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      <description><![CDATA[在IVD注册的世界里，最可怕的不是看得见的波动，而是那个看不见的、让所有结果都朝着错误方向稳步前进的“偏移”。]]></description>
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      <author>诊断科学</author>
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      <pubDate>Wed, 15 Apr 2026 06:28:12 +0000</pubDate>
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      <title>IVD人必看！随机误差与系统误差的核心区别及临床意义解析</title>
      <link>https://www.iivd.net/article-42581-1.html</link>
      <description><![CDATA[如何科学评估并控制这些误差？]]></description>
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      <author>诊断科学</author>
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      <pubDate>Thu, 11 Sep 2025 08:03:00 +0000</pubDate>
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      <title>以呼吸道三联为例，探讨IVD多项联检产品临床试验应该如何统计</title>
      <link>https://www.iivd.net/article-42560-1.html</link>
      <description><![CDATA[基于法规与多年的实践经验，我来为大家梳理一个清晰的解决方案。]]></description>
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      <author>诊断科学</author>
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      <pubDate>Wed, 10 Sep 2025 07:57:35 +0000</pubDate>
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      <title>8月浙江IVD赛道大爆发！32款产品获批上市，这些企业表现亮眼</title>
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      <description><![CDATA[8月，32款IVD产品获批上市]]></description>
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      <author>诊断科学</author>
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      <pubDate>Fri, 05 Sep 2025 07:15:20 +0000</pubDate>
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      <title>​​BioMérieux呼吸道检测新突破！Mini SpotFire鼻拭子版获FDA批准，15分钟测5类病原体​</title>
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      <description><![CDATA[新增标本类型的测试将于2025年第三季度在美国上市。]]></description>
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      <author>诊断科学</author>
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      <pubDate>Thu, 21 Aug 2025 08:06:46 +0000</pubDate>
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      <link>https://www.iivd.net/article-42160-1.html</link>
      <description><![CDATA[从样本到报告，全程无人操作]]></description>
      <category>开发与验证</category>
      <author>诊断科学</author>
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      <pubDate>Tue, 05 Aug 2025 10:00:00 +0000</pubDate>
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      <link>https://www.iivd.net/article-42046-1.html</link>
      <description><![CDATA[这一决定并非草率之举，而是基于长达十余年的科学研究和大规模临床数据验证。]]></description>
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      <author>诊断科学</author>
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      <pubDate>Fri, 25 Jul 2025 07:33:00 +0000</pubDate>
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      <link>https://www.iivd.net/article-42031-1.html</link>
      <description><![CDATA[从“拿来主义”到自主进化]]></description>
      <category>开发与验证</category>
      <author>诊断科学</author>
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      <pubDate>Thu, 24 Jul 2025 07:00:10 +0000</pubDate>
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      <link>https://www.iivd.net/article-41880-1.html</link>
      <description><![CDATA[两类证明覆盖全场景，监管更精细化]]></description>
      <category>开发与验证</category>
      <author>诊断科学</author>
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      <pubDate>Fri, 11 Jul 2025 08:00:08 +0000</pubDate>
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      <title>从“跟跑”到“领跑”，国家药监局发布十项举措，高端医疗器械创新迎来“全生命周期”政策红利</title>
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      <description><![CDATA[高端医疗器械成为新质生产力核心赛道]]></description>
      <category>开发与验证</category>
      <author>诊断科学</author>
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      <pubDate>Wed, 09 Jul 2025 07:30:00 +0000</pubDate>
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      <link>https://www.iivd.net/article-41692-1.html</link>
      <description><![CDATA[本文将深入解读该案例，提炼出对企业注册申报有借鉴意义的关键要素。]]></description>
      <category>开发与验证</category>
      <author>沙糖桔</author>
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      <pubDate>Fri, 27 Jun 2025 03:40:00 +0000</pubDate>
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      <link>https://www.iivd.net/article-41482-1.html</link>
      <description><![CDATA[该设备可替代Verigene系统。]]></description>
      <category>开发与验证</category>
      <author>诊断科学</author>
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      <pubDate>Tue, 10 Jun 2025 08:09:11 +0000</pubDate>
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      <pubDate>Thu, 05 Jun 2025 06:56:00 +0000</pubDate>
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