• ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type.

• Organizations which are involved in one or more stages of the life-cycle of medical devices, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities.

• Can be used by suppliers or external parties that provide medical devices, including quality management system-related services to such organizations.