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.

Url https://research.thea.ie/handle/20.500.12065/2242

Collections Ireland -> Dundalk IT -> Subject = Computer Science
Ireland -> Dundalk IT -> Subject = Computer Science: Computer Software
Ireland -> University of Limerick -> Faculty of Science and Engineering
Ireland -> Dundalk IT -> Open Access DRIVERset
Ireland -> Dundalk IT -> Status = Published
Ireland -> University of Limerick -> LERO - The Irish Software Research Centre
Ireland -> Dundalk IT -> Type = Conference or Workshop Item
Ireland -> University of Limerick -> LERO - Project partner authors