EasyMed Aura (Shenzhen) Medical Co., Ltd. officially secured ISO 13485 Medical Device Quality Management System Certification in April 2026. This milestone accreditation validates that the company has implemented a standardized end-to-end quality management system aligned with global regulatory requirements, laying a solid foundation for market access and commercial expansion across Europe, the United States and other mainstream global markets.

Production Capacity & Quality Assurance System

The company's Phase I manufacturing base covers over 5,000 square meters, featuring a Class 10,000 cleanroom constructed in full compliance with the latest domestic and international GMP and regulatory standards, supported by a complete set of professional production and testing equipment. EasyMed Aura currently boasts a team of more than 150 employees, among which professionals specializing in product registration, quality management and process R&D account for over 30% of the total workforce. This elite talent structure enables rigorous full-lifecycle quality control for high-risk, high-value interventional medical devices.

In parallel, the company has built an experienced commercial team with profound expertise in the interventional device industry, fully equipping the enterprise for official product launches and global market distribution.