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- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
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- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- 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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ICMC (International Certification Management Center Co., Ltd.)
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| 유럽대리인 (Authorised representative) 의료기기/체외진단의료기기업체가 유럽 내 사업체가 없는 경우, 대리인(Authorised representative, AR)을 의무적으로 지정해야 한다. 유럽대리인은 EU지역에 설립된 자연인 또는 법인이어야 하며, 제품설명서(Instruction For Use)와 제품라벨에 정보를 기재해야 한다. **유럽대리인의 업무 및 역할** - EU 적합성 선언(DoC)와 기술문서 보관 - 유럽 내 의료기기 관련 사고 발생 시, 관계당국에 보고 - 국가책임기관(competent national authority) 요청 시, 제품적합성 입증에 필요한 문서 제공 - 국가책임기관(competent national authority) 요청 시, 기관과 협력하여 제품의 위험요소 제거 |
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- Company : ICMC (International Certification Management Center Co., Ltd.)
- CEO : Bong Ju Kim
- Address: 16 Digital-ro 32-ga-gil, Guro-gu, Seoul (Guro-dong) Partner Tower 2nd Room 1001.
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