Core Viewpoint - The company, Gaoshi Medical (02407), has announced that its subsidiary, Shenzhen Gaoshi Technology Co., Ltd., has officially obtained ISO13485:2016/EN ISO13485:2016 medical device quality management system certification from DEKRA, which covers the entire process of design, development, production, and sales of its products [1] Group 1: Certification Details - The certification encompasses the eye electrophysiological diagnostic system, corneal contact lens, and phacoemulsification vitreous cutting system collection box [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] - The certification is recognized by major global medical device regulatory bodies, including China's NMPA, the EU's CE, and the US FDA, serving as a core compliance basis [1] Group 3: Implications for the Company - The acquisition of this important qualification represents a significant achievement in the company's quality management system development [1] - It lays a solid foundation for the company to continuously expand into international markets [1]

Core Viewpoint - The company, GaoShi Medical (02407), has received ISO 13485:2016/EN ISO 13485:2016 certification from DEKRA, indicating compliance with international quality management standards for medical devices [1] Group 1: Certification Details - The certification covers the entire process of design, development, production, and sales of the company's 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 ISO 13485 - ISO 13485 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 is recognized by global medical device regulatory bodies such as China's NMPA, the EU's CE, and the US FDA, ensuring that products meet regulatory requirements and are subject to 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, laying a solid foundation for the company to expand into international markets [1]

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]

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 ...

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