Core Viewpoint - The company, Gaoshi Medical (02407), has announced that its subsidiary, Shenzhen Gaoshi Technology Co., Ltd., has officially obtained ISO13485:2016/EN ISO13485:2016 medical device quality management system certification from DEKRA, which covers the entire process of design, development, production, and sales of its products [1] Group 1: Certification Details - The certification encompasses the eye electrophysiological diagnostic system, corneal contact lens, and phacoemulsification vitreous cutting system collection box [1] - DEKRA, established in 1925, is a globally recognized independent non-listed professional inspection, testing, and certification organization [1] Group 2: Importance of ISO13485 - ISO13485 is a specialized quality management system standard for the medical device industry, focusing on patient-centered risk management and comprehensive quality control throughout the product lifecycle [1] - The certification is recognized by major global medical device regulatory bodies, including China's NMPA, the EU's CE, and the US FDA, serving as a core compliance basis [1] Group 3: Implications for the Company - The acquisition of this important qualification represents a significant achievement in the company's quality management system development [1] - It lays a solid foundation for the company to continuously expand into international markets [1]
高视医疗附属获得医疗器械质量管理体系国际认证证书