{"id":11431,"date":"2026-05-14T11:54:38","date_gmt":"2026-05-14T03:54:38","guid":{"rendered":"https:\/\/www.behealthventures.com\/knowledge_base\/fda%e5%af%a9%e6%9f%bb%e3%81%ae%e8%a6%96%e7%82%b9%ef%bd%9cai-samd%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8biec-62304%e3%81%ae%e5%ae%9f%e8%a3%85-%e8%a8%ad%e8%a8%88%e7%ae%a1%e7%90%86%e3%81%8a%e3%82%88\/"},"modified":"2026-05-14T11:54:38","modified_gmt":"2026-05-14T03:54:38","slug":"fda%e5%af%a9%e6%9f%bb%e3%81%ae%e8%a6%96%e7%82%b9%ef%bd%9cai-samd%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8biec-62304%e3%81%ae%e5%ae%9f%e8%a3%85-%e8%a8%ad%e8%a8%88%e7%ae%a1%e7%90%86%e3%81%8a%e3%82%88","status":"publish","type":"knowledge_base","link":"https:\/\/behealthventures.com\/ja\/knowledge_base\/fda%e5%af%a9%e6%9f%bb%e3%81%ae%e8%a6%96%e7%82%b9%ef%bd%9cai-samd%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8biec-62304%e3%81%ae%e5%ae%9f%e8%a3%85-%e8%a8%ad%e8%a8%88%e7%ae%a1%e7%90%86%e3%81%8a%e3%82%88\/","title":{"rendered":"FDA\u5be9\u67fb\u306e\u8996\u70b9\uff5cAI 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data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;134245417&quot;:true}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u5b9f\u88c5\u53ef\u80fd\u304b\u3064\u5b9f\u52b9\u6027\u306e\u3042\u308b\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u4e00\u3064\u306b\u96c6\u7d04\u3055\u308c\u307e\u3059\u3002\u3059\u306a\u308f\u3061\u3001AI\u306e\u975e\u6c7a\u5b9a\u6027\u3092\u6709\u3059\u308b\u30e2\u30b8\u30e5\u30fc\u30eb\u3092\u6c7a\u5b9a\u8ad6\u7684\u306a\u30b7\u30b9\u30c6\u30e0\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u5185\u306b\u5185\u5305\u3057\u3001\u6700\u5c0f\u9650\u3067\u3042\u308a\u306a\u304c\u3089\u5b8c\u5168\u6027\u3092\u62c5\u4fdd\u3057\u305f\u8a2d\u8a08\u7ba1\u7406\uff08Design 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data-contrast=\"none\">\u4e00\u3001AI\u306e\u4f4d\u7f6e\u3065\u3051\u3092\u660e\u78ba\u306b\u3059\u308b \u2015 \u4f8b\u5916\u3067\u306f\u306a\u304f\u3001Software Item\u3068\u3057\u3066\u5b9a\u7fa9\u3059\u308b<\/span><br \/>\n<span data-contrast=\"none\">IEC 62304\u202f\u306f\u3001AI\u3092\u7528\u3044\u305f\u304b\u3089\u3068\u3044\u3063\u3066\u30eb\u30fc\u30eb\u304c\u5909\u308f\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u672c\u898f\u683c\u304c\u4e00\u8cab\u3057\u3066\u91cd\u8996\u3057\u3066\u3044\u308b\u306e\u306f\u3001\u300c\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u5b89\u5168\u30af\u30e9\u30b9\u5206\u985e\uff08Class\u00a0A\uff0fB\uff0fC\uff09\u300d\u304a\u3088\u3073\u300c\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30d7\u30ed\u30bb\u30b9\u300d\u306e2\u70b9\u3067\u3059\u3002\u3057\u305f\u304c\u3063\u3066\u3001\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u5192\u982d\u306b\u304a\u3044\u3066\u3001AI\u30e2\u30b8\u30e5\u30fc\u30eb\u3092IEC 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data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;134245417&quot;:true}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u3053\u306e\u4f4d\u7f6e\u3065\u3051\u306f\u5358\u306a\u308b\u5f62\u5f0f\u8ad6\u3067\u306f\u306a\u304f\u3001\u5be9\u67fb\u306b\u304a\u3051\u308b\u8ad6\u7406\u69cb\u9020\u305d\u306e\u3082\u306e\u306b\u95a2\u308f\u308b\u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8\u3067\u3059\u3002AI\u3092Software Item\u3068\u3057\u3066\u5b9a\u7fa9\u3059\u308b\u3053\u3068\u3067\u3001\u5be9\u67fb\u8005\u306b\u5bfe\u3057\u3066\u306f\u30cb\u30e5\u30fc\u30e9\u30eb\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u306e\u5185\u90e8\u69cb\u9020\u3092\u8a73\u7d30\u306b\u8aac\u660e\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u300c\u9ad8\u30ea\u30b9\u30af\u306a\u30d6\u30e9\u30c3\u30af\u30dc\u30c3\u30af\u30b9\u30e2\u30b8\u30e5\u30fc\u30eb\u3092\u3044\u304b\u306b\u30b7\u30b9\u30c6\u30e0\u5168\u4f53\u306e\u7d71\u5236\u4e0b\u306b\u7f6e\u304d\u3001\u691c\u8a3c\u53ef\u80fd\u6027\uff08Verifiability\uff09\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\uff08Traceability\uff09\u3001\u304a\u3088\u3073\u30ed\u30fc\u30eb\u30d0\u30c3\u30af\u53ef\u80fd\u6027\uff08<\/span><span data-contrast=\"none\">Rollbackability<\/span><span data-contrast=\"none\">\uff09\u3092\u62c5\u4fdd\u3057\u3066\u3044\u308b\u304b\u300d\u3092\u793a\u3059\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;134245417&quot;:true}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u3055\u3089\u306b\u5b9f\u52d9\u7684\u306a\u89b3\u70b9\u3067\u306f\u3001\u5b89\u5168\u30af\u30e9\u30b9\u306e\u904e\u5c0f\u8a55\u4fa1\u306f\u91cd\u5927\u306a\u30ea\u30b9\u30af\u3092\u4f34\u3044\u307e\u3059\u3002\u4e00\u5ea6\u5206\u985e\u3092\u8aa4\u308b\u3068\u3001\u305d\u306e\u5f8c\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u69cb\u6210\u3084\u691c\u8a3c\u30fb\u8a66\u9a13\u6226\u7565\u5168\u4f53\u306b\u5bfe\u3057\u3066\u5f37\u3044\u7591\u7fa9\u304c\u5448\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u7279\u306b\u8a3a\u65ad\u307e\u305f\u306f\u6cbb\u7642\u610f\u601d\u6c7a\u5b9a\u306b\u95a2\u4e0e\u3059\u308bAI\u306e\u5834\u5408\u3001\u5b9f\u52d9\u4e0a\u306fClass B\u307e\u305f\u306fClass C\u306b\u5206\u985e\u3055\u308c\u308b\u30b1\u30fc\u30b9\u304c\u4e00\u822c\u7684\u3067\u3059\u3002\u5b89\u5168\u30af\u30e9\u30b9\u5206\u985e\u306f\u5358\u306a\u308b\u898f\u5236\u4e0a\u306e\u9078\u629e\u80a2\u3067\u306f\u306a\u304f\u3001\u5fc5\u8981\u3068\u306a\u308b\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u30b3\u30b9\u30c8\u69cb\u9020\u3001\u4e0a\u5e02\u307e\u3067\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3001\u3055\u3089\u306b\u306f\u5be9\u67fb\u904e\u7a0b\u306b\u304a\u3051\u308b\u8cea\u7591\u306e\u6df1\u5ea6\u3092\u76f4\u63a5\u7684\u306b\u898f\u5b9a\u3059\u308b\u91cd\u8981\u306a\u8981\u7d20\u3067\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;134245417&quot;:true}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;134245417&quot;:true}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u4e8c\u3001\u8a2d\u8a08\u7ba1\u7406\uff08Design