Medical

Service Scope: Provides end-to-end manufacturing from molds to finished products for Class I/II/III medical devices.

Technical Advantages:

• ISO 13485 medical device quality management system certification.

• Class 10,000 cleanrooms meeting sterile production requirements.

• Expertise in biocompatible materials: titanium alloys, PEEK, medical-grade stainless steel.

• Implant-grade surface treatments: anodizing, sandblasting, passivation.

Core Capabilities: Precision components for artificial hearts, core mechanisms for surgical robots, precision systems for insulin pumps, etc.

Industry Challenges: Extremely high regulatory requirements (FDA, ISO 13485); implants require excellent biocompatibility and long-term durability; surgical instruments demand utmost precision and reliability; production environment must meet sterile requirements.

Our Solution: We are ISO 13485 certified and operate a Class 10,000 cleanroom. We specialize in the precision machining of implant-grade materials such as titanium alloys, PEEK, and stainless steel. Our products span orthopedic implants, dental implants, core mechanisms for surgical robots, endoscopic parts, and artificial heart pump components. We provide complete biocompatibility test reports, material certifications, and a full traceability system from raw material to finished product, ensuring patient safety.

Typical Products: Bone screws/plates, joint prostheses, surgical instrument handles, insulin pump precision gears, minimally invasive surgical instrument components.