Medical CNC Machining Services.
ISO 13485 certified CNC machining for medical devices and surgical instruments with stringent quality requirements and full traceability.
Surgical Instruments
Precision machining of surgical instruments with biocompatible materials.
Medical Implants
Orthopedic and dental implants machined to exacting specifications.
Medical Equipment
Components for diagnostic and therapeutic medical equipment.
Medical Device Manufacturing
Medical device manufacturing requires the highest levels of quality, precision, and regulatory compliance. Xofah's medical CNC machining services provide access to ISO 13485 certified machine shops with expertise in producing surgical instruments, implants, and medical equipment components.
Our certified partners maintain cleanroom facilities, implement rigorous quality management systems, and provide complete traceability from raw materials through final inspection. We support all phases of medical device development from prototyping through production, with full documentation for regulatory submissions.
With expertise in biocompatible materials, surface treatments, and sterilization compatibility, Xofah ensures your medical components meet all applicable standards including FDA, ISO, and CE requirements.
ISO 13485 Certified
Certified facilities with medical device quality systems
Biocompatible Materials
Titanium, PEEK, stainless steel, and other approved materials
Full Traceability
Complete documentation and material certifications
Regulatory Support
FDA, ISO, and CE compliance assistance
Operational Logic
ISO 13485 Certification
ISO 13485 is the international standard for quality management systems in medical device manufacturing. Our certified partners maintain comprehensive quality systems that ensure consistent production of safe, effective medical devices.
Quality Management System
Documented procedures for all manufacturing processes
Risk Management
ISO 14971 compliant risk analysis and mitigation
Design Controls
Formal design verification and validation processes
Process Validation
IQ, OQ, PQ validation for manufacturing processes
Supplier Management
Qualified suppliers with material certifications
Corrective Actions
CAPA system for continuous improvement
Biocompatible Materials
Medical devices require materials that are biocompatible and suitable for their intended use. We machine a wide range of FDA-approved and biocompatible materials.
Metals
Plastics
Cleanroom Manufacturing
Many medical devices require manufacturing in controlled environments to prevent contamination. Our partners maintain ISO Class 7 and Class 8 cleanrooms for medical device production.
ISO Class 7 Cleanrooms
10,000 particles per cubic foot for critical components
ISO Class 8 Cleanrooms
100,000 particles per cubic foot for general medical devices
Environmental Monitoring
Continuous monitoring of temperature, humidity, and particle counts
Gowning Procedures
Strict gowning and hygiene standards for personnel
Cleaning Validation
Validated cleaning procedures for equipment and parts
Sterilization Compatibility
Parts designed for autoclave, EtO, or gamma sterilization
Quality and Traceability
Medical device manufacturing requires complete traceability from raw materials through final inspection and delivery.
Documentation
Inspection and Testing
Medical Device Applications
Xofah's medical CNC machining services support a wide range of medical device applications.
Regulatory Compliance
Medical device manufacturing must comply with regulations in target markets. We support compliance with major regulatory frameworks.
FDA (United States)
21 CFR Part 820 Quality System Regulation compliance
ISO 13485
International medical device quality management standard
CE Mark (Europe)
EU Medical Device Regulation (MDR) compliance
Health Canada
Canadian Medical Devices Regulations compliance
PMDA (Japan)
Japanese pharmaceutical and medical device regulations
TGA (Australia)
Therapeutic Goods Administration compliance
Design Guidelines for Medical Devices
Follow these guidelines to optimize your medical device designs for manufacturing and regulatory compliance.
Design for Sterilization
Consider sterilization method (autoclave, EtO, gamma) in material and design selection
Surface Finish Requirements
Specify appropriate surface finish for biocompatibility and cleaning
Material Selection
Choose biocompatible materials with appropriate certifications
Tolerance Specifications
Specify tolerances based on functional requirements and inspection capability
Design for Inspection
Ensure critical features are accessible for inspection and measurement
Risk Management
Conduct FMEA and risk analysis per ISO 14971
Advantages of Xofah Medical CNC Machining
ISO 13485 Certified
Access to certified facilities with medical device quality systems
Regulatory Expertise
Support for FDA, ISO, and CE compliance requirements
Biocompatible Materials
Expertise in titanium, PEEK, stainless steel, and other medical materials
Cleanroom Capability
ISO Class 7 and 8 cleanrooms for contamination control
Full Traceability
Complete documentation from raw materials through delivery
Quality Assurance
Comprehensive inspection and testing per medical device standards
Get Started with Medical CNC Machining
Contact our medical device experts for consultation and quoting.