Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model

McCaffery, Fergal and Regan, Gilbert and Flood, Derek and McDaid, Kevin (2013) Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model. Computer Standards & Interfaces, 36 (1). pp. 3-9. ISSN ISSN: 0920-5489

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Abstract

Software systems are becoming increasingly complex. Within safety critical domains such as medical device software, this increasing complexity is placing growing demands on manufacturers who must ensure their software not only meets functional requirements but is also safe and reliable. However, the Food and Drugs Administration who regulate medical device software in the United States report a significant increase in recalls between years 2003 and 2012 and have cited software difficulties as one of the frequent causes of recalls. Furthermore a recent analysis of traceability documentation submitted to the Administration has revealed that the traceability data was incomplete, incorrect, and conflicting in many cases. This is problematic as traceability plays an important role in the development of safe and reliable software. In this paper we present the validation, through industry trial, of a traceability assessment and implementation framework which we have developed to assist medical device organizations implement traceability in an efficient and regulatory compliant manner. Our findings show that implementation of the framework within two organizations improved their traceability process and that both organizations found the framework to be both useful and usable.

Item Type:	Article
Uncontrolled Keywords:	Med-Trace; Medical Device Standard; Software Traceability; Software Process Assessment and Improvement; Software development lifecycle.
Subjects:	Computer Science > Computer Software
Research Centres:	Regulated Software Research Centre
Depositing User:	Enda Kelly
Date Deposited:	28 Nov 2018 14:31
Last Modified:	28 Nov 2018 14:31
License:	Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI:	https://eprints.dkit.ie/id/eprint/602

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