- Asia’s first orthopaedic implant manufacturing organization to reach this milestone for its Trauma Orthopaedic Solutions
- Certifications such as CE (EU-MDR), MDSAP, EN ISO 13485, USFDA 510K and More, Auxein Continues to Impact Global Healthcare
Auxein, a global innovator in orthopaedic and arthroscopy solutions, is proud to announce the successful achievement of the prestigious European Union Medical Device Regulation (EU-MDR) certification 2017 issued by DNV, Norway. Auxein has made history as the first Asia’s orthopaedic implant manufacturing organization to reach this milestone for its Trauma Plating, Screws & Nailing System including Tibia Plate and Screw and Femoral Nailing System. This certification strengthens Auxein’s role as a leader in delivering safe, high-quality medical devices across Europe, ensuring compliance with the latest regulatory standards.
The state-of-the-art R&D and manufacturing facility is globally recognized for adhering to the highest standards in medical device production. Certification such as CE(EU-MDR), Medical Device Single Audit Program (MDSAP), ENISO 13485, USFDA 510(k), and many, Auxein’s compliance aligns us with European Union health, safety, and environmental standards.
Auxein offers a comprehensive portfolio of over 3000 orthopaedic products, designed to meet a variety of patient and clinical needs. All products are CE-certified and fully compliant with the European Medical Device Directive MDD/93/42/EEC, as amended 2007/47/EC. Additionally, a selected range of products has been US FDA 510(k) cleared, further validating the safety and efficacy of Auxein's product offerings for global markets.
EU-MDR Certification – A Step Towards a Safer, Compliant Future
Achieving EU-MDR certification is a landmark accomplishment for Auxein, ensuring that all orthopaedic implants—including joint arthroplasties, screws, plates, and trauma devices—meet the stringent safety and performance standards established by the European Union. This compliance positions Auxein as a key player in the European medical device market, enhancing product traceability, clinical evaluation, and patient safety.
Mr. Gaurav Luthra, Vice President Global Manufacturing and Regulatory Head at Auxein, stated, “Securing EU-MDR certification is a testament to our relentless dedication to providing the safest, most innovative orthopaedic solutions. This achievement, combined with our extensive global certifications, positions us to drive advancements in healthcare on a global scale.”
Auxein’s Ongoing Commitment to Innovation
With its globally certified R&D facility and an unparalleled range of orthopaedic products, Auxein remains at the forefront of medical technology. The company’s dedication to cutting-edge research and superior manufacturing enables it to deliver solutions that meet the evolving needs of healthcare professionals worldwide.
