{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,1]],"date-time":"2025-05-01T16:11:03Z","timestamp":1746115863273,"version":"3.40.4"},"publisher-location":"Berlin, Heidelberg","reference-count":43,"publisher":"Springer Berlin Heidelberg","isbn-type":[{"type":"print","value":"9783642388323"},{"type":"electronic","value":"9783642388330"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2013]]},"DOI":"10.1007\/978-3-642-38833-0_5","type":"book-chapter","created":{"date-parts":[[2013,5,21]],"date-time":"2013-05-21T00:50:44Z","timestamp":1369097444000},"page":"49-60","source":"Crossref","is-referenced-by-count":0,"title":["The Development and Current Status of Medi SPICE"],"prefix":"10.1007","author":[{"given":"Valentine","family":"Casey","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fergal","family":"McCaffery","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","reference":[{"issue":"14","key":"5_CR1","doi-asserted-by":"publisher","first-page":"296","DOI":"10.7326\/0003-4819-140-4-200402170-00012","volume":"140","author":"W.H. Maisel","year":"2004","unstructured":"Maisel, W.H.: Medical device regulation: an introduction for the practicing physician. Annals of Internal Medicine\u00a0140(14), 296\u2013302 (2004)","journal-title":"Annals of Internal Medicine"},{"issue":"4","key":"5_CR2","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1109\/MC.2006.180","volume":"39","author":"I. Lee","year":"2006","unstructured":"Lee, I., Pappas, G., Cleaveland, R., Hatcliff, J., Krogh, B., Lee, P., Rubin, H., Sha, L.: High-Confidence Medical Device Software and Systems. Computer\u00a039(4), 33\u201338 (2006)","journal-title":"Computer"},{"issue":"3","key":"5_CR3","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(3), 157\u2013170 (2011)","journal-title":"International Journal of Medical Informatics"},{"issue":"4","key":"5_CR4","doi-asserted-by":"publisher","first-page":"40","DOI":"10.1109\/MC.2006.123","volume":"39","author":"R. Rakitin","year":"2006","unstructured":"Rakitin, R.: Coping with defective software in medical devices. Computer\u00a039(4), 40\u201345 (2006)","journal-title":"Computer"},{"issue":"5","key":"5_CR5","doi-asserted-by":"publisher","first-page":"459","DOI":"10.1002\/smr.500","volume":"24","author":"P.A. McQuaid","year":"2012","unstructured":"McQuaid, P.A.: Software Disasters\u2014Understanding the Past, to Improve the Future. Journal of Software: Evolution and Process\u00a024(5), 459\u2013470 (2012)","journal-title":"Journal of Software: Evolution and Process"},{"key":"5_CR6","unstructured":"European Council, Council Directive 2007\/47\/EC (Amendment). Official Journal of the European Union, Luxembourg (2007)"},{"key":"5_CR7","unstructured":"European Commission, MEDICAL DEVICES: Guidance document- Qualification and Classification of stand alone software (MEDDEV 2.1\/6), Brussels, Belgium (2012)"},{"key":"5_CR8","unstructured":"US FDA, Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications (2011), http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM263366.pdf (accessed March 12, 2013)"},{"key":"5_CR9","volume-title":"Medical Device Software Verification, Validation and Compliance","author":"D.A. Vogel","year":"2010","unstructured":"Vogel, D.A.: Medical Device Software Verification, Validation and Compliance. Artech House, Norwood (2010)"},{"key":"5_CR10","doi-asserted-by":"crossref","unstructured":"IEC 62304:2006, Medical device software\u2014Software life cycle processes. IEC, Geneva (2006)","DOI":"10.1049\/ic:20060141"},{"key":"5_CR11","unstructured":"ISO 14971:2007, Medical Devices \u2014 Application of risk management to medical devices. ISO, Geneva (2007)"},{"key":"5_CR12","unstructured":"ISO 13485:2003, Medical devices \u2014 Quality management systems \u2014 Requirements for regulatory purposes. ISO, Geneva (2003)"},{"key":"5_CR13","unstructured":"BS EN 60601-1-4:2000, Medical