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Improving Verification & Validation in the Medical Device Domain

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Systems, Software and Service Process Improvement (EuroSPI 2011)

Part of the book series: Communications in Computer and Information Science ((CCIS,volume 172))

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Abstract

The benefits of effective verification and validation activities in the medical device domain include increased usability and reliability, decreased failure rate and recalls and reduced risks to patients and users. Though there is guidance on verification and validation in multiple standards in the medical device domain, these are difficult for the manufacturer to implement, as there is no consolidated information on how they can be successfully achieved. The paper is intended to highlight three major areas for improvement in the medical device software development domain. This research is based on an analysis of available literature in the field of verification and validation in generic software development, safety-critical and medical device software domains. Additionally, we also performed a review of the standards and process improvement models available in these domains.

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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. of Sixth IEEE International Symposium on High Assurance Systems Engineering, 2001, 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. US FDA Centre for Devices and Radiological Health, General Principles of Software Validation; Final Guidance for Industry and FDA Staff. CDRH, Rockville (2002)

    Google Scholar 

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

    Google Scholar 

  7. 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 

  8. Monteiro, P., Machado, R.J., Kazman, R.: Inception of Software Validation and Verification Practices within CMMI Level 2. In: 2009 Fourth International Conference on Software Engineering Advances, icsea, pp. 536–541 (2009)

    Google Scholar 

  9. IEEE Standard for Software Verification and Validation Plans, IEEE Std 1012-1986, p. I (1986)

    Google Scholar 

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

    Google Scholar 

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

    Google Scholar 

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

    Google Scholar 

  13. Automotive SPICE Process Assessment Model 2.2, Automotive SIG (August 21, 2005)

    Google Scholar 

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

    Google Scholar 

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

    Google Scholar 

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

    Google Scholar 

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

    Google Scholar 

  18. Andersson, C., Runeson, P.: Verification and validation in industry - a qualitative survey on the state of practice. In: Proceedings of 2002 International Symposium on Empirical Software Engineering, 2002, pp. 37–47 (2002)

    Google Scholar 

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

    Google Scholar 

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

    Google Scholar 

  21. ISO/IEC 29119 Software Testing, http://www.softwaretestingstandard.org/projecttimeline.php (accessed on April 18, 2011)

  22. Why Software Requirements Traceability Remains a Challenge, Cross Talk (July/August 2009) Issue, http://www.crosstalkonline.org/storage/issue-archives/2009/200907/200907-Kannenberg.pdf (accessed on April 18, 2011)

  23. Heimdahl, M.P.E.: Safety and Software Intensive Systems: Challenges Old and New. In: Future of Software Engineering, FOSE 2007, May 23-25, page 1, pp. 137–152 (2007)

    Google Scholar 

  24. 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, vol. 10, p. 418 (2006)

    Google Scholar 

  25. Leveson, N.G.: Paper on System Safety in Computer-Controlled Automotive Systems. MIT, Cambridge (2011), http://www.sunnyday.mit.edu/papers/sae.pdf (accessed on April 18, 2011)

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

    Google Scholar 

  27. 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 

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

    Google Scholar 

  29. 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: Proc. 13th IEEE International Workshop on Software Technology and Engineering Practice, 2005, pp. 17–24 (2005)

    Google Scholar 

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

    Google Scholar 

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

    Google Scholar 

  32. IEEE, IEEE Standards for Software Verification and Validation, Page 58 (1998)

    Google Scholar 

  33. Lee, I., Pappas, G.J., Cleaveland, R., Hatcliff, J., Krogh, B.H., Lee, P., Rubin, H., Sha, L.: High-Confidence Medical Device Software and Systems. Computer 39(4), 33–38 (2006)

    Article  Google Scholar 

  34. Jetley, R., Iyer, S.P., Jones, P.L., Spees, W.: A Formal Approach to Pre-Market Review for Medical Device Software. In: 30th Annual International on Computer Software and Applications Conference, COMPSAC 2006, September 17-21, vol. 1, pp. 169–177 (2006)

    Google Scholar 

  35. Caffery, F.M., Dorling, A., Casey, V.: Medi SPICE: “An Update”. In: The 10th International Spice Conference (SPICE 2010), Pisa, Italy, May 18-20 (2010)

    Google Scholar 

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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. Roskilde University, Roskilde, Denmark

    Jan Pries-Heje

  3. ISCN Ltd., Graz, Austria

    Richard Messnarz

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© 2011 Springer-Verlag Berlin Heidelberg

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Sivakumar, M.S., Casey, V., McCaffery, F., Coleman, G. (2011). Improving Verification & Validation in the Medical Device Domain. In: O‘Connor, R.V., Pries-Heje, J., Messnarz, R. (eds) Systems, Software and Service Process Improvement. EuroSPI 2011. Communications in Computer and Information Science, vol 172. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-22206-1_6

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  • DOI: https://doi.org/10.1007/978-3-642-22206-1_6

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-22205-4

  • Online ISBN: 978-3-642-22206-1

  • eBook Packages: Computer ScienceComputer Science (R0)

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