Quality System
ISO 13485 Certification
Certified Medical Device Quality Management System covering design, manufacturing, inspection, and delivery of orthopedic surgical implants.
Regulatory Integrity
Engineered for Precision, Certified for Trust
Orthomanufacturer Medical Co., Ltd maintains stringent quality control protocols from raw titanium inspection to final sterile packaging. Our manufacturing infrastructure is fully compliant with ISO 13485, CE MDR, and FDA regulatory standards to minimize registration timelines for international buyers.
Strict Adherence to International Standards
Every orthopedic implant and surgical instrument produced by Orthomanufacturer Medical Co., Ltd undergoes full-lifecycle quality verification. We empower medical device importers with complete technical documentation (STED), ISO certificates, and material traceability.
- 100% Raw Material Lot Traceability (ASTM F136 Ti-6Al-4V ELI, PEEK ASTM F2026, CoCrMo)
- Cleanroom Packaging Operating Under ISO Class 7 Cleanroom Standards
- Third-party Audited Quality Systems by DNV and Notified Bodies
Verified Credentials
International Certifications & Approvals
Explore our official accreditation documentation available for hospital tender review and national medical device registration.
EU Compliance
CE MDR - Spine System
Conformité Européenne approval under EU Medical Device Regulation (MDR 2017/745) for pedicle screws, cages, and cervical plates.
EU Compliance
CE MDR - Trauma Nails
EU MDR approval for interlocking intramedullary nails, femoral nails, and tibial fixation systems engineered for trauma surgery.
US Market
FDA Clearance & Listing
US Food and Drug Administration establishment registration and 510(k) cleared product families for global export compatibility.
Multi-Country
MDSAP Audit Certificate
Medical Device Single Audit Program certification satisfying regulatory requirements across USA, Canada, Australia, Japan, and Brazil.
EU Compliance
CE Mark Compliance
Valid European Union conformity compliance for locking compression plates, micro CMF plates, and joint replacement implants.
Audited System
DNV Certification
Rigorous third-party quality system audits performed by DNV GL, ensuring operational standardization and risk management.
Enterprise Management
ISO 9001 Certification
International standard for continuous quality management, customer service excellence, and supply chain accountability.
Distributor Support
Regulatory Dossier & Registration Technical File
We assist our distribution partners in navigating MOH (Ministry of Health) registration procedures by providing standardized documentation packages upon request.
| Dossier Document | Standards Compliance | Scope & Details | Distributor Value |
|---|---|---|---|
| Summary Technical Documentation (STED) | ISO 13485 EU MDR 2017/745 |
Comprehensive technical files including design validation, risk management (ISO 14971), and clinical evaluation. | Accelerates MOH product registration timelines in target markets. |
| Certificate of Analysis (CoA) & Mill Tests | ASTM F136 ASTM F67 ASTM F2026 |
Chemical composition analysis, mechanical testing, and heat-treatment certificates per titanium/PEEK batch. | Guarantees bio-compatibility and structural integrity for tender audits. |
| Biocompatibility Test Reports | ISO 10993 Series |
Cytotoxicity, sensitization, systemic toxicity, and genotoxicity validation testing from accredited labs. | Fulfills safety criteria for high-risk surgical implants (Class IIb / Class III). |
| Sterilization & Shelf-Life Validation | ISO 11137 ISO 11607 |
Gamma radiation sterilization validation, packaging integrity, and accelerated aging stability data. | Ensures compliant shelf life and sterile integrity during transport. |
Need Certification Dossiers for Local Registration?
Contact the regulatory team at Orthomanufacturer Medical Co., Ltd to request certified copies of our ISO 13485, CE certificates, or technical files for your target distribution market.
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