As a manufacturer of medical products we are subject to strict EN ISO13485;2003 Quality Management System. EN13795 standards, and the guideline MDD93/42/EEC, we are CE certified by TUV and with FDA registration.

Medical devices, validation and routine control of Ethylene Oxide sterilization.

International sterilization Standard-ANSI, AAMI, ISO7135 and EN550 are applied.