Core Viewpoint - The company has received ISO13485:2016 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, covering the entire process of design, development, production, and sales of intraocular lenses for cataract and presbyopia patients [1] - ISO13485 is recognized by global regulatory bodies such as China's NMPA, EU's CE, and the US FDA, focusing on patient-centered risk management and quality control throughout the product lifecycle [1] Group 2: Implications for the Company - The achievement of 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] - This important qualification lays a solid foundation for the company to further expand into international markets [1]
高视医疗(02407.HK)附属高视泰靓获得医疗器械质量管理体系国际认证证书