About ISO 13485

ISO 13485:2015 is an international standard that represents the need for a comprehensive quality management system for the design and manufacture of medical devices. While it conforms to industry quality system expectations and regulatory requirements, an organization is not required to actively manufacture medical devices or their components for certification to this standard.

ISO 13485:2015 applies to the design, development, production, installation and maintenance of medical devices. Compliance is a measure of your ability to meet customer and legal needs. ISO 13485 is based on the ISO 9001:2015 procedural model approach and is a management system standard specially developed for the manufacturing of medical devices.

Its main objective is to facilitate harmonization of regulatory requirements for medical devices. EN ISO 13485:2015 certification granted by the International Organization for Standardization, the world's largest developer and publisher of global quality and safety standards. This certification describes the specific requirements to establish and run a structured quality management system for medical devices in all areas from development to distribution.

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