I.S. EN ISO 13485:2016/A11:2021現行
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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基本信息
標準編號： I.S. EN ISO 13485:2016/A11:2021
標準類別：Standard
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標準頁數：0
標準簡介
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.
