Medical device contract manufacturing enables companies to bring innovative products to market without the capital investment of building in-house manufacturing capabilities. As a medical device contract manufacturer, we provide comprehensive OEM/ODM services from design support and prototyping through full-scale production and global distribution.
| Process | Capabilities | Applications |
|---|---|---|
| CNC Machining | Turning, milling, drilling, ±0.01mm | Surgical instruments, implants, housings |
| Cold Drawing | Capillary tubes OD 0.1-6.0mm | Needles, catheter components, sensing tubes |
| Laser Cutting | Micro-precision, burr-free | Stents, shaver blades, micro-channels |
| Grinding & Polishing | Bevel grinding, electropolishing | Needle tips, cutting edges, surgical blades |
| Heat Treatment | Hardening, annealing, stress relief | 420J2/440C blades, springs, structural parts |
| Laser Welding | Micro-welding, TIG welding | Needle hubs, sensor assemblies |
| Assembly | Sub-assembly, final assembly, testing | Complete devices, multi-component systems |
| Standard | Description |
|---|---|
| ISO 9001:2016 | Medical device quality management system |
| ISO 9001:2015 | Quality management system |
| FDA 21 CFR Part 820 | Quality System Regulation (QSR) |
| EU MDR 2017/745 | Medical Application Regulation |
| ISO 10993 | Biocompatibility evaluation |
| ISO 14971 | Risk management for medical applications |
| ISO 17665 | Sterilization requirements |
| Advantage | Details |
|---|---|
| 20+ Years Experience | Specialized in stainless steel medical device manufacturing |
| Full In-House Capability | Design → prototyping → tooling → production → inspection → packaging |
| Quality First | ISO 9001 certified, FDA registered, comprehensive documentation |
| Competitive Pricing | Direct manufacturer, no middleman, volume discounts |
| Fast Turnaround | 2-4 weeks prototyping, 4-8 weeks production |
| IP Protection | NDA, confidentiality agreement, secure data handling |
| Global Supply Chain | Experienced in international shipping, customs, regulatory compliance |
Contact us with your product specifications, drawings, or concepts. Our engineering team will provide a comprehensive DFM review and competitive quote within 24 hours. Free prototyping samples available for qualified projects.
Leading Stainless Steel Capillary Tube Factory. 1,400+ standard sizes IN STOCK & ready to ship worldwide! High precision, factory-direct price.
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