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Medical Device CNC Machining

Precision manufacturing of biocompatible components for medical devices, surgical instruments, and healthcare equipment with FDA compliance and ISO 13485 certification.

Medical Manufacturing Excellence

  • ISO 13485 Certified
  • FDA Compliant Facility
  • Biocompatible Materials
  • Clean Room Manufacturing

Medical Device Manufacturing Capabilities

Specialized CNC machining capabilities designed to meet the stringent requirements of medical device manufacturing and regulatory compliance.

Micro Machining
Ultra-precision machining for miniature medical components with tolerances to ±0.00005".
Biocompatible Materials
Titanium, stainless steel, PEEK, and other FDA-approved materials for implants and devices.
Clean Room Production
ISO Class 7 clean room environment for sterile and contamination-free manufacturing.
Regulatory Documentation
Complete traceability, validation protocols, and documentation for FDA submissions.
Metrology & Inspection
Advanced measurement systems including optical comparators and surface analysis equipment.
Prototype to Production
From R&D prototypes to full-scale production with design for manufacturability support.

Medical Components We Manufacture

Precision manufacturing of critical medical components from surgical instruments to implantable devices.

Surgical Instruments

  • • Forceps and clamps
  • • Surgical scissors
  • • Biopsy needles
  • • Laparoscopic tools
  • • Endoscopic components

Orthopedic Implants

  • • Hip and knee components
  • • Spinal hardware
  • • Bone plates and screws
  • • Joint replacement parts
  • • Trauma fixation devices

Diagnostic Equipment

  • • MRI components
  • • CT scanner parts
  • • Ultrasound housings
  • • X-ray equipment
  • • Laboratory instruments

Cardiovascular Devices

  • • Stent components
  • • Catheter parts
  • • Pacemaker housings
  • • Heart valve components
  • • Vascular grafts

Medical Device Compliance & Standards

Comprehensive regulatory compliance and quality systems to ensure patient safety and product efficacy.

Regulatory Compliance

  • ISO 13485:Medical device quality management system
  • FDA 21 CFR Part 820:Quality System Regulation compliance
  • EU MDR:European Medical Device Regulation compliance

Quality Systems

  • Design Controls:Comprehensive design history file maintenance
  • Risk Management:ISO 14971 risk analysis and mitigation
  • Biocompatibility:ISO 10993 biological evaluation testing

Ready to Advance Your Medical Device Project?

Get a specialized quote for your medical device manufacturing needs. Our FDA-compliant facility and experienced team ensure the highest quality standards for patient safety.