Software Process Improvement and Roadmapping – A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software

  • Peter Rust
  • Derek Flood
  • Fergal McCaffery
Conference paper
Part of the Communications in Computer and Information Science book series (CCIS, volume 526)


Organizations engaged in medical device software are required to demonstrate compliance with a set of medical device standards and regulations before the device can be marketed. One such standard IEC 62304, Medical device software – Software life cycle processes, is a standard that defines the processes that are required to be executed in order to develop safe software. Demonstrating compliance with IEC 62304 can be problematic for organizations that are new to or have limited experience in the domain. The standard defines what processes must be carried out, but does not state how. This paper presents a research method for generating a roadmap that will guide organizations in the implementation of IEC 62304.


Medical device software Medical device standards Regulatory compliance Software roadmap Software process improvement Software process improvement roadmaps IEC 62304 


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Ward, J.R., Clarkson, P.J.: An analysis of medical device-related errors: prevalence and possible solutions. J. Med. Eng. Technol. 28(1), 2–21 (2004)CrossRefGoogle Scholar
  2. 2.
    Alemzadeh, H., Iyer, R.K., Kalbarczyk, Z., Raman, J.: Analysis of Safety-Critical Computer Failures in Medical Devices. IEEE Secur. Priv. 11(4), 14–26 (2013)CrossRefGoogle Scholar
  3. 3.
    ISO 13485:2003 - Medical devices – Quality management systems – Requirements for regulatory purposes. ISO, Geneva (2003)Google Scholar
  4. 4.
    ISO 14971:2007 - Medical devices – Application of risk management to medical devices. ISO, Geneva (2007)Google Scholar
  5. 5.
    IEC 62366-1:2007 - Medical devices – Part 1: Application of usability engineering to medical devices. ISO, Geneva (2007)Google Scholar
  6. 6.
    McHugh, M., McCaffery, F., Casey, V.: Standalone software as an active medical device. In: O’Connor, R.V., Rout, T., McCaffery, F., Dorling, A. (eds.) SPICE 2011. CCIS, vol. 155, pp. 97–107. Springer, Heidelberg (2011)CrossRefGoogle Scholar
  7. 7.
    IEC 62304:2006 - Medical device software – Software life cycle processes. ISO, Geneva (2006)Google Scholar
  8. 8.
    Team, C.P.: CMMI for Development, Version 1.3. Carnegie Mellon Univ., no. (November 2010)Google Scholar
  9. 9.
    ISO/IEC 15504-5, Information technology - Process Assessment - Part 5: An Exemplar Process Assessment Model. ISO, Geneva (2012)Google Scholar
  10. 10.
    McCaffery, F., Dorling, A.: Medi SPICE Development. Softw. Process Maint. Evol. Improv. Pract. J. 22(4), 255–268 (2010)Google Scholar
  11. 11.
    IEC 62304:2006: Medical device software—Software life cycle processes. IEC, Geneva, vol. 3 (2006)Google Scholar
  12. 12.
    ISO/IEC 12207:2008, Systems and software engineering — Software life cycle processes. ISO, Geneva (2008)Google Scholar
  13. 13.
    ISO/IEC 15504-2:2003, Software engineering — Process assessment — Part 2: Performing an assessment. ISO, Geneva (2003)Google Scholar
  14. 14.
    Phaal, R.: Public Domain Roadmaps. Centre for Technology Management, University of Cambridge (2011)Google Scholar
  15. 15.
    Hall, L.: Space Technology Roadmaps: The Future Brought To You By NASA. Brian Dunbar, June 07, 2013Google Scholar
  16. 16.
    McFeeley, R., McKeehan, D., Temple, T.: Software Process Improvement Roadmap. Software Engineering Institute (1995)Google Scholar
  17. 17.
    Höss, A., Lampe, C., Panse, R., Ackermann, B., Naumann, J., Jäkel, O.: First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit. Radiat. Oncol. 9, 79 (2014)CrossRefGoogle Scholar
  18. 18.
    Flood, D., Caffery, F.M., Casey, V., Regan, G.: A methodology for software process improvement roadmaps for regulated domains – example with IEC 62366. In: McCaffery, F., O’Connor, R.V., Messnarz, R. (eds.) EuroSPI 2013. CCIS, vol. 364, pp. 25–35. Springer, Heidelberg (2013)CrossRefGoogle Scholar
  19. 19.
    Flood, D., Mc Caffery, F., Casey, V., McKeever, R., Peter, R.: A Roadmap to ISO 14971 Implementation. J. Softw. Process Evol. Accept. Awaiting PublGoogle Scholar
  20. 20.
    62304 and TIR32 Training Slides - Eagles_Dundalk_04Sept13.pdf. (accessed: March 12, 2015)
  21. 21.
    Regan, G., Casey, V., Flood, D., Mc Caffery, F.: A critical evaluation of a methodology for the generation of software process improvement roadmaps. In: Barafort, B., O’Connor, R.V., Poth, A., Messnarz, R. (eds.) EuroSPI 2014. CCIS, vol. 425, pp. 36–47. Springer, Heidelberg (2014)CrossRefGoogle Scholar
  22. 22.
    ISO/IEC TR 24774:2010 - Systems and software engineering – Life cycle management – Guidelines for process description. ISO, Geneva (2010)Google Scholar
  23. 23.
    Farrukh, C.J.P., Phaal, R., Probert, D.: Technology roadmapping: linking technology resources into business planning. Int. J. Technol. Manag. 26, 2 (2003)CrossRefGoogle Scholar
  24. 24.
    Gindy, A.H.N.N.Z., Morcos, M.S., ulent Cerit, B.: Strategic Technology Alignment Roadmapping STAR® Aligning R&D Investments with Business Needs – document. International Journal of Computer Integrated Manufacturing, Taylor & Francis, STM, Behavioural Science and Pub- lic Health Titles (2008)Google Scholar
  25. 25.
    Regnell, B., Svensson, R.B., Olsson, T.: Supporting Roadmapping of Quality Requirements. IEEE Softw. 25(2), 42–47 (2008)CrossRefGoogle Scholar
  26. 26.
    Phaal, R., Farrukh, C.J.P., Probert, D.R.: T-plan: The Fast Start to Technology Roadmapping. Planning Your Route to Success. University of Cambridge. Institute for Manufacturing (2001)Google Scholar

Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  1. 1.Regulated Software Research Centre & LeroDundalk Institute of TechnologyDundalkIreland

Personalised recommendations