CNC Machining for Medical Devices

Medical Device Machining

KGL is ISO 13485:2016 certified (NQCC, cert 50526YY00027R000) for machining medical device components. We produce surgical instruments, implant-grade titanium parts, and device housings under controlled processes with full traceability.

Materials for Medical

• Titanium (Grade 5 / Ti-6Al-4V) for implants
• Stainless steel (316L, 17-4PH) for surgical instruments
• PEEK and PEI for radiolucent components
• Aluminum for device housings

Quality for Medical

• Full material traceability with mill certificates
• FAI and production inspection reports
• Controlled environment for critical parts
• Passivation per ASTM A967 for stainless steel

Typical parts: 10 part families with tolerances and documentation paths.

Process Coverage for Medical Programs

Medical parts run under our ISO 13485:2016 scope on the same 100+ machine floor: 5-axis milling for implant-grade titanium and PEEK components, turning for instrument bodies, and controlled cleaning and packaging for parts entering regulated assembly. Special processes such as passivation per ASTM A967 are completed with documented process control, and storage and handling follow the same written rules the certificate audit inspected.

Tolerances, Materials and Documents

Requirement	Standard capability	Evidence provided
Machined dimensions	±0.005 mm	Batch CMM report
Surface finish on worn or cleaned faces	Ra 0.4 to 0.8	Surface roughness records
Material identity	Ti Grade 5, 316L, 17-4PH, PEEK, 6061	Mill certificates to heat number
Stainless passivation	ASTM A967	Process record per lot

Every shipment can include first-article inspection, full dimensional layout, and batch records linking parts, machines, programs, and inspection data, so your regulatory file keeps its evidence chain from prototype to volume.