
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
出版:Netherlands Standards

专家解读视频
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.