GIGAAMED Successfully Achieves EU MDR Certification

GIGAAMED is proud to announce that our core product lines have successfully transitioned from the previous MDD directive and officially received the new EU Medical Device Regulation (MDR, EU 2017/745) CE Certificate.

The EU MDR is one of the world’s most rigorous regulatory frameworks for medical device safety and quality. Securing this certification serves as a powerful validation of GIGAAMED’s strict quality management systems and advanced technology.

This major milestone ensures that we will continue to provide a seamless, uninterrupted supply of our innovative medical solutions to our partners, clinicians, and patients across the European Union and global markets.

GIGAAMED remains deeply committed to upholding the highest compliance standards while driving continuous technological innovation in healthcare.

For more information about our certified products, please contact us at info@gigaamedical.com.