Abstract
This experience-based paper provides an introduction to U.S. regulations, example methodology documents, and practical advice for planning and executing medical device usability studies.
Chapter PDF
Similar content being viewed by others
References
Association for the Advancement of Medical Instrumentation. ANSI/AAMI HE75:2009: Human Factors engineering – Design of Medical Devices. AAMI, Arlington (2009)
Dumas, J.S., Redish, J.C.: A Practical Guide to Usability Testing. Intellect, Portland (1993)
International Standards Organization. Medical Devices – Application of usability engineering to medical devices. Geneva, Switzerland: International Electrotechnical Commission (2007)
National Institute of Standards and Technology, Common Industry Format for Usability Test Reports. Washington, DC: U.S. Government Printing Office (1999), http://zing.ncsl.nist.gov/iusr/documents/cifv1.1b.htm (retrieved) United States Food & Drug Administration, Quality System (QS) Regulation/Medical Device Good Manufacturing Practices (2011), http://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/qualitysystemsregulations/default.htm (retrieved)
United States Department of Health & Human Services. Health Insurance Portability and Accountability Act of 1996. (US H&HS publication f:publ191.104). Washington, DC: U.S. Government Printing Office (1996)
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2013 Springer-Verlag Berlin Heidelberg
About this paper
Cite this paper
Hass, C., Berlin, D. (2013). Usability Testing Medical Devices: A Practical Guide to Minimizing Risk and Maximizing Success. In: Marcus, A. (eds) Design, User Experience, and Usability. Health, Learning, Playing, Cultural, and Cross-Cultural User Experience. DUXU 2013. Lecture Notes in Computer Science, vol 8013. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-39241-2_45
Download citation
DOI: https://doi.org/10.1007/978-3-642-39241-2_45
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-39240-5
Online ISBN: 978-3-642-39241-2
eBook Packages: Computer ScienceComputer Science (R0)