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- ISO 45001 Occupational Health and Safety
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- ABOUT ICMC
- DOMESTIC RA
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-
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
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- ACHIEVEMENT
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OnSurgNet의 식약청(KFDA)인,허가 컨설팅 착수함..제품명:이식용메시(3등급).ICMC는 의료기기 기술문서.FSC확인.ISO13485확인.수입인허가등......
- Admin Hits:3405
- 2008-06-11 13:14:00
국내 병원에서 사용되는 이식용메시 제품에 대한 식약청 수입의료기기 인,허가 컨설팅을 착수하였습니다.
식약청 품목구분에 따라 B03330 이식용메시 [3] Surgical mesh 연 조직이나 뼈의 약한 부분을 강화하기 위하여 임플란트되는 금속 또는 고분자 화합물 막. 예를 들면 탈장에 쓰이는 폴리머메시, 정형외과 수술 시의 관골구 메시 등이 있다.
본 제품은 Biocompatitbility 시험을 통하여 안정성과 신뢰성에 통과하여 수입허가를
취득할 예정임...
의료기기 수입업허가.품목허가.수입품질관리기준등 컨설팅을 통하여 국내에 시판에 할예정임.
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