GAUSH MEDITECH (02407) announced that its subsidiary, Shenzhen Gaush Technology Co., Ltd., has recently received the ISO 13485:2016/EN ISO 13485:2016 Medical Device Quality Management System certification (Certificate No.: 4932952) issued by DEKRA. The certification comprehensively covers the design, development, production, and sales of ophthalmic electrophysiological diagnostic systems, corneal contact caps, and collection boxes for phacoemulsification and vitrectomy surgery systems.
DEKRA, established in 1925, is a globally leading independent, non-listed professional inspection, testing, and certification organization serving a wide range of industries. ISO 13485 is a specialized quality management system standard for the medical device industry issued by the International Organization for Standardization (ISO). It emphasizes patient-centered risk management and full-process quality control, serving as a core compliance benchmark recognized by global medical device regulatory authorities, including China's NMPA, the EU's CE, and the U.S. FDA.
Achieving this certification signifies that the company has established a quality management system covering the entire product lifecycle—from design and development to production, inspection, and after-sales service—ensuring compliance with regulatory requirements and continuous improvement. This milestone marks another significant achievement in the company's quality management system development and lays a solid foundation for its ongoing expansion into international markets.
