DIN EN ISO 13485 : 2016現行
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
出版：German Institute for Standardisation (Deutsches Institut für Normung)
專家解讀視頻
基本信息
標準編號： DIN EN ISO 13485 : 2016
標準類別：Standard
出版單位：German Institute for Standardisation (Deutsches Institut für Normung)
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.