Control\uff09\u306eMVP \u2015 \u6700\u77ed\u7d4c\u8def\u3067DHF\u306e\u9aa8\u683c\u3092\u69cb\u7bc9\u3059\u308b<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">IEC 62304\u202f\u306b\u304a\u3051\u308b\u8a2d\u8a08\u7ba1\u7406\u3068\u306f\u3001\u5b9f\u52d9\u7684\u306b\u306f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u3068\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3092\u4e00\u4f53\u306e\u6d41\u308c\u3068\u3057\u3066\u7d50\u3073\u3064\u3051\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002\u3053\u306e\u6700\u5c0f\u69cb\u9020\u306f\u3001\u305d\u306e\u307e\u307eDHF\uff08Design History File\uff1a\u8a2d\u8a08\u5c65\u6b74\u30d5\u30a1\u30a4\u30eb\uff09\u306e\u539f\u578b\u306b\u5bfe\u5fdc\u3057\u307e\u3059\u3002\u3053\u3053\u3067\u6c42\u3081\u3089\u308c\u308b\u306e\u306f\u3001\u81a8\u5927\u306a\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u96c6\u5408\u3067\u306f\u306a\u304f\u3001\u5be9\u67fb\u306b\u304a\u3044\u3066\u4e00\u8cab\u3057\u3066\u8ffd\u8de1\u53ef\u80fd\u306a\u300c\u901a\u308b\u3079\u304d\u7d4c\u8def\u300d\u3092\u69cb\u7bc9\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u305d\u3057\u3066\u3001\u305d\u306e\u5404\u30b9\u30c6\u30c3\u30d7\u304c\u5fc5\u305a\u30a8\u30d3\u30c7\u30f3\u30b9\u3078\u3068\u63a5\u7d9a\u3055\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6700\u77ed\u7d4c\u8def\u306f\u4ee5\u4e0b\u306b\u96c6\u7d04\u3055\u308c\u307e\u3059\uff1aSRS \u2192 SAD \u2192 SDS \u2192\u00a0\u5b9f\u88c5\u00a0\u2192 V&amp;V\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u5b9f\u88c5\u306b\u3042\u305f\u3063\u3066\u306f\u3001\u5be9\u67fb\u8005\u306b\u3068\u3063\u3066\u7406\u89e3\u3057\u3084\u3059\u30443\u3064\u306e\u8a2d\u8a08\u30a2\u30af\u30b7\u30e7\u30f3\u3092\u78ba\u5b9f\u306b\u62bc\u3055\u3048\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u5be9\u67fb\u8005\u304c\u8a55\u4fa1\u3059\u308b\u306e\u306f\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u5206\u91cf\u3067\u306f\u306a\u304f\u3001\u4e0d\u78ba\u5b9f\u6027\u304c\u5de5\u5b66\u7684\u306b\u5236\u5fa1\u53ef\u80fd\u306a\u5f62\u3078\u3068\u53ce\u675f\u3055\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3067\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u7b2c\u4e00\u306e\u30a2\u30af\u30b7\u30e7\u30f3\uff1aSRS\u306b\u304a\u3044\u3066AI\u8981\u4ef6\u3092\u300c\u691c\u8a3c\u53ef\u80fd\u306a\u30b7\u30b9\u30c6\u30e0\u6319\u52d5\u300d\u3068\u3057\u3066\u5b9a\u7fa9\u3059\u308b<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u30b7\u30b9\u30c6\u30e0\u8981\u6c42\u4ed5\u69d8\u66f8\uff08SRS\uff09\u3067\u306f\u3001\u300cAI\u304c\u75c5\u5909\u3092\u691c\u51fa\u3059\u308b\u300d\u3068\u3044\u3063\u305f\u62bd\u8c61\u7684\u306a\u8a18\u8ff0\u306b\u7559\u3081\u3066\u306f\u3044\u3051\u307e\u305b\u3093\u3002AI\u306e\u4e0d\u78ba\u5b9f\u6027\u3092\u3001\u30b7\u30b9\u30c6\u30e0\u3068\u3057\u3066\u5236\u5fa1\u53ef\u80fd\u306a\u30eb\u30fc\u30eb\u3078\u3068\u5909\u63db\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u300cAI\u30e2\u30b8\u30e5\u30fc\u30eb\u306e\u51fa\u529b\u306b\u306f\u5fc5\u305a\u4fe1\u983c\u5ea6\uff08confidence score\uff09\u3092\u4ed8\u4e0e\u3059\u308b\u3053\u3068\u300d\u300c\u5f53\u8a72\u4fe1\u983c\u5ea6\u304c\u4e8b\u524d\u306b\u5b9a\u7fa9\u3055\u308c\u305f\u95be\u5024\u3092\u6e80\u305f\u3057\u305f\u5834\u5408\u306b\u306e\u307f\u3001\u30b7\u30b9\u30c6\u30e0\u306f\u305d\u306e\u7d50\u679c\u3092\u63a1\u7528\u3059\u308b\u3053\u3068\u300d\u300c\u95be\u5024\u3092\u4e0b\u56de\u308b\u5834\u5408\u306b\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u306f\u30d5\u30a7\u30a4\u30eb\u30bb\u30fc\u30d5\u3068\u3057\u3066\u4f4e\u6a5f\u80fd\u30e2\u30fc\u30c9\u3078\u79fb\u884c\u3059\u308b\u3001\u3082\u3057\u304f\u306f\u4eba\u306b\u3088\u308b\u30ec\u30d3\u30e5\u30fc\u3092\u8981\u6c42\u3059\u308b\u3053\u3068\u300d\u3068\u3044\u3063\u305f\u5f62\u3067\u660e\u78ba\u306b\u898f\u5b9a\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3053\u3053\u3067\u91cd\u8981\u306a\u306e\u306f\u3001\u95be\u5024\u304c0.8\u304b0.75\u304b\u3068\u3044\u3063\u305f\u6570\u5024\u305d\u306e\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u304c\u691c\u8a3c\u53ef\u80fd\u304b\u3064\u8a66\u9a13\u53ef\u80fd\u306a\u30b7\u30b9\u30c6\u30e0\u6319\u52d5\u3068\u3057\u3066\u8a18\u8ff0\u3055\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3067\u3059\u3002\u3053\u306e\u30b9\u30c6\u30c3\u30d7\u306e\u672c\u8cea\u306f\u3001\u30e2\u30c7\u30eb\u6027\u80fd\u306b\u5185\u5728\u3059\u308b\u4e0d\u78ba\u5b9f\u6027\u3092\u3001\u30b7\u30b9\u30c6\u30e0\u6319\u52d5\u3068\u3057\u3066\u306e\u78ba\u5b9f\u6027\u3078\u3068\u5909\u63db\u3059\u308b\u70b9\u306b\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u5be9\u67fb\u5f53\u5c40\u306f\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3092\u8a2d\u8a08\u306e\u4e00\u90e8\u3068\u3057\u3066\u7406\u89e3\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u3001\u30ea\u30b9\u30af\u3092\u5358\u306b\u30e2\u30c7\u30eb\u306b\u59d4\u306d\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u8a2d\u8a08\u3068\u3057\u3066\u7d71\u5408\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u304c\u660e\u78ba\u306b\u306a\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