A subsidiary of Gaoshi Medical (02407) obtained an international certification for medical device quality management systems

Zhitong Finance App News, Gaoshi Healthcare (02407) announced that the company's subsidiary Shenzhen Gaoshi Technology Co., Ltd. recently officially obtained the medical device quality management system certification (certificate number: 4932952) in accordance with ISO 13485:2016/EN ISO 13485:2016 issued by DEKRA. This certification covers the entire design, development, production and sales process of ocular electrophysiological diagnosis systems, corneal contact caps, and liquid collection boxes for ultra-breast hysterectomy systems.

DEKRA, founded in 1925, is the world's leading independent unlisted professional inspection, testing and certification agency, covering a wide range of industries.

ISO 13485 is a specific quality management system standard for the medical device industry issued by the International Organization for Standardization. It focuses on “patient-centered” risk management and full-process quality control, and is the core compliance basis approved by global medical device regulators (such as China NMPA, EU CE, US FDA, etc.). Passing this certification means that the company has established a quality management system covering the entire life cycle of products such as design and development, production, inspection, and after-sales to ensure that products meet regulatory requirements and continue to improve.

Obtaining this important qualification is another important achievement of the company in building a quality management system, and has laid a solid foundation for the company to continue to explore the international market.