Medical Device Manufacturing Services
XC Machining produces non-implantable medical device components — surgical instrument handles, diagnostic device housings, imaging equipment brackets, orthopedic surgical guide prototypes, and instrument trays — from titanium Grade 23 (ASTM F136), PEEK (ISO 10993 biocompatible grade), stainless steel 316L, and Ultem PEI — to ±0.005 mm tolerance. Lot-level material traceability and Certificate of Conformance on every order. ISO 9001:2015 certified. DFM review within 12 hours. Parts in 3–15 business days from Dongguan, China.
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We Help From Prototyping to Production
Prototyping
Engineering Validation and Testing
Design Validation and Testing
Bring your early-stage medical designs to life with prototypes crafted from production-grade materials. Our process enables you to evaluate and optimize your designs, ensuring they are fully functional and ready for testing.
Production Validation and Testing
Mass Production
- Prototyping
- Tooling
- Jigs & Fixtures
- Surrogate parts
- Drones
- UAVs
- CubeSat
- Fuel pumps
- Structural components
- Small sensors
Industry Facilities
Enhance brand recognition with customized packaging that reflects your brand’s identity.
Materials for Medical Devices Parts
- Steel & stainless steel: 304/304L, 316/316L, 17-4PH
- Titanium: grade 1, grade 2, grade 5
- Aluminum: 6061-T6, 7075-T6, 5083-H111, 2024-T351
- Brass & copper alloys: C360, copper C110, copper C101
- Commodity polymers: Polyethylene (PE), Polypropylene (PP)
- Medical-grade, FDA-approved materials: available via Protolabs
Surface finishes for Aerospace Industry
Industry Expertise at XC Machining
Automotive Industry
Semi Conductor
Energy Industry
Industrial Machinery
Electronics
Communications
Robotics
Medical Devices
Bring Your Designs to Life with XC Machining
- Expertise Shared Widely
- Market Reach Expanded
- Advanced Technology Integrated
- Collaborative Innovation Opportunities
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Manufacture Through Latest Technology
Our Medical Devices Prototype Manufacturing Capabilities
Provides injection molding for prototypes and custom parts, emphasizing expert support, competitive pricing, and faster production cycles.
Get reliable vacuum casting services for high-quality prototypes and production parts at competitive prices. XinCheng offers highly detailed casting parts with consistent quality.
Uses cutting, bending, and forming techniques to produce precision metal components suited for industrial, commercial, and manufacturing applications.
Frequently asked questions
What Tolerance Does XC Machining Hold for Medical Device CNC Machined Parts?
Standard: ±0.005 mm on 5-axis CNC machined titanium Grade 23, stainless steel 316L, PEEK, and Ultem medical device components. Precision: ±0.002 mm available on critical sealing surfaces, mating bores, and instrument pivot points — specify on 2D drawing. Surface roughness: Ra 0.8 μm standard; Ra 0.4 μm on contact surfaces; Ra 0.2–0.4 μm after electropolishing on stainless surgical parts. All verified by CMM with dimensional report per batch.
What Biocompatible Materials Does XC Machining Machine for Medical Device Parts?
XC Machining biocompatible materials: titanium Grade 23 ELI (ASTM F136 — highest biocompatibility, MRI-compatible), titanium Grade 4 CP (ASTM F67 — dental frameworks), PEEK (ISO 10993 — radiolucent, 250°C, autoclave-sterilizable), stainless steel 316L (ASTM A276 — surgical instruments, electropolishable), cobalt-chrome (ISO 5832-12 — dental and orthopedic bearing surfaces), and Ultem PEI medical grade (ISO 10993 — autoclave-sterilizable device housings).
Is XC Machining ISO 13485 Certified for Medical Device Manufacturing?
XC Machining holds ISO 9001:2015 quality management certification. XC Machining does not currently hold ISO 13485. ISO 13485 is the QMS standard required for medical device manufacturers and their direct supply chains. Medical device buyers requiring ISO 13485-certified suppliers should specify this at the quoting stage. XC Machining applies ISO 9001:2015 procedures on all medical orders — material traceability, DFM review, FAI, SPC monitoring, and CoC — as the quality baseline.
Does XC Machining Provide Material Traceability for Medical Device Parts?
Yes. Every medical device batch at XC Machining is traceable by lot number to a material certificate: titanium parts traced to ASTM F136 mill cert (interstitial content, tensile strength, heat treatment); PEEK parts traced to ISO 10993 biocompatible grade CoA; stainless steel 316L traced to ASTM A276 mill cert (chemistry, mechanical properties). Material certificates are filed and provided with every shipment — supporting incoming inspection and 510(k) submission documentation.
What Sterilization Methods Are Compatible with XC Machining's Medical Device Materials?
Autoclave (134°C, 3 bar steam): compatible with stainless steel 316L, titanium Grade 23, PEEK, Ultem PEI, and cobalt-chrome. Not compatible with most unreinforced plastics above 121°C. ETO (ethylene oxide, 55°C): compatible with all materials including PC and ABS. Gamma irradiation: compatible with stainless, titanium, PEEK, and Ultem — not recommended for PC (yellowing) or ABS (embrittlement). XC Machining specifies Ra ≤ 0.8 μm surface finish for autoclave-validated instrument designs.
