ISO13485 certification

ISO13485 Certification

Our company has received ISO 13485:2016 certification from IGC. This certification covers the company's quality management system that meet requirements specific to Production and Sale of Molecular Diagnostic kits, including eg. packaging, manufacturing and quality control. Certification covers the quality management system used to control production of our Molecular Diagnostic Kits. The International Organization for Standardization (ISO) is the world's largest developer and publisher of international standards quality management systems. The ISO 13485:2016 standard contains requirements for a comprehensive management system for the design and manufacture of medical devices including in vitro diagnostic devices.

ISO 13485 인증 획득

당사는 ISO13485:2016 인증을 획득하였습니다.

ISO13485는 체외진단 및 의료기기에서 요구하는 높은 안전성을 만족하는 품질수준을 충족 하기위하여 제정된 국제표준 품질시스템으로서 당사는 국제표준 규격인 ISO13485 인증을 획득하여 제품생산에 있어 국제규격에서 요구하는 안전한 제품을 생산하게 되었습니다.


ISO13485 Certificate


A-1806 Woolim Lions Valley 2, Sagimakgol-ro 45beon-gil 14, Jungwon-gu, Seongnam,

South Korea 13209


T: 070 7013 5066   (국내영업)

T: +82 70 7605 5066   (Global sales)

F: +82 31 624 3066

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