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ISO13485 Certification

KHMEDICAL 2019.12.27 09:54 hit 373

We, KH Medical, have been certified in standard of Medical Device Quality Management System by U.S Certification Body in compliance with the requirement of ISO 13485:2016.
This certification covers the company's quality management system that meet requirements specific to Design & Development, Manufacture, Sales and Services of In-Vitro Diagnostic Medical Device and Reagent.
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 Certi.JPG


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