u7b2c\u4e8c\u306e\u30a2\u30af\u30b7\u30e7\u30f3\uff1aSAD\u306b\u304a\u3044\u3066AI\u3092\u30d6\u30e9\u30c3\u30af\u30dc\u30c3\u30af\u30b9\u30b5\u30fc\u30d3\u30b9\u3068\u3057\u3066\u62bd\u8c61\u5316\u3057\u3001\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u5b9a\u7fa9\u3092\u53b3\u683c\u306b\u884c\u3046<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u8a2d\u8a08\uff08SAD\uff09\u30ec\u30a4\u30e4\u30fc\u3067\u306f\u3001\u30e2\u30c7\u30eb\u5185\u90e8\u306e\u69cb\u9020\u3092\u8a73\u7d30\u306b\u958b\u793a\u3059\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001AI\u3092\u7d71\u5236\u53ef\u80fd\u306a\u30b5\u30fc\u30d3\u30b9\u30e2\u30b8\u30e5\u30fc\u30eb\u3068\u3057\u3066\u5b9a\u7fa9\u3059\u308b\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u5c11\u306a\u304f\u3068\u3082\u4ee5\u4e0b\u306e\u5883\u754c\u6761\u4ef6\u3092\u660e\u78ba\u306b\u3057\u3001\u691c\u8a3c\u53ef\u80fd\u304b\u3064\u30c6\u30b9\u30c8\u53ef\u80fd\u306a\u5f62\u3067\u5b9a\u7fa9\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e00\u306b\u3001\u5165\u529b\u4ed5\u69d8\u306e\u5b9a\u7fa9\u3067\u3059\u3002\u5165\u529b\u30c7\u30fc\u30bf\u306e\u5f62\u5f0f\u304a\u3088\u3073\u8a31\u5bb9\u7bc4\u56f2\u3001\u753b\u50cf\u3084\u4fe1\u53f7\u306e\u4ed5\u69d8\u3001\u6b20\u640d\u5024\u306e\u53d6\u308a\u6271\u3044\u3001\u4f8b\u5916\u30b1\u30fc\u30b9\u3092\u542b\u3081\u3066\u660e\u78ba\u306b\u898f\u5b9a\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e8c\u306b\u3001\u524d\u51e6\u7406\u306e\u5b9a\u7fa9\u3067\u3059\u3002\u3069\u306e\u51e6\u7406\u304c\u56fa\u5b9a\u30eb\u30fc\u30eb\u3068\u3057\u3066\u5b9f\u88c5\u3055\u308c\u308b\u306e\u304b\u3001\u3069\u306e\u51e6\u7406\u304c\u30e2\u30c7\u30eb\u51fa\u529b\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u306e\u304b\u3092\u533a\u5225\u3057\u3066\u660e\u793a\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e09\u306b\u3001\u51fa\u529b\u4ed5\u69d8\u306e\u5b9a\u7fa9\u3067\u3059\u3002\u51fa\u529b\u306f\u5fc5\u305a\u69cb\u9020\u5316\u30c7\u30fc\u30bf\u3068\u3057\u3066\u5b9a\u7fa9\u3057\u3001\u5206\u985e\u7d50\u679c\u3001\u4f4d\u7f6e\u60c5\u5831\u3001\u4fe1\u983c\u5ea6\uff08confidence\uff09\u3001\u30a2\u30e9\u30fc\u30c8\u30d5\u30e9\u30b0\u306a\u3069\u306e\u5fc5\u9808\u30d5\u30a3\u30fc\u30eb\u30c9\u3092\u660e\u78ba\u306b\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u56db\u306b\u3001\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u4ed5\u69d8\u306e\u5b9a\u7fa9\u3067\u3059\u3002API\u30b7\u30b0\u30cd\u30c1\u30e3\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u7ba1\u7406\u3001\u5f8c\u65b9\u4e92\u63db\u6027\u3001\u306a\u3089\u3073\u306b\u30ed\u30fc\u30eb\u30d0\u30c3\u30af\u6226\u7565\u3092\u542b\u3081\u3066\u898f\u5b9a\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e94\u306b\u3001\u30a8\u30e9\u30fc\u30cf\u30f3\u30c9\u30ea\u30f3\u30b0\u304a\u3088\u3073\u30bf\u30a4\u30e0\u30a2\u30a6\u30c8\u51e6\u7406\u3067\u3059\u3002\u969c\u5bb3\u767a\u751f\u6642\u307e\u305f\u306f\u9045\u5ef6\u6642\u306b\u304a\u3044\u3066\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u3069\u306e\u3088\u3046\u306a\u72b6\u614b\u3078\u9077\u79fb\u3059\u308b\u304b\u3092\u5b9a\u7fa9\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"6\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u516d\u306b\u3001\u4fe1\u983c\u5ea6\u95be\u5024\u306e\u30b7\u30b9\u30c6\u30e0\u3078\u306e\u7d44\u307f\u8fbc\u307f\u65b9\u6cd5\u3067\u3059\u3002\u4f4e\u4fe1\u983c\u5ea6\u6642\u306e\u51e6\u7406\u30d5\u30ed\u30fc\u3001UI\u4e0a\u306e\u8868\u793a\u3001\u30ed\u30b0\u8a18\u9332\u304a\u3088\u3073\u76e3\u67fb\u30c8\u30ec\u30a4\u30eb\u306e\u8a2d\u8a08\u3092\u660e\u78ba\u306b\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">\u5be9\u67fb\u8005\u304c\u78ba\u8a8d\u3059\u308b\u30dd\u30a4\u30f3\u30c8\u306f\u3001\u30d6\u30e9\u30c3\u30af\u30dc\u30c3\u30af\u30b9\u3067\u3042\u308bAI\u306e\u5883\u754c\u6761\u4ef6\u304c\u9069\u5207\u306b\u5236\u5fa1\u3055\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3067\u3059\u3002\u4eee\u306b\u30e2\u30c7\u30eb\u304c\u5b8c\u5168\u306b\u8aac\u660e\u53ef\u80fd\u3067\u306a\u3044\u5834\u5408\u3067\u3042\u3063\u3066\u3082\u3001\u5de5\u5b66\u7684\u306b\u5b9a\u7fa9\u3055\u308c\u305f\u5883\u754c\u6761\u4ef6\u306b\u3088\u308a\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u7570\u5e38\u6642\u306b\u304a\u3044\u3066\u3082\u5236\u5fa1\u53ef\u80fd\u306a\u72b6\u614b\u3092\u7dad\u6301\u3067\u304d\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u3059\u306a\u308f\u3061\u3001\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3092\u30e2\u30c7\u30eb\u5185\u90e8\u306b\u59d4\u306d\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u30b7\u30b9\u30c6\u30e0\u8a2d\u8a08\u3068\u3057\u3066\u62c5\u4fdd\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u660e\u78ba\u306b\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u7b2c\u4e09\u306e\u30a2\u30af\u30b7\u30e7\u30f3\uff1aSDS\u306f\u9010\u6b21\u7684\u306a\u8aac\u660e\u3067\u306f\u306a\u304f\u3001\u300c\u898f\u7bc4\u5316\u300d\u306b\u3088\u308b\u7d71\u5236\u3092\u884c\u3046<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u6700\u5c0f\u5b9f\u884c\u53ef\u80fd\u306a\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8a73\u7d30\u8a2d\u8a08\uff08SDS\uff09\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u306e\u306f\u3001AI\u30e2\u30b8\u30e5\u30fc\u30eb\u3092\u300c\u76e3\u67fb\u53ef\u80fd\u306a\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u6210\u679c\u7269\u300d\u3068\u3057\u3066\u5b9a\u7fa9\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u30cb\u30e5\u30fc\u30e9\u30eb\