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, 2024

Check online Verification

ISO 13485:2016
Validity: November 19, 2024

Check online Verification

FDA Register
FEI Number: 3005974802

Check online Verification

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

Declaration of Conformity
Validity: December 31, 2023

 

Page last updated: November 19, 2023

Gynamed Instruments - All rights reserves 2024-25