ISO 13485 is a quality management system standard created specifically for medical devices and equipment. This International Standard establishes the criteria for an organization's QMS to consistently deliver high-quality medical products. It allows organizations to monitor, maintain, control and minimize errors and waste. It helps companies deliver high-quality medical equipment that consistently meets customer needs. In addition, the ISO 13485 standard ensures that companies comply with applicable legal requirements. certificación ISO 13485 en Argentina