An ISO 13485 certificate is essential for businesses as it provides a framework for an effective quality management system. The standard is based on the Plan-Do-Check-Act model and is designed to help organizations continually improve their quality management systems. It covers all aspects of the design and production of medical devices, from initial concept to final delivery.

ISO 13485 certification demonstrates to customers, regulators, and other stakeholders that an organization is committed to quality and safety. It can also help organizations to win business, as many tend to prefer working with suppliers who have an ISO 13485 certificate.