DIN EN ISO 13485-2007 标准详情
- 标准号:DIN EN ISO 13485-2007
- 中文标题:医疗装置.质量管理体系.调整要求
- 英文标题:medical devices - quality management systems - requirements for regulatory purposes (iso 13485:2003); german version en iso 13485:2003+ac:2007
- 标准类别:德国标准
- 发布日期:2007-10-01
1.1 GeneralThis International Standard specifies requirements for a quality management system where an organizationneeds to demonstrate its ability to provide medical devices and related services that consistently meetcustomer requirements and regul
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