Shenzhen Zhuoyuan Tiancheng Consulting Co., Ltd. is a professional consulting organization engaged in international consulting of medical devices. To provide consulting and agency services for international registration and certification of medical devices in various countries or regions (such as FDA 510k, EU CE certification, Canadian cmdcas certification, Australian TGA certification, CFDA registration, etc.), medical device quality system review (such as qsr820 inspection in the United States, GMP of medical devices in China (including reagents), GMP of Japan, GMP of Brazil, ISO13485, etc.); It can also provide you with special training services such as medical device risk management, software validation, sterilization validation, clinical evaluation, usability validation, etc.

The consultant and expert team of Zhuoyuan Tiancheng company has working experience in senior management positions and professional background of certification audit in large and medium-sized medical device manufacturing enterprises. They are familiar with the operation mode and industry characteristics of medical device manufacturing enterprises, and are proficient in the laws and regulations, product standards, standards of medical devices in European Union, the United States, Canada, Australia, Japan, Brazil and China Technical specifications have strong advantages in law interpretation, standard understanding, product testing, document writing, product improvement, etc.