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NSAI/ISO Guide to ISO 13485:2016现行

Medical Devices Advice from ISO/TC 210 a practical guide

出版:National Standards Authority of Ireland

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基本信息
标准编号: NSAI/ISO Guide to ISO 13485:2016
发布时间:2017/11/17 0:00:00
标准类别:Handbook
出版单位:National Standards Authority of Ireland
标准页数:224
标准简介

Defines 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.