{"id":1951,"date":"2026-06-04T12:14:10","date_gmt":"2026-06-04T04:14:10","guid":{"rendered":"https:\/\/wiz.cn\/blog\/?p=1951"},"modified":"2026-06-04T12:14:10","modified_gmt":"2026-06-04T04:14:10","slug":"engineering-management-tools-guide","status":"publish","type":"post","link":"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide","title":{"rendered":"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417\uff1f2026\u5e74\u9009\u578b\u6307\u5357"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_83 counter-hierarchy ez-toc-counter ez-toc-light-blue ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#2026%E5%B9%B4%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%9A%84%E6%96%B0%E6%8C%91%E6%88%98%E4%B8%8E%E7%A0%B4%E5%B1%80\" >2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7684\u65b0\u6311\u6218\u4e0e\u7834\u5c40<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#%E6%9E%84%E5%BB%BA%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E8%83%BD%E5%8A%9B%E7%9A%84%E8%AF%84%E4%BC%B0%E6%A8%A1%E5%9E%8B\" >\u6784\u5efa\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u7684\u8bc4\u4f30\u6a21\u578b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#2026%E5%B9%B4%E4%B8%BB%E6%B5%81%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%A0%B8%E5%BF%83%E7%89%B9%E5%BE%81%E6%A6%82%E8%A7%88\" >2026\u5e74\u4e3b\u6d41\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6838\u5fc3\u7279\u5f81\u6982\u89c8<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#2026%E5%B9%B4%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%8E%92%E8%A1%8C%E6%A6%9C%E6%9C%89%E5%90%97%E6%B7%B1%E5%BA%A6%E6%B5%8B%E8%AF%84\" >2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417\u6df1\u5ea6\u6d4b\u8bc4<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#ONES\" >ONES<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#Tower\" >Tower<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#Jira\" >Jira<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#Azure_DevOps\" >Azure DevOps<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#Helix_ALM\" >Helix ALM<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#Jama_Connect\" >Jama Connect<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E9%80%89%E5%9E%8B%E5%BB%BA%E8%AE%AE%E4%B8%8E%E5%B1%95%E6%9C%9B\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u9009\u578b\u5efa\u8bae\u4e0e\u5c55\u671b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#FAQ%EF%BC%9A2026%E5%B9%B4%E5%B7%A5%E5%85%B7%E9%80%89%E5%9E%8B%E5%B8%B8%E8%A7%81%E9%97%AE%E9%A2%98\" >FAQ\uff1a2026\u5e74\u5de5\u5177\u9009\u578b\u5e38\u89c1\u95ee\u9898<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%8E%92%E8%A1%8C%E6%A6%9C%E6%9C%89%E5%90%97%EF%BC%9F%E5%BA%94%E8%AF%A5%E5%8F%82%E8%80%83%E5%93%AA%E4%BA%9B%E6%8C%87%E6%A0%87%EF%BC%9F\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417\uff1f\u5e94\u8be5\u53c2\u8003\u54ea\u4e9b\u6307\u6807\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#%E4%B8%BA%E4%BB%80%E4%B9%88%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%89%B9%E5%88%AB%E5%BC%BA%E8%B0%83%E9%9C%80%E6%B1%82%E8%BF%BD%E6%BA%AF%E7%9F%A9%E9%98%B5%EF%BC%88RTM%EF%BC%89%EF%BC%9F\" >\u4e3a\u4ec0\u4e48\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7279\u522b\u5f3a\u8c03\u9700\u6c42\u8ffd\u6eaf\u77e9\u9635\uff08RTM\uff09\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#Jira%E5%92%8CTower%E9%80%82%E5%90%88%E7%94%A8%E4%BA%8E%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0%E8%BD%AF%E4%BB%B6%E7%9A%84%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E5%90%97%EF%BC%9F\" >Jira\u548cTower\u9002\u5408\u7528\u4e8e\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7684\u7814\u53d1\u7ba1\u7406\u5417\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-guide\/#2026%E5%B9%B4%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E9%80%89%E5%9E%8B%EF%BC%8C%E7%A7%81%E6%9C%89%E5%8C%96%E9%83%A8%E7%BD%B2%E6%98%AF%E5%BF%85%E9%A1%BB%E7%9A%84%E5%90%97%EF%BC%9F\" >2026\u5e74\u533b\u7597\u5065\u5eb7\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u9009\u578b\uff0c\u79c1\u6709\u5316\u90e8\u7f72\u662f\u5fc5\u987b\u7684\u5417\uff1f<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"2026%E5%B9%B4%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%9A%84%E6%96%B0%E6%8C%91%E6%88%98%E4%B8%8E%E7%A0%B4%E5%B1%80\"><\/span>2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7684\u65b0\u6311\u6218\u4e0e\u7834\u5c40<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u968f\u7740\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u6570\u5b57\u5316\u8f6c\u578b\u7684\u6301\u7eed\u6df1\u5165\uff0c2026\u5e74\u7684\u7814\u53d1\u73af\u5883\u9762\u4e34\u7740\u66f4\u4e3a\u4e25\u82db\u7684\u5408\u89c4\u8981\u6c42\u4e0e\u66f4\u5feb\u7684\u8fed\u4ee3\u8282\u594f\u3002\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u3001\u6570\u5b57\u7597\u6cd5\u53ca\u533b\u836f\u4fe1\u606f\u5316\u7cfb\u7edf\u7684\u7814\u53d1\uff0c\u4e0d\u4ec5\u9700\u8981\u654f\u6377\u54cd\u5e94\u5e02\u573a\u9700\u6c42\uff0c\u66f4\u5fc5\u987b\u4e25\u683c\u9075\u5faaFDA 