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]