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u306e\u5185\u90e8\u69cb\u9020\u3092\u9010\u4e00\u8aac\u660e\u3059\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3080\u3057\u308d\u3001\u300c\u5f53\u8a72\u30e2\u30c7\u30eb\u304c\u3069\u306e\u3088\u3046\u306b\u5b9a\u7fa9\u3055\u308c\u3001\u3069\u306e\u3088\u3046\u306b\u69cb\u7bc9\u3055\u308c\u3001\u3069\u306e\u3088\u3046\u306b\u518d\u73fe\uff08\u518d\u5b9f\u884c\uff09\u53ef\u80fd\u3067\u3042\u308b\u304b\u300d\u3092\u8aac\u660e\u3067\u304d\u308b\u3001\u518d\u73fe\u6027\u304a\u3088\u3073\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u3042\u308b\u5236\u5fa1\u30dd\u30a4\u30f3\u30c8\u3092\u78ba\u7acb\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u305d\u306e\u305f\u3081\u3001SDS\u3067\u306f\u5c11\u306a\u304f\u3068\u3082\u4ee5\u4e0b\u306e\u8981\u7d20\u3092\u8a18\u8ff0\u3057\u3001\u304b\u3064\u4e00\u8cab\u3057\u305f\u30d0\u30fc\u30b8\u30e7\u30f3\u7ba1\u7406\u306e\u3082\u3068\u3067\u7d10\u3065\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e00\u306b\u3001\u30e2\u30c7\u30eb\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u306e\u7a2e\u985e\u304a\u3088\u3073\u5236\u7d04\u6761\u4ef6\u3067\u3059\u3002\u5206\u985e\u30fb\u691c\u51fa\u30fb\u30bb\u30b0\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u306e\u3044\u305a\u308c\u306b\u8a72\u5f53\u3059\u308b\u306e\u304b\u3001\u524d\u51e6\u7406\u304a\u3088\u3073\u5f8c\u51e6\u7406\u30d1\u30a4\u30d7\u30e9\u30a4\u30f3\u306e\u6709\u7121\u3092\u542b\u3081\u3066\u660e\u78ba\u306b\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e8c\u306b\u3001\u5165\u529b\u30fb\u51fa\u529b\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u304a\u3088\u3073\u524d\u51e6\u7406\uff0f\u5f8c\u51e6\u7406\u306e\u898f\u5b9a\u3067\u3059\u3002\u6b63\u898f\u5316\u3001\u30af\u30ed\u30c3\u30d4\u30f3\u30b0\u3001\u30ce\u30a4\u30ba\u9664\u53bb\u3001\u7279\u5fb4\u91cf\u62bd\u51fa\u306a\u3069\u3001\u56fa\u5b9a\u30eb\u30fc\u30eb\u3068\u3057\u3066\u5b9f\u88c5\u3055\u308c\u308b\u51e6\u7406\u3092\u660e\u793a\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e09\u306b\u3001\u5b66\u7fd2\u30c7\u30fc\u30bf\u306e\u51fa\u6240\u304a\u3088\u3073\u30a2\u30ce\u30c6\u30fc\u30b7\u30e7\u30f3\u54c1\u8cea\u7ba1\u7406\u3067\u3059\u3002\u30a2\u30ce\u30c6\u30fc\u30b7\u30e7\u30f3\u57fa\u6e96\u3001\u30a2\u30ce\u30c6\u30fc\u30bf\u30fc\u306e\u8cc7\u683c\u8981\u4ef6\u3001\u76f8\u4e92\u8a55\u4fa1\uff08inter-rater agreement\uff09\u3001\u304a\u3088\u3073\u30c7\u30fc\u30bf\u9664\u5916\u57fa\u6e96\u3092\u542b\u3081\u3066\u5b9a\u7fa9\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u56db\u306b\u3001\u30c7\u30fc\u30bf\u5206\u5272\u6226\u7565\u3067\u3059\u3002\u5c11\u306a\u304f\u3068\u3082train\uff0fvalidation\uff0ftest\u306e\u5206\u5272\u65b9\u91dd\u3092\u660e\u78ba\u306b\u3057\u3001\u5916\u90e8\u30c7\u30fc\u30bf\u3084\u591a\u65bd\u8a2d\u30c7\u30fc\u30bf\u306e\u4f4d\u7f6e\u3065\u3051\u304a\u3088\u3073\u4f7f\u7528\u65b9\u6cd5\u3092\u8aac\u660e\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e94\u306b\u3001\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u30d7\u30ed\u30bb\u30b9\u306e\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u8a2d\u8a08\u3067\u3059\u3002\u4e3b\u8981\u306a\u30cf\u30a4\u30d1\u30fc\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u7ba1\u7406\u3001\u4e71\u6570\u30b7\u30fc\u30c9\u306e\u56fa\u5b9a\u3001\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u74b0\u5883\u304a\u3088\u3073\u4f9d\u5b58\u30e9\u30a4\u30d6\u30e9\u30ea\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">\u3053\u3053\u3067\u884c\u3063\u3066\u3044\u308b\u306e\u306f\u5b66\u8853\u8ad6\u6587\u306e\u8a18\u8ff0\u3067\u306f\u306a\u304f\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30ac\u30d0\u30ca\u30f3\u30b9\u306e\u69cb\u7bc9\u3067\u3059\u3002\u3059\u3079\u3066\u306e\u518d\u5b9f\u884c\u306b\u304a\u3044\u3066\u3001\u300c\u3053\u306e\u7d50\u679c\u306f\u540c\u4e00\u306e\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u6761\u4ef6\u4e0b\u3067\u518d\u73fe\u53ef\u80fd\u3067\u3042\u308a\u3001\u304b\u3064\u76e3\u67fb\u53ef\u80fd\u304b\u300d\u3068\u3044\u3046\u554f\u3044\u306b\u5bfe\u3057\u3066\u660e\u78ba\u306b\u7b54\u3048\u3089\u308c\u308b\u72b6\u614b\u3092\u62c5\u4fdd\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u4e09\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u7ba1\u7406\u304a\u3088\u3073\u5909\u66f4\u7ba1\u7406 \u2015 Retraining\u3092\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u66f4\u65b0\u3068\u3057\u3066\u6271\u3046\u3053\u3068\u3067\u3001\u5408\u898f\u6027\u306f\u4e00\u6c17\u306b\u62c5\u4fdd\u3055\u308c\u308b<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">AI\u00a0SaMD<\/span><span data-contrast=\"auto\">\u306b\u304a\u3044\u3066\u6700\u3082\u983b\u51fa\u3059\u308b\u8ab2\u984c\u306f\u3001\u30e2\u30c7\u30eb\u306e\u66f4\u65b0\u30b5\u30a4\u30af\u30eb\u306f\u9ad8\u901f\u3067\u3042\u308b\u4e00\u65b9\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u304c\u78ba\u4fdd\u3055\u308c\u3066\u3044\u306a\u3044\u70b9\u3067\u3059\u3002IEC 