{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,6,19]],"date-time":"2025-06-19T04:40:45Z","timestamp":1750308045144,"version":"3.41.0"},"publisher-location":"New York, NY, USA","reference-count":13,"publisher":"ACM","license":[{"start":{"date-parts":[[2006,5,21]],"date-time":"2006-05-21T00:00:00Z","timestamp":1148169600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.acm.org\/publications\/policies\/copyright_policy#Background"}],"content-domain":{"domain":["dl.acm.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2006,5,21]]},"DOI":"10.1145\/1137702.1137705","type":"proceedings-article","created":{"date-parts":[[2006,7,24]],"date-time":"2006-07-24T16:53:01Z","timestamp":1153759981000},"page":"3-8","update-policy":"https:\/\/doi.org\/10.1145\/crossmark-policy","source":"Crossref","is-referenced-by-count":15,"title":["A risk management capability model for use in medical device companies"],"prefix":"10.1145","author":[{"given":"John","family":"Burton","sequence":"first","affiliation":[{"name":"Vitalograph Ltd., Ennis, Ireland"}]},{"given":"Fergal","family":"McCaffery","sequence":"additional","affiliation":[{"name":"University of Limerick, Ireland"}]},{"given":"Ita","family":"Richardson","sequence":"additional","affiliation":[{"name":"University of Limerick, Ireland"}]}],"member":"320","published-online":{"date-parts":[[2006,5,21]]},"reference":[{"volume-title":"New Guidance Offered on Software Risk Management","author":"AAMI","key":"e_1_3_2_1_1_1","unstructured":"AAMI , New Guidance Offered on Software Risk Management , Vol. 40 , No. 2. February 2005. AAMI, New Guidance Offered on Software Risk Management, Vol. 40, No. 2. February 2005."},{"key":"e_1_3_2_1_2_1","volume-title":"Medical device software risk management","author":"AAMI","year":"2005","unstructured":"AAMI TIR32:2004 , Medical device software risk management , 2005 . AAMI TIR32:2004, Medical device software risk management, 2005."},{"key":"e_1_3_2_1_3_1","volume-title":"Medical devices -- Application of risk management to medical devices","author":"ISO","year":"2000","unstructured":"ANSI\/AAMI\/ ISO 14971 , Medical devices -- Application of risk management to medical devices . 2000 . ANSI\/AAMI\/ISO 14971, Medical devices -- Application of risk management to medical devices. 2000."},{"key":"e_1_3_2_1_4_1","volume-title":"Medical device software -- Software life cycle processes","author":"AAMI","year":"2001","unstructured":"ANSI\/ AAMI SW68 , Medical device software -- Software life cycle processes . 5 June , 2001 . ANSI\/AAMI SW68, Medical device software -- Software life cycle processes. 5 June, 2001."},{"key":"e_1_3_2_1_5_1","unstructured":"Capability Maturity Model\u00ae IntegrationCM (CMMISMSM) for Software Engineering (CMMI-SW V1.1 Version 1.1 August 2002).  Capability Maturity Model\u00ae IntegrationCM (CMMISMSM) for Software Engineering (CMMI-SW V1.1 Version 1.1 August 2002)."},{"key":"e_1_3_2_1_6_1","volume-title":"July-August","author":"Rados Carol","year":"2003","unstructured":"Carol Rados , medical device Works to Reduce Preventable Medical Device Injuries. medical device Consumer Magazine , July-August 2003 . Carol Rados, medical device Works to Reduce Preventable Medical Device Injuries. medical device Consumer Magazine, July-August 2003."},{"key":"e_1_3_2_1_7_1","volume-title":"General Principles of Software Validation","author":"CDRH","year":"2002","unstructured":"CDRH , General Principles of Software Validation ; Final Guidance for Industry and medical device Staff . January 11, 2002 . CDRH, General Principles of Software Validation; Final Guidance for Industry and medical device Staff. January 11, 2002."},{"key":"e_1_3_2_1_8_1","volume-title":"Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices","author":"CDRH","year":"2005","unstructured":"CDRH , Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices ; Guidance for Industry and medical device Staff . May 11, 2005 . CDRH, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry and medical device Staff. May 11, 2005."},{"key":"e_1_3_2_1_9_1","volume-title":"Off-The-Shelf Software Use in Medical Devices","author":"CDRH","year":"1999","unstructured":"CDRH , Off-The-Shelf Software Use in Medical Devices ; Guidance for Industry, medical device Reviewers and Compliance . Sept 9, 1999 . CDRH, Off-The-Shelf Software Use in Medical Devices; Guidance for Industry, medical device Reviewers and Compliance. Sept 9, 1999."},{"key":"e_1_3_2_1_10_1","first-page":"1","volume":"6060","unstructured":"EN 6060 1- 1 - 4 :1996, Medical electrical equipment, Part 1. General requirements for safety, Section 1.4 Collateral standard: General requirements for programmable electrical medical systems, 1996. EN 60601-1-4:1996, Medical electrical equipment, Part 1. General requirements for safety, Section 1.4 Collateral standard: General requirements for programmable electrical medical systems, 1996.","journal-title":"EN"},{"key":"e_1_3_2_1_11_1","unstructured":"FDA's Mission Statement - http:\/\/www.fda.gov\/opacom\/morechoices\/mission.html  FDA's Mission Statement - http:\/\/www.fda.gov\/opacom\/morechoices\/mission.html"},{"key":"e_1_3_2_1_12_1","volume-title":"GAMP Guide for Validation of Automated Systems. GAMP","author":"ISPE","year":"2001","unstructured":"ISPE , GAMP Guide for Validation of Automated Systems. GAMP 4, Dec 2001 . ISPE, GAMP Guide for Validation of Automated Systems. GAMP 4, Dec 2001."},{"key":"e_1_3_2_1_13_1","volume-title":"Linda Kohn, Janet Corrigan, Molla Donaldson, eds","author":"Human To Err","year":"2000","unstructured":"To Err is Human : Building a Safer Health System , Linda Kohn, Janet Corrigan, Molla Donaldson, eds , National Academy Press 2000 . To Err is Human: Building a Safer Health System, Linda Kohn, Janet Corrigan, Molla Donaldson, eds, National Academy Press 2000."}],"event":{"name":"ICSE06: International Conference on Software Engineering","sponsor":["ACM Association for Computing Machinery","SIGSOFT ACM Special Interest Group on Software Engineering"],"location":"Shanghai China","acronym":"ICSE06"},"container-title":["Proceedings of the 2006 international workshop on Software quality"],"original-title":[],"link":[{"URL":"https:\/\/dl.acm.org\/doi\/10.1145\/1137702.1137705","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/dl.acm.org\/doi\/pdf\/10.1145\/1137702.1137705","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,6,18]],"date-time":"2025-06-18T15:14:29Z","timestamp":1750259669000},"score":1,"resource":{"primary":{"URL":"https:\/\/dl.acm.org\/doi\/10.1145\/1137702.1137705"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2006,5,21]]},"references-count":13,"alternative-id":["10.1145\/1137702.1137705","10.1145\/1137702"],"URL":"https:\/\/doi.org\/10.1145\/1137702.1137705","relation":{},"subject":[],"published":{"date-parts":[[2006,5,21]]},"assertion":[{"value":"2006-05-21","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}