21 CFR Part 11\u3001ISO 13485\u53caIEC 62304\u7b49\u884c\u4e1a\u6cd5\u89c4\u3002\u8bb8\u591a\u56e2\u961f\u5728\u9009\u578b\u521d\u671f\u5e38\u95ee\uff1a\u201c\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417\uff1f\u201d\u4e8b\u5b9e\u4e0a\uff0c\u8131\u79bb\u5177\u4f53\u4e1a\u52a1\u573a\u666f\u7684\u6392\u540d\u5f80\u5f80\u7f3a\u4e4f\u5b9e\u9645\u6307\u5bfc\u610f\u4e49\u3002\u672c\u6587\u5c06\u6452\u5f03\u6d6e\u4e8e\u8868\u9762\u7684\u6392\u884c\uff0c\u805a\u7126\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\uff0c\u4e3a\u60a8\u63d0\u4f9b\u4e00\u4efd\u5ba2\u89c2\u3001\u53ef\u6267\u884c\u76842026\u5e74\u9009\u578b\u6307\u5357\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E6%9E%84%E5%BB%BA%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E8%83%BD%E5%8A%9B%E7%9A%84%E8%AF%84%E4%BC%B0%E6%A8%A1%E5%9E%8B\"><\/span>\u6784\u5efa\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u7684\u8bc4\u4f30\u6a21\u578b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5728\u8bc4\u4f30\u7814\u53d1\u7ba1\u7406\u5de5\u5177\u65f6\uff0c\u533b\u7597\u5065\u5eb7\u4f01\u4e1a\u9700\u5efa\u7acb\u7b26\u5408\u884c\u4e1a\u7279\u6027\u7684\u6d4b\u8bc4\u7ef4\u5ea6\u3002\u4ee5\u4e0b\u662f2026\u5e74\u9009\u578b\u7684\u6838\u5fc3\u8003\u91cf\u70b9\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d4b\u8bc4\u7ef4\u5ea6<\/th>\n<th>\u5173\u952e\u8003\u91cf\u70b9<\/th>\n<th>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7279\u5b9a\u8981\u6c42<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5408\u89c4\u4e0e\u8ffd\u6eaf\u80fd\u529b<\/td>\n<td>\u9700\u6c42\u8ffd\u6eaf\u77e9\u9635\uff08RTM\uff09\u3001\u7535\u5b50\u7b7e\u540d\u3001\u5ba1\u8ba1\u65e5\u5fd7<\/td>\n<td>\u6ee1\u8db3ISO 13485\u3001IEC 62304\u5bf9\u5168\u751f\u547d\u5468\u671f\u8ffd\u6eaf\u7684\u5f3a\u5236\u8981\u6c42<\/td>\n<\/tr>\n<tr>\n<td>\u8d28\u91cf\u4e0e\u98ce\u9669\u7ba1\u7406<\/td>\n<td>CAPA\u7ba1\u7406\u3001FMEA\u96c6\u6210\u3001\u7f3a\u9677\u95ed\u73af<\/td>\n<td>\u786e\u4fdd\u60a3\u8005\u5b89\u5168\u4e0e\u4ea7\u54c1\u6709\u6548\u6027\uff0c\u5b9e\u73b0\u98ce\u9669\u63a7\u5236\u7684\u53cc\u5411\u5173\u8054<\/td>\n<\/tr>\n<tr>\n<td>\u654f\u6377\u4e0e\u534f\u540c\u80fd\u529b<\/td>\n<td>\u770b\u677f\u3001\u51b2\u523a\u89c4\u5212\u3001\u8de8\u90e8\u95e8\u534f\u540c<\/td>\n<td>\u5728\u5408\u89c4\u6846\u67b6\u4e0b\u5b9e\u73b0\u654f\u6377\u8fed\u4ee3\uff0c\u6253\u7834\u8f6f\u786c\u4ef6\u7814\u53d1\u58c1\u5792<\/td>\n<\/tr>\n<tr>\n<td>\u5b89\u5168\u4e0e\u6743\u9650\u7ba1\u63a7<\/td>\n<td>\u6570\u636e\u52a0\u5bc6\u3001\u7ec6\u7c92\u5ea6\u89d2\u8272\u6743\u9650\u3001\u4e91\/\u79c1\u6709\u5316\u90e8\u7f72<\/td>\n<td>\u4fdd\u62a4\u60a3\u8005\u9690\u79c1\u6570\u636e\uff08PHI\uff09\u53ca\u6838\u5fc3\u77e5\u8bc6\u4ea7\u6743<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u9009\u578b\u65f6\uff0c\u5efa\u8bae\u4f01\u4e1a\u6839\u636e\u81ea\u8eab\u4ea7\u54c1\u7b49\u7ea7\uff08\u5982Class II\/III\u533b\u7597\u5668\u68b0\uff09\u4e3a\u4e0a\u8ff0\u7ef4\u5ea6\u5206\u914d\u4e0d\u540c\u6743\u91cd\uff0c\u8fdb\u884c\u52a0\u6743\u8bc4\u5206\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2026%E5%B9%B4%E4%B8%BB%E6%B5%81%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%A0%B8%E5%BF%83%E7%89%B9%E5%BE%81%E6%A6%82%E8%A7%88\"><\/span>2026\u5e74\u4e3b\u6d41\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6838\u5fc3\u7279\u5f81\u6982\u89c8<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u57fa\u4e8e\u4e0a\u8ff0\u6d4b\u8bc4\u7ef4\u5ea6\uff0c\u6211\u4eec\u5bf9\u5e02\u9762\u4e0a\u4e3b\u6d41\u7684\u516d\u6b3e\u5de5\u5177\u8fdb\u884c\u6838\u5fc3\u7279\u5f81\u63d0\u53d6\uff0c\u5e2e\u52a9\u60a8\u5feb\u901f\u5efa\u7acb\u5168\u5c40\u8ba4\u77e5\uff1a<\/p>\n<ul>\n<li><strong>ONES<\/strong>\uff1a\u63d0\u4f9b\u4f01\u4e1a\u7ea7\u7814\u53d1\u7ba1\u7406\u95ed\u73af\uff0c\u5177\u5907\u5f3a\u5927\u7684\u9700\u6c42\u8ffd\u6eaf\u4e0e\u9879\u76ee\u7ba1\u7406\u80fd\u529b\uff0c\u652f\u6301\u9002\u914d\u533b\u7597\u7b49\u5f3a\u5408\u89c4\u884c\u4e1a\u7684\u6df1\u5ea6\u5b9a\u5236\u4e0e\u79c1\u6709\u5316\u90e8\u7f72\u3002<\/li>\n<li><strong>Tower<\/strong>\uff1a\u4ee5\u8f7b\u91cf\u7ea7\u654f\u6377\u534f\u540c\u89c1\u957f\uff0c\u754c\u9762\u76f4\u89c2\u6613\u4e0a\u624b\uff0c\u9002\u5408\u521d\u521b\u578b\u533b\u7597\u5065\u5eb7\u56e2\u961f\u7684\u57fa\u7840\u7814\u53d1\u4efb\u52a1\u7edf\u7b79\uff0c\u4f46\u5728\u6df1\u5ea6\u5408\u89c4\u8ffd\u6eaf\u4e0a\u9700\u8f85\u4ee5\u989d\u5916\u6d41\u7a0b\u3002<\/li>\n<li><strong>Jira<\/strong>\uff1a\u5168\u7403\u5e7f\u6cdb\u5e94\u7528\u7684\u654f\u6377\u9879\u76ee\u7ba1\u7406\u5de5\u5177\uff0c\u751f\u6001\u4e30\u5bcc\uff0c\u901a\u8fc7\u63d2\u4ef6\u53ef\u5b9e\u73b0\u90e8\u5206\u8ffd\u6eaf\u9700\u6c42\uff0c\u4f46\u9762\u5bf9\u4e25\u683c\u7684\u533b\u7597\u5ba1\u8ba1\u65f6\uff0c\u539f\u751f\u7684\u5408\u89c4\u652f\u6491\u7a0d\u663e\u4e0d\u8db3\u3002<\/li>\n<li><strong>Azure