SANS 13485 : 1ED 2004(R2011)現行
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
出版：South African Bureau of Standards
專家解讀視頻
基本信息
標準編號： SANS 13485 : 1ED 2004(R2011)
標準類別：Standard
出版單位：South African Bureau of 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 requirements and regulatory requirements applicable to medical devices and related services, and aims to facilitate harmonized medical device regulatory requirements for quality management systems.
等同采用的國際標準
ISO 13485 : 2016 - Identical
