A Lightweight Assessment Method for Medical Device Software Processes

  • Fergal McCaffery
  • Paul Clarke
  • Marion Lepmets
Conference paper
Part of the Communications in Computer and Information Science book series (CCIS, volume 477)


This paper outlines the MDevSPICE-Adept process assessment method. MDevSPICE-Adept is a lightweight process assessment method that has been created for the MDevSPICE software process assessment model which is currently being developed for the medical device industry. MDevSPICE is a fully validated release of a medical device software process assessment model (formerly known as Medi SPICE), which was developed by the authors. While the MDevSPICE process assessment model is detailed and comprehensive, there is industry demand for a lightweight medical device software process assessment method. To address this requirement the MDevSPICE-Adept method has been developed. Details on how this has taken place and the procedures for implementing an MDevSPICE-Adept process assessment are presented. Information is also provided regarding how an MDevSPICE process assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this process assessment and the actions taken to facilitate process improvement is also presented. Finally, plans for future work are discussed.


Medical Device Software Software Process Improvement Lightweight Process Assessment Method Medical Device Software Process Assessment MDevSPICE 


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  1. 1.
    Abraham, C., Nishiharas, E., Akiyama, M.: Transforming healthcare with information technology in Japan: A review of policy, people, and progress. International Journal of Medical Informatics 80(3), 157–170 (2011)CrossRefGoogle Scholar
  2. 2.
    Lee, I., Pappas, G., Cleaveland, R., Hatcliff, J., Krogh, B., Lee, P., Rubin, H., Sha, L.: High-Confidence Medical Device Software And Systems. Computer 39(4), 33–38 (2006)CrossRefGoogle Scholar
  3. 3.
    European Council, Council Directive 2007/47/EC (Amendment). In: Official Journal of The European Union: Luxembourg (2007)Google Scholar
  4. 4.
    European Commission, MEDICAL DEVICES: Guidance document- Qualification and Classification of stand alone software (MEDDEV 2.1/6). Brussels, Belgium (2012)Google Scholar
  5. 5.
    US FDA Center for Devices and Radiological Health, General Principles of Software Validation; Final Guidance for Industry and FDA Staff. CDRH: Rockville (2002)Google Scholar
  6. 6.
    US FDA Center for Devices and Radiological Health, Off-The-Shelf Software Use in Medical Devices; Guidance for Industry, medical device Reviewers and Compliance. CDRH: Rockville (1999)Google Scholar
  7. 7.
    US FDA Center for Devices and Radiological Health, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. CDRH: Rockville (2005)Google Scholar
  8. 8.
    US FDA, 21 CFR Part 880 Medical Devices; Medical Device Data Systems Final Rule. Federal Register, 2011. vol. 76(31), pp. 8637 – 8649 (2011)Google Scholar
  9. 9.
    US FDA, Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications (2011)Google Scholar
  10. 10.
    Vogel, D.A.: Medical Device Software Verification, Validation and Compliance, p. 432. Artech House, Norwood (2010)Google Scholar
  11. 11.
    IEC 62304:2006, Medical device software—Software life cycle processes. IEC: Geneva, Switzerland (2006)Google Scholar
  12. 12.
    ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes. ISO: Geneva, Switzerland (2003)Google Scholar
  13. 13.
    ISO 14971:2007, Medical Devices — Application of risk management to medical devices. ISO: Geneva, Switzerland (2007)Google Scholar
  14. 14.
    BS EN 60601-1:2005Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. IEC: Geneva, Switzerland (2005)Google Scholar
  15. 15.
    IEC 62366:2007, Medical devices - Application of usability engineering to medical devices. IEC: Geneva, Switzerland (2007)Google Scholar
  16. 16.
    IEC 60812:2006, Analysis technique for system reliability - Procedure for failure modes and effects analysis (FMEA). IEC: Geneva, Switzerland (2006)Google Scholar
