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- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
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- ICMC NEWS & LIBRARY
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- 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
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ICMC NEWS & LIBRARY
ICMC (International Certification Management Center Co., Ltd.)
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ICMC NEWS & LIBRARY
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CE MDR
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CE MDR
[CE/MDD] Clinical Investigation & Evaluation
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- 2017-01-11 19:21:00
유럽에서는 임상조사 및 평가를 위해 다음과 같은 가이드라인을 제시하고 있습니다.
MEDDEV 2.7/1 rev.4 Clinical evaluation: Guide for manufacturers and notified bodies.
MEDDEV 2.7/3 rev.3 Clnical investigations: Serious adverse reporting under directives 90/385/EEC and 93/42/EEC
임상평가에 대한 가이드라인은 최근(2016.06) rev.4로 개정되었습니다.
자세한 내용은 첨부파일을 참조하시기 바랍니다.
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