DevOps<\/strong>\uff1a\u5fae\u8f6f\u751f\u6001\u4e0b\u7684\u4e00\u4f53\u5316DevOps\u5e73\u53f0\uff0c\u63d0\u4f9b\u7aef\u5230\u7aef\u7684\u4ee3\u7801\u7ba1\u7406\u4e0eCI\/CD\uff0c\u6743\u9650\u7ba1\u63a7\u7cbe\u7ec6\uff0c\u9002\u5408\u6709\u4e00\u5b9a\u5f00\u53d1\u89c4\u6a21\u7684\u533b\u7597IT\u56e2\u961f\u3002<\/li>\n<li><strong>Helix ALM<\/strong>\uff1a\u4e13\u4e3a\u5f3a\u5408\u89c4\u884c\u4e1a\u8bbe\u8ba1\u7684\u5e94\u7528\u751f\u547d\u5468\u671f\u7ba1\u7406\u5de5\u5177\uff0c\u63d0\u4f9b\u5f00\u7bb1\u5373\u7528\u7684\u9700\u6c42\u8ffd\u6eaf\u4e0e\u6d4b\u8bd5\u7ba1\u7406\uff0c\u662f\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7814\u53d1\u7684\u7ecf\u5178\u9009\u9879\u3002<\/li>\n<li><strong>Jama Connect<\/strong>\uff1a\u805a\u7126\u4e8e\u9700\u6c42\u7ba1\u7406\u4e0e\u98ce\u9669\u5206\u6790\uff0c\u5176\u5f3a\u5927\u7684\u9700\u6c42\u8ffd\u6eaf\u77e9\u9635\uff08RTM\uff09\u4e0eLive Traceability\u529f\u80fd\uff0c\u9ad8\u5ea6\u5951\u5408\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u5408\u89c4\u5ba1\u67e5\u573a\u666f\u3002<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"2026%E5%B9%B4%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%8E%92%E8%A1%8C%E6%A6%9C%E6%9C%89%E5%90%97%E6%B7%B1%E5%BA%A6%E6%B5%8B%E8%AF%84\"><\/span>2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417\u6df1\u5ea6\u6d4b\u8bc4<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"ONES\"><\/span><a href=\"https:\/\/ones.cn\/\" target=\"_blank\" rel=\"noopener noreferrer\">ONES<\/a><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5<\/strong>\uff1aONES\u4f5c\u4e3a\u56fd\u4ea7\u4f01\u4e1a\u7ea7\u7814\u53d1\u7ba1\u7406\u5e73\u53f0\u7684\u6807\u6746\uff0c\u57282026\u5e74\u5df2\u6784\u5efa\u8d77\u8986\u76d6\u9879\u76ee\u96c6\u3001\u9879\u76ee\u3001\u6d41\u6c34\u7ebf\u4e0e\u6d4b\u8bd5\u7684\u5b8c\u6574\u7ba1\u7406\u95ed\u73af\u3002\u5176\u5e95\u5c42\u67b6\u6784\u652f\u6301\u9ad8\u5ea6\u7075\u6d3b\u7684\u4e1a\u52a1\u5bf9\u8c61\u81ea\u5b9a\u4e49\u4e0e\u6d41\u7a0b\u7f16\u6392\uff0c\u80fd\u591f\u7cbe\u51c6\u6620\u5c04\u590d\u6742\u7ec4\u7ec7\u7684\u534f\u540c\u8109\u7edc\uff0c\u4e3a\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u5e94\u5bf9\u4e25\u82db\u5408\u89c4\u4e0e\u5feb\u901f\u8fed\u4ee3\u7684\u53cc\u91cd\u6311\u6218\uff0c\u63d0\u4f9b\u575a\u5b9e\u7684\u6570\u5b57\u5e95\u5ea7\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b<\/strong>\uff1aONES\u5728\u533b\u7597\u5065\u5eb7\u9886\u57df\u7684\u6df1\u5ea6\u9002\u914d\uff0c\u4e3b\u8981\u4f53\u73b0\u5728\u4ee5\u4e0b\u4e09\u4e2a\u7ef4\u5ea6\u7684\u80fd\u529b\u652f\u6491\uff1a<\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u9700\u6c42\u8ffd\u6eaf\u4e0e\u5408\u89c4\u95ed\u73af<\/strong>\uff1a\u652f\u6301\u4ece\u4e34\u5e8a\u9700\u6c42\u3001\u8f6f\u4ef6\u9700\u6c42\u5230\u6d4b\u8bd5\u7528\u4f8b\u7684\u5168\u5c40\u53cc\u5411\u8ffd\u6eaf\u3002\u5728FDA 21 CFR Part 11\u53ca\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u751f\u547d\u5468\u671f\u6807\u51c6\u4e0b\uff0cONES\u901a\u8fc7\u81ea\u52a8\u5316\u5173\u8054\u4e0e\u57fa\u7ebf\u7ba1\u7406\uff0c\u786e\u4fdd\u6bcf\u4e00\u6b21\u8bbe\u8ba1\u53d8\u66f4\u5747\u53ef\u5ba1\u8ba1\uff0c\u5927\u5e45\u964d\u4f4e\u5408\u89c4\u5ba1\u67e5\u7684\u4e3e\u8bc1\u6210\u672c\u3002<\/li>\n<li><strong>\u8d28\u91cf\u4f53\u7cfb\u6587\u6863\u4e0e\u8bc4\u5ba1\u6d41\u7a0b\u6df1\u5ea6\u5185\u5d4c<\/strong>\uff1a\u533b\u7597\u7814\u53d1\u6781\u5ea6\u4f9d\u8d56\u8bbe\u8ba1\u63a7\u5236\u4e0e\u8bc4\u5ba1\u673a\u5236\u3002ONES\u652f\u6301\u5c06DHF\uff08\u8bbe\u8ba1\u5386\u53f2\u6587\u4ef6\uff09\u7684\u8bc4\u5ba1\u8282\u70b9\u5185\u5316\u4e3a\u6807\u51c6\u5de5\u4f5c\u6d41\uff0c\u7ed3\u5408\u7535\u5b50\u7b7e\u7ae0\u4e0e\u5ba1\u8ba1\u65e5\u5fd7\uff0c\u5b9e\u73b0\u8d28\u91cf\u4f53\u7cfb\u6587\u6863\u7684\u5728\u7ebf\u5316\u3001\u89c4\u8303\u5316\u7ba1\u63a7\uff0c\u8ba9\u5408\u89c4\u4e0d\u518d\u6210\u4e3a\u7814\u53d1\u6548\u7387\u7684\u74f6\u9888\u3002<\/li>\n<li><strong>\u591a\u89d2\u8272\u8de8\u57df\u534f\u540c\u4e0e\u6570\u636e\u770b\u677f<\/strong>\uff1a\u4e34\u5e8a\u4e13\u5bb6\u3001\u6cd5\u89c4\u6ce8\u518c\u4e0e\u7814\u53d1\u56e2\u961f\u5f80\u5f80\u5b58\u5728\u534f\u540c\u58c1\u5792\u3002ONES\u63d0\u4f9b\u8de8\u9879\u76ee\u96c6\u7684\u7518\u7279\u56fe\u4e0e\u591a\u7ef4\u6570\u636e\u770b\u677f\uff0c\u6253\u7834\u90e8\u95e8\u4fe1\u606f\u5b64\u5c9b\uff0c\u5b9e\u73b0\u4ece\u4e34\u5e8a\u53cd\u9988\u5230\u4ea7\u54c1\u8fed\u4ee3\u7684\u654f\u6377\u54cd\u5e94\u4e0e\u5168\u