  17. 17.
    IEC/TR 80002-1:2009, Medical device software Part 1: Guidance on the application of ISO 14971 to medical device software. BSI: London (2009)Google Scholar
  18. 18.
    IEC/TR 61508:2005, Functional safety of electrical/electronic/ programmable electronic safety related systems. BSI: London (2005)Google Scholar
  19. 19.
    Mc Caffery, F., Burton, J., Casey, V., Dorling, A.: Software Process Improvement in the Medical Device Industry. In: Laplante, P. (ed.) Encyclopedia of Software Engineering, pp. 528–540. CRC Press Francis Taylor Group, New York (2010)Google Scholar
  20. 20.
    Denger, C., Feldmann, R., Host, M., Lindholm, C., Shull, F.: A Snapshot of the State of Practice in Software Development for Medical Devices. In: First International Symposium on Empirical Software Engineering and Measurement, Madrid, Spain (2007)Google Scholar
  21. 21.
    Mc Caffery, F., Dorling, A.: Medi SPICE: An Overview. In: International Conference on Software Process Improvement and Capability Determinations (SPICE), Finland (2009)Google Scholar
  22. 22.
    Casey, V., Mc Caffery, F.: Med-Trace: Traceability Assessment Method for Medical Device Software Development. In: European Systems and Software Process Improvement and Innovation Conference. Roskilde University, Denmark (2011)Google Scholar
  23. 23.
    CMMI Product Team, Capability Maturity Model Integration for Development Version1.3. Software Engineering Institute, Pittsburg PA (2010)Google Scholar
  24. 24.
    ISO/IEC 15504-5:2012, Information technology - Process Assessment - Part 5: An Exemplar Software Life Cycle Process Assessment Model. ISO (2012)Google Scholar
  25. 25.
    Mc Caffery, F., Dorling, A.: Medi SPICE Development. Software Process Maintenance and Evolution: Improvement 22(4), 255–268 (2010)Google Scholar
  26. 26.
    Automotive SIG, Automotive SPICE Process Assessment V 2.2 (August 21, 2005) Google Scholar
  27. 27.
    IEC/CD 82304:2014, Health Software - Part 1: General Requirements for Product Safety. ISO: Geneva, Switzerland (2014)Google Scholar
  28. 28.
    IEC/TR 80002-3:2014, Medical Device Software - Part 3: Process reference model for medical device software life cycle processes (IEC 62304). ISO: Geneva, Switzerland (2014)Google Scholar
  29. 29.
    ISO/IEC 12207:2008, Systems and software engineering - Software life cycle processes. ISO: Geneva, Switzerland (2008)Google Scholar
  30. 30.
    ISO/IEC 15504-2:2003, Software engineering - Process assessment - Part 2: Performing an assessment, ISO: Geneva, Switzerland (2003)Google Scholar
  31. 31.
    Mc Caffery, F., Dorling, A., Casey, V.: Medi SPICE: An Update. In: International Conference on Software Process Improvement and Capability Determinations (SPICE), Pisa, Italy (2010)Google Scholar
  32. 32.
    Casey, V.: Virtual Software Team Project Management. Journal of the Brazilian Computer Society 16(2), 83–96 (2010)MathSciNetCrossRefGoogle Scholar
  33. 33.
    Mc Caffery, F., Richardson, I., Coleman, G.: Adept – A Software Process Appraisal Method for Small to Medium-sized Irish Software Development Organisations. In: European Systems & Software Process Improvement and Innovation (EuroSPI 2006), Joensuu, Finland (2006)Google Scholar
  34. 34.
    Mc Caffery, F., Casey, V.: Med-Adept: A Lightweight Assessment Method for the Irish Medical Device Software Industry. In: European Systems & Software Process Improvement and Innovation Conference (EuroSPI), Grenoble, France (2010)Google Scholar
  35. 35.
    Casey, V., Mc Caffery, F.: A lightweight traceability assessment method for medical device software. Journal of Software Maintenance and Evolution Research and Practice (2011)Google Scholar

Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  • Fergal McCaffery
    • 1
  • Paul Clarke
    • 1
  • Marion Lepmets
    • 1
  1. 1.Regulated Software Research CentreDundalk Institute of TechnologyDundalkIreland

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