DIN EN ISO 13485 E : 2016现行
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
出版：German Institute for Standardisation (Deutsches Institut für Normung)
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基本信息
标准编号： DIN EN ISO 13485 E : 2016
标准类别：Standard
出版单位：German Institute for Standardisation (Deutsches Institut für Normung)
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.
本标准替代的旧标准
