Recently, the Company has been successfully certified by an international authoritative certification center in accordance with ISO 13485:2016 Medical Device Quality Management System and was awarded the quality management system certificate recognized by IAF. The certification covers the Company's diagnostic imaging products including YS-1100 and YS-1200, which marks that the Company has stepped into a standardized and scientific modern enterprise management track.

Zhe'an Healthcare ISO13485:2016 Quality Management System Certificate

The ISO 13485:2016 Medical Device Quality Management System certification is a recognition of our existing management system and product quality, which is complementary to the Company's consistent emphasis on providing customers with the most satisfactory service. Since its establishment, Zhe'an Healthcare has gradually built a strict and standardized production quality management system to carry out strict and standardized management on staff, machinery and equipment, materials, systems, production and working environment. Based on our excellent quality management system, we have successfully passed the preliminary examination and reexamination of ISO 13485:2016 Quality Management System Certification by third-party audit institutions, and obtained the ISO 13485:2016 Quality Management System Certification Certificate.

Zhe'an Healthcare ISO 13485:2016 Quality Management System Audit Site

Zhe'an Healthcare ISO 13485:2016 Quality Management System Audit Site

The ISO 13485:2016 Certification is a recognition and affirmation of the product development, production and quality management of Zhe'an Healthcare, and it is also a commendation for Zhe'an staff's continuous pursuit of excellence on the road of innovation. The ISO 13485:2016 Certification proved that under our quality assurance system, Zhe'an Healthcare can continue to provide high-quality products and services to meet the needs of medical device customers. It is not only a key step for Zhe'an Healthcare to take a development road of high specification and high standard in the field of medical device production and sales, but also our most solemn commitment on quality assurance to customers. The ISO 13485:2016 certification is of far-reaching significance to the improvement of the market competitiveness and brand influence, the long-term development of the Company and the realization of the corporate vision, and it is an important milestone in the development process of Zhe'an Healthcare.

Encouraged by this success, Zhe'an Healthcare will continue to rely on refined management as the basic guarantee, constantly improve internal control, provide customers with quality, safe and effective products, striving to achieve the goal of promoting corporate development while bearing social responsibilities, and make greater contributions to China's medical and health care cause!

About ISO 13485 Certification

ISO 13485,also called Medical devices — Quality management systems — Requirements for regulatory purposes), is an independent international standard developed by the International Organization for Standardization (ISO) for the medical device industry. The existing version of ISO 13485 was released on March 1, 2016.

ISO 13485 is a quality management system standard for medical device industry, and it is also the most authoritative international quality system standard for the medical device industry. ISO 13485 specifies special requirements for the medical device industry on the basis of ISO 9000 and states more stringent requirements for product identification, process control and other aspects.

ISO 13485 supports companies that manufacture or use medical products and services by helping them to reduce unanticipated risks. The equivalent standard of ISO 13485 for the medical device industry in China is YY/T0287:2017 Medical devices - Quality management systems - Requirements for regulatory purposes.

About Zhe'an Healthcare

Zhangjiagang Production Base

Shanghai Innovation Center

Suzhou Zhe'an Healthcare Co., Ltd. has long been focusing on the innovation development of digital dental diagnosis and treatment equipment and intelligent solutions. Since its establishment, according to the development demands of the medical industry, it has adhered to the advanced concepts in the medical device field and implemented its advanced technology. It has formulated a company development plan of "adhering to quality and continuous innovation", establishing core capabilities with technical advantages, and reengineering systems with talent advantages, and actively applying artificial intelligence technology to the field of dental medical devices.

The Company has strong technical force, advanced production equipment and complete testing means. It strictly implements management according to ISO13485 International Quality System Standard, and controls technology, quality and inspection in a strict way. It has built its own research and development, process and production teams. At the same time, the Company has been working with medical institutions and universities and other research institutes to develop various projects.

After long-term practice and innovation, Zhe'an Healthcare has successfully developed high-end dental chairside digital imaging equipment, dental digital imaging management system, dental digital cloud platform and other serialized products. The Company adopts advanced technologies in each step of the process and manufacturing, and makes all its products pass comprehensive quality testing, aiming to provide customers with advanced and overall dental digital solutions.