Skip to main content
Springer Nature Link
Log in

Standalone Software as an Active Medical Device

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

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

Abstract

With the release of the latest European Medical Device Directive (MDD) standalone software can now be classified as an active medical device. Consequently the methods used to ensure device safety and reliability needs to be reviewed. IEC 62304 is the current software development lifecycle framework followed by medical device software developers but important processes are beyond the scope of IEC 62304. These processes are covered by additional standards. However since the MDD became mandatory these additional standards are not comprehensive enough to ensure the reliability of an active medical device consisting of only software. By employing software process improvement techniques this software can be developed and validated to ensure it performs the required task in a safe and reliable way.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution

Subscribe and save

Springer+ Basic
$34.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or eBook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

Similar content being viewed by others

References

  1. Blacksmith Enterprise, http://www.blackenterprise.com/2010/09/30/healthcare-it-on-the-rise/

  2. PCMag.com, http://www.pcmag.com/article2/0,2817,2343550,00.asp

  3. Borrás, C.: Overexposure of Radiation Theraphy in Panama. Articles and special reports, 173–187 (2006)

    Google Scholar 

  4. U.S. Department of Health & Human Service, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

  5. Diabetes. Bayer Contour USB Glucose Meter (2010), http://www.diabeticlive.com/glucose-meters/bayer-contour-usb-glucose-meter/

  6. British Standards Online (America), http://www.bsiamerica.com/en-us/Sectors-and-Services/Industry-sectors/Healthcare-and-medical-devices/CE-marking-for-medical-devices/

  7. EN ISO 13485:2003. Medical Device: Quality Management Systems. Requirements for the Regulatory Process, July 24 (2003)

    Google Scholar 

  8. EN ISO 14971:2009. Medical Devices. Application of Risk management to medical devices July 31 (2009)

    Google Scholar 

  9. EN 60601-1. Medical Electrical Equipment. General requirements for basic safety and essential performance. Collateral standard. Usability May 31 (2010)

    Google Scholar 

  10. Emergo Group, http://www.bsiamerica.com/en-us/Sectors-and-Services/Industry-sectors/Healthcare-and-medical-devices/CE-marking-for-medical-devices

  11. European Council, Council Directive 93/42/EEC Concerning Medical Devices, June 14 (1993)

    Google Scholar 

  12. Webb, K.: Changes to the Medical Device Legislation in Europe- The Impact of Directive 2007/47/EC (2007), http://www.slideshare.net/mediqol/changes-to-the-medical-device-legislation-in-europe-presentation

  13. European Council, 2007. Council Directive 2007/47/EC (September 2007)

    Google Scholar 

  14. ANSI/AAMI/IEC 62304. Medical device Software - Software life cycle processes, Association for the Advancement of Medical Instrumentation, July 19 (2006)

    Google Scholar 

  15. IEC 62366. Medical Devices - Application of usability engineering to medical devices, November13 (2007)

    Google Scholar 

  16. AAMI/IEC TIR 80002-1:2009. Medical Device Software 1: Guidance on the application of ISO 14971 to Medical Device Software, May31 (2010)

    Google Scholar 

  17. ISO/IEC 15504-5:2006. Information Technology. Process Assessment. An exemplar process assessment model, April 28 (2006)

    Google Scholar 

  18. ISO/IEC 12207:1995. Information Technology. Software Lifecycle Processes, February 28 (1995)

    Google Scholar 

  19. Qmed, http://www.qmed.com/consultants/19204/global-perspectives-north-america-iec-62304-questions-and-answers?quicktabs_5=1

  20. Eagles, S.: International Standards and EU regulation of medical device software – An update (2009)

    Google Scholar 

  21. Emergo Group, http://www.emergogroup.com/newsletters/directive-2007-47-ec-sep2007

  22. ComputerWorld. FCC mobile network plan could revolutionize health care (2010), http://www.computerworld.com/s/article/9174429/FCC_mobile_network_plan_could_revolutionize_health_care

  23. McCaffery, F., Coleman, G.: The need for a software process improvement model for the Medical Device Industry. In: International Review on Computers and Software, vol. 2, pp. 10–15 (2007)

    Google Scholar 

  24. Wiegers, K.: Software Process Improvement: Ten Traps to avoid, http://www.processimpact.com

  25. Humphrey, W.S.: Introduction to Software Process Improvement. Technical Report CMU/SEI-92-TR-007 ESC-TR-92-007

    Google Scholar 

  26. Embedded Forecasters - Embedded Market Forecasters Survey (2010)

    Google Scholar 

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

    Google Scholar 

  28. Miura, S.: Industry View Point on software. In: 11th Conference of the Global Harmonisation Task Force (2007)

    Google Scholar 

  29. Gerber, C.: Introduction to IEC 62304 Software Life cycle for medical devices, September 4 (2008)

    Google Scholar 

  30. McCaffery, F., Dorling, A.: Medi SPICE: An Overview. Journal of Software Maintenance and Evolution: Research and Practice 22, 255–267 (2010)

    Google Scholar 

Download references

Author information

Authors and Affiliations

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

    Martin McHugh, Fergal McCaffery & Valentine Casey

Authors
  1. Martin McHugh
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Fergal McCaffery
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Valentine Casey
    View author publications

    You can also search for this author in PubMed Google Scholar

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

Rights and permissions

Reprints and permissions

Copyright information

© 2011 Springer-Verlag Berlin Heidelberg

About this paper

Cite this paper

McHugh, M., McCaffery, F., Casey, V. (2011). Standalone Software as an Active Medical Device. 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_9

Download citation

  • DOI: https://doi.org/10.1007/978-3-642-21233-8_9

  • 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)

Publish with us

Policies and ethics