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

專家解讀視頻
基本信息
標準編號: NEN EN ISO 13485 : 2016 C11 2017
標準類別:Standard
出版單位:Netherlands Standards
標準頁數:0
標準簡介
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.