Core Components for Medical Devices: Defining Micron-Level Precision
From implants to highly complex surgical instruments, we use state-of-the-art machining processes to imbue every component with the essential characteristics required by ISO 13485 standards.
Specializing in precision manufacturing solutions for Class III medical devices and high-value consumables
| Machining Category | CNC Machining |
|---|---|
| Materials | Any Material |
| Machining Dimensions | Any Size |
| Machining Accuracy | ±0.005mm |
Cleanliness Control
Equipped with a Class 7 (10,000-class) clean workshop, with strict monitoring of particulate contaminants. Whether for orthopedic implants or cardiovascular interventional accessories, burrs and oil residues are completely eliminated, meeting the absolute safety standards for implantation into the human body.
Ultra-High Tolerances & Surface Finishing
Machining precision up to ±0.005mm, with surface roughness Ra < 0.2μm. Whether for titanium alloys, PEEK, cobalt-chromium-molybdenum alloys, or ultra-high molecular weight polyethylene, mirror-like finishing is achieved to reduce friction loss.
Full Lifecycle Traceability
Based on the ISO 13485 quality system, full-process barcode traceability is realized from raw material chemical composition analysis through CNC machining, post-processing, and sterile packaging, ensuring full traceability of “man, machine, material, method, and environment” for each batch.
| Parameter Category | Capability Indicator |
|---|---|
| Machining Precision | ±0.005mm (special cases up to ±0.002mm) |
| Minimum Machining Dimension | 0.2mm (core components of minimally invasive surgical instruments) |
| Surface Roughness | Ra ≤ 0.2μm (mirror finish) |
| Applicable Materials | 304/316L stainless steel, titanium alloy (TC4), PEEK, PPSU, cobalt-chromium alloy |
| Machining Equipment | Swiss Tornos sliding-head lathes, 5-axis simultaneous machining centers, EDM slow wire cutting |
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