What CNC tolerances can you achieve?

Standard CNC tolerances are ±0.01mm. Tighter tolerances of ±0.005mm are achievable for critical features with additional inspection. Our quality control includes CMM reports and FAI documentation.

What is your typical CNC lead time?

Prototypes typically ship in 3–7 business days. Low-volume production (10–50 pcs) takes 10–20 days. Full production batches (100+ pcs) take 15–25 days. Rush service is available for urgent orders.

What CNC materials do you work with?

We machine aluminum (6061, 7075), stainless steel (303, 304, 316), titanium (Ti-6Al-4V), carbon steel, brass, copper, Delrin, PEEK, nylon, and other engineering plastics from certified suppliers.

What is your minimum order quantity for CNC parts?

We accept orders starting from 1 piece for prototypes. Production orders are quoted based on volume, with per-part costs decreasing at higher quantities.

CNC Machining Medical Devices: FDA and ISO 13485 Guide

CNC Machining for Medical Devices: Materials, Certifications & Validation Guide (2026)

Critical distinction: CNC machining for medical devices requires significantly more documentation than general industrial machining. A typical medical device CNC part costs 2–4x more than an equivalent industrial part — not because the machining is harder, but because of material traceability, validation protocols, and regulatory documentation overhead.

Medical-Grade Materials for CNC Machining

Material	Biocompatibility	Common Medical Use	Cost Premium vs Industrial Grade
Ti-6Al-4V ELI (Grade 23)	★★★★★	Implants, bone plates, spinal cages	+30–50%
316L Stainless (Implant Grade)	★★★★★	Surgical instruments, temporary implants	+20–40%
PEEK (Medical Grade)	★★★★★	Spinal implants, dental abutments	+50–100%
CoCr (Cobalt-Chrome)	★★★★★	Joint replacements, dental frameworks	+100–200%
UHMWPE	★★★★★	Bearing surfaces in joint replacements	+20–30%

Regulatory Requirements by Device Class

Device Class	Examples	Required Standards	Documentation Level
Class I (Low Risk)	Surgical trays, retractors	inspection workflow, material certs	Basic
Class II (Moderate Risk)	Endoscopic tools, drill guides	ISO 13485, FAI, process validation	Moderate
Class III (High Risk)	Implants, pacemaker components	ISO 13485, full IQ/OQ/PQ, lot traceability	Extensive

Medical CNC Cost Breakdown: Same Part, Different Requirements

Cost Component	Industrial Part	Medical Class II	Medical Class III
Material cost	$5 (standard 316L)	$12 (implant-grade 316L)	$18 (lot-certified 316L)
Machining	$30	$45 (+cleanroom surcharge)	$60 (+validated process)
Inspection	$5 (basic dims)	$25 (CMM + FAI)	$80 (CMM + IQ/OQ/PQ)
Documentation	$0	$15 (material certs, FAI)	$50 (DHR, lot trace, validation)
Total per part	$40	$97	$208
Premium vs Industrial	Baseline	2.4x	5.2x

Checklist: Is Your CNC Supplier Ready for Medical?

☐ ISO 13485 certified (not just inspection workflow)
☐ Material traceability to heat/lot number
☐ Validated cleaning and passivation processes
☐ Cleanroom or controlled environment for finishing
☐ IQ/OQ/PQ documentation capability
☐ Device History Record (DHR) management
☐ Non-conformance and CAPA system

Discuss Your Medical Device Project

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