ISO 13485是国际标准化组织(ISO)发布的医疗器械行业专用质量管理体系标准,聚焦“以患者为中心”的风险管理与全流程质量控制,是全球医疗器械监管机构(如中国NMPA、欧盟CE、美国FDA等)认可的核心合规性依据。通过该认证,意味着企业建立了覆盖设计开发、生产、检验、售后等产品全生命周期的质量管理体系,确保产品符合法规要求并持续改进。
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