Well Trust(Tianjin) Tech. Co., Ltd Quality Policy For Arthroscopic Surgery Tools.
Mission & Vision
Committed to becoming an innovative leader in the global orthopedic sports medicine field, we aim to improve patient rehabilitation quality and contribute to the development of sports medicine through safe, precise, and reliable medical equipment products. Taking customer health as the core, ensuring quality management throughout the entire lifecycle from research and development to delivery, and building an international high-end medical brand.
1. Compliance
Strictly implement ISO 13485 medical device quality management system, EU MDR regulations, and target market country regulations. Ensure 100% compliance of product registration and certification.
2.Customer demand orientation
Establish a dynamic customer feedback mechanism (clinical doctors, agents, end users) to integrate requirements into the design and improvement process.
Implement customized services and optimize product performance for segmented scenarios in sports medicine, such as arthroscopic surgery and sports injury repair.
3.Whole process risk control
Based on international risk management standard, it runs through the research and development, production, transportation, and after-sales processes.
Perform FMEA analysis on the biocompatibility and mechanical properties of implant materials (such as titanium alloys and PEEK) to ensure clinical safety.
4. Quality Culture
The annual quality arthroscopy training for all employees must be at least 20 hours long, with a product quality inspection pass rate of ≥ 99.9% for quality department employees and a customer complaint response time of<24 hours.
5. Zero tolerance for quality issues
Each product undergoes 100% critical performance testing (such as implant fatigue strength testing, sterility assurance level).
Zero tolerance for quality issues, establish a global recall emergency mechanism, and initiate traceability of problematic products within 48 hours.
