Auxein, an India-based orthopaedic and arthroscopy solutions provider, has achieved the European Union Medical Device Regulation (EU-MDR) certification 2017 from DNV, Norway for its orthopaedic products.
The certification has been granted for Auxein’s Trauma Plating, Screws, and Nailing Systems, including the Tibia Plate and Screw as well as the Femoral Nailing System.
This development makes Auxein the first orthopaedic implant manufacturer in Asia to earn this certification.
According to the orthopaedic solutions provider, the certification will help provide safe, high-quality medical devices in Europe while ensuring compliance with the latest regulatory standards.
The company also has a research and development (R&D) and manufacturing facility for medical device production.
Auxein has multiple certifications, including CE (EU-MDR), the Medical Device Single Audit Program (MDSAP), EN ISO 13485, and US Food and Drug Administration (FDA) 510(k) clearance.
The orthopaedic products developer is also said to comply with European Union health, safety, and environmental standards.
Auxein regulatory head and global manufacturing vice president Gaurav Luthra said: “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 provides a portfolio of over 3,000 orthopaedic products tailored to various patient and clinical needs.
All products are CE-certified and comply with the European Medical Device Directive MDD/93/42/EEC, as amended by 2007/47/EC.
Additionally, a select range of products has received FDA 510(k) clearance.
The company also has facilities in the US, Mexico, Dubai, and India, to boost research and manufacturing.
Recently, Auxein announced its entry into the Egyptian market. The company plans to offer its solutions at competitive prices and intends to advance medical technology there to improve patient outcomes.
The orthopaedic and arthroscopy solutions provider has also announced a simulation study focusing on a customised Temporomandibular Joint (TMJ) implant this October.
The study will focus on enhancing the stability and functional behaviour of TMJ implants for long-term applications.
