From Prototype to Production with Global Medical Compliance.
Certification + Compliance
ISO 13485 |FDA 21 CFR Part 820| CE Marking
Customizable services based on your unique requirements
✅ Medical OEM device manufacturers
✅ Aftermarket medical component suppliers
✅ Tier1 & Tier2 medical parts suppliers
✅ Electric medical equipment producers
✅ Medical design and engineering companies
✅ Custom modified medical device manufacturers
✅ Commercial hospital equipment suppliers
✅ Medical electronic system suppliers
✅ Medical mold and fixture manufacturers
| Process | Mold Making, Injection Molding |
| Materials | TP, SI |
| Surface Finishes | Mold Polishing |
| Tolerance | ±0.005″ |
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背景：实验室需要用于手术器械的精度要求较高的小型不锈钢部件，这些部件需具有极高的光滑度和抗腐蚀性。
我们的解决方案：五轴數控加工 + 鏡面抛光 + 退化处理。
关键成果：无尖刺、耐腐蚀、可进行高压灭菌，完全符合医疗安全标准。
医疗诊断设备外壳
手术器械精密金属部件
医疗传感器PCBA模块
背景：该医疗品牌需要高精度的 ABS 医疗外壳，易于消毒，表面光滑且组装精度高。
我们的解决方案：医用级塑料注塑 + CNC 精细修整 + 医用表面处理。
关键成果：符合ISO 13485标准，采用无毒材料，完全兼容医院消毒环境，稳定批量生产。
背景：实验室需要用于手术器械的精度要求较高的小型不锈钢部件，这些部件需具有极高的光滑度和抗腐蚀性。
我们的解决方案：五轴數控加工 + 鏡面抛光 + 退化处理。
关键成果：无尖刺、耐腐蚀、可进行高压灭菌，完全符合医疗安全标准。
背景：医疗监测设备需要具备高稳定性的 PCBA 传感器模块。
我们的解决方案：医疗级零部件采购 + SMT 高精度焊接 + 老化及功能全面测试。
关键成果：干扰小、运行稳定、长期可靠，通过了医疗电子安全测试。
| Material | Key Features | Available Processes | Typical Medical Applications |
|---|---|---|---|
| Medical Stainless Steel | Biocompatible, autoclave sterilization resistant | CNC Machining, Stamping | Surgical tool parts, orthopedic screws, fixture hardware |
| Medical Grade Aluminum | Lightweight, corrosion-proof, easy disinfection | CNC, Die Casting, Sheet Metal | Medical device housings, diagnostic equipment frames |
| Titanium Grade5 | Ultra-biocompatible, high strength for human implantation | Precision CNC, SLM 3D Printing | Bone implants, dental base, minimally invasive surgical parts |
| Medical PA/PP(USP VI) | FDA approved, sterilizable via EO gas | CNC, Injection Molding, SLS 3D | Disposable lab consumables, infusion device housings |
| POM Medical Grade | Low friction, dimension stable, chemical resistant | CNC, Injection Molding | Valve components for medical fluid equipment |
| Medical Silicone(LSR) | Biocompatible, flexible, autoclavable | Liquid Silicone Injection | Seal gaskets for infusion equipment, respiratory masks parts |
| ABS Medical | Impact resistant, easy sterilization | CNC, Injection Molding | Diagnostic analyzer outer shells |
Turnkey Medical Manufacturing Solutions: From rapid prototyping and custom medical tooling to regulated mass production, we provide a seamless end-to-end service. Our optimized manufacturing processes deliver ISO 13485-compliant quality at highly competitive costs.
Experienced Engineering Team: Backed by over 20 years of experience in the medical industry, our engineers provide professional DFM optimization, material recommendations, and technical support throughout the product lifecycle.
Global Regulatory Support: With extensive knowledge of international medical device standards, we assist customers in preparing CE/FDA-related documentation and compliance requirements for smoother market entry.
Confidentiality & Compliance Assurance: Every medical project is handled under strict confidentiality protocols. We use certified medical-grade materials that are non-toxic, skin-safe, and suitable for routine medical sterilization processes. Complete documentation is provided to support product registration, export requirements, and market approval procedures.
请将您的医疗部件图纸、设备规格或研发想法发送给我们。我们将在 24 小时内为您提供免费的 DFM 分析、医疗材料推荐以及专业报价服务。
