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Investigation of Traceability within a Medical Device Organization

  • Gilbert Regan
  • Fergal McCaffery
  • Kevin McDaid
  • Derek Flood
Part of the Communications in Computer and Information Science book series (CCIS, volume 349)

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.

Keywords

traceability requirements traceability software traceability medical device software process improvement 

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Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • Gilbert Regan
    • 1
  • Fergal McCaffery
    • 1
  • Kevin McDaid
    • 1
  • Derek Flood
    • 1
  1. 1.Dundalk Institute of TechnologyDundalkIreland

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