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ISO13485认证-13485-ISO13485-医疗器械质量管理体系认证
2003标准的全称是 医疗器械 质量管理体系 用于法规的要求 Medical device-Quality management system-requirements for regulatory。 目前美国、加拿大和欧洲普遍以ISO 9001,、EN 46001或 ISO13485. ISO/DIS 13485对ISO 9001 2000标准进行重大删减. ISO/DIS 13485标准对ISO 9001 2000标准的修改. 13485认证免费咨询电话:400-633-9001 电子邮箱 a9001@126.com.
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