DS EN ISO 13485 : 2016 COR 2016现行
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
出版：Danish Standards
专家解读视频
基本信息
标准编号： DS EN ISO 13485 : 2016 COR 2016
标准类别：Standard
出版单位：Danish 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
ISO 13485 : 2016 - Identical
EN ISO 13485 : 2016 COR 2018 - Identical
