01
Requirement Collection
We review your product specifications, target clinical applications, material grade choices, private labeling needs, and local regulatory requirements.
End-to-End Capabilities
Precision Engineering & Custom Manufacturing Expertise
Ortix Medical Devices Co., Ltd. empowers global medical device distributors and brand owners to turn concepts into market-ready orthopedic products. From custom spinal implants and trauma locking plates to specialized surgical instrument sets, we combine strict regulatory compliance with agile manufacturing capacity.
450+Advanced Machining Centers
ISO 13485FDA Registered
Full Technical Support
From Concept to High-Quality Medical Devices
Our in-house R&D center is staffed by over 70 experienced engineers specializing in biomechanics, materials engineering, and surgical instrument design.
Whether you require private labeling (laser marking, branding, and custom packaging) or complete contract design (ODM) for modified anatomical implants, Ortix Medical Devices Co., Ltd. delivers consistent precision, complete raw material lot traceability, and rapid lead times.
- Biocompatible materials: Ti-6Al-4V ELI, PEEK, 316L Stainless Steel
- In-house mechanical, dimensional, and fatigue test laboratory
- Technical dossier support for local product registration
- Class 100,000 cleanroom packaging and sterilization options
Collaboration Workflow
Structured OEM / ODM Process
A systematic, transparent workflow designed to mitigate risk, ensure regulatory compliance, and accelerate time-to-market for international buyers.
02
Solution & Design Evaluation
Our engineering team performs technical feasibility studies, conducts 3D CAD modeling and finite element analysis (FEA), and presents initial engineering drawings.
03
Prototyping & Testing
High-precision prototype samples are produced. Dimensional accuracy, surface finish, and mechanical strength testing are executed in our certified laboratory.
04
Sample Approval
Prototypes and evaluation instrument kits are provided for clinical and mechanical inspection. We adjust specifications based on your feedback until final approval.
05
Mass Production & QC
Automated CNC machining and multi-axis processing run under strict ISO 13485 quality control, ensuring zero-defect batch consistency across all production lots.
06
Packaging & Global Delivery
Custom sterile or non-sterile packaging, private label laser etching, barcode generation, and international export documentation prepared for fast customs clearance.
Clear Timelines
Customized OEM / ODM Solutions: Execution Matrix
Understand stage deliverables, technical responsibilities, and expected timelines for your custom orthopedic project.
| Project Stage | Customer Responsibilities | Ortix Medical Engineering Deliverables | Typical Timeframe |
|---|---|---|---|
| Initial Communication | Requirement descriptions, clinical concepts, or sample sketches | Project scope assessment, confidentiality NDA, feasibility review | 1–2 Days |
| Design & Engineering | Confirmation of functional parameters and sizing requirements | 2D/3D CAD models, finite element analysis (FEA), drawing sign-off | 5–7 Days |
| Prototype Manufacturing | Evaluation criteria and custom packaging guidelines | Precision prototype machining, mechanical verification, test reports | 3–5 Days |
| Physical Sample Approval | Surgeon/technical evaluation and final sample confirmation | Tooling refinement, mold manufacturing, final sample lock-in | ~2 Weeks |
| Mass Production & Delivery | Purchase order placement and delivery schedule approval | Multi-axis CNC mass manufacturing, batch testing, sterile packaging, export shipping | Scheduled per Order |
Talk to Ortix Medical Orthopedic Engineering Experts
Expand your product catalog or launch private label orthopedic implants with a reliable contract manufacturer trusted by distributors across North America, Europe, Asia, and Latin America.
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