ANSI/AAMI/ISO 13485:2016(R2019)現行
Medical devices—Quality management systems— Requirements for regulatory purposes
出版：Association for the Advancement of Medical Instrumentation
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基本信息
標準編號： ANSI/AAMI/ISO 13485:2016(R2019)
標準類別：Standard
出版單位：Association for the Advancement of Medical Instrumentation
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.
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