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NEN EN ISO 13485 : 2016 C11 2017现行

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES

出版:Netherlands Standards

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基本信息
标准编号: NEN EN ISO 13485 : 2016 C11 2017
标准类别:Standard
出版单位:Netherlands Standards
标准页数:0
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.

等同采用的国际标准

ISO 13485 : 2016 - Identical

EN ISO 13485 : 2016 COR 2018 - Identical