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- 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
- 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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[CE]MDR 개정에 따른 ISO13485
- Admin Hits:942
- 2017-04-17 19:24:00
CE MDD의 MDR 개정에 따른 ISO13455 적용에 대해 안내드리겠습니다.
MDR(유럽 의료지침: European Medical Device Regulation) 은 모든 의료기기에 대해 QMS(품질경영시스템: Quality Management System) 준수를 요구하고 있습니다.
따라서 MDR 을 적용하고자 하는 의료기기 업체는 Article 120 내용에 따라 전환기간 내에 품질경영시스템을 유지하도록 해야합니다.
덧붙여, ISO13485 또한 2016으로 개정되었으며, 2019년 3월까지 2016년판으로 개정되어야합니다. MDR 이 공표된 후에 ISO13485 규격과도 조화될 것으로 예측합니다.
ISO13485:2016 인증전환/신규인증 및 CE/MDD 인증은 언제든지 당사로 문의하시기 바랍니다.
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