Recently, Dongguan Zeyuan Energy Co., Ltd. (Shenzhen Bak Technology Co., Ltd. ) has achieved a significant qualification milestone. The company has successfully passed the comprehensive audit by SGS, the world-renowned authoritative certification body, and obtained the ISO13485:2016 Medical Devices Quality Management System Certificate.

 

 

 

ISO13485:2016 is an international quality management standard exclusively for the medical device industry, focusing on risk control, process standardization, quality traceability and regulatory compliance throughout the entire life cycle of medical devices. It is a core qualification for global medical industry chain procurement, cooperation and market access. With audit standards much stricter than general quality management systems, it imposes extremely rigorous requirements on enterprise R&D processes, production environment, quality control, document systems and supply chain management.

 

This certification was independently audited by SGS United Kingdom Ltd. After multiple on-site inspections, system document reviews, process verification and compliance assessments, Zeyuan Energy's (Shenzhen Bak Technology) quality management system, manufacturing capacity and medical-grade product control level fully comply with the requirements of ISO13485:2016 and global medical regulations, which fully confirms the company's professional strength and compliance capability in the field of medical-purpose lithium batteries.

 

 

The acquisition of this qualification is not only an authoritative recognition of Zeyuan Energy's (Shenzhen Bak Technology) product quality and management system, but also lays a solid compliance foundation for the company to expand the global medical device market, serve high-end medical equipment customers and participate in international medical supply chain cooperation.

 

Adhering to the business philosophy of "Safety First, Quality Priority, Compliance as the Principle", Zeyuan Energy (Shenzhen Bak Technology) focuses on the R&D and manufacturing of medical-grade lithium battery packs. In the future, the company will take the ISO13485 system as the benchmark, continuously optimize quality management processes, deepen technological innovation and product upgrading, strictly control the safety, stability and reliability of each product, provide global customers with more competitive power solutions for medical devices, and empower the development of the medical and health industry with professional quality.