and capability

Clarke, Paul, Lepmets, Marion, Dorling, Alec and McCaffery, Fergal (2015) Safety critical software process assessment: how MDevSPICE® addresses the challenge of integrating compliance and capability. In: Software Process Improvement and Capability Determination. Communications in Computer and Information Science, 526 . Springer, pp. 13-18. ISBN 978-3-319-19860-6

One of the primary outcomes of a software process assessment is visibility of the capability of a software process which among other things, informs us of the ability of a process to deliver consistent product quality levels. In safety critical domains, such as the medical device sector, high product quality – and particularly high product safety - is an important consideration. To address this safety concern, the medical device sector traditionally employs audits to determine compliance to software process standards and guidance. Unlike an audit which results in a pass/fail outcome, an assessment provides a process capability profile which identifies areas for improvement and enables a comparison with broader best practice. MDevSPICE® integrates the various medical device software standards and guidance within the infrastructure of a SPICE assessment model, thus encompassing aspects of compliance and capability. This paper describes some of the key enablers of this integration.
Item Type:Book Section
Uncontrolled Keywords:Safety critical software; Medical device software; Software process improvement; Software process assessment; MDevSPICE®
Subjects:Computer Science > Software engineering
DCU Faculties and Centres:Research Institutes and Centres > Lero: The Irish Software Engineering Research Centre
Official URL:http://link.springer.com/chapter/10.1007%2F978-3-3...
Copyright Information:© 2015 Springer. The original 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:21088
Deposited On:05 Feb 2016 09:42 by Fran Callaghan . Last Modified 04 Feb 2020 15:37

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