Abstract
Software failures in medical devices can lead to catastrophic situations. Therefore is it crucial to handle software related risks when developing medical devices. This paper presents the experiences gained from an ongoing case study with a medical device development organisation. This part of the study focuses on the two first steps of the risk management process, i.e. risk identification and risk analysis. The research is conducted as action research, with the aim of analysing and giving input to the organisation’s introduction of a software risk management process. The risk identification activities focus on user risks based on scenarios describing the expected use of the medical device in its target environment. Challenging problems have been found in the risk management process with respect to definition of the system boundary and system context, the use of scenarios as input to the risk identification and estimation of detectability used during risk assessment.
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References
Gall, H.: Functional Safety IEC 61508 / IEC 61511 The Impact to Certification and the User. In: IEEE International Conference on Computer Systems and Applications (2008)
Lindholm, C., Notander, J.P., Höst, M.: Software Risk Analysis in Medical Device Development. Accepted for Publication in Proceedings of EUROMICRO Conference on Software Engineering and Advanced Applications (SEAA), Oulu, Finland, August 30-September 2 (2011)
Garde, S., Knaup, P.: Requirements engineering in health care: the example of chemotherapy planning in paediatric oncology. Requirements Engineering, 265–278 (2006)
Fairley, R.E.: Software Risk Management. IEEE Software, 101 (May/June 2005)
Rakitin, S.R.: Coping with Defective Software in Medical Devices. IEEE Computer 39(4), 40–45 (2006)
Commission of the European Communities, Council Directive 93/42/EEC EEC concerning medical devices (1993)
U.S. Food and Drug Administration, Federal Food, Drug and Cosmetic Act section 201(h) (2005)
Hall, E.M.: Managing Risk: Methods for Software systems development. Addison Wesley (1998)
McCaffery, F., Burton, J., Richardson, I.: Risk management capability model for the development of medical device software. Software Quality Journal (18), 81–107 (2010)
McCaffery, F., Burton, J., Richardson, I.: Improving Software Risk Management in a Medical Device Company. In: Proceedings of International Conference on Software Engineering (ICSE), Vancouver Canada (2009)
Schmuland, C.: Value- Added Medical-Device Risk Management. IEEE Transactions on Device and Materials Reliability 5(3), 488–493 (2005)
Sayre, K., Kenner, J., Jones, P.: Safety Models: An Analytical Tool for Risk Analysis of Medical Device Systems. In: Proceedings of 14th IEEE Symposium on Computer-Based Medical Systems (CMBS 2001), Maryland, USA (2001)
Yin, R.K.: Case Study Research Design and Methods, 3rd edn. Sage, Thousand Oaks (2003)
Robson, C.: Real World Research, 2nd edn. Blackwell Publishers Ltd., Oxford (2002)
Runeson, P., Höst, M.: Guidelines for Conducting and Reporting Case Study Research in Software Engineering. Empirical Software Engineering 14(2), 131–164 (2009)
Boehm, B.: Software Risk Management: Principles and Practices. IEEE Software 8(1), 32–41 (1991)
Leveson, N.G.: Safeware: System Safety and Computers, Addison-Wesley Professional (1995)
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Lindholm, C., Notander, J.P., Höst, M. (2012). A Case Study on Software Risk Analysis in Medical Device Development. In: Biffl, S., Winkler, D., Bergsmann, J. (eds) Software Quality. Process Automation in Software Development. SWQD 2012. Lecture Notes in Business Information Processing, vol 94. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-27213-4_10
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DOI: https://doi.org/10.1007/978-3-642-27213-4_10
Publisher Name: Springer, Berlin, Heidelberg
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