遵守ISO 13485:2016！这是ANSI/AAMI/ISO标准13485:2016医疗器械-质量管理体系-监管要求ISO 13485的检查表。本标准是所有医疗器械生产商的要求。该标准在文件要求方面比ISO 9001更进一步；这代表着观念上的重大转变，成为医疗器械的“独立”质量体系标准。该清单通过提供易于使用的产品证据清单来澄清合规性所需的内容，该清单将帮助任何组织满足这一重要标准的要求。本产品提供4小时免费咨询。SEPT将在购买后60天内回答有关标准或检查表的任何问题。新订购“自解压文件格式”选项，以在可编辑的Microsoft Word文档中获取此产品！

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