Electrical Equipment, Part 1 - General requirements for safety. BSI, London (2000)"},{"key":"5_CR14","unstructured":"IEC\/TR 80002-1:2009, Medical device software Part 1: Guidance on the application of ISO 14971 to medical device software. BSI, London (2009)"},{"key":"5_CR15","unstructured":"IEC 62366:2007, Medical devices - Application of usability engineering to medical devices. IEC, Geneva (2007)"},{"key":"5_CR16","unstructured":"IEC\/TR 61508:2005, Functional safety of electrical\/electronic\/programmable electronic safety related systems. BSI, London (2005)"},{"key":"5_CR17","unstructured":"IEC 60812:2006, Analysis technique for system reliability - Procedure for failure modes and effects analysis (FMEA). IEC, Geneva (2006)"},{"key":"5_CR18","first-page":"528","volume-title":"Encyclopedia of Software Engineering","author":"F. Mc Caffery","year":"2010","unstructured":"Mc Caffery, F., Burton, J., Casey, V., Dorling, A.: Software Process Improvement in the Medical Device Industry. In: Laplante, P. (ed.) Encyclopedia of Software Engineering, pp. 528\u2013540. CRC Press Francis Taylor Group, New York (2010)"},{"key":"5_CR19","unstructured":"Mc Caffery, F., Dorling, A.: Medi SPICE: An Overview. In: International Conference on Software Process Improvement and Capability Determinations (SPICE), Turku, Finland (2009)"},{"key":"5_CR20","doi-asserted-by":"crossref","unstructured":"Denger, C., Feldmann, R., Host, M., Lindholm, C., Shull, F.: A Snapshot of the State of Practice in Software Development for Medical Devices. In: First International Symposium on Empirical Software Engineering and Measurement, Madrid, Spain (2007)","DOI":"10.1109\/ESEM.2007.54"},{"issue":"1","key":"5_CR21","first-page":"10","volume":"2","author":"F. Mc Caffery","year":"2007","unstructured":"Mc Caffery, F., Coleman, G.: The Need for a Software Process Improvement Model for the Medical Device Industry. International Review on Computers and Software Journal\u00a02(1), 10\u201315 (2007)","journal-title":"International Review on Computers and Software Journal"},{"issue":"4","key":"5_CR22","doi-asserted-by":"crossref","first-page":"255","DOI":"10.1002\/spip.439","volume":"22","author":"F. Mc Caffery","year":"2010","unstructured":"Mc Caffery, F., Dorling, A.: Medi SPICE Development. Software Process Maintenance and Evolution: Improvement and Practice Journal\u00a022(4), 255\u2013268 (2010)","journal-title":"Software Process Maintenance and Evolution: Improvement and Practice Journal"},{"key":"5_CR23","unstructured":"Casey, V., Mc Caffery, F.: Medi SPICE and the Development of a Process Reference Model for Inclusion in IEC 62304. In: The 7th International Conference on Software Paradigm Trends (ICSOFT), Rome, Italy (2012)"},{"key":"5_CR24","unstructured":"ISO\/IEC 12207:2008, Systems and software engineering - Software life cycle processes. ISO, Geneva (2008)"},{"key":"5_CR25","unstructured":"ISO\/IEC 15504-5:2012, Information technology - Process Assessment - Part 5: An Exemplar Software Life Cycle Process Assessment Model. ISO, Geneva (2012)"},{"key":"5_CR26","unstructured":"Mc Caffery, F., Donnelly, P., Dorling, A., Wilkie, F.G.: A Software Process Development Assessment and Improvement Framework for the Medical Device Industry. In: The Fourth International SPICE Conference, Lisbon, Portugal (2004)"},{"key":"5_CR27","unstructured":"CMMI Product Team, Capability Maturity Model\u00ae Integration for Development Version 1.2. Software Engineering Institute, Pittsburgh, PA (2006)"},{"key":"5_CR28","unstructured":"ISO\/IEC 15504-5:2006, Information technology - Process Assessment - Part 5: An Exemplar Process Assessment Model. ISO, Geneva (2006)"},{"key":"5_CR29","volume-title":"European Systems and Software Process Improvement and Innovation Conference","author":"V. Casey","year":"2011","unstructured":"Casey, V., Mc Caffery, F.: Med-Trace: Traceability Assessment