On the Impact of Medical Device Regulations on Software Architecture

Klaus Marius Hansen, Konstantinos Manikas

Abstract

Compliance to regulations and regulatory approval are requirements for many medical device software systems. In this paper, we investigate the implications of medical device software regulations to the design of software systems. We do so by focusing on the American and European regulatory authorities and review the legal requirements for regulatory approval of medical devices. We define a simplified process for regulatory approval, consisting of five steps, and enhance this process by descriptions of how to decide whether a software system is a medical device and how to identify the class of the device. Moreover, we review software modularity in the implementation of software medical device and propose a set of preliminary principles for architectural design of software medical device based on a set of constrains identified from the reviewed regulations.

References

  1. Aanestad, M. and Jensen, T. B. (2011). Building nationwide information infrastructures in healthcare through modular implementation strategies. The Journal of Strategic Information Systems, 20(2):161 - 176.
  2. Bass, L., Clements, P., and Kazman, R. (2013). Software Architecture in Practice. Addison-Wesley, 3rd edition.
  3. Bundtz, B. (2010). Developing medical device software to iec 62304. European Medical Device Technology, 1(6). http://www.emdt.co.uk/article/developingmedical-device-software-iso-62304.
  4. Christensen, H. B., Hansen, K. M., Kyng, M., and Manikas, K. (2014). Analysis and design of software ecosystem architectures - towards the 4s telemedicine ecosystem. Information and Software Technology, 56(11):1476 - 1492.
  5. FDA (2014). Title 21 of the code of federal regulations. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cf cfr/cfrsearch.cfm.
  6. Federal Food, Drug, and Cosmetic Act of 1938 (2007). United States Code, Title 21.
  7. Food and Drug Administration (2011). Medical devices; medical device data systems. Federal Register, 76(31):8637-8649. http://www.gpo.gov/fdsys/pkg/FR-2011-02- 15/pdf/2011-3321.pdf.
  8. Food and Drug Administration (2015). Medical device accessories: Defining accessories and classification pathway for new accessory types. draft guidance for industry and food and drug administration staff. http://www.fda.gov/downloads/medicaldevices/device regulationandguidance/guidancedocuments/ucm4296 72.pdf.
  9. IEC 62304:2006 (2006). Medical device software - software life cycle processes. ISO/IEC.
  10. Intertek (2015). Quick guide: 5 steps to market approval for medical devices. http://www.intertek.com/5-stepmarket-approval-medical-devices/. Accessed May 2015.
  11. Manikas, K. and Hansen, K. M. (2013). Reviewing the health of software ecosystems - a conceptual framework proposal. In Alves, C. F., Hanssen, G. K., Bosch, J., and Jansen, S., editors, Proceedings of the 5th International Workshop on Software Ecosystems, Potsdam, Germany, June 11, 2013, volume 987, pages 33- 44.
  12. MDD (2007). Council directive 93/42/eec of of 14 june 1993 concerning medical devices. http://eur-lex.europa.eu/legalcontent/EN/TXT/PDF/?uri=CELEX:01993L0042- 20071011&from=EN. Amended up until and including Directive 2007/47/EC.
  13. MEDDEV 2.1/6 (2012). Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices. http://ec.europa.eu/growth/sectors/medicaldevices old/documents/guidelines/files/meddev/2 1 6 ol en.pdf.
  14. MEDDEV 2.4/1 Rev. 9 (2010). Medical devices: Guidance document - classification of medical devices. http://ec.europa.eu/health/medicaldevices/files/meddev/2 4 1 rev 9 classification en.pdf.
Download


Paper Citation


in Harvard Style

Hansen K. and Manikas K. (2016). On the Impact of Medical Device Regulations on Software Architecture . In Proceedings of the 9th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 5: HEALTHINF, (BIOSTEC 2016) ISBN 978-989-758-170-0, pages 389-394. DOI: 10.5220/0005776803890394


in Bibtex Style

@conference{healthinf16,
author={Klaus Marius Hansen and Konstantinos Manikas},
title={On the Impact of Medical Device Regulations on Software Architecture},
booktitle={Proceedings of the 9th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 5: HEALTHINF, (BIOSTEC 2016)},
year={2016},
pages={389-394},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0005776803890394},
isbn={978-989-758-170-0},
}


in EndNote Style

TY - CONF
JO - Proceedings of the 9th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 5: HEALTHINF, (BIOSTEC 2016)
TI - On the Impact of Medical Device Regulations on Software Architecture
SN - 978-989-758-170-0
AU - Hansen K.
AU - Manikas K.
PY - 2016
SP - 389
EP - 394
DO - 10.5220/0005776803890394