62304\u202f\u306b\u57fa\u3065\u304f\u5b9f\u52d9\u7684\u306a\u89e3\u6c7a\u7b56\u306f\u6975\u3081\u3066\u660e\u78ba\u3067\u3059\u3002\u3059\u306a\u308f\u3061\u3001\u3059\u3079\u3066\u306e\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u304a\u3088\u3073\u518d\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\uff08Retraining\uff09\u3092\u300c\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u66f4\u65b0\u300d\u3068\u3057\u3066\u6271\u3044\u3001\u66f4\u65b0\u8a08\u753b\u304a\u3088\u3073\u30ed\u30fc\u30eb\u30d0\u30c3\u30af\u6226\u7565\u3092\u5fc5\u305a\u5b9a\u7fa9\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u307e\u305f\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u547d\u540d\u306f\u5358\u306a\u308b\u300cv1.2\u300d\u3068\u3044\u3063\u305f\u5185\u90e8\u30e9\u30d9\u30eb\u306b\u7559\u3081\u308b\u3079\u304d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30e2\u30c7\u30eb\u30d0\u30fc\u30b8\u30e7\u30f3\u306f\u3001\u4f7f\u7528\u3057\u305f\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u30c7\u30fc\u30bf\u30bb\u30c3\u30c8\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u3001\u304a\u3088\u3073\u30cf\u30a4\u30d1\u30fc\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u3068\u53b3\u5bc6\u306b\u7d10\u3065\u3051\u3066\u7ba1\u7406\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u4efb\u610f\u306e\u6642\u70b9\u306b\u304a\u3044\u3066\u4ee5\u4e0b\u306e\u554f\u3044\u306b\u5373\u5ea7\u306b\u56de\u7b54\u53ef\u80fd\u3068\u306a\u308a\u307e\u3059\uff1a\u300c\u73fe\u5728\u5e02\u5834\u306b\u63d0\u4f9b\u3055\u308c\u3066\u3044\u308b\u30e2\u30c7\u30eb\u306f\u3069\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u304b\u300d\u300c\u3069\u306e\u30c7\u30fc\u30bf\u30bb\u30c3\u30c8\u3067\u5b66\u7fd2\u3055\u308c\u305f\u304b\u300d\u300c\u3069\u306e\u30cf\u30a4\u30d1\u30fc\u30d1\u30e9\u30e1\u30fc\u30bf\u304c\u4f7f\u7528\u3055\u308c\u305f\u304b\u300d\u300c\u524d\u30d0\u30fc\u30b8\u30e7\u30f3\u3068\u306e\u5dee\u5206\u306f\u4f55\u304b\u300d\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3053\u306e\u9818\u57df\u306f\u4e00\u898b\u3059\u308b\u3068\u5358\u306a\u308b\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u7ba1\u7406\u306e\u554f\u984c\u306b\u898b\u3048\u307e\u3059\u304c\u3001\u5b9f\u969b\u306b\u306f\u30b0\u30ed\u30fc\u30d0\u30eb\u898f\u5236\u5bfe\u5fdc\u306b\u304a\u3051\u308b\u5171\u901a\u8a00\u8a9e\u3067\u3082\u3042\u308a\u307e\u3059\u3002FDA\u202f\u304c\u91cd\u8996\u3059\u308b\u306e\u306f\u3001\u5e02\u8ca9\u30d0\u30fc\u30b8\u30e7\u30f3\u3068\u5909\u66f4\u5f8c\u30d0\u30fc\u30b8\u30e7\u30f3\u306e\u5dee\u7570\u3092\u660e\u78ba\u306b\u8aac\u660e\u3067\u304d\u308b\u304b\u3001\u305d\u3057\u3066\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u304c\u5f15\u304d\u7d9a\u304d\u6709\u52b9\u3067\u3042\u308b\u304b\u3068\u3044\u3046\u70b9\u3067\u3059\u3002\u4e00\u65b9\u3001\u6b27\u5dde\u306eMDR\u202f\u306a\u3069\u306e\u5e02\u5834\u3067\u306f\u3001\u5909\u66f4\u7ba1\u7406\u304cQMS\uff08\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff09\u306b\u7d44\u307f\u8fbc\u307e\u308c\u3066\u3044\u308b\u304b\u3001\u3055\u3089\u306b\u76e3\u67fb\u6642\u306b\u30d0\u30fc\u30b8\u30e7\u30f3\u3068\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u9023\u9396\u3092\u4e00\u8cab\u3057\u3066\u63d0\u793a\u3067\u304d\u308b\u304b\u304c\u91cd\u8996\u3055\u308c\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u52a0\u3048\u3066\u3001\u4f01\u696d\u7d71\u6cbb\u304a\u3088\u3073\u6295\u8cc7\u5bb6\u306e\u8996\u70b9\u306b\u304a\u3044\u3066\u3082\u3001\u3053\u306e\u9818\u57df\u306f\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\u3002\u6295\u8cc7\u5f8c\u306e\u76e3\u67fb\u3084M&amp;A\u306b\u304a\u3051\u308b\u30c7\u30e5\u30fc\u30c7\u30ea\u30b8\u30a7\u30f3\u30b9\u306b\u304a\u3044\u3066\u983b\u7e41\u306b\u78ba\u8a8d\u3055\u308c\u308b\u30dd\u30a4\u30f3\u30c8\u3067\u3042\u308a\u3001\u6700\u7d42\u7684\u306b\u306f\u300c\u5f53\u8a72\u4f01\u696d\u306e\u30a8\u30d3\u30c7\u30f3\u30b9\u304c\u4fe1\u983c\u306b\u8db3\u308b\u304b\u3069\u3046\u304b\u300d\u3092\u5de6\u53f3\u3059\u308b\u4e2d\u6838\u8981\u7d20\u3068\u306a\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u56db\u3001V&amp;V\uff08\u691c\u8a3c\u30fb\u59a5\u5f53\u6027\u78ba\u8a8d\uff09\u306e\u6700\u5c0f\u5b9f\u88c5 \u2015 \u975eAI\u306f\u5358\u4f53\u30c6\u30b9\u30c8\u3001AI\u306f\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u3068\u6027\u80fd\u30a8\u30d3\u30c7\u30f3\u30b9\u3067\u62c5\u4fdd\u3059\u308b<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u591a\u304f\u306e\u30c1\u30fc\u30e0\u306f\u691c\u8a3c\u304a\u3088\u3073\u59a5\u5f53\u6027\u78ba\u8a8d\uff08V&amp;V\uff09\u3092\u904e\u5ea6\u306b\u8907\u96d1\u306b\u8a2d\u8a08\u3057\u304c\u3061\u3067\u3059\u304c\u3001\u305d\u306e\u7d50\u679c\u3001\u81ea\u3089\u7dad\u6301\u3067\u304d\u306a\u3044\u72b6\u614b\u306b\u9665\u308b\u30b1\u30fc\u30b9\u304c\u898b\u53d7\u3051\u3089\u308c\u307e\u3059\u3002\u6700\u5c0f\u5b9f\u884c\u53ef\u80fd\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u3001\u3080\u3057\u308d\u5be9\u67fb\u8005\u306e\u601d\u8003\u306b\u8fd1\u304f\u3001V&amp;V\u3092\u4e09\u5c64\u69cb\u9020\u3068\u3057\u3066\u6574\u7406\u3059\u308b\u3053\u3068\u3067\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u9023\u9396\u3092\u30b7\u30f3\u30d7\u30eb\u304b\u3064\u53ef\u8aad\u6027\u306e\u9ad8\u3044\u5f62\u3067\u69cb\u7bc9\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u3067\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e00\u5c64\uff1a\u975eAI\u30e2\u30b8\u30e5\u30fc\u30eb\u306f\u6a19\u6e96\u7684\u306a\u5358\u4f53\u30c6\u30b9\u30c8\uff08Unit Test\uff09\u3092\u9069\u7528\u3057\u307e\u3059\u3002\u30c7\u30fc\u30bf\u30d1\u30a4\u30d7\u30e9\u30a4\u30f3\u3001\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u3001\u30eb\u30fc\u30eb\u30ed\u30b8\u30c3\u30af\u3001UI\u8868\u793a\u3001\u4f8b\u5916\u51e6\u7406\u306b\u3064\u3044\u3066\u3001\u5404\u66f4\u65b0\u5f8c\u306b\u81ea\u52d5\u7684\u306b\u691c\u8a3c\u3055\u308c\u308b\u4ed5\u7d44\u307f\u3092\u78ba\u7acb\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e8c\u5c64\uff1aAI\u30e2\u30b8\u30e5\u30fc\u30eb\u306f\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u30c6\u30b9\u30c8\u304a\u3088\u3073\u6027\u80fd\u8a55\u4fa1\u8a66\u9a13\u3092\u5b9f\u65bd\u3057\u307e\u3059\u3002\u3053\u308c\u3089\u306f\u7533\u8acb\u6642\u306b\u898f\u5b9a\u3057\u305f\u81e8\u5e8a\u7528\u9014\uff08Intended