Abstract
Software is becoming an increasingly important aspect of medical devices (MDs) and MD regulation. MDs can only be marketed if compliance and approval is achieved from the appropriate regulatory bodies. MD companies must produce a design history file detailing the processes undertaken in the design and development of their MD software. The safety of all MD software produced is of primary importance and it is crucial that an effective and efficient risk management (RM) process is in place. The authors have developed a software process improvement RM model that integrates regulatory MD RM requirements with the goals and practices of the Capability Maturity Model Integration (CMMI). This model is known as the RM Capability Model (RMCM). This paper evaluates how introducing the RMCM into a MD company improved their RM process.
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References
World Health Organisation: Medical device regulations: global overview and guiding principles (2003), ISBN 92 4 154618 2
Burton, J., McCaffery, F., Richardson, I.: A Risk Management Capability Model for use in Medical Device Companies. In: 4th Workshop on Software Quality, ICSE 2006, Shanghai, China, May 21, 2006, pp. 3–8 (2006)
FDA: Quality Systems for Medical Device & Equipment/Software Manufacturers (QSR). Code of Federal Regulations (April 2005)
Donawa, M.: Useful US Guidance on Device Software. Medical Device Technology (December 2005), http://www.medicaldevicesonline.com
Boehm, B.W.: Software Risk Management: Principles and Practices. IEEE Software 8(1), 32–41 (1991)
FDA Mission Statement, http://www.fda.gov/opacom/morechoices/mission.html
Eagles, S., Murray, J.: Medical Device Software Standards: Vision and Status (2001), http://www.devicelink.com/medicaldevicedi/archive/01/05/002.html
CMMI Product Team: Capability Maturity Model® Integration for Development, Version 1.2, Technical Report CMU/SEI-2006-TR-008 (2006), http://www.sei.cmu.edu/publications/documents/06.reports/06tr008.html
FDA/CDRH: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005), http://www.fda.gov/cdrh/ode/guidance/337.pdf
FDA/CDRH: Guidance for Off-the-Shelf Software Use in Medical Devices (September 1999), http://www.fda.gov/cdrh/ode/guidance/585.pdf
FDA/CDRH Guidance Document. General Principles of Software Validation, Final Guidance for Industry and FDA Staff (January 2002)
FDA Regulations: Code of Federal Regulations 21 CFR Part 820 (April 2006), http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1
ANSI/AAMI/ISO 14971: Medical devices – Application of risk management to medical devices (2007)
ANSI/AAMI/IEC 62304:2006: Medical device software - Software life cycle processes Association for the Advancement of Medical Instrumentation (July 2006), http://www.techstreet.com/cgi-bin/detail?product_id=1277045 ISBN 1-57020-258-3
BS EN 60601-1-4: Medical Electrical Equipment, Part 1 - General requirements for safety (2000)
IEC 60812: Analysis technique for system reliability- procedure for failure modes and effects analysis (FMEA) (1985)
ISPE: GAMP Guide for Validation of Automated Systems. GAMP 4 (December 2001), http://www2.ispe.org/eseries/scriptcontent/orders/ProductDetail.cfm?pc=4BOUNDFUS
AAMI TIR32: Medical device software risk management (2005)
AAMI: New Guidance Offered on Software Risk Management 40(2) (2005)
Baskerville, R.L.: Investigating Information Systems with Action Research. Communications of the Association of Information Systems 2, article 19 (1999)
Susman, G., Evered, R.: An Assessment of The Scientific Merits of Action Research. Administrative Science Quarterly 4(23), 582–603 (1978)
Liamputtong, P., Ezzy, D.: Qualitative Research Methods, 2nd edn. (2006), ISBN 9 78019551 7446
FDA/CDRH: Software related recalls for fiscal years 1983-91. US Department of Health and Human Services (1992)
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Burton, J., McCaffery, F., Richardson, I. (2008). Improving Software Risk Management Practices in a Medical Device Company. In: Wang, Q., Pfahl, D., Raffo, D.M. (eds) Making Globally Distributed Software Development a Success Story. ICSP 2008. Lecture Notes in Computer Science, vol 5007. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-79588-9_4
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DOI: https://doi.org/10.1007/978-3-540-79588-9_4
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