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Verification & Validation in Medi SPICE

  • Conference paper
Book cover Software Process Improvement and Capability Determination (SPICE 2011)

Part of the book series: Communications in Computer and Information Science ((CCIS,volume 155))

  • 1476 Accesses

Abstract

Effective verification and validation are central to medical device software development and are essential for regulatory approval. Although guidance is available in multiple standards in the medical device software domain, it is difficult for the manufacturer to implement as there is no consolidated view of this information. Likewise, the standards and guidance documents do not consider process improvement initiatives. This paper assists in relation to both these aspects and introduces the development of processes for verification and validation in the medical device domain.

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References

  1. Bernard, E., Legeard, B., Luck, X., Peureux, F.: Generation of test sequences from formal specifications: GSM 11-11 standard case study. Software: Practice and Experience 34(10), 915–948 (2004)

    Google Scholar 

  2. Rayadurgam, S., Heimdahl, M.P.E.: Test-sequence generation from formal requirement models. In: Proc. Sixth IEEE International Symposium on High Assurance Systems Engineering, pp. 23–31 (2001)

    Google Scholar 

  3. Myers, G., Sandler, C., Badgett, T., Thomas, T.: The Art of Software Testing, 2nd edn. Wiley, Chichester (2004)

    Google Scholar 

  4. Wallace, D.R., Fujii, R.U.: Software verification and validation: an overview. IEEE Software 6(3), 10–17 (1989)

    Article  Google Scholar 

  5. Berling, T., Thelin, T.: An industrial case study of the verification and validation activities. In: Proceedings of Ninth International, Software Metrics Symposium, September 3–5, pp. 226–238 (2003)

    Google Scholar 

  6. Arthur, J.D., Groner, M.K., Hayhurst, K.J., Holloway, C.M.: Evaluating the effectiveness of independent verification and validation. Computer 32(10), 79–83 (1999)

    Article  Google Scholar 

  7. Tassy, G.: The Economic Impacts of Inadequate Infrastructure for Software Testing. National Institute of Standards and Technology (NIST), report 02-3 (May 2002)

    Google Scholar 

  8. CMMI Product Team, Capability Maturity Model® Integration for Development Version 1.2. Software Engineering Institute (2006)

    Google Scholar 

  9. ISO/IEC 15504-5:2006, Information technology — Process Assessment — Part 5: An Exemplar Process Assessment Model. ISO, Geneva, Switzerland (2006)

    Google Scholar 

  10. ISO/IEC 12207:1995/Amd.1, Information Technology — Software life Cycle Processes Amendment 1. ISO, Geneva, Switzerland (2002)

    Google Scholar 

  11. Kit, E.: Software Testing in the Real World. Addison-Wesley, London (1995)

    Google Scholar 

  12. Jacobs, J.C., Trienekens, J.J.M.: Improving verification and validation in hardware/software environments. In: Introduction to the workshop. Proceedings of 10th International Workshop on Software Technology and Engineering Practice, STEP 2002, October 6-8, pp. 121- 122 (2002)

    Google Scholar 

  13. Why Software Requirements Traceability Remains a Challenge - Cross Talk, Issue (July/August 2009), http://www.stsc.hill.af.mil/crosstalk/2009/07/0907KannenbergSaiedian.html

  14. Leveson, N.G.: Paper on System Safety in Computer-Controlled Automotive Systems. Massachusetts Institute of Technology, http://sunnyday.mit.edu/papers/sae.pdf

  15. Alawneh, L., Debbabi, M., Hassaine, F., Jarraya, Y., Soeanu, A.: A unified approach for verification and validation of systems and software engineering models. In: 13th Annual IEEE International Symposium and Workshop on Engineering of Computer Based Systems, ECBS 2006, March 27-30 pp. 409–418, (2006)

    Google Scholar 

  16. MIL-STD-498. Military Standard - Software Development And Documentation. US Department of Defense, USA, December 5 (1994)

    Google Scholar 

  17. ISO/DIS 26262 Road vehicles - Functional safety. ISO, Geneva, Switzerland

    Google Scholar 

  18. IEC 60880:2006, Nuclear power plants - Instrumentation and control systems important to safety - Software aspects for computer-based systems performing category A functions. IEC, Geneva, Switzerland (2006)

    Google Scholar 

  19. IEC/TR 61508:2005, Functional safety of electrical/electronic/ programmable electronic safety related systems. BSI, London (2005)

    Google Scholar 

  20. Kyung, A.Y., Seung-Hun, P., Doo-Hwan, B., Hoon-Seon, C., Jae-Cheon, J.: A Framework for the V&V Capability Assessment Focused on the Safety-Criticality. In: 13th IEEE International Workshop, Proc. Software Technology and Engineering Practice, pp. 17–24 (2005)

    Google Scholar 

  21. ISO 9001:2000 - Quality management systems - Requirements (2000)

    Google Scholar 

  22. Eastaughffe, A., Cant, A., Ozols, M.A.: A Framework for Assessing Standards for Safety-critical Computer-Based Systems. In: Fourth IEEE International Symposium and Forum on Software Engineering Standards. ISESS, p. 33 (1999)