Use\uff09\u3068\u6574\u5408\u3055\u305b\u308b\u5fc5\u8981\u304c\u3042\u308a\u3001\u6027\u80fd\u6307\u6a19\u306f\u5fc5\u305a\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u8981\u4ef6\u3068\u7d10\u3065\u3051\u3066\u5b9a\u7fa9\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e09\u5c64\uff1a\u30b7\u30b9\u30c6\u30e0\u30ec\u30d9\u30eb\u3067\u306f\u7d71\u5408\u8a66\u9a13\u304a\u3088\u3073\u30b7\u30b9\u30c6\u30e0\u691c\u8a3c\u3092\u5b9f\u65bd\u3057\u307e\u3059\u3002\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u4ed5\u69d8\u3001\u5883\u754c\u6761\u4ef6\u3001\u30d5\u30a7\u30a4\u30eb\u30bb\u30fc\u30d5\u3068\u3057\u3066\u306e\u964d\u683c\u52d5\u4f5c\uff08degradation\uff09\u3001\u304a\u3088\u3073\u4eba\u306b\u3088\u308b\u30ec\u30d3\u30e5\u30fc\u4ecb\u5165\u30d5\u30ed\u30fc\u304c\u9069\u5207\u306b\u30c8\u30ea\u30ac\u30fc\u3055\u308c\u308b\u304b\u3092\u78ba\u8a8d\u3057\u3001\u3055\u3089\u306b\u81e8\u5e8a\u30c7\u30fc\u30bf\u307e\u305f\u306f\u30b7\u30df\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u30c7\u30fc\u30bf\u4e0a\u3067\u3001\u611f\u5ea6\uff08sensitivity\uff09\u3001\u7279\u7570\u5ea6\uff08specificity\uff09\u306a\u3069\u306e\u4e3b\u8981\u6027\u80fd\u6307\u6a19\u304c\u7dad\u6301\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u691c\u8a3c\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">\u3053\u3053\u3067\u91cd\u8981\u306a\u306e\u306f\u3001\u30c6\u30b9\u30c8\u306e\u91cf\u3067\u306f\u306a\u304f\u3001AI\u306e\u4e0d\u78ba\u5b9f\u6027\u3092\u300c\u6e2c\u5b9a\u53ef\u80fd\u306a\u6027\u80fd\u6307\u6a19\u300d\u3068\u300c\u691c\u8a3c\u53ef\u80fd\u306a\u30b7\u30b9\u30c6\u30e0\u6319\u52d5\u300d\u306b\u843d\u3068\u3057\u8fbc\u3081\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3067\u3059\u3002SRS\u306b\u304a\u3044\u3066\u4fe1\u983c\u5ea6\u95be\u5024\u304a\u3088\u3073\u964d\u683c\u30e2\u30fc\u30c9\u3092\u5b9a\u7fa9\u3057\u305f\u5834\u5408\u3001V&amp;V\u3067\u306f\u5c11\u306a\u304f\u3068\u3082\u4ee5\u4e0b\u306e2\u70b9\u3092\u8a3c\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3059\u306a\u308f\u3061\u3001\u9ad8\u4fe1\u983c\u5ea6\u9818\u57df\u306b\u304a\u3044\u3066\u306f\u6027\u80fd\u304c\u898f\u5b9a\u5024\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3001\u4f4e\u4fe1\u983c\u5ea6\u9818\u57df\u306b\u304a\u3044\u3066\u306f\u30ec\u30d3\u30e5\u30fc\u8981\u6c42\u307e\u305f\u306f\u964d\u683c\u52d5\u4f5c\u304c\u78ba\u5b9f\u306b\u767a\u52d5\u3059\u308b\u3053\u3068\u3001\u3055\u3089\u306b\u7d71\u5408\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u304c\u5883\u754c\u6761\u4ef6\u4e0b\u3067\u3082\u7834\u7dbb\u3057\u306a\u3044\u3053\u3068\u3067\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u5be9\u67fb\u8005\u304c\u78ba\u8a8d\u3057\u305f\u3044\u306e\u306f\u3001\u30ea\u30b9\u30af\u304c\u4e3b\u5f35\u306b\u3088\u3063\u3066\u3067\u306f\u306a\u304f\u3001\u5236\u5fa1\u69cb\u9020\u306b\u3088\u3063\u3066\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3067\u3059\u3002\u3059\u306a\u308f\u3061\u3001\u30ea\u30b9\u30af\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u304c\u8a2d\u8a08\u304a\u3088\u3073\u691c\u8a3c\u30d7\u30ed\u30bb\u30b9\u306e\u4e2d\u306b\u4e00\u8cab\u3057\u3066\u7d44\u307f\u8fbc\u307e\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u4e94\u3001Traceability Matrix\u306eMVP \u2015 \u5de8\u5927\u306a\u30af\u30ed\u30b9\u8868\u3067\u306f\u306a\u304f\u3001\u76e3\u67fb\u53ef\u80fd\u306a\u300c\u30a8\u30d3\u30c7\u30f3\u30b9\u30c1\u30a7\u30fc\u30f3\u300d\u3092\u69cb\u7bc9\u3059\u308b<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Traceability\u306e\u6700\u5c0f\u53ef\u884c\u5b9a\u7fa9\u306f\u975e\u5e38\u306b\u30b7\u30f3\u30d7\u30eb\u3067\u3059\u3002\u3059\u306a\u308f\u3061\u3001\u300c\u30ea\u30b9\u30af\u304b\u3089\u30a8\u30d3\u30c7\u30f3\u30b9\u307e\u3067\u4e00\u8cab\u3057\u3066\u8fbf\u308c\u308b\u4e00\u672c\u306e\u7dda\u3092\u69cb\u7bc9\u3067\u304d\u308b\u3053\u3068\u300d\u3067\u3059\u3002\u7db2\u7f85\u7684\u3067\u5de8\u5927\u306a\u30af\u30ed\u30b9\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9\u30c6\u30fc\u30d6\u30eb\u3092\u7dad\u6301\u3059\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u91cd\u8981\u306a\u306e\u306f\u3001\u5404\u30ea\u30b9\u30af\u304c\u5c11\u306a\u304f\u3068\u30821\u3064\u306e\u8981\u6c42\u4e8b\u9805\u3001\u8a2d\u8a08\u9805\u76ee\u3001\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u3001\u304a\u3088\u3073\u30a8\u30d3\u30c7\u30f3\u30b9\u6587\u66f8\u306b\u78ba\u5b9f\u306b\u7d10\u3065\u3044\u3066\u3044\u308b\u3053\u3068\u3067\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u5b9f\u52d9\u4e0a\u306f\u3001Traceability\u306e\u4e3b\u8868\uff08\u30de\u30b9\u30bf\u30fc\u30c6\u30fc\u30d6\u30eb\uff09\u3092\u5358\u4e00\u306e\u4fe1\u983c\u3067\u304d\u308b\u60c5\u5831\u6e90\uff08Single Source of Truth\uff09\u3068\u3057\u3066\u7ba1\u7406\u3059\u308b\u3053\u3068\u3092\u5f37\u304f\u63a8\u5968\u3057\u307e\u3059\u3002\u4e3b\u8868\u306b\u306f\u6700\u5c0f\u9650\u3001\u4ee5\u4e0b\u306e\u9805\u76ee\u3092\u660e\u78ba\u306b\u5b9a\u7fa9\u3057\u3001\u5168\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3067\u4e00\u8cab\u3057\u305f\u547d\u540d\u898f\u5247\u3092\u9069\u7528\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e00\u306b\u3001Risk ID\uff1aISO 14971\u202f\u306b\u57fa\u3065\u304f\u30ea\u30b9\u30af\u9805\u76ee\u3068\u306e\u5bfe\u5fdc\u4ed8\u3051<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e8c\u306b\u3001Requirement