Core Viewpoint - Kangde (Shenzhen) Biotechnology Co., Ltd. has officially passed the ISO13485:2016 international certification for medical device quality management systems, indicating that the company's quality management capabilities in the research, production, and service of cancer detection in vitro diagnostic reagents have reached international standards, enabling the continuous provision of reliable products and services to global customers [1][3][4] Group 1 - ISO13485 certification is recognized as the "gold standard" in the medical device industry, covering the entire lifecycle of product design, production, storage, sales, and after-sales service, with an emphasis on risk control and traceability [3] - The World Health Organization states that approximately one-third of cancers can be completely prevented, one-third can be cured through early detection, and one-third can be managed with medical measures to prolong life and alleviate suffering, highlighting the importance of early cancer screening and diagnosis [3] - Effective and reliable early cancer detection in vitro diagnostic reagent technology addresses the clinical challenge of late-stage cancer diagnosis, where most patients are diagnosed at advanced stages, missing the optimal treatment window [3] Group 2 - The successful ISO13485 certification represents a significant milestone in establishing a comprehensive quality management system for Kangde (Shenzhen) Biotechnology Co., Ltd., marking an upgrade in the company's quality management level [4] - The certification serves as strong evidence of the company's adherence to international standards in research, production, and sales, ensuring product safety and effectiveness [4] - The company is committed to empowering the field of precision cancer diagnosis with high-quality technology and products, reflecting its mission and dedication to advancing human health [4]