I.S. EN ISO 13485:2016/A11:2021现行
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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基本信息
标准编号： I.S. EN ISO 13485:2016/A11:2021
标准类别：Standard
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标准页数：0
标准简介
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.
