Core Viewpoint - The company, Gaoshi Medical (02407.HK), has officially obtained ISO13485:2016/ENISO13485:2016 certification for its subsidiary, Shenzhen Gaoshi Technology Co., Ltd., which enhances its quality management system for medical devices [1] Group 1: Certification Details - The certification covers the entire process of design, development, production, and sales of ophthalmic electrophysiological diagnostic systems, corneal contact caps, and phacoemulsification vitreous cutting surgical system collection boxes [1] - DEKRA, established in 1925, is a leading independent non-listed professional inspection, testing, and certification organization with a wide industry coverage [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 signifies that the company has established a quality management system that meets regulatory requirements and ensures continuous improvement [1] Group 3: Strategic Implications - The acquisition of this important qualification represents a significant achievement in the company's quality management system development [1] - This certification lays a solid foundation for the company to continuously expand into international markets [1]
高视医疗(02407.HK)：高视科技获医疗器械质量管理体系国际认证证书