EN ISO 13485 : 2016 COR 2018現行
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
出版：Comite Europeen de Normalisation
專家解讀視頻
基本信息
標準編號： EN ISO 13485 : 2016 COR 2018
標準類別：Standard
出版單位：Comite Europeen de Normalisation
標準頁數：0
標準簡介
Provides 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.
