New certificate ISO13485

Our factory obtained ISO13485 certification in May 2023.  ISO 13485 is an international standard for the quality management system of medical devices, providing quality management requirements and guidelines for medical device manufacturers and suppliers. Its structure and content are based on the ISO 9001 quality management system but with a focus on the regulations and standards specific to medical devices. This certification is one of the necessary conditions for international medical device manufacturers to enter the global medical device market.