certificación ISO 13485 is an international standard designed for organizations involved in the medical device industry. It focuses on establishing a quality management system that ensures the safe design, development, production, and distribution of medical devices. Companies that obtain certificación ISO 13485 demonstrate their commitment to meeting regulatory requirements and maintaining high product quality. This certification helps businesses improve operational processes, manage risks effectively, and ensure product safety throughout the lifecycle. Many global markets require compliance with certificación ISO 13485, making it important for manufacturers seeking international opportunities while building trust with customers, healthcare providers, and regulatory authorities.