Professional CNC Machining for Medical Components Services

AOOM Technology delivers precision CNC machining solutions purpose-built for the medical device industry. Our facility operates under ISO 13485 protocols, producing surgical instruments, orthopedic implants, and diagnostic equipment components that meet FDA and EU MDR regulatory requirements. With over 15 years of focused experience in medical component manufacturing, our engineering team understands the stringent demands of Class I, II, and III medical devices and works closely with each client to ensure full regulatory conformity from prototype through production.

Key Technical Specifications

• Tolerance capability: ±0.005mm (±0.0002") for critical dimensions on mating and sealing surfaces
• Medical-grade materials: Titanium (Grade 5 ELI), Stainless Steel 316LVM, Cobalt-Chrome MP35N, PEEK, Ultem, medical ABS, and PTFE
• 5-axis and multi-tasking CNC machining centers for complex organic geometries and thin-wall sections
• Surface finish: Ra 0.4µm on mating surfaces; electropolishing to Ra 0.2µm available
• Cleanroom-compatible post-processing: passivation per ASTM A967, electropolishing, ultrasonic cleaning in DI water, and sterile-ready packaging
• Full traceability with lot control, material certification per ASTM/ISO, and device history records compliant with 21 CFR Part 820

Applications

Our medical CNC components are deployed in surgical instruments (forceps, retractors, bone drills, and trocars), orthopedic implants (hip stem trials, knee replacement tibial trays, bone screws, and spinal cage blanks), diagnostic imaging equipment housings and positioning fixtures for MRI and CT systems, drug delivery system components including pump housings and valve bodies, and robotic surgical system actuator components requiring complex geometries and absolute repeatability. Each application benefits from our ability to hold tight tolerances on complex organic geometries while maintaining complete material traceability and biocompatibility validation under strict regulatory oversight.

Quality Assurance

Every cnc machining for medical components order from AOOM Technology is manufactured under a comprehensive quality management system certified to ISO 9001:2015. We employ coordinate measuring machines (CMM) for full dimensional verification, First Article Inspection (FAI) per AS9102 for new production runs, and in-process statistical process control (SPC) to maintain consistent quality across all batches. Material certifications, dimensional reports, and compliance documentation are provided with every shipment.

Contact AOOM Technology today to discuss your cnc machining for medical components requirements. Our engineering team provides free DFM analysis, competitive pricing, and rapid-quote turnaround to move your project from design to production without delay.