The ISO 13485:2016 standard outlines the requirements for companies in the medical device industry to follow for both medical device development and quality management systems (QMS).

Certification to the ISO 13485 standard indicates that an organization in the medical device industry has a compliant Quality Management System. This applies not only to medical device manufacturers but also supporting organizations such as subcontractors, suppliers, consulting firms, and European Authorized Representatives.

The International Organization for Standardization (ISO), the world’s largest developer and publisher of worldwide quality and safety standards, awards the EN ISO 13485:2016 certification. This certification provides specific guidelines for establishing and implementing a structured quality management system for medical devices across all areas, from development to delivery.

The benefits of obtaining an ISO 13485 certificate include the following:

• Optimization of costs: This includes reducing operating costs, minimizing costs associated with nonconforming products, and savings on raw materials, energy, and other resources.
• Simplifying the procedure for conformity attestation to meet the requirements of EU directives and corresponding government orders.
• Improving public trust and the trust of public monitoring bodies in the medical device manufacturer.
• Attesting to the efficiency and effectiveness of the established quality management system by an independent third party.
• Guaranteeing production procedure stability, which results in steady and high-quality products and services being supplied to customers.