<?xml version="1.0" encoding="utf-8"?>
<rss version="2.0">
  <channel>
    <title>小桔灯网 - 研发视野</title>
    <link>https://www.iivd.net/portal.php?mod=list&amp;catid=264</link>
    <description>Latest 20 articles of 研发视野</description>
    <copyright>Copyright(C) 小桔灯网</copyright>
    <generator>Discuz! Board by Discuz! Team</generator>
    <lastBuildDate>Thu, 18 Jun 2026 08:17:07 +0000</lastBuildDate>
    <ttl>60</ttl>
    <image>
      <url>https://www.iivd.net/static/image/common/logo_88_31.gif</url>
      <title>小桔灯网</title>
      <link>https://www.iivd.net/</link>
    </image>
    <item>
      <title>备案or注册？5分钟搞清你的IVD产品该走哪条路</title>
      <link>https://www.iivd.net/article-44569-1.html</link>
      <description><![CDATA[起步方向正，上市路才顺。]]></description>
      <category>研发视野</category>
      <author>诊断科学</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202604/09/154340ur79wx0x27hwyym7.jpg" length="987133" type="image/jpeg" />
      <pubDate>Thu, 09 Apr 2026 07:43:44 +0000</pubDate>
    </item>
    <item>
      <title>存量时代IVD的产品研发</title>
      <link>https://www.iivd.net/article-43603-1.html</link>
      <description><![CDATA[存量时代比单纯的速度和规模的优势，其意义有多少？]]></description>
      <category>研发视野</category>
      <author>药石漫谈</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202601/08/101800bgxgj04xzxog09ey.png" length="3445715" type="image/jpeg" />
      <pubDate>Thu, 08 Jan 2026 02:18:06 +0000</pubDate>
    </item>
    <item>
      <title>医疗器械注册证转让的变通路径</title>
      <link>https://www.iivd.net/article-43388-1.html</link>
      <description><![CDATA[“不直接转证，只转持有证的公司”]]></description>
      <category>研发视野</category>
      <author>IVD研发视野</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202512/17/104819vop71f2i5g7g1oe5.jpg" length="890517" type="image/jpeg" />
      <pubDate>Wed, 17 Dec 2025 02:49:09 +0000</pubDate>
    </item>
    <item>
      <title>二代测序RNA建库步骤和原理</title>
      <link>https://www.iivd.net/article-42903-1.html</link>
      <description><![CDATA[关注我们！]]></description>
      <category>研发视野</category>
      <author>PCR医学检验</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202510/20/133728xrv7zk5zrrzbyybn.jpg" length="123983" type="image/jpeg" />
      <pubDate>Mon, 20 Oct 2025 05:38:35 +0000</pubDate>
    </item>
    <item>
      <title>IVD人查询专利必看的20个网站</title>
      <link>https://www.iivd.net/article-42815-1.html</link>
      <description><![CDATA[收藏！]]></description>
      <category>研发视野</category>
      <author>IVD的地</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202510/13/093528qbdvmkdkwk5mb5qz.png" length="886" type="image/jpeg" />
      <pubDate>Mon, 13 Oct 2025 01:37:00 +0000</pubDate>
    </item>
    <item>
      <title>《体外诊断试剂变更注册审查指导原则》的重点</title>
      <link>https://www.iivd.net/article-41418-1.html</link>
      <description><![CDATA[有助于企业更好地理解变更注册的要求和流程，提高变更注册的效率和成功率。]]></description>
      <category>研发视野</category>
      <author>IVD研发视野</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202506/04/164430u4x93c58cxne4xnx.png" length="26771" type="image/jpeg" />
      <pubDate>Wed, 04 Jun 2025 08:44:36 +0000</pubDate>
    </item>
    <item>
      <title>如何选择IVD临床试验机构</title>
      <link>https://www.iivd.net/article-41278-1.html</link>
      <description><![CDATA[在三类IVD产品中，需要临床试验的项目占比93%。]]></description>
      <category>研发视野</category>
      <author>IVD研发视野</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202505/22/152923ip4llln4p8pljtl1.png" length="32368" type="image/jpeg" />
      <pubDate>Thu, 22 May 2025 07:27:00 +0000</pubDate>
    </item>
    <item>
      <title>《体外诊断试剂说明书编写指导原则（2023年修订版）》有哪些变化？ ...</title>
      <link>https://www.iivd.net/article-35017-1.html</link>
      <description><![CDATA[体外诊断试剂使用说明书（简称IFU）是一个产品的核心和必要组分]]></description>
      <category>研发视野</category>
      <author>IVD研发视野 | 作者：溜溜NONO</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202401/05/114149ybbxr2bez6zo2wbq.png" length="1740957" type="image/jpeg" />
      <pubDate>Fri, 05 Jan 2024 03:42:07 +0000</pubDate>
    </item>
    <item>
      <title>医疗器械GMP“设计变更控制”---分类的难点问题</title>
      <link>https://www.iivd.net/article-33647-1.html</link>
      <description><![CDATA[根据设计变更的影响程度，可分为重大变更、中等变更、微小变更；]]></description>
      <category>研发视野</category>
      <author>IVD研发视野 | 作者：溜溜NONO</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202309/01/161711kkwon1y2okwp2pn0.png" length="860553" type="image/jpeg" />
      <pubDate>Fri, 01 Sep 2023 08:17:00 +0000</pubDate>
    </item>
    <item>
      <title>“设计变更控制”---最不能轻举妄动的过程</title>
      <link>https://www.iivd.net/article-33451-1.html</link>
      <description><![CDATA[没有什么是不变的，唯一不变的是变化本身。]]></description>
      <category>研发视野</category>
