Transform your medical innovations from concept to market with our ISO 13485 certified precision manufacturing services. We specialize in rapid prototyping, CNC machining, 3D printing, and injection molding for the healthcare industry.
Over 86% of Fortune 500 medical equipment companies rely on our manufacturing capabilities
From rapid prototyping to full-scale production, we accelerate your time-to-market with precision manufacturing capabilities designed specifically for the medical industry.
5-axis CNC machining with tolerances up to ±0.001″ for surgical instruments, implants, and medical components using medical-grade materials.
Advanced additive manufacturing for complex geometries, rapid prototyping, and patient-specific medical devices with biocompatible materials.
High-volume production of medical device components with cleanroom manufacturing and comprehensive quality documentation.
Fast iteration cycles for medical device development with production-grade materials and comprehensive design feedback.
Our systematic approach ensures your medical device moves efficiently through each development stage with regulatory compliance at every step.
Create functional prototypes for initial design validation and proof-of-concept testing.
Test functionality and performance with engineering-grade materials and processes.
Validate performance, appearance, and manufacturing feasibility for market readiness.
Verify manufacturing processes and quality systems for full-scale production.
Scale to full production with consistent quality and regulatory compliance.
Our manufacturing capabilities serve diverse medical applications, from handheld diagnostic devices to complex surgical instruments and implantable components.
Housings, sensors, and precision components for medical testing devices and analyzers.
Precision-machined tools, forceps, scissors, and minimally invasive surgical devices.
Hip, knee, and spinal implants with complex geometries and biocompatible surfaces.
Stents, catheters, and components for cardiac monitoring and treatment systems.
Custom prosthetics, aligners, surgical guides, and dental instrument components.
Lightweight, durable components for prosthetic limbs and assistive devices.
We work with the most advanced medical-grade materials and provide specialized surface treatments for biocompatibility and performance.
Our quality management system ensures every medical device component meets the highest industry standards and regulatory requirements.
Medical Device Quality Management System certification for design and manufacturing.
Processes designed to support 510(k) submissions and FDA device approvals.
ISO Class 7 (10,000) cleanroom with continuous particle monitoring.
Complete traceability, CoCs, material certifications, and inspection reports.
How we helped a leading medical device company accelerate their minimally invasive surgical tool development
A medical device startup needed to develop a new minimally invasive surgical instrument with complex geometry and tight tolerances. Traditional manufacturing methods were too slow and expensive for their rapid iteration needs.
Get answers to common questions about medical device manufacturing and prototyping
We work with a wide range of medical-grade materials including titanium Ti-6Al-4V ELI, 316L stainless steel, PEEK, PPSU, medical-grade silicones, and biocompatible 3D printing resins. All materials come with full traceability documentation and comply with relevant biocompatibility standards (ISO 10993).
Our facility is ISO 13485:2016 certified with FDA-compliant processes. We provide comprehensive documentation including design controls, risk management documentation, material certifications, dimensional reports, and process validation records to support your regulatory submissions.
We routinely achieve dimensional tolerances of ±0.001″ (±0.025mm) and geometric tolerances of ±0.0005″ using our precision CNC machining capabilities. For surface finish, we can achieve Ra 0.2μm to 3.2μm depending on application requirements.
Prototyping timelines vary by complexity, but typical lead times are: 3D printed prototypes (3-5 days), CNC machined prototypes (5-10 days), and injection molded prototypes (2-4 weeks). We offer expedited services for urgent projects and can often reduce lead times by 50% compared to traditional manufacturing.
Yes, our engineering team provides comprehensive DFM analysis to optimize your design for manufacturability, cost-effectiveness, and quality. We review tolerances, material selection, surface finishes, and manufacturing processes to ensure the best possible outcome for your medical device.
We provide complete quality documentation including: Certificate of Compliance (CoC), material certifications with mill test certificates, full dimensional inspection reports, surface finish verification, first article inspection reports, and process validation documentation. All documentation is designed to support regulatory submissions and audits.
Professional CNC machining and custom parts manufacturing services, meeting your precision machining needs with rapid delivery of high-quality components.
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