Abraham, C., Nishiharas, E., Akiyama, M.: Transforming healthcare with information technology in Japan: A review of policy, people, and progress. International Journal of Medical Informatics 80(2011), 157–170 (2011)
Article
Google Scholar
Ge, X., Paige, R.F., McDermid, J.A.: An Iterative Approach for Development of Safety-Critical Software and Safety Arguments. In: Agile 2010, pp. 35–43. IEEE, Orlando (2010)
Chapter
Google Scholar
VersionOne, State of Agile Survey - The Stage of Agile Development (2010)
Google Scholar
http://agilemindstorm.com/agile-glossary/
(accessed February 20, 2012)
Turk, D., France, R.: Assumptions Underlying Agile Software Development Processes. Journal of Database Management 16(4), 62–87 (2004)
Article
Google Scholar
Cawley, O., Wang, X., Richardson, I.: Lean/Agile Software Development Methodologies in Regulated Environments – State of the Art. In: Abrahamsson, P., Oza, N. (eds.) LESS 2010. LNBIP, vol. 65, pp. 31–36. Springer, Heidelberg (2010)
Chapter
Google Scholar
European Council, Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 (2007)
Google Scholar
European Commission, Medical Devices Guidance Document - Qualification and Classification of stand alone software MEDDEV 2.1/6 (2012)
Google Scholar
FDA, Title 21–Food and Drugs Chapter I –Food and Drug Administration Department of Health and Human Services subchapter h–Medical Devices part 820 Quality System Regulation, U.S. Department of Health and Human Services (2007)
Google Scholar
FDA, General Principles of Software Validation: Final Guidance for Industry and FDA Staff, Centre for Devices and Radiological Health (2002)
Google Scholar
FDA, Federal Register 73(31), 8637 (February 15, 2011)
Google Scholar
FDA, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, U.S. Department of Health and Human Services (2005)
Google Scholar
FDA, Draft Guidance for Industry and Food and Drug Administration - Mobile Device Applications, Centre for Devices and Radiological Health (2011)
Google Scholar
FDA, Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software use in Medical Devices, U.S. Department of Health and Human Services (1999)
Google Scholar
AAMI, ANSI/AAMI/IEC 62304, Medical device Software - Software life cycle processes (2006)
Google Scholar
European Council, Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Publication of titles and references of harmonised standards under the directive) (2010)
Google Scholar
Rottier, P.A., Rodrigues, V.: Agile Development in a Medical Device Company. In: Proceedings of the 11th AGILE Conference, AGILE 2008. Springer, Girona (2008)
Google Scholar
Rasmussen, R., Hughes, T., Jenks, J.R., Skach, J.: Adopting Agile in an FDA Regulated Environment. In: Agile Conference, AGILE 2009, pp. 151–155. Springer, Chicago (2009)
Chapter
Google Scholar
Spence, J.W.: There has to be a better way! [software development]. In: Proceedings to Agile Conference, pp. 272–278. Springer, Denver (2005)
Google Scholar
Heeager, L.T., Nielsen, P.A.: Agile Software Development and its Compatibility with a Document-Driven Approach? A Case Study. In: 20th Australasian Conference on Information Systems Compatibility of Agile and Document-Driven Approaches, Melbourne (2009)
Google Scholar
Martin, R.C.: Agile Software Development - Principles, Patterns and Practices. Prentice Hall (2003)
Google Scholar
Vogel, D.: Agile Methods:Most are not ready for prime time in medical device software design and development. Design Fax Online (July 2006)
Google Scholar
Berard, E.V.: Misconceptions of the Agile Zealots. In: Software and System Process Improvement Network (2003)
Google Scholar
Lee, C., Guadagno, L., Jia, X.: An Agile Approach to Capturing Requirements and Traceability. In: Proceedings of the 2nd International Workshop on Traceability in Emerging Forms of Software Engineering (TEFSE 2003), Canada (2003)
Google Scholar
AAMI, Gudiance on the use of agile practices in the development of medical device software TIR-Master_4-00. Association for the Advancement of Medical Instrumentation (2011)
Google Scholar
Paetsch, F., Eberlein, A., Maurer, F.: Requirements engineering and agile software development. In: Proceedings of Twelfth IEEE International Workshops on Enabling Technologies: Infrastructure for Collaborative Enterprises, WET ICE 2003, pp. 308–313 (2003)
Google Scholar
Berczu, S., Cowham, R., Appleton, B.: An Agile Approach to Release Management (2008)
Google Scholar
http://subversion.apache.org/
(accessed January 12, 2012)