Research findings from an industrial trial of a traceability assessment and implementation framework

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. CCS Concepts• Software and its engineering ~Traceability Software verification and validation

Mobile medical app development with a focus on traceability

“…A comparison of the initial and follow‐up assessments indicates that both organizations had significantly improved almost all traceability processes, although none of the processes improved to a level of 100% adherence. For further details on the findings and how the traceability improvements were measured, refer to Regan et al The overriding reason given for this is resource issues (mostly time) within the organizations. These resource issues are clearly outside the scope of the TAIF.…”