Type

Book Chapter

Authors

Derek Flood
Gilbert Regan
Fergal McCaffery
Kevin McDaid

Subjects

Mathematics

Topics
medical device quality assurance computer software software quality requirements traceability impact analysis safety critical medical device standards

Investigation of Traceability within a Medical Device Organization (2013)

Abstract Requirements traceability helps to ensure software quality. It supports quality assurance activities such as impact analysis, regression test selection, compliance verification and validation of requirements. Its implementation has long been promoted by the research and expert practitioner communities. However, evidence indicates that few software organizations choose to implement traceability processes, in the most part due to cost and complexity issues. Organizations operating within the safety critical domains are mandated to implement traceability, and find the implementation and maintenance of an efficient and compliant traceability process a difficult and complex issue. Through interviews with a medical device SME, this paper seeks to determine how traceability is implemented within the organization, the difficulties it faces in implementing traceability, how compliant it is with the medical device standards and guidelines, and what changes could be made to improve the efficiency of their traceability implementation and maintenance.
Collections Ireland -> Dundalk IT -> Subject = Computer Science: Computer Software
Ireland -> Dundalk IT -> Status = Published
Ireland -> Dundalk IT -> Type = Book Section

Full list of authors on original publication

Derek Flood, Gilbert Regan, Fergal McCaffery, Kevin McDaid

Experts in our system

1
Derek Flood
Dundalk IT
Total Publications: 30
 
2
Gilbert Regan
Dundalk IT
Total Publications: 17
 
3
Fergal McCaffery
Dundalk IT
Total Publications: 91