5c40\u900f\u89c6\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f<\/strong>\uff1a\u9ad8\u5ea6\u9002\u914d\u9700\u8981\u8fdb\u884c\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u5408\u89c4\u8ba4\u8bc1\u3001\u8ffd\u6c42\u7814\u53d1\u4e0e\u8d28\u91cf\u4f53\u7cfb\u4e00\u4f53\u5316\u8fd0\u4f5c\u7684\u533b\u7597\u79d1\u6280\u4f01\u4e1a\uff0c\u5c24\u5176\u9002\u5408\u5904\u4e8e\u9ad8\u901f\u6269\u5f20\u671f\u3001\u9700\u7edf\u7b79\u591a\u6761\u4ea7\u54c1\u7ebf\u4e0e\u591a\u4e2d\u5fc3\u4e34\u5e8a\u534f\u540c\u7684\u4e2d\u5927\u578b\u7ec4\u7ec7\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9<\/strong>\uff1aONES\u7684\u6838\u5fc3\u4f18\u52bf\u5728\u4e8e\u5c06\u201c\u654f\u6377\u4ea4\u4ed8\u201d\u4e0e\u201c\u4e25\u82db\u5408\u89c4\u201d\u5728\u5e95\u5c42\u67b6\u6784\u4e0a\u5b9e\u73b0\u4e86\u65e0\u7f1d\u878d\u5408\u3002\u9009\u578b\u56e2\u961f\u53ef\u4f18\u5148\u542f\u7528\u5176\u9700\u6c42\u8ffd\u6eaf\u77e9\u9635\u4e0e\u8bc4\u5ba1\u5de5\u4f5c\u6d41\uff0c\u5c06\u4f20\u7edf\u7684\u7ebf\u4e0b\u5408\u89c4\u52a8\u4f5c\u8f6c\u5316\u4e3a\u7cfb\u7edf\u5185\u7684\u81ea\u52a8\u5316\u6d41\u8f6c\uff0c\u771f\u6b63\u5b9e\u73b0\u7814\u53d1\u6548\u80fd\u4e0e\u8d28\u91cf\u5408\u89c4\u7684\u53cc\u8f6e\u9a71\u52a8\u3002<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/blogcdn.ones-ai.cn\/blog\/uploads\/2026\/04\/04f5ddf81ca3_ONES-\u4ea7\u54c1\u5168\u666f\u56fe.png\" alt=\"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417+ONES \u4ea7\u54c1\u5168\u666f\u56fe\" \/><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Tower\"><\/span>Tower<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5\uff1a<\/strong>\u4f5c\u4e3a\u56fd\u5185\u8001\u724c\u7684\u8f7b\u91cf\u7ea7\u534f\u4f5c\u5e73\u53f0\uff0cTower\u4ee5\u654f\u6377\u4e0e\u770b\u677f\u7ba1\u7406\u4e3a\u6838\u5fc3\uff0c\u81f4\u529b\u4e8e\u89e3\u51b3\u56e2\u961f\u4efb\u52a1\u534f\u540c\u4e0e\u8fdb\u5ea6\u53ef\u89c6\u5316\u95ee\u9898\u3002\u5176\u8bbe\u8ba1\u54f2\u5b66\u504f\u5411\u4e8e\u901a\u7528\u578b\u4e0e\u6613\u7528\u6027\uff0c\u4e0a\u624b\u95e8\u69db\u6781\u4f4e\uff0c\u80fd\u591f\u5feb\u901f\u5728\u4e2d\u5c0f\u89c4\u6a21\u56e2\u961f\u4e2d\u94fa\u5f00\uff0c\u4f46\u5728\u5782\u76f4\u884c\u4e1a\u7684\u6df1\u5ea6\u5408\u89c4\u4e0e\u590d\u6742\u5de5\u7a0b\u7ba1\u7406\u4e0a\uff0c\u5b58\u5728\u5929\u7136\u7684\u80fd\u529b\u8fb9\u754c\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/strong>\u5728\u533b\u7597\u5065\u5eb7\u9886\u57df\uff0cTower\u7684\u6838\u5fc3\u80fd\u529b\u66f4\u591a\u4f53\u73b0\u5728\u7814\u53d1\u524d\u7aef\u7684\u8f7b\u91cf\u7ea7\u654f\u6377\u534f\u540c\uff0c\u800c\u975e\u540e\u7aef\u7684\u5408\u89c4\u8ffd\u6eaf\u3002\u5177\u4f53\u800c\u8a00\uff1a<\/p>\n<ul>\n<li><strong>\u8f7b\u91cf\u7ea7\u9700\u6c42\u4e0e\u4efb\u52a1\u6d41\u8f6c\uff1a<\/strong>\u652f\u6301\u901a\u8fc7\u770b\u677f\u4e0e\u5217\u8868\u89c6\u56fe\u5feb\u901f\u62c6\u89e3\u4e34\u5e8a\u8c03\u7814\u3001UI\u8bbe\u8ba1\u7b49\u975e\u6d89\u89c4\u4efb\u52a1\uff0c\u5b9e\u73b0\u654f\u6377\u8fed\u4ee3\uff0c\u4f46\u5bf9\u590d\u6742\u7684\u57fa\u7ebf\u5316\u7ba1\u7406\u7f3a\u4e4f\u539f\u751f\u5b58\u50a8\u673a\u5236\u3002<\/li>\n<li><strong>\u8de8\u804c\u80fd\u56e2\u961f\u534f\u540c\uff1a<\/strong>\u4e3a\u4e34\u5e8a\u8fd0\u8425\u3001\u5e02\u573a\u4e0e\u57fa\u7840\u7814\u53d1\u56e2\u961f\u63d0\u4f9b\u7edf\u4e00\u6c9f\u901a\u4e0e\u4efb\u52a1\u8ba4\u9886\u5165\u53e3\uff0c\u964d\u4f4e\u8de8\u90e8\u95e8\u6c9f\u901a\u6469\u64e6\uff0c\u4f46\u5728\u7814\u53d1\u4e0e\u8d28\u91cf\u4fdd\u8bc1\uff08QA\uff09\u7684\u53cc\u5411\u8ffd\u6eaf\u4e0a\u5b58\u5728\u65ad\u5c42\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u533b\u7597\u5065\u5eb7\u4f01\u4e1a\u4e2d\u65e0\u9700\u5f3a\u5408\u89c4\u7ea6\u675f\u7684\u521b\u65b0\u5b75\u5316\u9879\u76ee\u3001\u4e92\u8054\u7f51\u533b\u7597\u4ea7\u54c1\u7684\u524d\u7aef\u4ea4\u4e92\u8fed\u4ee3\uff0c\u6216\u4f5c\u4e3a\u4e34\u5e8a\u6ce8\u518c\u4e0e\u5408\u89c4\u4f53\u7cfb\u4e4b\u5916\u7684\u8f85\u52a9\u654f\u6377\u534f\u540c\u5de5\u5177\u3002\u5207\u52ff\u5c06\u5176\u4f5c\u4e3a\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u7684\u6838\u5fc3\u7814\u53d1\u4e0e\u5408\u89c4\u8ffd\u6eaf\u8f7d\u4f53\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5b66\u4e60\u6210\u672c\u6781\u4f4e\uff0c\u90e8\u7f72\u4e0e\u5f00\u7bb1\u5373\u7528\u901f\u5ea6\u5feb\uff1b\u5728\u8f7b\u91cf\u7ea7\u9879\u76ee\u8fdb\u5ea6\u53ef\u89c6\u5316\u4e0e\u8de8\u90e8\u95e8\u4fe1\u606f\u900f\u660e\u5316\u4e0a\u8868\u73b0\u4f18\u5f02\uff1b\u8ba2\u9605\u6210\u672c\u53ef\u63a7\uff0c\u5bf9\u521d\u521b\u578b\u533b\u7597\u5927\u5065\u5eb7\u56e2\u961f\u7684\u65e9\u671f\u534f\u4f5c\u6548\u7387\u63d0\u5347\u663e\u8457\u3002<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/blogcdn.ones-ai.cn\/blog\/uploads\/2026\/04\/966458e0716a_Tower-\u4ea7\u54c1\u56fe-scaled-1.png\" alt=\"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417+Tower \u4ea7\u54c1\u56fe\" \/><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Jira\"><\/span>Jira<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5<\/strong>\uff1a\u4f5c\u4e3a\u5168\u7403\u5e94\u7528\u6700\u5e7f\u6cdb\u7684\u7814\u53d1\u7ba1\u7406\u5de5\u5177\uff0cJira\u51ed\u501f\u5176\u9ad8\u5ea6\u53ef\u5b9a\u5236\u7684Issue\u8ffd\u8e2a\u673a\u5236\u4e0e\u4e30\u5bcc\u7684\u63d2\u4ef6\u751f\u6001\uff0c\u6784\u5efa\u4e86\u5e9e\u5927\u7684\u9879\u76ee\u7ba1\u7406\u57fa\u5ea7\u3002\u5386\u7ecf\u591a\u5e74\u6f14\u8fdb\uff0c\u5b83\u5df2\u6210\u4e3a\u4f17\u591a\u4f01\u4e1a\u6784\u5efa\u7814\u53d1\u6d41\u7a0b\u7684\u5e95\u5c42\u64cd\u4f5c\u7cfb\u7edf\uff0c\u4f46\u5728\u9762\u5bf9\u5f3a\u5408\u89c4\u4e0e\u91cd\u8ffd\u6eaf\u7684\u7279\u5b9a\u884c\u4e1a\u65f6\uff0c\u5f80\u5f80\u9700\u4f9d\u8d56\u4e8c\u6b21\u5f00\u53d1\u6216\u751f\u6001\u8865\u5145\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b<\/strong>\uff1a\u5728\u533b\u7597\u5065\u5eb7\u9886\u57df\uff0cJira\u7684\u6838\u5fc3\u80fd\u529b\u5e76\u975e\u5f00\u7bb1\u5373\u7528\u7684\u5408\u89c4\u6027\uff0c\u800c\u662f\u5176\u9ad8\u5ea6\u7075\u6d3b\u7684\u5e95\u5c42\u67b6\u6784\u5bf9\u884c\u4e1a\u7279\u5b9a\u6d41\u7a0b\u7684\u627f\u8f7d\u4e0e\u6539\u9020\u6f5c\u529b\u3002<\/p>\n<ul>\n<li><strong>\u53ef\u8ffd\u6eaf\u6027\u67b6\u6784\u642d\u5efa<\/strong>\uff1a\u901a\u8fc7Issue Linking\u4e0e\u81ea\u5b9a\u4e49\u5b57\u6bb5\uff0c\u53ef\u5efa\u7acb\u4ece\u7528\u6237\u9700\u6c42\u5230\u6d4b\u8bd5\u7528\u4f8b\u7684\u8ffd\u6eaf\u77e9\u9635\uff0c\u4f46\u9700\u4e25\u683c\u89c4\u8303\u64cd\u4f5c\u7eaa\u5f8b\uff0c\u5426\u5219\u6613\u4ea7\u751f\u6570\u636e\u5b64\u5c9b\u3002<\/li>\n<li><strong>\u5408\u89c4\u5de5\u4f5c\u6d41\u5b9a\u5236<\/strong>\uff1a\u652f\u6301\u914d\u7f6e\u7b26\u5408FDA 21 CFR Part 11\u6216ISO 13485\u8981\u6c42\u7684\u5ba1\u6279\u6d41\u4e0e\u7535\u5b50\u7b7e\u540d\u673a\u5236\uff0c\u786e\u4fdd\u72b6\u6001\u53d8\u66f4\u7684\u5408\u89c4\u7559\u75d5\u3002<\/li>\n<li><strong>\u751f\u6001\u6269\u5c55\u5e94\u5bf9\u5ba1\u8ba1<\/strong>\uff1a\u501f\u52a9Xray\u7b49\u63d2\u4ef6\u5b9e\u73b0\u9a8c\u8bc1\u4e0e\u786e\u8ba4\u95ed\u73af\uff0c\u5f25\u8865\u539f\u751f\u5728\u533b\u7597\u5ba1\u8ba1\u62a5\u8868\u4e0a\u7684\u77ed\u677f\uff0c\u652f\u6491\u9a8c\u8bc1\u751f\u547d\u5468\u671f\u7ba1\u7406\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f<\/strong>\uff1a\u9002\u7528\u4e8e\u5177\u5907\u8f83\u5f3a\u7814\u53d1\u5de5\u7a0b\u5316\u57fa\u7840\u4e0eIT\u8fd0\u7ef4\u56e2\u961f\u7684\u533b\u7597\u79d1\u6280\u4f01\u4e1a\uff0c\u5c24\u5176\u662f\u9700\u8981\u5c06\u654f\u6377\u5f00\u53d1\u4e0e\u91cd\u578b\u5408\u89c4\u8981\u6c42\u76f8\u878d\u5408\uff0c\u4e14\u613f\u610f\u6295\u5165\u8d44\u6e90\u8fdb\u884c\u6df1\u5ea6\u5b9a\u5236\u4e0e\u63d2\u4ef6\u96c6\u6210\u7684\u4e2d\u5927\u578b\u7ec4\u7ec7\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9<\/strong>\uff1a\u65e0\u53ef\u5339\u654c\u7684\u654f\u6377\u9879\u76ee\u7ba1\u7406\u6210\u719f\u5ea6\u4e0e\u793e\u533a\u8d44\u6e90\uff1b\u5de5\u4f5c\u6d41\u5f15\u64ce\u6781\u5ea6\u7075\u6d3b\uff0c\u80fd\u9002\u914d\u590d\u6742\u7684\u533b\u7597\u7814\u53d1\u7ba1\u63a7\u8282\u70b9\uff1b\u63d2\u4ef6\u5e02\u573a\u7e41\u8363\uff0c\u53ef\u901a\u8fc7\u7ec4\u5408\u5b9e\u73b0\u4ece\u9700\u6c42\u5230\u6d4b\u8bd5\u9a8c\u8bc1\u7684\u7aef\u5230\u7aef\u8986\u76d6\u3002\u9009\u578b\u65f6\u9700\u91cd\u70b9\u8bc4\u4f30\u63d2\u4ef6\u91c7\u8d2d\u6210\u672c\u4e0e\u7cfb\u7edf\u7ef4\u62a4\u95e8\u69db\u3002<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/blogcdn.ones-ai.cn\/blog\/uploads\/2026\/04\/e2b0188e556d_Jira-\u4ea7\u54c1\u56fe.png\" alt=\"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417+Jira \u4ea7\u54c1\u56fe\" \/><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Azure_DevOps\"><\/span>Azure DevOps<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5\uff1a<\/strong>\u4f5c\u4e3a\u5fae\u8f6f\u65d7\u4e0b\u7684\u4f01\u4e1a\u7ea7\u7814\u53d1\u534f\u540c\u5e73\u53f0\uff0cAzure DevOps\u63d0\u4f9b\u4e86\u4ece\u9700\u6c42\u89c4\u5212\u3001\u4ee3\u7801\u7ba1\u7406\u3001CI\/CD\u5230\u6d4b\u8bd5\u8ffd\u8e2a\u7684\u7aef\u5230\u7aef\u5de5\u5177\u94fe\u3002\u5176\u5e95\u5c42\u67b6\u6784\u6210\u719f\uff0c\u4e0e\u5fae\u8f6f\u751f\u6001\u6df1\u5ea6\u878d\u5408\uff0c\u662f\u5168\u7403\u5316\u56e2\u961f\u53ca\u5927\u578b\u4f01\u4e1a\u6784\u5efa\u7814\u53d1\u57fa\u7840\u8bbe\u65bd\u7684\u5e38\u89c4\u8303\u5f0f\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u5408\u89c4\u9a71\u52a8\u7684\u5168\u94fe\u8def\u53ef\u8ffd\u6eaf\u6027\uff1a<\/strong>\u4f9d\u6258Work Item\u4e0eGit\u53d8\u66f4\u96c6\u3001PR\u53ca\u6d4b\u8bd5\u7528\u4f8b\u7684\u6df1\u5ea6\u7ed1\u5b9a\uff0c\u5b9e\u73b0\u4ece\u9700\u6c42\u5230\u4ee3\u7801\u63d0\u4ea4\u518d\u5230\u9a8c\u8bc1\u7684\u7aef\u5230\u7aef\u8ffd\u6eaf\uff0c\u4e3aFDA 