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Quality & Compliance Certifications

Internationally validated regulatory compliance meeting US FDA 510(k), EU-MDR 2017/745, CE Mark, and ISO 13485:2016 standards for global medical device distribution.

Committed to Excellence & Global Standards

Our certifications reflect Auxein Medical's unwavering commitment to product safety, clinical efficacy, and rigorous regulatory compliance. Engineered in accordance with international medical device directives, our trauma, spine, and sports medicine implant systems empower hospital procurement teams and global healthcare partners in 75+ countries.

EU-MDR 2017/745 & CE Marking

Full compliance with European Medical Device Regulations, backed by technical documentation assessments and stringent EU quality management system audits.

CE 721730 Rev 3 C674419 C642947

US FDA 510(k) Approvals

Comprehensive FDA cleared orthopedic implant portfolios spanning upper & lower extremity trauma plating, intramedullary nailing, and sports medicine suture anchors.

Trauma Systems Spine Fixation Arthroscopy

ISO 13485 & MDSAP Audit

Certified Quality Management System under ISO 13485:2016 and MDSAP (Medical Device Single Audit Program), guaranteeing systematic process quality across R&D and manufacturing.

ISO 13485:2016 MDSAP 720782 GMP Facility

Global Regulatory Dossier & Approvals

EU-MDR 2017/745 & CE Quality System Certificates

Auxein Medical's European CE certificates validate our adherence to the highest EU safety and clinical performance standards, managed under rigorous notified body oversight.

CE 721730 Rev 3 Quality System Certificate
C674419 EU Quality Assurance Certificate
C721730 Rev 2 Technical Approval
C642947 Rev 1 Technical Documentation Certificate
US FDA 510(k) Cleared Implant Systems

Our US FDA 510(k) clearances confirm substantial equivalence and safety for distribution across North American healthcare markets.

US FDA 510(k) Clavicle & Scapula System
US FDA 510(k) DHS-DCS Plate System
US FDA 510(k) 2.4mm Distal Radius System
US FDA 510(k) Intramedullary Nailing System (Sterile/Non-Sterile)
US FDA 510(k) Auxilock Draw Tight Suture-Based Anchor
US FDA 510(k) Auxilock Titanium Interference Screw
US FDA 510(k) PEEK OPTIMA Screw-In Suture Anchor
US FDA 510(k) Vertaux Pedicle Screw System
Manufacturing Licenses & Foreign Government Approvals

State-of-the-art manufacturing plants licensed by Central and State Licensing Authorities, supported by official Free Sale and Foreign Government certifications for hassle-free customs clearance and tender compliance.

Indian FDA Manufacturing License MD-5 & MD-9
Certificate to Foreign Government (CFG 8733 & 8739)
Free Sale Certificate — Implants & Surgical Instruments
Recognized Two-Star Export House & Non-Conviction Certificate

Request Regulatory Documents & Dossiers

Are you an international medical device distributor, hospital procurement manager, or OEM partner? Contact our regulatory affairs team for technical files, SSCP reports, and certification documentation.

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