ISO 13485-2016 标准详情
- 标准号:ISO 13485-2016
- 中文标题:医疗器械 质量管理体系 用于法规的要求
- 英文标题:Medical devices -- Quality management systems -- Requirements for regulatory purposes
- 标准类别:国际标准化组织ISO
- 发布日期:2016-02-25
ISO 13485:2016 specifies 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. Such
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