Precision Medical Device CNC Machining Services
XTJ delivers ISO 13485-certified CNC machining with over 20 years of expertise in medical component manufacturing. We combine high precision tolerances, full regulatory compliance, and rapid turnaround times—with no minimum order requirements. Save up to 30% on manufacturing costs while ensuring exceptional quality and patient safety through our advanced machining capabilities.
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Precision Tolerances
Exceptional accuracy for critical medical components -
On-Time Delivery
Reliable production schedules you can trust -
Minimum Order
Full flexibility from prototype to production -
Days for Prototypes
Rapid turnaround for development cycles
Uncompromising Precision and Quality Standards
The life-critical nature of medical devices demands exceptional precision and uncompromised quality. Any deviation in manufacturing tolerances could lead to device failure and jeopardize patient safety. At XTJ, we recognize this responsibility and implement rigorous quality protocols at every production stage.
We double-check engineering drawings and machining specifications throughout the entire process—from initial prototype development through low-volume validation runs to high-volume production. During prototyping, our engineering team collaborates closely on design iterations to ensure flawless execution before committing to production tooling.
Our management considers overlooking quality details completely unacceptable. This commitment guarantees you receive standardized, reliable parts that meet your exact specifications every time, maintaining consistency across production batches.
Deep Technical Expertise
20+ years specializing in medical device precision machining with proven capabilities in complex geometries
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Custom manufacturing approaches aligned perfectly with your unique device requirements
Your Success Defines Ours
We measure our performance by your product success and market acceptance
Material Compliance and Regulatory Certainty
Ensuring materials meet rigorous regulatory standards is non-negotiable for medical device manufacturing. Biocompatibility, sterilization compatibility, and full material traceability are essential requirements. Our material selections strictly comply with FDA regulations, ISO 13485 standards, and CE Marking requirements to safeguard device performance and patient well-being.
XTJ sources materials exclusively from trusted domestic suppliers who meet stringent global safety benchmarks. For specialized applications requiring premium grades, we import raw materials directly from certified European and US suppliers, complete with comprehensive certification documentation including MSDS and RoHS/REACH compliance reports.
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Ti-6Al-4V Grade 5 & 23 ELI: Biocompatible, lightweight, and high-strength—ideal for implants, prosthetics, and
load-bearing medical components requiring excellent corrosion resistance.
Ruostumaton teräs
316L, 17-4PH: Superior corrosion resistance and sterilization compatibility make these grades perfect for surgical
instruments and reusable medical tools.
Cobalt Chrome
CoCrMo: Exceptional wear resistance and biocompatibility for demanding applications like joint replacements
and dental framework structures.
Engineering Polymers
PEEK & UHMWPE: Radiolucent materials with bone-like modulus for spinal cages, orthopedic applications,
and applications requiring MRI compatibility.
Aluminum Alloys
6061, 7075: Cost-effective solutions for non-implant device housings, enclosures, and structural components
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Material Compliance and Regulatory Certainty
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Suunnittelu valmistettavuuden mukaan
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Uncompromising Precision and Quality Standards
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Deep Technical Expertise
20+ years specializing in medical device precision machining with proven capabilities in complex geometries
Räätälöidyt ratkaisut
Custom manufacturing approaches aligned perfectly with your unique device requirements
Your Success Defines Ours
We measure our performance by your product success and market acceptance
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We’re proud to support pioneering medical device companies and healthcare innovators worldwide. Our partnerships with industry leaders demonstrate our capability to meet the most demanding technical specifications and regulatory requirements while delivering exceptional quality and reliability.
Through our advanced technology center, we collaborate with global medical technology leaders including LEPU Medical, Yuwell Medical, Haier Biomedical, and United Imaging Medical. These strategic partnerships drive peak manufacturing performance, consistently exceed expectations, and deliver precise solutions through unmatched craftsmanship and engineering expertise.
Elevate Your Medical Devices with XTJ Precision
Partner with XTJ for compliant, high-quality CNC machining solutions that accelerate your development timeline and reduce manufacturing costs. Our ISO 13485-certified facility combines decades of medical device expertise with cutting-edge technology to deliver the precision, quality, and reliability your innovations demand.
Full Regulatory Compliance
ISO 13485, FDA, and CE certified manufacturing with complete documentation
Nopea toimitus
Prototypes in 3-7 days with scalable production capabilities
Cost Optimization
Save 20-40% through DFM expertise and efficient processes
IP Protection
Comprehensive NDAs and secure systems safeguard your innovations
No Minimum Orders
Complete flexibility from single prototypes to high-volume production
Asiantuntijatuki
Dedicated engineering assistance throughout your project lifecycle
From concept validation through full-scale manufacturing, XTJ provides the precision machining partnership you need to bring life-changing medical devices to market faster and more cost-effectively. Experience the difference that true medical manufacturing expertise makes.
Usein kysytyt kysymykset
Here are answers to some of the most common questions about medical device machining, based on our expertise at XTJ Precision Manufacturing.