格隆汇12月1日丨高视医疗(02407.HK)宣布，公司附属公司深圳高视科技有限公司(「深圳高视科技」) 于近日正式获得由DEKRA签发的符合ISO13485：2016/ENISO13485：2016医疗器械质量管理体系认证 证书(证书编号：4932952)。此次认证全面覆盖了眼电生理诊断系统、角膜接触帽、超乳玻切手术系统 集液盒的设计、开发、生产及销售全流程。 ISO13485是国际标准化组织(「ISO」)发布的医疗器械行业专用质量管理体系标准，聚焦「以患者为中 心」的风险管理与全流程质量控制，是全球医疗器械监管机构(如中国NMPA、欧盟CE、美国FDA等)认 可的核心合规性依据。通过该认证，意味着企业建立了覆盖设计开发、生产、检验、售後等产品全生命 周期的质量管理体系，确保产品符合法规要求并持续改进。 本次重要资质的获得，是公司在质量管理体系建设上的又一重要成果，为公司持续开拓国际市场奠定了 坚实基础。 DEKRA，成立于1925年，为一家全球领先的独立非上市专业检验检测认证机构，覆盖广阔的行业领 域。 ...

Gaush Meditech Ltd 高視醫療科技有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 責 任 公 司 ） （股 份 代 號：2407） 自願公告 深圳高視科技獲得醫療器械質量管理體系國際認證證書 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 本公告由高視醫療科技有限公司（「本公司」，連同其附屬公司統稱「本集團」） 自願作出，以告知本公司股東及潛在投資者有關本集團的最新業務發展。 本 公 司 董 事（「董 事」）會（「董事會」）欣 然 宣 佈，本 公 司 附 屬 公 司 深 圳 高 視 科 技 有 限 公 司（「深圳高視科技」）於 近 日 正 式 獲 得 由DEKRA簽發的符合ISO 13485：2016/EN ISO 13485：2016醫療器械質量管理體系認證證書（證書編號： 4932952）。此次認證全面覆蓋了眼電生理診斷系統、角膜接觸帽、超乳玻切手 術系統集液盒的設計、開發、生產及銷售全流程。 DEKRA，成立於19 ...

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]

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]

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]