ID\uff1aSRS\u306b\u304a\u3051\u308b\u30b7\u30b9\u30c6\u30e0\u8981\u6c42\u3068\u306e\u5bfe\u5fdc\u4ed8\u3051<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e09\u306b\u3001Design Item ID\uff1aSAD\u307e\u305f\u306fSDS\u306b\u304a\u3051\u308b\u8a2d\u8a08\u9805\u76ee\u3068\u306e\u5bfe\u5fdc\u4ed8\u3051<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u56db\u306b\u3001Test Case ID\uff1aV&amp;V\u306b\u304a\u3051\u308b\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u3068\u306e\u5bfe\u5fdc\u4ed8\u3051<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e94\u306b\u3001Evidence Location\uff1a\u8a66\u9a13\u5831\u544a\u66f8\u3084\u95a2\u9023\u30d5\u30a1\u30a4\u30eb\u306e\u4fdd\u5b58\u5834\u6240\uff08\u30a2\u30af\u30bb\u30b9\u53ef\u80fd\u304b\u3064\u76e3\u67fb\u8ffd\u8de1\u53ef\u80fd\u3067\u3042\u308b\u3053\u3068\uff09<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">\u5b9f\u8df5\u7684\u306a\u5236\u5fa1\u30ed\u30b8\u30c3\u30af\u306f\u3001\u4e00\u672c\u306e\u30b9\u30c8\u30fc\u30ea\u30fc\u3068\u3057\u3066\u63a5\u7d9a\u3059\u308b\u3053\u3068\u3067\u660e\u78ba\u306b\u306a\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u300c\u5e0c\u5c11\u75c5\u5909\u306e\u898b\u9003\u3057\u30ea\u30b9\u30af\u300d\u3092\u5bfe\u8c61\u3068\u3059\u308b\u5834\u5408\u3001\u307e\u305a\u30ea\u30b9\u30af\u9805\u76eeR-001\u3092\u5b9a\u7fa9\u3057\u307e\u3059\u3002\u6b21\u306b\u8981\u6c42\u4ed5\u69d8\u3068\u3057\u3066SR-001\u3092\u8a2d\u5b9a\u3057\u3001\u300cAI\u51fa\u529b\u306b\u4fe1\u983c\u5ea6\u3092\u4ed8\u4e0e\u3057\u3001\u95be\u5024\u672a\u6e80\u306e\u5834\u5408\u306b\u306f\u5fc5\u305a\u4eba\u7684\u30ec\u30d3\u30e5\u30fc\u3092\u8981\u6c42\u3059\u308b\u300d\u3053\u3068\u3092\u898f\u5b9a\u3057\u307e\u3059\u3002\u8a2d\u8a08\u6bb5\u968e\u3067\u306fD-AI-001\u3068\u3057\u3066\u3001AI\u51fa\u529b\u3068\u30b7\u30b9\u30c6\u30e0\u306b\u3088\u308b\u30ec\u30d3\u30e5\u30fc\u4fc3\u9032\u30ed\u30b8\u30c3\u30af\u3092\u5b9f\u88c5\u3057\u307e\u3059\u3002\u30c6\u30b9\u30c8\u6bb5\u968e\u3067\u306fTC-001\u3092\u7528\u3044\u3001\u5916\u90e8\u306e\u5e0c\u5c11\u75c5\u5909\u30c7\u30fc\u30bf\u30bb\u30c3\u30c8\u306b\u57fa\u3065\u304d\u3001\u9ad8\u4fe1\u983c\u5ea6\u9818\u57df\u306b\u304a\u3051\u308b\u611f\u5ea6\u304c\u898f\u5b9a\u5024\u3092\u6e80\u305f\u3059\u3053\u3068\u3001\u306a\u3089\u3073\u306b\u4f4e\u4fe1\u983c\u5ea6\u30b5\u30f3\u30d7\u30eb\u304c\u9069\u5207\u306b\u30ec\u30d3\u30e5\u30fc\u5bfe\u8c61\u3068\u3057\u3066\u30d5\u30e9\u30b0\u4ed8\u3051\u3055\u308c\u308b\u3053\u3068\u3092\u691c\u8a3c\u3057\u307e\u3059\u3002\u6700\u5f8c\u306b\u3001AI_Test_Report_v1.0.pdf\u306a\u3069\u306e\u8a66\u9a13\u5831\u544a\u66f8\u3092\u30a8\u30d3\u30c7\u30f3\u30b9\u3068\u3057\u3066\u4e3b\u8868\u306b\u7d10\u3065\u3051\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3053\u306e\u3088\u3046\u306b\u4e00\u672c\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30e9\u30a4\u30f3\u304c\u78ba\u7acb\u3055\u308c\u3066\u3044\u308c\u3070\u3001\u305d\u308c\u81ea\u4f53\u304c\u6700\u5c0f\u69cb\u6210\u3067\u3042\u308a\u306a\u304c\u3089\u3001\u5341\u5206\u306b\u76e3\u67fb\u53ef\u80fd\u306a\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u69cb\u9020\u3068\u3057\u3066\u6a5f\u80fd\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u516d\u3001\u7dad\u6301\u53ef\u80fd\u306a\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u8a2d\u8a08 \u2015 \u300c\u4e3b\u8868\uff0b3\u5206\u8868\u300d\u3068AI\u7279\u6709\u306e2\u3064\u306e\u5236\u5fa1\u30dd\u30a4\u30f3\u30c8<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u898b\u843d\u3068\u3055\u308c\u304c\u3061\u306a\u30dd\u30a4\u30f3\u30c8\u306e\u4e00\u3064\u304c\u3001\u5c06\u6765\u7684\u306a\u4fdd\u5b88\u30b3\u30b9\u30c8\u3067\u3059\u3002\u5b9f\u52d9\u7684\u306b\u6210\u719f\u3057\u305f\u6700\u5c0f\u69cb\u6210\u3067\u306f\u30011\u3064\u306e\u4e3b\u8868\uff08\u30de\u30b9\u30bf\u30fc\u30c6\u30fc\u30d6\u30eb\uff09\u306b\u52a0\u3048\u30663\u3064\u306e\u5206\u8868\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001\u66f4\u65b0\u30b3\u30b9\u30c8\u3092\u6291\u5236\u3057\u3064\u3064\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u660e\u78ba\u306b\u7dad\u6301\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e00\u306e\u5206\u8868\uff1a\u30ea\u30b9\u30af \u2192 \u8981\u6c42\uff08Risk to Requirement\uff09<\/span><br \/>\n<span data-contrast=\"auto\">\u3000\u3059\u3079\u3066\u306e\u30ea\u30b9\u30af\u304c\u78ba\u5b9f\u306b\u8981\u6c42\u4e8b\u9805\u3078\u3068\u5c55\u958b\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u62c5\u4fdd\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e8c\u306e\u5206\u8868\uff1a\u8981\u6c42 \u2192 \u8a2d\u8a08\uff08Requirement to Design\uff09<\/span><br \/>\n<span data-contrast=\"auto\">\u3000\u3059\u3079\u3066\u306e\u8981\u6c42\u304c\u8a2d\u8a08\u4e0a\u306e\u5b9f\u88c5\u30dd\u30a4\u30f3\u30c8\u3078\u3068\u8ffd\u8de1\u53ef\u80fd\u3067\u3042\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">\u7b2c\u4e09\u306e\u5206\u8868\uff1a\u8981\u6c42 \u2192 \u30c6\u30b9\u30c8\uff08Requirement to Test\uff09<\/span><br \/>\n<span