Core Viewpoint - The company, Gaoshi Medical (02407), has announced that its subsidiary, Gaoshi Tailiang Medical Technology Co., Ltd., has officially received ISO13485:2016/EN ISO13485:2016 medical device quality management system certification from DEKRA, indicating compliance with international standards in quality management for medical devices [1] Group 1: Certification Details - The certification covers the entire process of design, development, production, and sales of intraocular lenses used for treating cataracts and presbyopia, along with their associated implantation systems [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] - Achieving this certification signifies that the company has established a quality management system that meets regulatory requirements and is committed to continuous improvement [1] Group 3: Strategic Implications - The acquisition of this important qualification demonstrates the company's determination to enhance its quality management system and indicates that it has reached international standards in medical device quality management, risk control, and compliance operations [1] - This certification lays a solid foundation for the company to further expand into international markets [1]
高视医疗：高视泰靓获得医疗器械质量管理体系国际认证证书