Core Viewpoint - The company has received ISO 13485:2016/EN ISO 13485:2016 certification for its medical device quality management system, indicating compliance with international standards in the medical device industry [1] Group 1: Certification Details - The certification was issued by DEKRA, a leading independent certification body established in 1925, covering a wide range of industry sectors [1] - The certification encompasses the entire process of design, development, production, and sales of intraocular lenses for cataract and presbyopia patients [1] Group 2: Importance of Certification - ISO 13485 is recognized by global medical device regulatory bodies such as China's NMPA, the EU's CE, and the US FDA, focusing on patient-centered risk management and quality control throughout the product lifecycle [1] - Achieving this certification demonstrates the company's commitment to enhancing its quality management system and signifies its capability in medical device quality management, risk control, and compliance operations at an international standard [1] Group 3: Market Implications - The acquisition of this important qualification lays a solid foundation for the company to further expand into international markets [1]
高视医疗(02407)：高视泰靓获得医疗器械质量管理体系国际认证证书