{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,3,7]],"date-time":"2025-03-07T05:20:16Z","timestamp":1741324816789,"version":"3.38.0"},"publisher-location":"Berlin, Heidelberg","reference-count":35,"publisher":"Springer Berlin Heidelberg","isbn-type":[{"type":"print","value":"9783642222054"},{"type":"electronic","value":"9783642222061"}],"license":[{"start":{"date-parts":[[2011,1,1]],"date-time":"2011-01-01T00:00:00Z","timestamp":1293840000000},"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":[[2011]]},"DOI":"10.1007\/978-3-642-22206-1_6","type":"book-chapter","created":{"date-parts":[[2011,6,25]],"date-time":"2011-06-25T15:36:59Z","timestamp":1309016219000},"page":"61-71","source":"Crossref","is-referenced-by-count":1,"title":["Improving Verification &amp; Validation in the Medical Device Domain"],"prefix":"10.1007","author":[{"given":"M. S.","family":"Sivakumar","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valentine","family":"Casey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fergal","family":"McCaffery","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerry","family":"Coleman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","reference":[{"issue":"10","key":"6_CR1","first-page":"915","volume":"34","author":"E. Bernard","year":"2004","unstructured":"Bernard, E., Legeard, B., Luck, X., Peureux, F.: Generation of test sequences from formal specifications: GSM 11-11 standard case study. Software: Practice and Experience\u00a034(10), 915\u2013948 (2004)","journal-title":"Software: Practice and Experience"},{"key":"6_CR2","doi-asserted-by":"crossref","unstructured":"Rayadurgam, S., Heimdahl, M.P.E.: Test-sequence generation from formal requirement models. In: Proc. of Sixth IEEE International Symposium on High Assurance Systems Engineering, 2001, pp. 23\u201331 (2001)","DOI":"10.1109\/HASE.2001.966804"},{"key":"6_CR3","volume-title":"The Art of Software Testing","author":"G. Myers","year":"2004","unstructured":"Myers, G., Sandler, C., Badgett, T., Thomas, T.: The Art of Software Testing, 2nd edn. Wiley, Chichester (2004)","edition":"2"},{"issue":"3","key":"6_CR4","doi-asserted-by":"publisher","first-page":"10","DOI":"10.1109\/52.28119","volume":"6","author":"D.R. Wallace","year":"1989","unstructured":"Wallace, D.R., Fujii, R.U.: Software verification and validation: an overview. IEEE Software\u00a06(3), 10\u201317 (1989)","journal-title":"IEEE Software"},{"key":"6_CR5","unstructured":"US FDA Centre for Devices and Radiological Health, General Principles of Software Validation; Final Guidance for Industry and FDA Staff. CDRH, Rockville (2002)"},{"key":"6_CR6","doi-asserted-by":"crossref","unstructured":"Berling, T., Thelin, T.: An industrial case study of the verification and validation activities. In: Proceedings of Ninth International Symposium on Software Metrics, 2003, September 3-5, pp. 226\u2013238 (2003)","DOI":"10.1109\/METRIC.2003.1232470"},{"issue":"10","key":"6_CR7","doi-asserted-by":"publisher","first-page":"79","DOI":"10.1109\/2.796141","volume":"32","author":"J.D. Arthur","year":"1999","unstructured":"Arthur, J.D., Groner, M.K., Hayhurst, K.J., Holloway, C.M.: Evaluating the effectiveness of independent verification and validation. Computer\u00a032(10), 79\u201383 (1999)","journal-title":"Computer"},{"key":"6_CR8","doi-asserted-by":"crossref","unstructured":"Monteiro, P., Machado, R.J., Kazman, R.: Inception of Software Validation and Verification Practices within CMMI Level 2. In: 2009 Fourth International Conference on Software Engineering Advances, icsea, pp. 536\u2013541 (2009)","DOI":"10.1109\/ICSEA.2009.84"},{"key":"6_CR9","unstructured":"IEEE Standard for Software Verification and Validation Plans, IEEE Std 1012-1986, p. I (1986)"},{"key":"6_CR10","unstructured":"CMMI Product Team, Capability Maturity Model\u00ae Integration for Development Version 1.2. Software Engineering Institute (2006)"},{"key":"6_CR11","unstructured":"ISO\/IEC 15504-5:2006. Information technology \u2014 Process Assessment \u2014 Part 5: An Exemplar Process Assessment Model. ISO, Geneva, Switzerland (2006)"},{"key":"6_CR12","unstructured":"RTCA, RTCA DO-178B, Software Considerations in Airborne Systems and Equipment Certification (1992)"},{"key":"6_CR13","unstructured":"Automotive SPICE Process Assessment Model 2.2, Automotive SIG (August 21, 2005)"},{"key":"6_CR14","unstructured":"ISO 13485:2003. Medical devices \u2014 Quality management systems \u2014 Requirements for regulatory purposes. Second edn. ISO, Geneva, Switzerland (2003)"},{"key":"6_CR15","doi-asserted-by":"crossref","unstructured":"ANSI\/AAMI\/IEC 62304:2006. Medical device software\u2014Software life cycle processes. AAMI, Arlington (2006)","DOI":"10.1049\/ic:20060141"},{"key":"6_CR16","unstructured":"ISO 14971:2007. Medical Devices \u2014 Application of risk management to medical devices. Second edn. ISO, Geneva (2007)"},{"key":"6_CR17","unstructured":"ISO\/IEC 12207:1995\/Amd.1. Information Technology \u2014 Software life Cycle Processes Amendment 1. ISO, Geneva, Switzerland (2002)"},{"key":"6_CR18","doi-asserted-by":"crossref","unstructured":"Andersson, C., Runeson, P.: Verification and validation in industry - a qualitative survey on the state of practice. In: Proceedings of 2002 International Symposium on Empirical Software Engineering, 2002, pp. 37\u201347 (2002)","DOI":"10.1109\/ISESE.2002.1166923"},{"key":"6_CR19","doi-asserted-by":"crossref","unstructured":"Jacobs, J.C., Trienekens, J.J.M.: Improving verification and validation in hardware\/software environments. Introduction to the workshop. In: Proceedings of 10th International Workshop on Software Technology and Engineering Practice, STEP 2002., pp. 121\u2013122, October 6-8 (2002)","DOI":"10.1109\/STEP.2002.1267621"},{"key":"6_CR20","volume-title":"Software Testing in the Real World","author":"E. Kit","year":"1995","unstructured":"Kit, E.: Software Testing in the Real World. Addison-Wesley, Reading (1995)"},{"key":"6_CR21","unstructured":"ISO\/IEC 29119 Software Testing, http:\/\/www.softwaretestingstandard.org\/projecttimeline.php (accessed on April 18, 2011)"},{"key":"6_CR22","unstructured":"Why Software Requirements Traceability Remains a Challenge, Cross Talk (July\/August 2009) Issue, http:\/\/www.crosstalkonline.org\/storage\/issue-archives\/2009\/200907\/200907-Kannenberg.pdf (accessed on April 18, 2011)"},{"key":"6_CR23","doi-asserted-by":"crossref","unstructured":"Heimdahl, M.P.E.: Safety and Software Intensive Systems: Challenges Old and New. In: Future of Software Engineering, FOSE 2007, May 23-25, page 1, pp. 137\u2013152 (2007)","DOI":"10.1109\/FOSE.2007.18"},{"key":"6_CR24","doi-asserted-by":"crossref","unstructured":"Alawneh, L., Debbabi, M., Hassaine, F., Jarraya, Y., Soeanu, A.: A unified approach for verification and validation of systems and software engineering models. In: 13th Annual IEEE International Symposium and Workshop on Engineering of Computer Based Systems, ECBS 2006, March 27-30, vol.\u00a010, p. 418 (2006)","DOI":"10.1109\/ECBS.2006.17"},{"key":"6_CR25","unstructured":"Leveson, N.G.: Paper on System Safety in Computer-Controlled Automotive Systems. MIT, Cambridge (2011), http:\/\/www.sunnyday.mit.edu\/papers\/sae.pdf (accessed on April 18, 2011)"},{"key":"6_CR26","unstructured":"ISO\/DIS 26262 Road vehicles - Functional safety. ISO, Geneva, Switzerland"},{"key":"6_CR27","unstructured":"IEC 60880:2006. Nuclear power plants - Instrumentation and control systems important to safety - Software aspects for computer-based systems performing category A functions. IEC, Geneva, Switzerland (2006)"},{"key":"6_CR28","unstructured":"IEC\/TR 61508:2005. Functional safety of electrical\/electronic\/ programmable electronic safety related systems. BSI, London (2005)"},{"key":"6_CR29","unstructured":"Kyung, A.Y., Seung-Hun, P., Doo-Hwan, B., Hoon-Seon, C., Jae-Cheon, J.: A Framework for the V&V Capability Assessment Focused on the Safety-Criticality. In: Proc. 13th IEEE International Workshop on Software Technology and Engineering Practice, 2005, pp. 17\u201324 (2005)"},{"key":"6_CR30","unstructured":"ISO 9001:2000 - Quality management systems - Requirements (2000)"},{"key":"6_CR31","doi-asserted-by":"crossref","unstructured":"Eastaughffe, K.A., Cant, A., Ozols, M.A.: A Framework for Assessing Standards for Safety-critical Computer-Based Systems, isess. In: Fourth IEEE International Symposium and Forum on Software Engineering Standards, p. 33 (1999)","DOI":"10.1109\/SESS.1999.766576"},{"key":"6_CR32","unstructured":"IEEE, IEEE Standards for Software Verification and Validation, Page 58 (1998)"},{"issue":"4","key":"6_CR33","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.J., Cleaveland, R., Hatcliff, J., Krogh, B.H., Lee, P., Rubin, H., Sha, L.: High-Confidence Medical Device Software and Systems. Computer\u00a039(4), 33\u201338 (2006)","journal-title":"Computer"},{"key":"6_CR34","doi-asserted-by":"crossref","unstructured":"Jetley, R., Iyer, S.P., Jones, P.L., Spees, W.: A Formal Approach to Pre-Market Review for Medical Device Software. In: 30th Annual International on Computer Software and Applications Conference, COMPSAC 2006, September 17-21, vol.\u00a01, pp. 169\u2013177 (2006)","DOI":"10.1109\/COMPSAC.2006.9"},{"key":"6_CR35","unstructured":"Caffery, F.M., Dorling, A., Casey, V.: Medi SPICE: \u201cAn Update\u201d. In: The 10th International Spice Conference (SPICE 2010), Pisa, Italy, May 18-20 (2010)"}],"container-title":["Communications in Computer and Information Science","Systems, Software and Service Process Improvement"],"original-title":[],"link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/978-3-642-22206-1_6","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,6]],"date-time":"2025-03-06T17:36:01Z","timestamp":1741282561000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/978-3-642-22206-1_6"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011]]},"ISBN":["9783642222054","9783642222061"],"references-count":35,"URL":"https:\/\/doi.org\/10.1007\/978-3-642-22206-1_6","relation":{},"ISSN":["1865-0929","1865-0937"],"issn-type":[{"type":"print","value":"1865-0929"},{"type":"electronic","value":"1865-0937"}],"subject":[],"published":{"date-parts":[[2011]]}}}