21 CFR Part 11\u7b49\u5408\u89c4\u5ba1\u8ba1\u63d0\u4f9b\u4e0d\u53ef\u7be1\u6539\u7684\u5e95\u5c42\u6570\u636e\u652f\u6491\u3002<\/li>\n<li><strong>\u4f01\u4e1a\u7ea7\u5b89\u5168\u4e0e\u8bbf\u95ee\u63a7\u5236\uff1a<\/strong>\u7ed3\u5408Azure Active Directory\u63d0\u4f9b\u7ec6\u7c92\u5ea6\u7684\u8eab\u4efd\u9a8c\u8bc1\u4e0e\u6743\u9650\u9694\u79bb\uff0c\u6ee1\u8db3\u533b\u7597\u6570\u636e\u672c\u5730\u5316\u90e8\u7f72\u4e0e\u9ad8\u4fdd\u5bc6\u6027\u8981\u6c42\uff0c\u786e\u4fdd\u60a3\u8005\u9690\u79c1\u4e0e\u6838\u5fc3\u8d44\u4ea7\u5b89\u5168\u3002<\/li>\n<li><strong>\u81ea\u52a8\u5316\u5408\u89c4\u5ba1\u8ba1\u6d41\u6c34\u7ebf\uff1a<\/strong>\u901a\u8fc7Azure Pipelines\u4e0ePolicy\u914d\u7f6e\uff0c\u53ef\u5728\u4ee3\u7801\u5408\u5e76\u6216\u53d1\u5e03\u524d\u5f3a\u5236\u6267\u884c\u9759\u6001\u4ee3\u7801\u626b\u63cf\u3001\u4f9d\u8d56\u6f0f\u6d1e\u68c0\u6d4b\u4e0e\u5ba1\u6279\u95e8\u7981\uff0c\u5c06\u5408\u89c4\u68c0\u67e5\u5185\u5316\u4e8e\u5de5\u7a0b\u5b9e\u8df5\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u5408\u5177\u5907\u4e00\u5b9a\u7814\u53d1\u6210\u719f\u5ea6\u3001\u5f3a\u4f9d\u8d56\u5fae\u8f6f\u6280\u672f\u6808\u4e14\u6709\u4e25\u683c\u5408\u89c4\u4e0e\u5ba1\u8ba1\u8bc9\u6c42\u7684\u4e2d\u5927\u578b\u533b\u7597\u4f01\u4e1a\uff0c\u5c24\u5176\u662f\u9700\u8981\u8de8\u56fd\u534f\u4f5c\u6216\u8fdb\u884c\u533b\u7597\u5668\u68b0\u8f6f\u4ef6(SaMD)\u5f00\u53d1\u7684\u56e2\u961f\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u751f\u6001\u96c6\u6210\u80fd\u529b\u6781\u5f3a\uff0cCI\/CD\u4e0e\u5236\u54c1\u7ba1\u7406\u5f00\u7bb1\u5373\u7528\uff1b\u6743\u9650\u4f53\u7cfb\u4e25\u5bc6\uff0c\u5ba1\u8ba1\u65e5\u5fd7\u5b8c\u5584\uff1b\u652f\u6301\u4e91\u5730\u6df7\u5408\u90e8\u7f72\uff0c\u517c\u987e\u654f\u6377\u4e0e\u5408\u89c4\u7ba1\u63a7\u3002\u4f46\u914d\u7f6e\u5b66\u4e60\u66f2\u7ebf\u8f83\u9661\uff0c\u5bf9\u975e\u5fae\u8f6f\u4f53\u7cfb\u5de5\u5177\u7684\u517c\u5bb9\u9700\u989d\u5916\u5f00\u53d1\u6210\u672c\u3002<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/blogcdn.ones-ai.cn\/blog\/uploads\/2026\/04\/6c6e0ea47749_Azure-DevOps-\u4ea7\u54c1\u56fe.png\" alt=\"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417+Azure DevOps \u4ea7\u54c1\u56fe\" \/><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Helix_ALM\"><\/span>Helix ALM<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5<\/strong>\uff1aHelix ALM \u662f\u4e00\u6b3e\u4e13\u653b\u9ad8\u5408\u89c4\u6027\u884c\u4e1a\u7684\u5e94\u7528\u751f\u547d\u5468\u671f\u7ba1\u7406\u5e73\u53f0\uff0c\u4ee5\u9700\u6c42\u7ba1\u7406\u3001\u6d4b\u8bd5\u7ba1\u7406\u4e0e\u7f3a\u9677\u8ffd\u8e2a\u7684\u6df1\u5ea6\u7aef\u5230\u7aef\u95ed\u73af\u89c1\u957f\u3002\u5176\u5e95\u5c42\u67b6\u6784\u4e13\u4e3a\u5e94\u5bf9\u4e25\u82db\u7684\u76d1\u7ba1\u5ba1\u67e5\u800c\u8bbe\u8ba1\uff0c\u5728\u533b\u7597\u8bbe\u5907\u4e0e\u4f53\u5916\u8bca\u65ad\u9886\u57df\u62e5\u6709\u6df1\u539a\u7684\u884c\u4e1a\u6c89\u6dc0\uff0c\u662f\u4f20\u7edf\u91cd\u578b\u5408\u89c4\u7814\u53d1\u4f53\u7cfb\u7684\u5178\u578b\u4ee3\u8868\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b<\/strong>\uff1a<\/p>\n<ul>\n<li><strong>\u5168\u94fe\u8def\u8ffd\u6eaf\u4e0e\u7535\u5b50\u7b7e\u540d<\/strong>\uff1a\u63d0\u4f9b\u4ece\u9700\u6c42\u3001\u6e90\u7801\u5230\u6d4b\u8bd5\u7528\u4f8b\u7684\u6beb\u79d2\u7ea7\u53cc\u5411\u8ffd\u6eaf\uff0c\u5185\u7f6e\u7b26\u540821 CFR Part 11\u6807\u51c6\u7684\u7535\u5b50\u7b7e\u540d\u4e0e\u5ba1\u8ba1\u8ffd\u8e2a\uff0c\u76f4\u63a5\u6ee1\u8db3FDA\u5ba1\u6838\u7684\u6570\u636e\u5b8c\u6574\u6027\u5e95\u7ebf\u3002<\/li>\n<li><strong>\u9a8c\u8bc1\u5c31\u7eea\u4e0e\u5408\u89c4\u81ea\u52a8\u5316<\/strong>\uff1a\u7cfb\u7edf\u81ea\u5e26IQ\/OQ\/PQ\u9a8c\u8bc1\u5305\uff0c\u5927\u5e45\u964d\u4f4e\u533b\u7597\u4f01\u4e1a\u9996\u6b21\u90e8\u7f72\u65f6\u7684\u9a8c\u8bc1\u6210\u672c\u4e0e\u5468\u671f\uff0c\u89c4\u907f\u4f20\u7edf\u5de5\u5177\u5728\u9a8c\u8bc1\u73af\u8282\u7684\u5408\u89c4\u98ce\u9669\u3002<\/li>\n<li><strong>\u57fa\u7ebf\u51bb\u7ed3\u4e0e\u7248\u672c\u63a7\u5236<\/strong>\uff1a\u652f\u6301\u9879\u76ee\u7ea7\u57fa\u7ebf\u7edd\u5bf9\u51bb\u7ed3\uff0c\u786e\u4fdd\u8bbe\u8ba1\u5386\u53f2\u6587\u4ef6\uff08DHF\uff09\u5728\u4efb\u610f\u65f6\u95f4\u8282\u70b9\u7684\u4e0d\u53ef\u7be1\u6539\u6027\uff0c\u4e3a\u8bbe\u8ba1\u63a7\u5236\u63d0\u4f9b\u94c1\u8bc1\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f<\/strong>\uff1a\u9002\u7528\u4e8e\u5bf9\u5408\u89c4\u4e0e\u8ffd\u6eaf\u6709\u6781\u81f4\u8981\u6c42\u7684\u4e8c\u7c7b\u3001\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u7814\u53d1\u56e2\u961f\uff0c\u5c24\u5176\u662f\u9700\u8981\u9891\u7e41\u5e94\u5bf9FDA\u3001CE\u53caNMPA\u73b0\u573a\u5ba1\u6838\uff0c\u4e14\u7814\u53d1\u6d41\u7a0b\u4e25\u683c\u9075\u5faaIEC 