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.
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References
Ramesh, B.: Factors influencing requirements traceability practice. Commun. ACM 41, 37–44 (1998)
Rakitin, S.R.: Coping with Defective Software in Medical Devices. Computer, 40–45 (2006)
M.D. Technology. Certain J&J insulin pumps destined to fail over software issue (January 23, 2013), http://www.massdevice.com/news/diabetes-certain-jj-insulin-pumps-destined-fail-over-software-issue
S. a. H. o. R. o. t. U. S. o. A. i. Congress, Sarbanes-Oxley Act of 2002. P. L. 107–204, Washington (2002)
Cleland-Huang, J., et al.: Best Practices for Automated Traceability. Computer 40, 27–35 (2007)
ANSI/AAMI/IEC, 62304:2006 Medical device software—Software life cycle processes. AAMI, Arlington (2006)
FDA, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. CDRH, Rockville (2005)
FDA, General Principles, of Software Validation; Final Guidance for Industry and FDA Staff. CDRH, Rockville (2002)
FDA, Off-The-Shelf Software Use in Medical Devices; Guidance for Industry, FDA Reviewers and Compliance. CDRH, Rockville (1999)
ISO, ISO 14971:2007 Medical devices — Application of risk management to medical devices. ISO, Switzerland (2007)
McCaffery, F., et al.: Medical Device Software Traceability. In: Cleland-Huang, J., et al. (eds.) Software and Systems Traceability. Springer (2012)
Gotel, O., Mader, P.: Acquiring Tool Support for Traceability. In: Cleland-Huang, J., et al. (eds.) Software and Systems Traceability. Springer (2012)
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)
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)
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)
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)
Kannenberg, A., Saiedian, D.H.: Why Software Requirements Traceability Remains a Challenge. CrossTalk The Journal of Defense Software Engineering (July/August 2009)
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Regan, G., McCaffery, F., McDaid, K., Flood, D. (2013). Investigation of Traceability within a Medical Device Organization. In: Woronowicz, T., Rout, T., O’Connor, R.V., Dorling, A. (eds) Software Process Improvement and Capability Determination. SPICE 2013. Communications in Computer and Information Science, vol 349. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-38833-0_19
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DOI: https://doi.org/10.1007/978-3-642-38833-0_19
Publisher Name: Springer, Berlin, Heidelberg
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