{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,2]],"date-time":"2026-02-02T21:26:44Z","timestamp":1770067604074,"version":"3.49.0"},"publisher-location":"Berlin, Heidelberg","reference-count":30,"publisher":"Springer Berlin Heidelberg","isbn-type":[{"value":"9783642164156","type":"print"},{"value":"9783642164163","type":"electronic"}],"license":[{"start":{"date-parts":[[2010,1,1]],"date-time":"2010-01-01T00:00:00Z","timestamp":1262304000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2010]]},"DOI":"10.1007\/978-3-642-16416-3_4","type":"book-chapter","created":{"date-parts":[[2010,10,21]],"date-time":"2010-10-21T06:44:16Z","timestamp":1287643456000},"page":"31-36","source":"Crossref","is-referenced-by-count":52,"title":["Lean\/Agile Software Development Methodologies in Regulated Environments \u2013 State of the Art"],"prefix":"10.1007","author":[{"given":"Ois\u00edn","family":"Cawley","sequence":"first","affiliation":[]},{"given":"Xiaofeng","family":"Wang","sequence":"additional","affiliation":[]},{"given":"Ita","family":"Richardson","sequence":"additional","affiliation":[]}],"member":"297","reference":[{"key":"4_CR1","volume-title":"The Machine That Changed The World: How lean production revolutionized the global car wars","author":"J.P. Womack","year":"2007","unstructured":"Womack, J.P., Jones, D.T., Roos, D.: The Machine That Changed The World: How lean production revolutionized the global car wars. Simon & Schuster Ltd., New York (2007)"},{"key":"4_CR2","volume-title":"The Toyota Way","author":"J. Liker","year":"2003","unstructured":"Liker, J.: The Toyota Way. McGraw-Hill, New York (2003)"},{"key":"4_CR3","volume-title":"Agile Software Development Ecosystems","author":"J. Highsmith","year":"2002","unstructured":"Highsmith, J.: Agile Software Development Ecosystems. Addison-Wesley, Reading (2002)"},{"key":"4_CR4","volume-title":"Lean Software Development: An Agile Toolkit. Agile Software Development","author":"M. Poppendieck","year":"2003","unstructured":"Poppendieck, M., Poppendieck, T.: Lean Software Development: An Agile Toolkit. Agile Software Development. Addison-Wesley Professional, Reading (2003)"},{"key":"4_CR5","volume-title":"Implementing Lean Software Development From Concept to Cash","author":"M. Poppendieck","year":"2006","unstructured":"Poppendieck, M., Poppendieck, T.: Implementing Lean Software Development From Concept to Cash. Addison-Wesley Professional, Reading (2006)"},{"key":"4_CR6","first-page":"128","volume-title":"The Art of Lean Software Development","author":"C. Hibbs","year":"2009","unstructured":"Hibbs, C., Jewett, S.C., Sullivan, M.: The Art of Lean Software Development, p. 128. O\u2019Reilly Media, Sebastopol (2009)"},{"key":"4_CR7","unstructured":"RTCA, DO-178B: Software Considerations in Airborne Systems and Equipment Certification. RTCA, Radio Technical Commission for Aeronautics (1992)"},{"key":"4_CR8","unstructured":"ISO, ISO 13485:2003: Medical devices \u2013 Quality management systems \u2013 Requirements for regulatory purposes. International Organisation for Standardisation (2003)."},{"key":"4_CR9","unstructured":"Kitchenham, B., Charters, S.: Guidelines for performing Systematic Literature Reviews in Software Engineering (2007)"},{"key":"4_CR10","doi-asserted-by":"crossref","unstructured":"VanderLeest, S.H., Buter, A.: Escape the waterfall: Agile for aerospace. In: IEEE\/AIAA 28th Digital Avionics Systems Conference, DASC 2009 (2009)","DOI":"10.1109\/DASC.2009.5347438"},{"key":"4_CR11","series-title":"Lecture Notes in Computer Science","doi-asserted-by":"publisher","first-page":"123","DOI":"10.1007\/11774129_13","volume-title":"Extreme Programming and Agile Processes in Software Engineering","author":"A. Wils","year":"2006","unstructured":"Wils, A., Van Baelan, S., Holvoet, T., De Vlaminck, K.: Agility in the avionics software world. In: Abrahamsson, P., Marchesi, M., Succi, G. (eds.) XP 2006. LNCS, vol.\u00a04044, pp. 123\u2013132. Springer, Heidelberg (2006)"},{"key":"4_CR12","unstructured":"Chisholm, R.A.: Agile Software Development Methods and DO-178B Certification. In: Division of Graduate Studies and Research. Royal Military College of Canada (2007)"},{"key":"4_CR13","doi-asserted-by":"publisher","first-page":"218","DOI":"10.1109\/Agile.2008.52","volume-title":"AGILE 2008 Conference","author":"P.A. Rottier","year":"2008","unstructured":"Rottier, P.A., Rodrigues, V.: Agile Development in a Medical Device Company. In: AGILE 2008 Conference, pp. 218\u2013223. IEEE Computer Society, Los Alamitos (2008)"},{"key":"4_CR14","doi-asserted-by":"crossref","unstructured":"Lin, W., Fan, X.: Software development practice for FDA-compliant medical devices. In: The International Joint Conference on Computational Sciences and Optimization, China (2009)","DOI":"10.1109\/CSO.2009.191"},{"key":"4_CR15","doi-asserted-by":"publisher","first-page":"272","DOI":"10.1109\/ADC.2005.47","volume-title":"AGILE