Quality Management System
Our facility operates under full ISO 13485:2016 accreditation, ensuring systematic quality auditing across surgical implant design, prototyping, CNC precision machining, and cleanroom handling.
Quality & Regulatory Compliance
ISO 13485 & CE Certifications
Verified Quality Management Systems, EU Regulatory Approvals, and Complete Product Traceability for Global Medical Device Buyers.
Rigorous Regulatory Standards
Built on Uncompromised Quality & Global Compliance
At Orthovana Medical Co., Ltd, we adhere to stringent global regulatory frameworks. Our end-to-end manufacturing workflows—from raw material inspection to cleanroom packaging and final sterilization—strictly comply with international standards to ensure hospital safety and smooth market authorization.
EU Conformity Assessment
Orthovana Medical Co., Ltd orthopedic implant systems carry official CE certification, confirming full compliance with European health, safety, and performance directives for medical devices.
MDR Regulatory Continuity
Supported by valid Notified Body agreements (TÜV SÜD / TÜV Rheinland), our product lines maintain unbroken market validity and regulatory extension compliance under EU Regulation 2017/745 (MDR).
Regulatory Dossier Support
Comprehensive Registration Support for Distributors
We provide complete, auditor-ready technical packages to assist medical distributors with rapid product registration and tender submissions worldwide.
Material Test Reports (MTR)
Full chemical composition and mechanical testing certificates per ASTM F136 (Ti-6Al-4V ELI), ASTM F67 (Pure Titanium), and ASTM F2026 (Implant-Grade PEEK).
Free Sales Certificates (FSC)
EU-issued Free Sales Certificates and Apostille legalization for seamless registration in Latin America, Middle East, Asia-Pacific, and African health authorities.
Sterilization & Biocompatibility Validation
Cleanroom environment monitoring reports, ISO 11137 / ISO 11135 sterilization validation files, and ISO 10993 biological evaluation dossiers.
Lot-Level Traceability Dossiers
Each shipment is fully traceable with unique lot numbers, laser markings, raw material heat numbers, and final inspection sign-offs.
Certified Product Portfolio
Standardized & Certified Medical Solutions
Our certification scope covers a full range of trauma, spinal, and maxillofacial implant systems designed for optimal surgical outcomes.
Trauma Plating & Screws
Anatomically contoured locking compression plates (LCP), variable angle plates, and titanium bone screws manufactured under strict dimensional control.
Spinal Fixation Systems
Polyaxial pedicle screws, spinal rods, cervical plates, and PEEK interbody fusion cages (TLIF, PLIF, Cervical) manufactured from ASTM-certified materials.
CMF & Specialty Lines
Low-profile maxillofacial mini plates, mandibular reconstruction systems, rib & sternum fixation plates, and cannulated compression screw kits.
Request Official Certification Dossiers
Are you participating in hospital tenders or registering orthopedic implants in your country? Contact our regulatory export team at [email protected] to receive certified specification sheets and regulatory documentation.
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