의료기기로서 앱 허가제 확립을 위한 동향 분석

  • Published : 2011.04.29

Abstract

Keywords

References

  1. 신재용, "의료분야에 아이패드 등의 스마트패드 활용방안" 정보통신산업진흥원 IT기획 시리즈 모바일 애플리케이션 & 미디어 태블릿6, pp.18-19, 2011
  2. FDA Press Announcements - http://www.fda.gov/, Accessed in February 2011.
  3. 식품의약안전청-모바일 PACS 시스템 허가 심사 가이드라인, http://www.kfda.go.kr, Accessed in 2011.
  4. AAMI - http://www.aami.org/about/, Accessed in 2011
  5. IEC - http://www.iec.ch/about/, Accessed in 2011
  6. ISO - http://www.iso.org/about/, Accessed in 2011
  7. ASTM - http://http://www.astm.org/ABOUT/overview.html, Accessed in 2011
  8. ISO 14155 - http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=45557, Accessed in January 2011.
  9. Christy Foreman, U.S. FDA, "Assessing the Impact of the New 510(k) on the Use of Standards", Accessed in February 2011.
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  11. AAMI & FDA International Conference Presentation Slides, Hyatt Dulles, VA, USA, March 23-24, 2011.