9/27/2023 0 Comments Iso 13485 2016 pdf free download![]() ![]() This International Standard can also be used by suppliers or external parties that provide product, including 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 (e.g. This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Most recent SS-EN ISO 13485:2016/AC:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) (Swedish Standard)
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