Recently, Dongguan Zeyuan Energy Co., Ltd. (Shenzhen Bak Technology Co., Ltd. ) has officially been awarded the ISO13485:2016 Medical Devices Quality Management System Certificate issued by SGS, the world’s leading inspection, verification, testing and certification organization. The certification scope covers the design and manufacture of lithium battery packs for active non-implantable medical devices, with a validity period from January 20, 2026 to January 19, 2029.
ISO13485 is the globally recognized top-level quality management system standard for the medical device industry, which strictly regulates the entire process of product R&D, production, quality control and traceability, serving as a core qualification for accessing the global medical device market. The successful certification by SGS marks that Zeyuan Energy (Shenzhen Bak Technology) has fully met the international medical device industry standards in the design, R&D, manufacturing, quality control and compliance management of medical-grade lithium battery products, with a mature, stable and reliable management system.
In the future, Zeyuan Energy (Shenzhen Bak Technology) will continue to focus on the medical energy storage and medical device power supply sector with high standards and strict requirements, adhere to the bottom line of quality, strengthen technological innovation and compliance system construction, and provide global medical device customers with safer, more stable and compliant high-performance lithium battery pack solutions, supporting the high-quality development of the medical industry.