Certification in accordance with ISO 13485 means that an organization is able to provide medical devices and related services that consistently comply with their customer and regulatory requirements.
Organizations may be involved in one or more stages of the life cycle, including the design and development, production, storage and distribution, installation and maintenance of a medical device, and the design and development or delivery of associated activities (technical support, for example).
ISO 13485 can also be used by providers and external parties that supply products, including services related to these organizations’ quality management systems.
Under ISO 9000 standards, guidelines aimed at the manufacture of Medical Devices were developed, including sector-specific requirements.
Consequently, certification in accordance with ISO 13485 aims to facilitate the implementation of regulations and community directives.