Weyuan Medical has established a systematic quality management system covering the entire product lifecycle, based on international standards including ISO 13485, IEC 60601-1, and EMC requirements. From raw material processing to finished product delivery, we ensure that every surgical light, operating table, medical pendant, and integrated operating room system delivers outstanding performance and long-term reliability through strict process control, multi-level inspection, and continuous certification.

The designed service life is 5–10 years (depending on product series), fully meeting the stringent requirements of high-end hospitals for equipment stability and durability.

Precision In-house Manufacturing
Equipped with more than 10 types of high-precision equipment, including laser cutting machines (accuracy ±2 mm), CNC lathes, punching machines, and injection molding machines. All core components are manufactured in-house, ensuring material consistency and process stability from the source.

Professional Mold Development
Over 3,000 sets of dedicated molds have been developed, enabling rapid customization and flexible production to meet the differentiated needs of ODM customers and Global brand partners.

Long-life Material Selection
All critical components are made from corrosion-resistant, fatigue-resistant medical-grade materials, providing a solid foundation for long-term stable operation.

Full Traceability System
From drawing review and self-inspection at each process step, to in-process quality control (IPQC) and final commissioning, Weyuan implements closed-loop management with full traceability throughout production.

Standardized Process Management
Strictly compliant with the ISO 13485 quality system. Key processes are supported by detailed work instructions and digital records to ensure process consistency and long-term product reliability.

Burning-in Testing
All finished products undergo burning-in tests ranging from 4 hours to 7 days prior to shipment, simulating real operating loads to eliminate early-stage failure risks.

Four-stage Inspection System
Incoming Quality Control (IQC): Inspection of all raw materials and outsourced components
In-Process Quality Control (IPQC): Real-time production monitoring and sampling inspection
Final Quality Control (FQC): 100% inspection of each finished unit, including mechanical performance and electrical safety tests (leakage current, dielectric strength, grounding resistance)
Outgoing Quality Control (OQC): Final verification of packaging, documentation, and appearance prior to delivery

Comprehensive International Certifications
✅ ISO 13485:2016 – Medical Device Quality Management System
✅ EU MDR 2017/745 (CE) – European Medical Device Regulation
✅ IEC 60601-1 Series – Medical Electrical Equipment Safety and Performance Standards
✅ ISO 9001:2015 – Quality Management System
✅ ISO 14001:2015 – Environmental Management System

Continuous Compliance and Upgrading
Products are regularly tested and recertified by international authorities to ensure ongoing compliance with global market access requirements, supporting the sustainable operations of our partners.