Recently, Dongguan Zeyuan Energy Co., Ltd.(Shenzhen Bak Technology Co., Ltd. ) has been officially awarded the ISO13485:2016 Quality Management System certification by SGS United Kingdom Ltd. This achievement signifies that the company has established a quality management system compliant with international medical device regulations for the design and manufacture of lithium battery packs used in active medical devices (non-implantable).

The certificate, numbered CN26/00000622, is valid from January 20, 2026, to January 19, 2029. During this period, our company will undergo ongoing surveillance audits by SGS to ensure continued compliance with the standard requirements.

ISO13485 is a widely recognized quality management system standard in the medical device industry, focusing on quality management and risk control throughout the lifecycle of medical devices. With this certification, Dongguan Zeyuan Energy Co., Ltd. (Shenzhen Bak Technology Co., Ltd. ) strengthens its professional standing in the medical energy sector, providing safer, more reliable, and compliant lithium battery solutions to its customers.

As an internationally recognized inspection, verification, testing, and certification organization, SGS grants certifications with high credibility and global acceptance. The successful certification not only demonstrates the strength of Dongguan Zeyuan Energy’s (Shenzhen Bak Technology Co., Ltd. ) quality management system but also marks a significant milestone in its continuous pursuit of excellence and commitment to industry responsibility.

Moving forward, Dongguan Zeyuan Energy Co., Ltd. (Shenzhen Bak Technology Co., Ltd. ) will continue to uphold the principle of “quality first, safety foremost,” constantly improving its products and services to contribute to the development of the global medical device industry.

For more information, please visit the company's website or contact sale1@bak-tech.com.