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- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
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- ISO 37001 Anti-bribery Management
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- ACHIEVEMENT
- ICMC NEWS & LIBRARY
- NOTICE
- CUSTOMER
- ABOUT ICMC
- DOMESTIC RA
- GLOBAL RA
-
ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
- NOTICE
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임상 데이터의 용어 정의 (MDD/2007/42/EC)
- Admin Hits:1168
- 2011-03-14 18:37:00
임상 데이터의 용어 정의
‘임상 데이터’는 기기의 사용으로부터
발생하는 안전 혹은 성능정보를 의미한다.
임상 데이터는 다음으로부터 정보를
제공받는다.
- 관련 기기의 임상 조사
- 과학문헌에 보고된, 기기의 동등성에
관한 의문(쟁점)이 설명(해결)될 수 있는
유사기기에 관한 임상 조사 또는 기타 연구
혹은
- 그 기기와의 동등성에 관한 의문(쟁점)이
설명(해결)될 수 있는 그 기기, 혹은 유사
기기에 관한 발행 혹은 미발행 보고서MDD/2007/42/EC 발췌
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