      <author>IVD研发视野 | 作者：溜溜NONO</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202308/11/175101e33z1354vx352zr1.png" length="385542" type="image/jpeg" />
      <pubDate>Fri, 11 Aug 2023 09:51:05 +0000</pubDate>
    </item>
    <item>
      <title>医疗器械GMP的“验证”</title>
      <link>https://www.iivd.net/article-33281-1.html</link>
      <description><![CDATA[验证和确认经常相提并论，因为两者常如影随形，形同相似，让人难分难解。]]></description>
      <category>研发视野</category>
      <author>IVD研发视野 | 作者：溜溜NONO</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202307/26/145909wyuz6ucyx8voimlx.png" length="250758" type="image/jpeg" />
      <pubDate>Wed, 26 Jul 2023 06:59:13 +0000</pubDate>
    </item>
    <item>
      <title>“风险管理”—最熟悉的陌生人</title>
      <link>https://www.iivd.net/article-32930-1.html</link>
      <description><![CDATA[风险管理的核心是风险分析和风险控制]]></description>
      <category>研发视野</category>
      <author>IVD研发视野 | 作者：溜溜NONO</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202306/26/161337ob8w8ea8omz2qlbm.png" length="356034" type="image/jpeg" />
      <pubDate>Mon, 26 Jun 2023 08:13:48 +0000</pubDate>
    </item>
    <item>
      <title>医疗器械GMP的“设备管理”</title>
      <link>https://www.iivd.net/article-32445-1.html</link>
      <description><![CDATA[工欲善其事，必先利其器。]]></description>
      <category>研发视野</category>
      <author>IVD研发视野 | 作者：溜溜NONO</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202305/12/164929kybsxy9y889j288s.png" length="102214" type="image/jpeg" />
      <pubDate>Fri, 12 May 2023 08:49:31 +0000</pubDate>
    </item>
    <item>
      <title>医疗器械GMP的“机构与人员”</title>
      <link>https://www.iivd.net/article-32013-1.html</link>
      <description><![CDATA[培训的成本可见，收益难量化，每一家用心培训的公司都值得珍惜。]]></description>
      <category>研发视野</category>
      <author>IVD研发视野 | 作者：溜溜NONO</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202303/23/093541p77l9xnv967v4q76.png" length="146654" type="image/jpeg" />
      <pubDate>Thu, 23 Mar 2023 01:44:07 +0000</pubDate>
    </item>
    <item>
      <title>质量管理体系内部审核</title>
      <link>https://www.iivd.net/article-31459-1.html</link>
      <description><![CDATA[具体审核方法可以是向前追溯，可以是向后延伸。]]></description>
      <category>研发视野</category>
      <author>IVD研发视野 | 作者：溜溜NONO</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202301/18/143930ay0m000qa081yaqi.png" length="189203" type="image/jpeg" />
      <pubDate>Wed, 18 Jan 2023 06:39:35 +0000</pubDate>
    </item>
    <item>
      <title>《体外诊断试剂注册审查指导原则》重点提炼</title>
      <link>https://www.iivd.net/article-30627-1.html</link>
      <description><![CDATA[国家药监局器审中心发布了一系列的体外诊断试剂注册审查指导原则]]></description>
      <category>研发视野</category>
      <author>IVD研发视野 | 作者：溜溜NONO</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202210/10/111001jtb0lh773ol911a1.png" length="620200" type="image/jpeg" />
      <pubDate>Mon, 10 Oct 2022 03:10:03 +0000</pubDate>
    </item>
    <item>
      <title>验证和确认（verification &amp; validation）（三）</title>
      <link>https://www.iivd.net/article-30199-1.html</link>
      <description><![CDATA[现在我们来了解人为因素确认，人为因素确认这个词大家应该很陌生]]></description>
      <category>研发视野</category>
      <author>IVD研发视野 | 作者：溜溜NONO</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202208/16/103940iz8pr1zrfvp4kpec.png" length="73018" type="image/jpeg" />
      <pubDate>Tue, 16 Aug 2022 02:39:00 +0000</pubDate>
    </item>
    <item>
      <title>验证和确认（verification &amp; validation）（二）</title>
      <link>https://www.iivd.net/article-29953-1.html</link>
      <description><![CDATA[不管是验证还是确认，具体怎么实施，需要参考相应的指导文件，结合公司实际情况才能做出合理的方案。]]></description>
      <category>研发视野</category>
      <author>IVD研发视野 | 作者：溜溜NONO</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202207/26/105052zkzpijppbxoukokx.png" length="74259" type="image/jpeg" />
      <pubDate>Tue, 26 Jul 2022 02:51:00 +0000</pubDate>
    </item>
    <item>
      <title>验证和确认（verification &amp; validation）（一）</title>
      <link>https://www.iivd.net/article-29817-1.html</link>
      <description><![CDATA[工作中易将验证和确认混淆，今天简单介绍一下验证和确认相关内容。]]></description>
      <category>研发视野</category>
      <author>IVD研发视野 | 作者：溜溜NONO</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202207/14/110443v67oh3rage5j762h.png" length="48471" type="image/jpeg" />
      <pubDate>Thu, 14 Jul 2022 03:04:00 +0000</pubDate>
    </item>
    <item>
      <title>《广东省第二类医疗器械注册质量管理体系核查工作程序》</title>
      <link>https://www.iivd.net/article-29270-1.html</link>
      <description><![CDATA[该工作程序在全国范围内有示范性作用，广东省当局重视并在重点落实该程序的。]]></description>
      <category>研发视野</category>
      <author>IVD研发视野 | 作者：溜溜NONO</author>
<enclosure url="https://www.iivd.net/data/attachment/portal/202205/25/164734r5185m1pzlk22blm.png" length="110871" type="image/jpeg" />
      <pubDate>Wed, 25 May 2022 08:47:48 +0000</pubDate>
    </item>
  </channel>
</rss>