ONORM EN ISO 13485-2007 标准详情
- 标准号:ONORM EN ISO 13485-2007
- 中文标题:医疗器械 - 质量管理体系 - 要求出于监管目的
- 英文标题:Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes
- 标准类别:奥地利国家标准ONORM
- 发布日期:
Describes the 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 m
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