certificación ISO 13485 demonstrates that an organization has implemented a Quality Management System (QMS) for medical devices in accordance with internationally recognized ISO 13485 requirements. It helps ensure regulatory compliance, improve product quality, strengthen risk management, and maintain consistent manufacturing and documentation processes. certificación ISO 13485 enhances customer confidence, supports access to international markets, and promotes continual improvement in quality management practices. It is ideal for medical device manufacturers, suppliers, distributors, and service providers seeking to deliver safe, reliable, and compliant medical devices while meeting global regulatory requirements.