Surgical precision. Medical-grade materials. Traceable documentation.

We hold ISO 9001:2015 but not ISO 13485. Our medical device customers typically hold ISO 13485 and use us for Tier-2 component supply. We provide documentation packages (material certificates per EN 10204 3.1, CMM inspection reports, FAI documentation) that satisfy their ISO 13485 supplier qualification requirements. For final commercial production of regulated medical devices, customers typically move to ISO 13485-certified manufacturers.

Yes — for prototypes, pre-production samples, and clinical trial units. Working in Ti Gr.23 ELI (ASTM F136) or Invibio PEEK-OPTIMA LT1 implantable grade. Commercial production of implantable devices typically requires FDA-registered manufacturer under QSR compliance. We support the prototype-through-clinical-trial journey, with final commercial production moving to specialized implant manufacturers.

Typical medical surface finish requirements: Ra 0.4 µm on mating and functional surfaces (standard with our CNC), Ra 0.2 µm on bearing surfaces (needs polishing pass), Ra 0.1 µm on critical clinical surfaces (polished). Passivation per ASTM A967 standard on 316L stainless. Electropolishing available for sanitary surfaces. All finishes documented in inspection report.

Yes — standard on medical orders. Material certificate (EN 10204 3.1) links each part back to specific mill heat number with chemical composition, mechanical properties, and any special processing. For ASTM F136 Ti Gr.23 ELI, additional compliance documentation confirms extra-low-interstitial composition. Heat treatment records included if applicable. Complete documentation package archived for 5+ years.

Standard medical cleaning: ultrasonic wash with medical-grade cleaner, rinse in DI water, dry in clean environment, package in medical-grade clean bags (polyethylene, sealed). For specific cleanliness standards (ISO Class 5 assembly-ready), parts routed through dedicated medical cleaning partner. Documented cleaning procedure provided with each order.

All materials we machine for medical have documented sterilization compatibility: 316L stainless (autoclave, gamma, ETO, EtO), Ti Gr.23 ELI (all methods), PEEK-OPTIMA (autoclave, gamma, ETO), Ultem (autoclave, gamma, ETO). Material selection affects sterilization method — specify sterilization requirement on RFQ and we recommend appropriate material if yours isn't compatible.