Quality Management System

We have a comprehensive quality management system that is certified in accordance with ISO 13485, ISO 9001 and European medical device legislation. In addition, we have also integrated national guidelines from the American Food and Drug Administration (FDA)

ISO 9001:2015
Validity: November 19, 2021

ISO 13485:2016
Validity: November 19, 2021

FDA Register
FEI Number: 3005974802

CMC Medical Devices & Drugs (EC Representative)
No. CMC/CE/2019/17012020-2

Declaration of Conformity
Validity: December 31, 2020


Last updated: January 21, 2021

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