ISO 13485 defines the requirements for a quality management system by which an organization can demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
All requirements of ISO 13485 is specific to organizations providing medical devices, regardless of the type or size of the organization.