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Jiangsu Kebang Bioscience Co., Ltd. was established in August 2018. Covering an area of 20,000 square meters with a building area of over 20,000 square meters, it is a technology enterprise with strong capabilities in the research and development, manufacturing, and sales of medical device products. The company's main products include: disposable ligation clips, disposable specimen collection bags, disposable cannula puncture devices, recombinant collagen dressings, extracorporeal circulation tubing for blood purification devices, single-use injection kits, single-use injection needles, and single-use sterile dermal rollers—among other medical device products.

The company is located within the Yangzhou Health and Medical Industry Park in Touqiao Town, Guangling District, Yangzhou—a city renowned for its rich history and culture. The site is conveniently situated adjacent to a high-grade highway along the Yangtze River, offering excellent water and land transportation links. It boasts picturesque natural scenery and is blessed with a remarkable blend of talented individuals and auspicious spiritual energy. The company’s factory premises are divided into an office area, a production area, and an inspection area. Among these, the 100,000-level cleanroom facility was designed and constructed in accordance with pharmaceutical GMP standards. The inspection area’s cleanroom achieves a cleanliness level of 10,000 grade, and is fully equipped with various types of production equipment as well as inspection and testing instruments, ensuring that it can meet the stringent requirements for the manufacture and inspection of sterile medical devices. The company places great emphasis on building a strong team of professionals in new product R&D, production management, and quality control. Guided by the quality policy—“Comply with laws and regulations to ensure product safety and efficacy; prioritize technology to guarantee trustworthy and reliable quality; enforce rigorous management to ensure continuous improvement of our systems”—the company constantly strives for self-improvement and consistently meets customer expectations. Adhering to the business development philosophy of “harmonious growth among society, enterprise, and employees,” the company is committed to becoming a nationally recognized, technologically advanced enterprise in the medical device industry.

The company has established the Quality Management System Document, Version A, in compliance with the requirements of GB/T 19001:2016 idt ISO 9001:2015 “Quality Management Systems — Requirements,” GB/T 42061-2022 idt ISO 13485:2016(E) “Medical Device Quality Management Systems — Requirements for Regulatory Purposes,” the “Regulations on the Supervision and Administration of Medical Devices,” the “Good Manufacturing Practice for Medical Devices,” the “Appendix to the Good Manufacturing Practice for Medical Devices—Sterile Medical Devices,” the “Guiding Principles for On-site Inspections of Sterile Medical Devices under the Good Manufacturing Practice for Medical Devices,” as well as the “Appendix to the Good Manufacturing Practice for Medical Devices—Implantable Medical Devices” and the “Guiding Principles for On-site Inspections of Implantable Medical Devices under the Good Manufacturing Practice for Medical Devices.” The company has also maintained and operated its quality management system in alignment with its specific circumstances.

This manual, issued by the General Manager, defines the company’s quality policy and quality objectives. It serves as a guiding document for implementing and maintaining the system, reflecting the content and requirements of quality management in our company’s product development, production, and business operations. It also constitutes our commitment to providing quality assurance to all customers.