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Volumn , Issue , 2009, Pages 34-41

Medi SPICE: An overview

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL EQUIPMENT; REGULATORY COMPLIANCE; SOFTWARE DESIGN;

EID: 80052613790     PISSN: None     EISSN: None     Source Type: Conference Proceeding    
DOI: None     Document Type: Conference Paper
Times cited : (15)

References (18)
  • 1
    • 84924037062 scopus 로고    scopus 로고
    • DA's Mission Statement
    • DA's Mission Statement - http://www.fda.gov/opacom/morechoices/mission.html
  • 3
    • 84924071039 scopus 로고    scopus 로고
    • DRH, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices May 11
    • DRH, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry and medical device Staff. May 11, 2005
    • (2005) Guidance for Industry and Medical Device Staff
  • 10
    • 33750000072 scopus 로고    scopus 로고
    • NSI/AAMI/IEC 62304 Association for the Advancement of Medical Instrumentation, 19-Jul (replacement for SW68)
    • NSI/AAMI/IEC 62304, Medical device software - Software life cycle processes, Association for the Advancement of Medical Instrumentation, 19-Jul-2006 (replacement for SW68)
    • (2006) Medical Device Software - Software Life Cycle Processes
  • 15
    • 77953220742 scopus 로고    scopus 로고
    • SAFE V1.2, Defence Materiel Organisation, Australian Department of Defence, March, Software Engineering Institute, TECHNICAL NOTE CMU/SEI-2007-TN-006
    • SAFE, V1.2: A Safety Extension to CMMI-DEV, V1.2, Defence Materiel Organisation, Australian Department of Defence, March 2007,Software Engineering Institute, TECHNICAL NOTE CMU/SEI-2007-TN-006http://www.sei.cmu.edu/pub/documents/07.reports/07tn006.pdf
    • (2007) V1.2: A Safety Extension to CMMI-DEV
  • 16
    • 12844262806 scopus 로고    scopus 로고
    • SO/IEC 15504 ISO/IEC JTC1/SC7, International Standards Organisation
    • SO/IEC 15504, Information Technology - Process Assessment - Part 2: Performing an Assessment, ISO/IEC JTC1/SC7, International Standards Organisation, 2003. http://www.iso.org/iso/iso-catalogue/catalogue-tc/catalogue-detail.htm?csnumber=37458
    • (2003) Information Technology - Process Assessment - Part 2: Performing an Assessment
  • 18
    • 84924068695 scopus 로고    scopus 로고
    • SO/IEC 15504 Part 7 - ISO/IEC TR 15504-7: November 2008
    • SO/IEC 15504 Part 7 - ISO/IEC TR 15504-7:2008, Information technology - Process assessment - Part 7: November 2008. http://www.iso.org/iso/iso-catalogue/catalogue-tc/catalogue-detail.htm?csnumber=50519
    • (2008) Information Technology - Process Assessment - Part 7


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.