Professional CNC Medical Device Components Services

AOOM Technology is an ISO 13485-certified CNC machining partner specializing in medical device components and surgical instruments. Our cleanroom-compatible manufacturing environment, combined with expertise in biocompatible materials and full material traceability, ensures every part meets the regulatory and performance demands of the healthcare industry.

Key Technical Specifications

• ISO 13485:2016 certified quality management system for medical device manufacturing
• Biocompatible material expertise: titanium (Ti-6Al-4V ELI), stainless steel (316LVM), PEEK, PPSU, UHMWPE
• 5-axis CNC machining with ±.005 mm tolerance for surgical instruments and implantable components
• Cleanroom-compatible packaging and assembly options available
• Full lot traceability with material certifications, process records, and inspection data
• Post-processing: passivation, electropolishing, medical-grade anodizing, and gamma/EtO sterilization preparation
• Design for Manufacturability (DFM) feedback with regulatory compliance guidance (FDA 21 CFR Part 820)

Applications

• Surgical instruments: forceps, scissors, bone saws, and retractors
• Implantable components: orthopedic plates, spinal cages, and dental abutments
• Diagnostic equipment parts: MRI housing brackets, CT scanner guide rails, and lab analyzer frames
• Drug delivery system components: syringe bodies, metering valves, and pump housings
• Rehabilitation and mobility aid parts requiring biocompatible materials and smooth finishes

Quality Assurance

Every component manufactured by AOOM Technology undergoes our multi-tier quality assurance framework, which is rooted in ISO 9001:2015 certified processes and supplemented by industry-specific standards. Our quality system encompasses first-article inspection (FAI) with full dimensional reports, in-process statistical process control (SPC), and final validation using coordinate measuring machines (CMM) with measurement uncertainty as low as 0.001 mm. Material certifications, process traceability, and compliance documentation are provided with every shipment, giving our clients complete confidence in the integrity and repeatability of their production parts.

Ready to bring your next project to life with precision machining you can trust? Contact AOOM Technology today to speak with our engineering team, request a DFM analysis, or receive a competitive quote tailored to your specific requirements.