ISO 13485:2016 certification

ISO 13485:2016 sets out criteria for a quality control program where a company needs to demonstrate the ability to provide medical devices and related services that regularly meet consumer and regulatory requirements applicable. Such organizations may be involved in one or more stages of the life-cycle, including design and development, production, storage and delivery, installation or maintenance of a medical device, and the design and development or provision of related activities (e.g. technical assistance). ISO 13485:2016 can also be used by suppliers or external parties providing the product to these organizations, including services relevant to the quality management system.
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