Certifications

Certification List

 

Product certification and production process verification are in compliance with ISO 11607 standards

ISO 13485 Medical Device Quality Management System Certification - Medicom Yilan Factory

ISO 13485 Medical Device QMS

(Medicom Yilan Plant)

Medical sterilization packaging design and manufacturing
ISO 13485 certified

ISO 13485 Medical Device Quality Management System Certification - Medicom Thailand Factory

ISO 13485 Medical Device QMS

(Medicom Thailand Plant)

Medical sterilization packaging design and manufacturing
ISO 13485 certified

TFDA Ministry of Health and Welfare Food and Drug Administration QMS 0845 certification

TFDA Food and Drug Administration

(QMS 0845 certification)

Medical sterilization packaging design and manufacturing
TFDA QMS0845 certified

FDA 510K Certification

FDA 510K Certification

(U.S. Food and Drug Administration)

Medical sterilization packaging design and manufacturing
FDA 510K cleared