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ISO 13485:2016 is the latest international standard for quality management systems in the medical device industry. This standard has been recognized by medical device regulatory authorities around the world, including the United States and the European Union. The regulations and requirements have become the benchmark for GMP, MDSAP in various countries, and the EU's device standards for medical device quality systems. Cross-cutting important activities such as management review and internal audit ensures that the quality management system capabilities of medical device industry personnel continue to meet the requirements of ISO 13485, which is the key to improving the quality system's compliance with regulatory requirements.

The company passed the ISO 13485 medical device quality management system certification in January 2024, which will help the company achieve compliance, improve product quality and safety, optimize internal processes, enhance market competitiveness and increase customer satisfaction, thereby achieving long-term sustainable business development.