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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
Medical Manufacturing Resources
Access our specialized reference guides and calculators for medical device manufacturing applications.
Material Hardness Chart
Hardness values for biocompatible materials including titanium and stainless steel.
Surface Finish Chart
Critical surface finish requirements for medical implants and surgical instruments.
Tolerance & Fit Chart
Precision tolerance standards for medical device assemblies.
Cutting Speed Calculator
Optimized machining parameters for biocompatible and exotic materials.