Conference","author":"J.W. Spence","year":"2005","unstructured":"Spence, J.W.: There has to be a better way! In: AGILE Conference, Denver, CO, USA, pp. 272\u2013278. IEEE Computer Society, Los Alamitos (2005)"},{"key":"4_CR16","first-page":"151","volume-title":"Agile Conference","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, pp. 151\u2013155. IEEE Computer Society, Los Alamitos (2009)"},{"issue":"6","key":"4_CR17","doi-asserted-by":"publisher","first-page":"4","DOI":"10.1145\/1317471.1317476","volume":"32","author":"L. Cordeiro","year":"2007","unstructured":"Cordeiro, L., Barreto, R., Barcelos, R., Oliveira, M., Lucena, V., Maciel, P.: TXM: an agile HW\/SW development methodology for building medical devices. ACM SIGSOFT Softw. Eng. Notes\u00a032(6), 4 (2007)","journal-title":"ACM SIGSOFT Softw. Eng. Notes"},{"key":"4_CR18","doi-asserted-by":"crossref","unstructured":"Kettunen, P., Laanti, M.: How to steer an embedded software project: tactics for selecting the software process model. Information and Software Technology (2005)","DOI":"10.1016\/j.infsof.2004.11.001"},{"key":"4_CR19","doi-asserted-by":"crossref","unstructured":"Srinivasan, J., Dobrin, R., Lundqvist, K.: State of the Art\u2019 in Using Agile Methods for Embedded Systems Development. In: Computer Software and Applications Conference (2009)","DOI":"10.1109\/COMPSAC.2009.186"},{"key":"4_CR20","doi-asserted-by":"crossref","unstructured":"Sidky, A., Arthur, J.: Determining the Applicability of Agile Practices to Mission and Life-Critical Systems. In: Proceedings of the 31st IEEE Software Engineering Workshop (2007)","DOI":"10.1109\/SEW.2007.61"},{"key":"4_CR21","unstructured":"Grenning, J.: Extreme programming and embedded software development. In: Embedded Systems Conference (2002)"},{"key":"4_CR22","doi-asserted-by":"crossref","unstructured":"Yoo, J., Cha, S., Kim, C.H., Song, D.Y.: Synthesis of FBD-based PLC design from NuSCR formal specification. Reliability Engineering & System Safety (2005)","DOI":"10.1016\/j.ress.2004.05.005"},{"key":"4_CR23","unstructured":"Tsai, W.T., Paul, R., Yu, L., Wei, X.: Rapid Pattern-Oriented Scenario-Based Testing for Embedded Systems. In: Yang, H. (ed.) Software Evolution with UML and XML (2005)"},{"key":"4_CR24","doi-asserted-by":"crossref","unstructured":"Ronkainen, J., Abrahamsson, P.: Software development under stringent hardware constraints: do agile methods have a chance? In: 4th International Conference on Extreme Programming and Agile Processes in Software Engineering (2003)","DOI":"10.1007\/3-540-44870-5_10"},{"issue":"10","key":"4_CR25","first-page":"82","volume":"31","author":"S.W. Ambler","year":"2006","unstructured":"Ambler, S.W.: Imperfectly agile: You too can be agile! Dr. Dobb\u2019s Journal\u00a031(10), 82\u201384 (2006)","journal-title":"Dr. Dobb\u2019s Journal"},{"key":"4_CR26","first-page":"26","volume-title":"Proceedings of the ICSE Workshop on Traceability in Emerging Forms of Software Engineering","author":"J. Huffman Hayes","year":"2009","unstructured":"Huffman Hayes, J., Dekhtyar, A., Janzen, D.S.: Towards traceable test-driven development. In: Proceedings of the ICSE Workshop on Traceability in Emerging Forms of Software Engineering, pp. 26\u201330. IEEE Computer Society, Los Alamitos (2009)"},{"key":"4_CR27","unstructured":"Ambler, S.W., Kroll, P.: Best practices for lean development governance (2007), \n                    \n                      http:\/\/www.ibm.com\/developerworks\/rational\/library\/jun07\/kroll\/"},{"key":"4_CR28","unstructured":"Van Schooenderwoert, N.: Safety-Critical Applications Built via Agile Discipline (2008), \n                    \n                      http:\/\/www.boston-spin.org\/slides\/boston_spin_slides_2008_09.pdf"},{"key":"4_CR29","doi-asserted-by":"crossref","unstructured":"Mueller, G., Borzuchowski, J.: Extreme embedded a report from the front line. In: OOPSLA 2002 Practitioners Reports (2002)","DOI":"10.1145\/604252.604257"},{"key":"4_CR30","unstructured":"Poppendieck, M.: XP in a Safety-Critical Environment. Cutter IT (2002)"}],"container-title":["Lecture Notes in Business Information Processing","Lean Enterprise Software and Systems"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/978-3-642-16416-3_4","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,5,20]],"date-time":"2019-05-20T19:02:28Z","timestamp":1558378948000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/978-3-642-16416-3_4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2010]]},"ISBN":["9783642164156","9783642164163"],"references-count":30,"URL":"https:\/\/doi.org\/10.1007\/978-3-642-16416-3_4","relation":{},"ISSN":["1865-1348","1865-1356"],"issn-type":[{"value":"1865-1348","type":"print"},{"value":"1865-1356","type":"electronic"}],"subject":[],"published":{"date-parts":[[2010]]}}}