Quality Control & Regulatory Compliance

Reliable Medical Device Manufacturing with International Standards

At Golead Medical, quality and safety are the foundation of our medical device manufacturing. As a professional manufacturer of Handheld Ultrasound Scanner, RF Lesion Generators and Radiofrequency Ablation Systems, we implement strict quality management procedures to ensure reliable performance and consistent product quality.

Our quality system covers product design, component selection, manufacturing, testing, and final inspection to meet the requirements of global healthcare markets.

ISO 13485 Certified Quality Management System

Our manufacturing facility operates under an ISO 13485 certified quality management system, the internationally recognized standard for medical device manufacturers.

ISO 13485 ensures:

✓ Controlled product design and development
✓ Strict supplier qualification
✓ Standardized production processes
✓ Risk management procedures
✓ Complete product traceability
✓ Continuous quality improvement

MDR CE & FDA Compliance

Our medical devices comply with applicable international regulatory requirements, including:

MDR CE Compliance

Our products meet European medical device requirements through:

• Technical documentation management
• Product safety evaluation
• Risk assessment
• Performance verification

FDA Registration

Our products have completed relevant FDA registration requirements to support distribution in the U.S. market.

These certifications demonstrate our commitment to global regulatory compliance and product safety.

Comprehensive Quality Control Process

To ensure reliable RF energy delivery and device performance, each product undergoes strict quality inspections.

Incoming Inspection

All key components and materials are evaluated before production.

Production Control

Manufacturing follows standardized procedures with controlled processes and trained operators.

Performance Testing

Each RF system is tested for:

• RF output performance
• Temperature monitoring accuracy
• Electrical safety
• System stability

Final Inspection

Before shipment, every device undergoes final quality verification, including:

• Functional testing
• Appearance inspection
• Documentation review
• Packaging inspection

Trusted Partner for Global Medical Device Distribution

With ISO 13485 certification, MDR CE compliance, FDA registration experience, and professional manufacturing capabilities, [Company Name] provides reliable RF medical solutions for hospitals, clinics, and international distributors.

We support:

✓ OEM / Private Label Manufacturing
✓ Global Distributor Cooperation
✓ Technical Support
✓ Customized Medical Solutions

Quality is our commitment to safer and more effective healthcare solutions.