{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,31]],"date-time":"2026-01-31T11:43:11Z","timestamp":1769859791021,"version":"3.49.0"},"publisher-location":"Berlin, Heidelberg","reference-count":28,"publisher":"Springer Berlin Heidelberg","isbn-type":[{"value":"9783642304385","type":"print"},{"value":"9783642304392","type":"electronic"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2012]]},"DOI":"10.1007\/978-3-642-30439-2_13","type":"book-chapter","created":{"date-parts":[[2012,6,1]],"date-time":"2012-06-01T08:20:29Z","timestamp":1338538829000},"page":"141-147","source":"Crossref","is-referenced-by-count":40,"title":["Barriers to Adopting Agile Practices When Developing Medical Device Software"],"prefix":"10.1007","author":[{"given":"Martin","family":"McHugh","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fergal","family":"McCaffery","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valentine","family":"Casey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","reference":[{"issue":"2011","key":"13_CR1","doi-asserted-by":"publisher","first-page":"157","DOI":"10.1016\/j.ijmedinf.2011.01.002","volume":"80","author":"C. Abraham","year":"2011","unstructured":"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\u00a080(2011), 157\u2013170 (2011)","journal-title":"International Journal of Medical Informatics"},{"key":"13_CR2","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1109\/AGILE.2010.10","volume-title":"Agile 2010","author":"X. Ge","year":"2010","unstructured":"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\u201343. IEEE, Orlando (2010)"},{"key":"13_CR3","unstructured":"VersionOne, State of Agile Survey - The Stage of Agile Development (2010)"},{"key":"13_CR4","unstructured":"http:\/\/agilemindstorm.com\/agile-glossary\/ (accessed February 20, 2012)"},{"issue":"4","key":"13_CR5","doi-asserted-by":"publisher","first-page":"62","DOI":"10.4018\/jdm.2005100104","volume":"16","author":"D. Turk","year":"2004","unstructured":"Turk, D., France, R.: Assumptions Underlying Agile Software Development Processes. Journal of Database Management\u00a016(4), 62\u201387 (2004)","journal-title":"Journal of Database Management"},{"key":"13_CR6","series-title":"LNBIP","doi-asserted-by":"publisher","first-page":"31","DOI":"10.1007\/978-3-642-16416-3_4","volume-title":"Lean Enterprise Software and Systems","author":"O. Cawley","year":"2010","unstructured":"Cawley, O., Wang, X., Richardson, I.: Lean\/Agile Software Development Methodologies in Regulated Environments \u2013 State of the Art. In: Abrahamsson, P., Oza, N. (eds.) LESS 2010. LNBIP, vol.\u00a065, pp. 31\u201336. Springer, Heidelberg (2010)"},{"key":"13_CR7","unstructured":"European Council, Directive 2007\/47\/EC of the European Parliament and of the Council of 5 September 2007 (2007)"},{"key":"13_CR8","unstructured":"European Commission, Medical Devices Guidance Document - Qualification and Classification of stand alone software MEDDEV 2.1\/6 (2012)"},{"key":"13_CR9","unstructured":"FDA, Title 21\u2013Food and Drugs Chapter I \u2013Food and Drug Administration Department of Health and Human Services subchapter h\u2013Medical Devices part 820 Quality System Regulation, U.S. Department of Health and Human Services (2007)"},{"key":"13_CR10","unstructured":"FDA, General Principles of Software Validation: Final Guidance for Industry and FDA Staff, Centre for Devices and Radiological Health (2002)"},{"key":"13_CR11","unstructured":"FDA, Federal Register 73(31), 8637 (February 15, 2011)"},{"key":"13_CR12","unstructured":"FDA, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, U.S. Department of Health and Human Services (2005)"},{"key":"13_CR13","unstructured":"FDA, Draft Guidance for Industry and Food and Drug Administration - Mobile Device Applications, Centre for Devices and Radiological Health (2011)"},{"key":"13_CR14","unstructured":"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)"},{"key":"13_CR15","doi-asserted-by":"crossref","unstructured":"AAMI, ANSI\/AAMI\/IEC 62304, Medical device Software - Software life cycle processes (2006)","DOI":"10.1049\/ic:20060141"},{"key":"13_CR16","unstructured":"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)"},{"key":"13_CR17","volume-title":"Proceedings of the 11th AGILE Conference, AGILE 2008","author":"P.A. Rottier","year":"2008","unstructured":"Rottier, P.A., Rodrigues, V.: Agile Development in a Medical Device Company. In: Proceedings of the 11th AGILE Conference, AGILE 2008. Springer, Girona (2008)"},{"key":"13_CR18","doi-asserted-by":"publisher","first-page":"151","DOI":"10.1109\/AGILE.2009.50","volume-title":"Agile Conference, AGILE 2009","author":"R. Rasmussen","year":"2009","unstructured":"Rasmussen, R., Hughes, T., Jenks, J.R., Skach, J.: Adopting Agile in an FDA Regulated Environment. In: Agile Conference, AGILE 2009, pp. 151\u2013155. Springer, Chicago (2009)"},{"key":"13_CR19","first-page":"272","volume-title":"Proceedings to Agile Conference","author":"J.W. Spence","year":"2005","unstructured":"Spence, J.W.: There has to be a better way! [software development]. In: Proceedings to Agile Conference, pp. 272\u2013278. Springer, Denver (2005)"},{"key":"13_CR20","unstructured":"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)"},{"key":"13_CR21","unstructured":"Martin, R.C.: Agile Software Development - Principles, Patterns and Practices. Prentice Hall (2003)"},{"key":"13_CR22","unstructured":"Vogel, D.: Agile Methods:Most are not ready for prime time in medical device software design and development. Design Fax Online (July 2006)"},{"key":"13_CR23","unstructured":"Berard, E.V.: Misconceptions of the Agile Zealots. In: Software and System Process Improvement Network (2003)"},{"key":"13_CR24","unstructured":"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)"},{"key":"13_CR25","unstructured":"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)"},{"key":"13_CR26","doi-asserted-by":"crossref","unstructured":"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\u2013313 (2003)","DOI":"10.1109\/ENABL.2003.1231428"},{"key":"13_CR27","unstructured":"Berczu, S., Cowham, R., Appleton, B.: An Agile Approach to Release Management (2008)"},{"key":"13_CR28","unstructured":"http:\/\/subversion.apache.org\/ (accessed January 12, 2012)"}],"container-title":["Communications in Computer and Information Science","Software Process Improvement and Capability Determination"],"original-title":[],"link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/978-3-642-30439-2_13.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,29]],"date-time":"2025-03-29T05:43:40Z","timestamp":1743227020000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/978-3-642-30439-2_13"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012]]},"ISBN":["9783642304385","9783642304392"],"references-count":28,"URL":"https:\/\/doi.org\/10.1007\/978-3-642-30439-2_13","relation":{},"ISSN":["1865-0929","1865-0937"],"issn-type":[{"value":"1865-0929","type":"print"},{"value":"1865-0937","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012]]}}}