    Google Scholar 

  23. RTCA, RTCA DO-178B, Software Considerations in Airborne Systems and Equipment Certification (1992)

    Google Scholar 

  24. Automotive SPICE Process Assessment. SIG, August 21 (2005)

    Google Scholar 

  25. 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 

  26. European Council, Council Directive 93/42/EEC Concerning Medical Devices. Official Journal of The European Communities, Luxembourg (1993)

    Google Scholar 

  27. European Council, Council Directive 2007/47/EC (Amendment). Official Journal of The European Union, Luxembourg (2007)

    Google Scholar 

  28. ANSI/AAMI/IEC 62304:2006, Medical device software—Software life cycle processes. AAMI, Arlington (2006)

    Google Scholar 

  29. ISO 13485:2003. Medical devices — Quality management systems — Requirements for regulatory purposes, 2nd edn. ISO, Geneva, Switzerland (2003)

    Google Scholar 

  30. ISO 14971:2007. Medical Devices — Application of risk management to medical devices, 2nd edn. ISO, Geneva (2007)

    Google Scholar 

  31. Future Trends in Medical Device Innovation. Advanced Medical Technology Association, AdvaMed (2004), http://www.advamed.org/MemberPortal/About/NewsRoom/MediaKits/futuretrendsinmedicaldeviceinnovaton.htm

  32. ITEA 2 Blue Book (September 2005), http://www.itea2.org/itea_2_blue_book

  33. Wallace, D.R., Richard Kuhn, D.: Failure Modes in Medical Device Software: An analysis of 15 years of recall data. International Journal of Reliability, Quality and Safety

    Google Scholar 

  34. Feldmann, R.L., Shull, F., Denger, C., Host, M., Lindholm, C.: A Survey of Software Engineering Techniques in Medical Device Development. In: Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability, HCMDSS-MDPnP, June 25-27, pp.46-54 (2007)

    Google Scholar 

  35. Lin. W., Fan, X.: Software Development Practice for FDA-Compliant Medical Devices. In: International Joint Conference on Computational Sciences and Optimization, CSO 2009, April 24-26, vol.2, pp. 388–390 (2009)

    Google Scholar 

  36. US FDA/CDRH, 21CFR820, Quality System Regulation (2007)

    Google Scholar 

  37. US FDA/CDRH, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)

    Google Scholar 

  38. Burton, J., McCaffery, F., Richardson, I.: A risk management capability model for use in medical device companies. In: International Workshop on Software quality (WoSQ 2006), Shanghai, China, pp. 3–8. ACM, New York (2006)

    Google Scholar 

  39. 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 

  40. Eagles, S., Murray, J.: Medical Device Software Standards: Vision and Status, Medical Device and Diagnostic Industry (May 2001), http://www.mddionline.com/archive/all/1969?page=475

  41. McCaffery, F., Dorling, A., Casey, V.: Medi SPICE: An Update. In: The 10th International Spice Conference, SPICE 2010, Pisa, Italy May 18–20 (2010)

    Google Scholar 

  42. IEEE Standards for Software Verification and Validation, p. 58. IEEE, Los Alamitos (1998)

    Google Scholar 

  43. 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 

  44. European Council, Council Directive 98/79/EC On in vitro diagnostic medical devices. Official Journal of The European Communities, Luxembourg (1998)

    Google Scholar 

  45. European Council, Council Directive 90/385/EEC On the approximation of the laws of the Members States relating to active implantable medical devices. Official Journal of The European Communities, Luxembourg (1990)

    Google Scholar 

  46. Medical & Radiation Emitting Device Recalls, FDA (2011), http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm (accessed February 10, 2011)

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Author information

Authors and Affiliations

  1. Regulated Software Research Group, Dundalk Institute of Technology & Lero, Ireland

    M. S. Sivakumar, Valentine Casey, Fergal McCaffery & Gerry Coleman

Authors
  1. M. S. Sivakumar
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  2. Valentine Casey
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  3. Fergal McCaffery
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  4. Gerry Coleman
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Editor information

Editors and Affiliations

  1. Lero, The Irish Software Engineering Research Centre, School of Computing, Dublin City University, Dublin, Ireland

    Rory V. O’Connor

  2. Software Quality Institute, Griffith University, Brisbane, Queensland, Australia

    Terry Rout

  3. Regulated Software Research Group, Lero, The Irish Software Engineering Research Centre, Dundalk Institute of Technology, Dundalk, Ireland

    Fergal McCaffery

  4. InterSPICE Ltd, 23 King Street, CB1 1AH, Cambridge, UK

    Alec Dorling

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© 2011 Springer-Verlag Berlin Heidelberg

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Sivakumar, M.S., Casey, V., McCaffery, F., Coleman, G. (2011). Verification & Validation in Medi SPICE. In: O’Connor, R.V., Rout, T., McCaffery, F., Dorling, A. (eds) Software Process Improvement and Capability Determination. SPICE 2011. Communications in Computer and Information Science, vol 155. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-21233-8_7

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  • DOI: https://doi.org/10.1007/978-3-642-21233-8_7

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-21232-1

  • Online ISBN: 978-3-642-21233-8

  • eBook Packages: Computer ScienceComputer Science (R0)

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