ISO 13485

ISO 13485 is an internationally recognized standard that specifies requirements for a quality management system (QMS) specifically for organizations involved in the design, development, production, installation, and servicing of medical devices. It emphasizes the importance of meeting regulatory requirements and ensuring consistent product quality to enhance customer satisfaction and safety. Adherence to ISO 13485 facilitates continuous improvement and risk management throughout the product lifecycle, thereby supporting innovation and compliance in the medical device setor.