BSI荷兰(2797)作为全球领先的欧盟公告机构，具备欧盟医疗器械法规(MDR)和体外诊断法规(IVDR)全范围认证资质授权。我们通过提供一系列灵活的产品评审服务，对您的医疗器械和体外诊断医疗器械(IVD)进行评审，评估产品是否符合欧盟法规，为您提供将产品推向市场的有效途径。
CE认证是医疗器械制造商对其产品符合所有相关欧盟医疗器械法规的通用安全和性能要求(GSPR)的声明。
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