Auxein Makes History with EU-MDR Certification for Orthopaedic Solutions

Auxein, an innovator in orthopaedic solutions, becomes the first Asian company to achieve EU-MDR certification for its trauma implant systems. This milestone emphasizes their commitment to safety and compliance in the European market, further solidifying their position as leaders in medical device innovation.

In a groundbreaking achievement, Auxein, a renowned global leader in orthopaedic and arthroscopy solutions, has secured the European Union Medical Device Regulation (EU-MDR) certification 2017 from DNV, Norway. This accomplishment marks Auxein as the first Asian orthopaedic implant manufacturer to reach this notable milestone with its complete Trauma Plating, Screws & Nailing System, including the Tibia Plate and Screw and Femoral Nailing System.

This prestigious certification reinforces Auxein's stature in providing safe, high-quality medical devices across Europe, ensuring compliance with the rigorous new regulatory standards. Recognized for its cutting-edge R&D and manufacturing capabilities, Auxein consistently meets the highest criteria in medical device production, including CE(EU-MDR), Medical Device Single Audit Program (MDSAP), ENISO 13485, and USFDA 510(k) certifications.

Gaurav Luthra, Vice President Global Manufacturing and Regulatory Head at Auxein, commented on this success, stating, 'Securing EU-MDR certification underscores our continuous dedication to delivering the safest and most innovative orthopaedic solutions globally. This achievement, together with our extensive international certifications, empowers us to drive healthcare advancements on a global stage.'

(With inputs from agencies.)