SANS 13485 : 1ED 2004(R2011)现行
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
出版：South African Bureau of Standards
专家解读视频
基本信息
标准编号： SANS 13485 : 1ED 2004(R2011)
标准类别：Standard
出版单位：South African Bureau of 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 requirements and regulatory requirements applicable to medical devices and related services, and aims to facilitate harmonized medical device regulatory requirements for quality management systems.
等同采用的国际标准
ISO 13485 : 2016 - Identical
