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)


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.


traceability requirements traceability software traceability medical device software process improvement 


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Ramesh, B.: Factors influencing requirements traceability practice. Commun. ACM 41, 37–44 (1998)CrossRefGoogle Scholar
  2. 2.
    Rakitin, S.R.: Coping with Defective Software in Medical Devices. Computer, 40–45 (2006)Google Scholar
  3. 3.
    M.D. Technology. Certain J&J insulin pumps destined to fail over software issue (January 23, 2013),
  4. 4.
    S. a. H. o. R. o. t. U. S. o. A. i. Congress, Sarbanes-Oxley Act of 2002. P. L. 107–204, Washington (2002)Google Scholar
  5. 5.
    Cleland-Huang, J., et al.: Best Practices for Automated Traceability. Computer 40, 27–35 (2007)CrossRefGoogle Scholar
  6. 6.
    ANSI/AAMI/IEC, 62304:2006 Medical device software—Software life cycle processes. AAMI, Arlington (2006)Google Scholar
  7. 7.
    FDA, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. CDRH, Rockville (2005)Google Scholar
  8. 8.
    FDA, General Principles, of Software Validation; Final Guidance for Industry and FDA Staff. CDRH, Rockville (2002)Google Scholar
  9. 9.
    FDA, Off-The-Shelf Software Use in Medical Devices; Guidance for Industry, FDA Reviewers and Compliance. CDRH, Rockville (1999)Google Scholar
  10. 10.
    ISO, ISO 14971:2007 Medical devices — Application of risk management to medical devices. ISO, Switzerland (2007)Google Scholar
  11. 11.
    McCaffery, F., et al.: Medical Device Software Traceability. In: Cleland-Huang, J., et al. (eds.) Software and Systems Traceability. Springer (2012)Google Scholar
  12. 12.
    Gotel, O., Mader, P.: Acquiring Tool Support for Traceability. In: Cleland-Huang, J., et al. (eds.) Software and Systems Traceability. Springer (2012)Google Scholar
  13. 13.
    Gotel, O.C.Z., Finkelstein, C.W.: An analysis of the requirements traceability problem. In: Proceedings of the First International Conference on Requirements Engineering, pp. 94–101 (1994)Google Scholar
  14. 14.
    Cleland-Huang, J.: Requirements Traceability - When and How does it Deliver more than it Costs? In: 14th IEEE International Conference on Requirements Engineering, p. 330 (2006)Google Scholar
  15. 15.
    Espinoza, A., Garbajosa, J.: A Proposal for Defining a Set of Basic Items for Project-Specific Traceability Methodologies. In: 32nd Annual IEEE Software Engineering Workshop, SEW 2008, Madrid, pp. 175–184 (2008)Google Scholar
  16. 16.
    Lucia, A.D., et al.: Information Retrieval Methods for Automated Traceability Recovery. In: Cleland-Huang, J., et al. (eds.) Software and Systems Traceability, pp. 88–111. Springer (2012)Google Scholar
  17. 17.
    Kannenberg, A., Saiedian, D.H.: Why Software Requirements Traceability Remains a Challenge. CrossTalk The Journal of Defense Software Engineering (July/August 2009)Google Scholar

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

Personalised recommendations