CNC for Medical Devices

Surgical precision.
Medical-grade materials.
Traceable documentation.

CNC machining for medical device OEMs. 316L stainless, Ti Gr.23 ELI (ASTM F136), USP Class VI PEEK, biocompatible polymers. Surgical instruments, orthopedic prototypes, diagnostic equipment, drug delivery hardware. ISO 13485-compatible documentation.

Medical CNC Quote Medical industry page

ASTM F136 USP Class VI Ra 0.4 µm ISO 13485 docs

01 · Medical materials

Medical-grade materials we machine.

Medical device manufacturing requires specific material grades with appropriate biocompatibility testing. These are the materials we work with regularly for medical customers.

316L Stainless (Medical)

ASTM F138

Most common medical metal. Used for surgical instruments, implantable hardware, orthopedic trials. Passivated per ASTM A967

Ti Gr.5 Medical

ASTM F136

Higher strength than Gr.2. Aerospace + medical crossover grade. Dental implants, orthopedic prototypes

Ti Gr.23 ELI

ASTM F136

Extra-low-interstitial titanium. Highest medical-grade choice. Permanent implants — spine cages, bone plates, joint components

PEEK-OPTIMA LT1

Invibio Implantable

Medical-grade PEEK from Invibio. Implantable-class per ISO 10993. Spine cages, dental abutments, orthopedic implants

Ultem 2300

USP Class VI

Transparent polyetherimide. Sterilization-compatible (autoclave, gamma, ETO). Surgical instrument components, diagnostic equipment

Delrin Medical

USP Class VI

Acetal copolymer medical grade. Injection molded + CNC machined. Non-implantable medical device components

02 · Medical applications

Where our medical parts ship.

Surgical instruments

Reusable scissors, forceps, retractors, drill guides in 316L — autoclave-compatible

Orthopedic implants (prototype)

Bone plates, fracture fixation, joint components in Ti Gr.23 ELI for pre-production

Dental implants (prototype)

Dental implant screws, abutments in Ti Gr.4/Gr.5 for clinical trial samples

Endoscopy components

Endoscope hardware, handle components, instrument channels

Diagnostic equipment

Imaging system hardware, centrifuge rotors, analytical instrument parts

Drug delivery devices

Pump hardware, autoinjector internals, syringe hardware in medical-grade polymers

Cardiovascular

Catheter handles, access device components, electrosurgical tool parts

Surgical robots

Robotic surgery system components, end-effectors, mounting hardware

Lab automation

Liquid handling robot components, sample preparation hardware, plate handling

FAQ

Medical CNC questions.

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.