LARGE Lithium (Dongguan LARGE Electronics Co., Ltd.) has officially obtained the ISO 13485:2016 Medical Device Quality Management System Certification. The certified scope covers the design and manufacturing of lithium batteries for active (non-implantable) medical devices.
This milestone signifies that LARGE’s quality management system is fully aligned with international medical standards and marks a critical step toward entering the global medical device market, further strengthening the company’s core competitiveness.
Internationally Recognized Medical Quality Standard
ISO 13485:2016 is an authoritative quality management standard for the medical device industry, placing strong emphasis on full life-cycle risk management and product traceability.
As a National-Level Specialized and Sophisticated “Little Giant” Enterprise and High-Tech Enterprise with 23 years of expertise in lithium battery innovation, LARGE has consistently focused on specialized market segments and deep technological development.
Adhering to stringent medical-industry process controls and manufacturing standards, LARGE operates a comprehensive testing system with 109 professional test capabilities to ensure product safety and reliability.
Its self-developed low-temperature medical lithium batteries maintain over 85% of rated capacity discharge stability at -40°C, ranking among the leading performance levels in the industry.
A Strategic Milestone in Medical Sector Expansion
Obtaining ISO 13485 certification represents a key milestone in LARGE’s strategic expansion into the medical field.
Moving forward, the company will continue to uphold its philosophy of “Custom Lithium Batteries · Safe & Fast”, leveraging 84 patented technologies and a robust quality control system to provide global medical equipment manufacturers with safer, more efficient integrated energy solutions.
Through precision-driven technology, LARGE is committed to safeguarding life and health while advancing the high-quality development of the medical battery industry.