62304\u6807\u51c6\u7684\u4f20\u7edf\u786c\u4ef6\u4e0e\u8f6f\u786c\u4ef6\u7ed3\u5408\u8bbe\u5907\u5236\u9020\u5546\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9<\/strong>\uff1a\u6838\u5fc3\u4f18\u52bf\u5728\u4e8e\u5176\u5f00\u7bb1\u5373\u7528\u7684\u5408\u89c4\u6846\u67b6\u4e0e\u6781\u81f4\u7684\u8ffd\u6eaf\u9897\u7c92\u5ea6\u3002\u5bf9\u4e8e\u533b\u7597\u4f01\u4e1a\u800c\u8a00\uff0cHelix ALM\u5c06\u5408\u89c4\u4ece\u201c\u540e\u671f\u8865\u6587\u6863\u201d\u524d\u7f6e\u4e3a\u201c\u7814\u53d1\u8fc7\u7a0b\u5373\u5408\u89c4\u201d\uff0c\u6781\u5927\u964d\u4f4e\u4e86\u5ba1\u6838\u88ab\u62d2\u7684\u7cfb\u7edf\u6027\u98ce\u9669\u3002\u4f46\u9700\u6ce8\u610f\uff0c\u5176\u4ea4\u4e92\u903b\u8f91\u504f\u4f20\u7edf\uff0c\u654f\u6377\u652f\u6301\u8f83\u5f31\uff0c\u9009\u578b\u65f6\u9700\u6743\u8861\u5408\u89c4\u521a\u6027\u4e0e\u56e2\u961f\u654f\u6377\u8bc9\u6c42\u3002<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/blogcdn.ones-ai.cn\/blog\/uploads\/2026\/04\/48afb5ec2fd9_Helix-ALM-\u4ea7\u54c1\u56fe-scaled-1.png\" alt=\"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417+Helix ALM \u4ea7\u54c1\u56fe\" \/><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Jama_Connect\"><\/span>Jama Connect<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5\uff1a<\/strong>Jama Connect \u662f\u4e00\u6b3e\u4e13\u6ce8\u4e8e\u9700\u6c42\u7ba1\u7406\u4e0e\u7aef\u5230\u7aef\u8ffd\u6eaf\u7684\u73b0\u4ee3\u5316\u5e73\u53f0\uff0c\u5728\u7cfb\u7edf\u5de5\u7a0b\u4e0e\u590d\u6742\u4ea7\u54c1\u7814\u53d1\u9886\u57df\u6df1\u8015\u591a\u5e74\u3002\u5b83\u4ee5\u201c\u5b9a\u4e49\u3001\u9a8c\u8bc1\u3001\u786e\u8ba4\u201d\u4e3a\u6838\u5fc3\u95ed\u73af\uff0c\u81f4\u529b\u4e8e\u6253\u7834\u9700\u6c42\u5b64\u5c9b\uff0c\u4e3a\u8de8\u804c\u80fd\u56e2\u961f\u63d0\u4f9b\u5355\u4e00\u4e14\u53ef\u4fe1\u7684\u9700\u6c42\u771f\u76f8\u6e90\u3002\u5bf9\u4e8e\u5f3a\u76d1\u7ba1\u884c\u4e1a\u800c\u8a00\uff0c\u5176\u5e95\u5c42\u67b6\u6784\u5929\u7136\u5951\u5408\u5408\u89c4\u5bfc\u5411\u7684\u7814\u53d1\u903b\u8f91\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/strong>\u5728\u533b\u7597\u5065\u5eb7\u9886\u57df\uff0cJama Connect \u7684\u6838\u5fc3\u4ef7\u503c\u5728\u4e8e\u5c06\u5408\u89c4\u8981\u6c42\u5185\u5316\u4e3a\u7814\u53d1\u6d41\u63a7\u80fd\u529b\uff0c\u5177\u4f53\u4f53\u73b0\u5728\uff1a<\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u53cc\u5411\u8ffd\u6eaf\uff1a<\/strong>\u63d0\u4f9b\u4ece\u7528\u6237\u9700\u6c42\u3001\u7cfb\u7edf\u9700\u6c42\u5230\u6d4b\u8bd5\u7528\u4f8b\u7684\u5b9e\u65f6\u53cc\u5411\u5173\u8054\uff0c\u4e00\u65e6\u4e0a\u6e38\u53d8\u66f4\u5373\u523b\u6ce2\u53ca\u4e0b\u6e38\u9884\u8b66\uff0c\u8fd9\u662f\u6ee1\u8db3FDA 21 CFR Part 820\u4e0eIEC 62304\u8ffd\u6eaf\u77e9\u9635\u5408\u89c4\u5ba1\u67e5\u7684\u57fa\u77f3\u3002<\/li>\n<li><strong>\u5185\u7f6e\u9a8c\u8bc1\u4e0e\u786e\u8ba4(V&amp;V)\u6d41\u63a7\uff1a<\/strong>\u5c06\u533b\u7597\u5668\u68b0\u7814\u53d1\u4e2d\u4e0d\u53ef\u6216\u7f3a\u7684V&amp;V\u6d41\u7a0b\u76f4\u63a5\u5d4c\u5165\u9700\u6c42\u751f\u547d\u5468\u671f\uff0c\u786e\u4fdd\u6bcf\u4e2a\u9700\u6c42\u8282\u70b9\u5747\u5177\u5907\u660e\u786e\u7684\u9a8c\u8bc1\u72b6\u6001\u4e0e\u5ba1\u6279\u8bb0\u5f55\uff0c\u5927\u5e45\u964d\u4f4e\u5408\u89c4\u5ba1\u8ba1\u7684\u6587\u6863\u4e3e\u8bc1\u6210\u672c\u3002<\/li>\n<li><strong>\u98ce\u9669\u4e0e\u5371\u5bb3\u5206\u6790\u8054\u52a8\uff1a<\/strong>\u652f\u6301\u5c06DFMEA\u4e0e\u5371\u5bb3\u5206\u6790\u7ed3\u679c\u76f4\u63a5\u5173\u8054\u81f3\u5177\u4f53\u9700\u6c42\u9879\uff0c\u5b9e\u73b0\u98ce\u9669\u63a7\u5236\u63aa\u65bd\u7684\u95ed\u73af\u8ffd\u8e2a\uff0c\u6ee1\u8db3ISO 14971\u98ce\u9669\u7ba1\u7406\u6807\u51c6\u7684\u6838\u5fc3\u8bc9\u6c42\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9ad8\u5ea6\u9002\u7528\u4e8e\u533b\u7597\u5668\u68b0\u3001\u4f53\u5916\u8bca\u65ad(IVD)\u8bbe\u5907\u53ca\u533b\u7597\u8f6f\u4ef6\u7b49\u5f3a\u76d1\u7ba1\u3001\u9ad8\u98ce\u9669\u4ea7\u54c1\u7684\u7814\u53d1\u56e2\u961f\uff1b\u5c24\u5176\u9002\u5408\u9762\u4e34FDA\u3001CE\u8ba4\u8bc1\u5ba1\u8ba1\u538b\u529b\uff0c\u4e14\u4e9f\u9700\u6784\u5efa\u5408\u89c4\u8ffd\u6eaf\u77e9\u9635\u4e0e\u81ea\u52a8\u5316V&amp;V\u8bc1\u636e\u94fe\u7684\u4f01\u4e1a\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5176\u6700\u5927\u4f18\u52bf\u5728\u4e8e\u5c06\u5408\u89c4\u4ece\u201c\u4e8b\u540e\u8865\u6587\u6863\u201d\u8f6c\u53d8\u4e3a\u201c\u4e8b\u524d\u878d\u6d41\u7a0b\u201d\uff0c\u901a\u8fc7\u52a8\u6001\u8ffd\u6eaf\u77e9\u9635\u4e0e\u57fa\u7ebf\u7ba1\u63a7\u5927\u5e45\u7f29\u77ed\u5ba1\u8ba1\u51c6\u5907\u5468\u671f\u3002\u4f46\u9700\u5ba2\u89c2\u6307\u51fa\uff0c\u5176\u654f\u6377\u9879\u76ee\u7ba1\u7406\u4e0e\u65e5\u5e38\u4efb\u52a1\u534f\u540c\u80fd\u529b\u76f8\u5bf9\u504f\u5f31\uff0c\u9009\u578b\u56e2\u961f\u9700\u8bc4\u4f30\u662f\u5426\u9700\u8f85\u4ee5\u8f7b\u91cf\u7ea7\u654f\u6377\u5de5\u5177\u4ee5\u8865\u9f50\u8fed\u4ee3\u89c4\u5212\u77ed\u677f\u3002<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/blogcdn.ones-ai.cn\/blog\/uploads\/2026\/04\/8fd2c4b79fe5_Jama-Connect-\u4ea7\u54c1\u56fe-scaled-1.png\" alt=\"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417+Jama