Pass ISO 13485 medical device quality management system certification in 2025
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 in countries around the world, including the United States and the European Union. Its regulations and requirements have become the benchmark for GMP, MDSAP in various countries, and EU medical device regulations in regulating medical device quality systems. Through important activities such as management review and internal audit, we can ensure that the quality management system of medical device manufacturers can continue to meet the requirements of ISO 13485 and enhance the key to the quality system's compliance with regulatory requirements.
The company passed the ISO 13485 medical device quality management system certification in January 2025, 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.
