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Good News | YZY MED Is Certified With ISO13485


YZY MED Successfully Passed ISO13485 Certification

Congratulations! YZY MED has successfully passed the ISO 13485:2016 medical device quality management system certification and obtain the certificate, which covers the design and manufacture of related reagents and devices, including pharmacogenomicsPGxand tumor targeting companion diagnostic(CDx) PCR kits, FISH devices and probes, CTCBIOPSY® circulating tumor cells autoanalyzer and chemiluminescence product line.

ISO13485 is one of the most authoritative international quality system standards in the medical device industry, and is an independent international standard developed by the International Organization for Standardization (ISO) and applicable to the medical device industry. ISO13485 is an increase in the special requirements of the medical deviceindustry on the basis of ISO9000, and more stringent requirements are put forward for product identification and process control. The standard focuses on the safety and effectiveness of medical devices, emphasizing that the medical devices provided by the organization should meet customer requirements and regulatory requirements, and has been highly valued and widely recognized by the global medical device industry, regulatory authorities and society.

This approval is a comprehensive certification of YZY MED's products based on individualized diagnosis and treatment strategies from research and development, production to sales, which means that our products are in line with the international quality management system.

YZY MED will continue to strictly follow the ISO 13485 quality management system standard, continuously improve the quality management level of the company, provide high-quality products and services, ensure the quality of products and services, and benefit more patients around the world with high-quality medical products.