Connect \u4ea7\u54c1\u56fe\" \/><\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E9%80%89%E5%9E%8B%E5%BB%BA%E8%AE%AE%E4%B8%8E%E5%B1%95%E6%9C%9B\"><\/span>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u9009\u578b\u5efa\u8bae\u4e0e\u5c55\u671b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u9488\u5bf9\u4e0d\u540c\u89c4\u6a21\u4e0e\u5408\u89c4\u7b49\u7ea7\u7684\u533b\u7597\u5065\u5eb7\u4f01\u4e1a\uff0c\u6211\u4eec\u63d0\u51fa\u4ee5\u4e0b\u5de5\u5177\u4f7f\u7528\u5efa\u8bae\uff1a<\/p>\n<ol>\n<li><strong>\u9ad8\u98ce\u9669\/\u5f3a\u5408\u89c4\u4ea7\u54c1\uff08\u5982Class III\u533b\u7597\u5668\u68b0\u3001SaMD\uff09<\/strong>\uff1a\u5efa\u8bae\u4f18\u5148\u8bc4\u4f30 <strong>Helix ALM<\/strong> \u6216 <strong>Jama Connect<\/strong>\uff0c\u8fd9\u4e24\u6b3e\u5de5\u5177\u5728\u9700\u6c42\u53cc\u5411\u8ffd\u6eaf\u4e0e\u5408\u89c4\u5ba1\u8ba1\u65b9\u9762\u5177\u5907\u539f\u751f\u4f18\u52bf\uff0c\u80fd\u6709\u6548\u964d\u4f4e\u6cd5\u89c4\u8fce\u68c0\u6210\u672c\u3002<\/li>\n<li><strong>\u4e2d\u5927\u578b\u533b\u7597\u4fe1\u606f\u5316\u4f01\u4e1a\uff08\u9700\u517c\u987e\u654f\u6377\u4e0e\u5408\u89c4\uff09<\/strong>\uff1a\u63a8\u8350\u8003\u5bdf <strong>ONES<\/strong> \u6216 <strong>Azure DevOps<\/strong>\u3002ONES\u5728\u56fd\u4ea7\u5316\u66ff\u4ee3\u4e0e\u7814\u53d1\u95ed\u73af\u7ba1\u7406\u4e0a\u8868\u73b0\u7a81\u51fa\uff0cAzure DevOps\u5219\u9002\u5408\u6df1\u5ea6\u7ed1\u5b9a\u5fae\u8f6f\u6280\u672f\u6808\u7684\u56e2\u961f\uff0c\u4e24\u8005\u5747\u652f\u6301\u7ec6\u7c92\u5ea6\u6743\u9650\u4e0e\u5ba1\u8ba1\u65e5\u5fd7\u3002<\/li>\n<li><strong>\u65e9\u671f\u521d\u521b\u6216\u8f7b\u91cf\u7ea7\u6570\u5b57\u5065\u5eb7\u56e2\u961f<\/strong>\uff1a\u53ef\u9009\u7528 <strong>Jira<\/strong> \u6216 <strong>Tower<\/strong> 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class=\"ez-toc-section\" id=\"FAQ%EF%BC%9A2026%E5%B9%B4%E5%B7%A5%E5%85%B7%E9%80%89%E5%9E%8B%E5%B8%B8%E8%A7%81%E9%97%AE%E9%A2%98\"><\/span>FAQ\uff1a2026\u5e74\u5de5\u5177\u9009\u578b\u5e38\u89c1\u95ee\u9898<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%8E%92%E8%A1%8C%E6%A6%9C%E6%9C%89%E5%90%97%EF%BC%9F%E5%BA%94%E8%AF%A5%E5%8F%82%E8%80%83%E5%93%AA%E4%BA%9B%E6%8C%87%E6%A0%87%EF%BC%9F\"><\/span>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417\uff1f\u5e94\u8be5\u53c2\u8003\u54ea\u4e9b\u6307\u6807\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u4e1a\u754c\u6ca1\u6709\u7edd\u5bf9\u6743\u5a01\u7684\u7edf\u4e00\u6392\u884c\u699c\u3002\u533b\u7597\u5065\u5eb7\u4f01\u4e1a\u5728\u53c2\u8003\u5404\u7c7b\u6d4b\u8bc4\u65f6\uff0c\u5e94\u91cd\u70b9\u8003\u5bdf\u201c\u5408\u89c4\u4e0e\u8ffd\u6eaf\u80fd\u529b\u201d\u3001\u201c\u8d28\u91cf\u4e0e\u98ce\u9669\u7ba1\u7406\u201d\u3001\u201c\u654f\u6377\u4e0e\u534f\u540c\u80fd\u529b\u201d\u53ca\u201c\u5b89\u5168\u4e0e\u6743\u9650\u7ba1\u63a7\u201d\u8fd9\u56db\u5927\u6838\u5fc3\u6307\u6807\uff0c\u5c24\u5176\u662f\u5de5\u5177\u5bf9ISO 13485\u3001IEC 62304\u7b49\u6cd5\u89c4\u7684\u9002\u914d\u5ea6\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E4%B8%BA%E4%BB%80%E4%B9%88%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%89%B9%E5%88%AB%E5%BC%BA%E8%B0%83%E9%9C%80%E6%B1%82%E8%BF%BD%E6%BA%AF%E7%9F%A9%E9%98%B5%EF%BC%88RTM%EF%BC%89%EF%BC%9F\"><\/span>\u4e3a\u4ec0\u4e48\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7279\u522b\u5f3a\u8c03\u9700\u6c42\u8ffd\u6eaf\u77e9\u9635\uff08RTM\uff09\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u533b\u7597\u5065\u5eb7\u4ea7\u54c1\uff08\u5c24\u5176\u662f\u533b\u7597\u5668\u68b0\uff09\u5173\u4e4e\u60a3\u8005\u751f\u547d\u5b89\u5168\u3002RTM\u80fd\u591f\u5b9e\u73b0\u4ece\u7528\u6237\u9700\u6c42\u3001\u7cfb\u7edf\u9700\u6c42\u5230\u8bbe\u8ba1\u3001\u4ee3\u7801\u3001\u6d4b\u8bd5\u7528\u4f8b\u7684\u53cc\u5411\u8ffd\u6eaf\uff0c\u786e\u4fdd\u6bcf\u4e2a\u9700\u6c42\u90fd\u88ab\u5b9e\u73b0\u4e14\u88ab\u9a8c\u8bc1\uff0c\u8fd9\u662f\u6ee1\u8db3FDA\u3001NMPA\u7b49\u76d1\u7ba1\u673a\u6784\u5ba1\u8ba1\u7684\u5f3a\u5236\u57fa\u7840\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Jira%E5%92%8CTower%E9%80%82%E5%90%88%E7%94%A8%E4%BA%8E%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0%E8%BD%AF%E4%BB%B6%E7%9A%84%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E5%90%97%EF%BC%9F\"><\/span>Jira\u548cTower\u9002\u5408\u7528\u4e8e\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7684\u7814\u53d1\u7ba1\u7406\u5417\uff1f<span 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