The company is located in the Yangzhou Health and Medical Industry Park, Touqiao Town, Guangling District, Yangzhou City, a historic and cultural city. This place is adjacent to the high-grade highway developed along the Yangtze River, with convenient water and land transportation, beautiful natural scenery, and outstanding people. The company's factory is divided into office area, production area, and inspection area. The 100000 level purification plant is designed and constructed in accordance with the drug GMP standards. The cleanliness of the purification workshop in the inspection area has reached Class 10000, and various production equipment and inspection and testing instruments are fully equipped, which can meet the requirements for the production and inspection of sterile medical devices. The company attaches great importance to the construction of a talent team in new product research and development, production management, and quality control, following the quality policy of "complying with laws and regulations to ensure product safety and effectiveness; emphasizing technology to ensure reliable and trustworthy quality; strict management to ensure continuous improvement of the system", constantly improving itself, and meeting customer expectations. Adhering to the business development philosophy of "harmonious development of society, enterprises, and employees", we are committed to developing into a well-known technology enterprise in the medical device industry in China.
        The company has established a version A quality system document in accordance with GB/T 19001:2016 idt ISO 9001:2015 "Quality Management System Requirements", GB/T42061-2022 idt ISO 13485:2016 (E) "Medical Device Quality Management System Requirements for Regulatory Purposes", "Regulations on the Supervision and Administration of Medical Devices", "Medical Device Production Quality Management Specification", "Appendix to the Medical Device Production Quality Management Specification for Sterile Medical Devices", "Guiding Principles for On site Inspection of Sterile Medical Devices in the Medical Device Production Quality Management Specification", "Appendix to the Medical Device Production Quality Management Specification for Implantable Medical Devices", "Guiding Principles for On site Inspection of Implantable Medical Devices in the Medical Device Production Quality Management Specification" and other relevant regulatory requirements, combined with the specific situation of the enterprise, and has maintained and operated the quality system document. Management system. (You can contact us to view detailed certificates)
        This manual is issued by the General Manager and sets out the company's quality policy and quality objectives. It is a guiding document for implementing and maintaining the system, reflecting the quality management content and requirements of our company in product development, production, and business activities. It is a commitment to quality assurance to all customers.