Business Capabilities
From cleanroom operations to GMP production quality management—comprehensive protection for product quality and delivery.
Cleanroom
Modern clean production workshop compliant with medical device GMP standards, ensuring environmental cleanliness and stability.
- 100,000-grade cleanroom
- Precise temperature and humidity control
- Regular Environmental Monitoring
Quality Management
ISO Quality Management System Certified: Full-process quality control from raw materials to finished products.
- ISO13485 Quality Management System
- Incoming Quality Control (IQC)
- In-Process Quality Control (IPQC)
- Final Inspection (OQC)
Engineering Capabilities
Led by a technical expert with over 10 years of experience, our professional engineering team brings deep industry expertise to deliver end-to-end technical support—from design to production.
- Customized Solution Design
- Process Optimization and Improvement
- Rapid response to technical issues
Stable Delivery
Extensive upstream supplier partnerships and robust supply chain management ensure stable raw material availability, competitive pricing, and value creation for customers.
- Supply Chain Diversification Management
- Project Management and Order Management in Parallel
- On-Time Delivery Guarantee
Quality Control Process
End-to-end quality management to ensure every step meets standards.
New Project Development
Complete and review tasks according to the workflow
Process Validation and Monitoring
Process controlled and regularly tracked
Inspection Activity
Full pre-shipment inspection
Continuous Improvement
Quality Issue Traceability and Improvement
Certifications
ISO 13485 Quality Management System Certification
ISO 9001 certified with standardized quality management processes in place.
Medical Device Manufacturing Qualification
Complies with Good Manufacturing Practice for Medical Devices; holds qualifications for production in 100,000-class cleanroom facilities.
Schedule an on-site visit
Welcome to visit our facility to see our production capabilities and quality management in person.
Contact Us