![]() ![]() The list below represents the main processes and procedures required by the ISO 13485:2016. ![]() It is thus the basis for companies that are in the field of medical technology. ISO 13485:2016 can also be used by suppliers or external parties that provide products, such as quality management system-related services to such organizations. 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. ![]() ISO 13485:2016 specifies requirements for a quality management system of an organization that needs to demonstrate its ability to provide medical devices and related services and consistently meet customer and applicable regulatory requirements.
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