Method for Medical Device Software Development. In: European Systems and Software Process Improvement and Innovation Conference. Roskilde University, Denmark (2011)"},{"key":"5_CR30","unstructured":"Automotive SIG, Automotive SPICE Process Assessment V 2.2 (August 21, 2005)"},{"key":"5_CR31","first-page":"112","volume":"107","author":"A. Cass","year":"2001","unstructured":"Cass, A., Volcker, C., Winzer, L., Carranza, J.M., Dorling, A.: SPiCE for SPACE: A Process Assessment and Improvement Method for Space Software Development. ESA Bulletin\u00a0107, 112\u2013119 (2001)","journal-title":"ESA Bulletin"},{"issue":"2","key":"5_CR32","doi-asserted-by":"publisher","first-page":"139","DOI":"10.1504\/IJISCM.2007.015117","volume":"2","author":"F. Mc Caffery","year":"2007","unstructured":"Mc Caffery, F., Coleman, G.: Developing a Configuration Management Capability Model (CMCM) for the Medical Device Industry. International Journal of Information Systems and Change Management\u00a02(2), 139\u2013154 (2007)","journal-title":"International Journal of Information Systems and Change Management"},{"key":"5_CR33","unstructured":"Mc Caffery, F., Burton, J., Richardson, I.: Development and Evaluation of a Risk Management Capability Model (RMCM) for the Medical Device Industry, Nuremberg, Germany (2008)"},{"key":"5_CR34","unstructured":"ISO\/IEC 12207:1995, Information Technology \u2014 Software life Cycle Processes. ISO, Geneva (1995)"},{"key":"5_CR35","unstructured":"ANSI\/AAMI SW68:2001, Medical device software - Software life cycle processes. AMMI, Arlington (2001)"},{"key":"5_CR36","doi-asserted-by":"crossref","unstructured":"ANSI\/AAMI\/IEC 62304:2006, Medical device software - Software life cycle processes. AAMI, Arlington (2006)","DOI":"10.1049\/ic:20060141"},{"key":"5_CR37","unstructured":"ISO\/IEC 12207:1995\/Amd.1, Information Technology \u2014 Software life Cycle Processes Amendment 1. ISO, Geneva (2002)"},{"key":"5_CR38","unstructured":"ISO\/IEC 12207:1995\/Amd.2, Information Technology \u2014 Software life Cycle Processes Amendment 2. ISO, Geneva (2004)"},{"key":"5_CR39","unstructured":"Walker, D.W.: CMMI and Medical Device Engineering. Software Engineering Institute (September 29, 2009)"},{"key":"5_CR40","doi-asserted-by":"crossref","unstructured":"Fabbrini, F., Fusani, M., Lami, G., Sivera, E.: Software Engineering in the European Automotive Industry: Achievements and Challenges. In: 32nd Annual IEEE International Computer Software and Applications, COMPSAC 2008 (2008)","DOI":"10.1109\/COMPSAC.2008.140"},{"issue":"2","key":"5_CR41","doi-asserted-by":"publisher","first-page":"41","DOI":"10.4067\/S0718-18762010000200004","volume":"5","author":"V. Casey","year":"2010","unstructured":"Casey, V.: Developing Trust in Virtual Software Development Teams. Journal of Theoretical and Applied Electronic Commerce Research\u00a05(2), 41\u201358 (2010)","journal-title":"Journal of Theoretical and Applied Electronic Commerce Research"},{"key":"5_CR42","unstructured":"ISO\/IEC 15288:2002, Systems Engineering \u2014 System life cycle processes. ISO, Geneva (2002)"},{"key":"5_CR43","unstructured":"ISO\/IEC 15504-2:2003, Software engineering - Process assessment - Part 2: Performing an assessment. ISO, Geneva (2003)"}],"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\/978-3-642-38833-0_5","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,30]],"date-time":"2025-04-30T10:43:06Z","timestamp":1746009786000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/978-3-642-38833-0_5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013]]},"ISBN":["9783642388323","9783642388330"],"references-count":43,"URL":"https:\/\/doi.org\/10.1007\/978-3-642-38833-0_5","relation":{},"ISSN":["1865-0929","1865-0937"],"issn-type":[{"type":"print","value":"1865-0929"},{"type":"electronic","value":"1865-0937"}],"subject":[],"published":{"date-parts":[[2013]]}}}