data-contrast=\"auto\">\u3000\u3059\u3079\u3066\u306e\u8981\u6c42\u306b\u5bfe\u3057\u3066\u5bfe\u5fdc\u3059\u308b\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u304a\u3088\u3073\u30a8\u30d3\u30c7\u30f3\u30b9\u304c\u5b58\u5728\u3059\u308b\u3053\u3068\u3092\u62c5\u4fdd\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">\u904b\u7528\u30c4\u30fc\u30eb\u306fExcel\u3067\u3082ALM\u30c4\u30fc\u30eb\uff08\u4f8b\uff1aJira\uff09\u3067\u3082\u69cb\u3044\u307e\u305b\u3093\u304c\u3001\u91cd\u8981\u306a\u306e\u306f\u30c4\u30fc\u30eb\u3067\u306f\u306a\u304f\u904b\u7528\u30eb\u30fc\u30eb\uff08SOP\uff09\u3067\u3059\u3002\u7279\u306b\u660e\u78ba\u306b\u5b9a\u7fa9\u3059\u3079\u304d\u306f\u3001\u300cAI\u30e2\u30c7\u30eb\u306e\u8ffd\u52a0\u307e\u305f\u306f\u5909\u66f4\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u306b\u306f\u3001\u5fc5\u305a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u8d77\u70b9\u304a\u3088\u3073\u95a2\u9023\u30ea\u30f3\u30af\u3092\u540c\u6642\u306b\u66f4\u65b0\u3059\u308b\u300d\u3068\u3044\u3046\u70b9\u3067\u3059\u3002\u3053\u308c\u3092\u5fb9\u5e95\u3057\u306a\u3051\u308c\u3070\u3001\u6b21\u56de\u306e\u76e3\u67fb\u3084\u4e0a\u5e02\u5f8c\u306e\u5909\u66f4\u7ba1\u7406\u306b\u304a\u3044\u3066\u3001\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u4f53\u7cfb\u306f\u5bb9\u6613\u306b\u5206\u65ad\u3055\u308c\u3066\u3057\u307e\u3044\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3055\u3089\u306b\u3001AI\u00a0<\/span><span data-contrast=\"auto\">SaMD<\/span><span data-contrast=\"auto\">\u306b\u304a\u3044\u3066\u306f\u307b\u307c\u78ba\u5b9f\u306b\u554f\u308f\u308c\u308b2\u3064\u306e\u8ad6\u70b9\u304c\u5b58\u5728\u3057\u307e\u3059\u3002\u3053\u308c\u3089\u306b\u3064\u3044\u3066\u306f\u6700\u5c0f\u9650\u306e\u62e1\u5f35\u3067\u4e8b\u524d\u306b\u5bfe\u5fdc\u3057\u3001Traceability\u30c1\u30a7\u30fc\u30f3\u306b\u81ea\u7136\u306b\u7d44\u307f\u8fbc\u3080\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u7b2c\u4e00\u306e\u8ad6\u70b9\u306f\u300c\u30d6\u30e9\u30c3\u30af\u30dc\u30c3\u30af\u30b9\u6027\u3068\u8aac\u660e\u53ef\u80fd\u6027\uff08Explainability\uff09\u300d\u3067\u3059\u3002\u5b8c\u5168\u306a\u53ef\u8aac\u660e\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u5408\u7406\u7684\u306a\u8aac\u660e\u624b\u6cd5\u304a\u3088\u3073\u9069\u7528\u30b7\u30ca\u30ea\u30aa\u3092\u63d0\u793a\u3067\u304d\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u4ee3\u8868\u7684\u306a\u75c7\u4f8b\u306b\u5bfe\u3059\u308b\u53ef\u8996\u5316\u7d50\u679c\u3084\u8aac\u660e\u51fa\u529b\u3092\u3001\u8a2d\u8a08\u304a\u3088\u3073\u691c\u8a3c\u30a8\u30d3\u30c7\u30f3\u30b9\u3068\u3057\u3066\u7d44\u307f\u8fbc\u3080\u3053\u3068\u304c\u6709\u52b9\u3067\u3059\u3002\u5b9f\u52d9\u7684\u306b\u306f\u3001SDS\u306b\u304a\u3044\u3066\u8aac\u660e\u53ef\u80fd\u6027\u306e\u624b\u6cd5\u304a\u3088\u3073\u51fa\u529b\u5f62\u5f0f\u3092\u5b9a\u7fa9\u3057\u3001Traceability\u306b\u300cExplainability Method\u300d\u9805\u76ee\u3092\u8ffd\u52a0\u3057\u3066\u3001\u95a2\u9023\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3084\u30ec\u30dd\u30fc\u30c8\u3078\u30ea\u30f3\u30af\u3055\u305b\u308b\u5f62\u304c\u63a8\u5968\u3055\u308c\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u7b2c\u4e8c\u306e\u8ad6\u70b9\u306f\u300c\u30c7\u30fc\u30bf\u30c9\u30ea\u30d5\u30c8\u304a\u3088\u3073\u30e2\u30c7\u30eb\u52a3\u5316\uff08Model Degradation\uff09\u300d\u3067\u3059\u3002\u30c7\u30fc\u30bf\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u304a\u3088\u3073\u6027\u80fd\u52a3\u5316\u306e\u691c\u77e5\u30ed\u30b8\u30c3\u30af\u3092SRS\u306b\u660e\u8a18\u3057\u3001\u305d\u308c\u3092\u76e3\u8996\u30e2\u30b8\u30e5\u30fc\u30eb\u8a2d\u8a08\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u76e3\u8996\uff08Post-market Surveillance\uff09\u8a08\u753b\u3078\u3068\u63a5\u7d9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u30ea\u30b9\u30af\u304c\u4e0a\u5e02\u524d\u3060\u3051\u3067\u306a\u304f\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u306b\u308f\u305f\u3063\u3066\u7ba1\u7406\u3055\u308c\u308b\u3079\u304d\u3082\u306e\u3067\u3042\u308b\u3053\u3068\u3092\u793a\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002Traceability\u306b\u306f\u300cDrift Monitoring\u300d\u307e\u305f\u306f\u300cPost-market Monitoring\u300d\u3068\u3044\u3063\u305f\u9805\u76ee\u3092\u8ffd\u52a0\u3057\u3001\u8a72\u5f53\u3059\u308b\u8a2d\u8a08\u304a\u3088\u3073\u8a08\u753b\u6587\u66f8\u3078\u30ea\u30f3\u30af\u3055\u305b\u308b\u3053\u3068\u304c\u6709\u52b9\u3067\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3053\u308c\u30892\u3064\u306e\u5236\u5fa1\u30dd\u30a4\u30f3\u30c8\u306f\u5358\u306a\u308b\u4ed8\u52a0\u6a5f\u80fd\u3067\u306f\u306a\u304f\u3001\u5be9\u67fb\u8005\u306b\u5bfe\u3057\u3066\u300cAI\u7279\u6709\u306e\u30ea\u30b9\u30af\u304c\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u306b\u308f\u305f\u308a\u5b58\u5728\u3059\u308b\u3053\u3068\u3092\u7406\u89e3\u3057\u3001\u305d\u308c\u3092\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30ac\u30d0\u30ca\u30f3\u30b9\u306b\u3088\u3063\u3066\u7d71\u5236\u3067\u304d\u3066\u3044\u308b\u300d\u3053\u3068\u3092\u793a\u3059\u305f\u3081\u306e\u91cd\u8981\u306a\u8981\u7d20\u3067\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u7d50\u8a9e\uff1aVC\u306e\u8996\u70b9<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u30d0\u30a4\u30aa\u30fb\u30d8\u30eb\u30b9\u30b1\u30a2\u9818\u57df\u306e\u30d9\u30f3\u30c1\u30e3\u30fc\u30ad\u30e3\u30d4\u30bf\u30eb\u306b\u304a\u3051\u308b\u30c7\u30e5\u30fc\u30c7\u30ea\u30b8\u30a7\u30f3\u30b9\u306e\u89b3\u70b9\u3067\u306f\u3001\u30c1\u30fc\u30e0\u304c\u202fIEC 62304\u202f\u3092\u5b9f\u52d9\u30ec\u30d9\u30eb\u3067\u9069\u5207\u306b\u5b9f\u88c5\u3067\u304d\u308b\u304b\u3069\u3046\u304b\u306f\u3001\u5358\u306a\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u5bfe\u5fdc\u30b3\u30b9\u30c8\u3067\u306f\u306a\u304f\u3001\u300c\u5e0c\u5c11\u306a\u7af6\u4e89\u512a\u4f4d\u6027\u300d\u3068\u3057\u3066\u8a55\u4fa1\u3055\u308c\u307e\u3059\u3002\u305d\u306e\u7406\u7531\u306f\u6975\u3081\u3066\u73fe\u5b9f\u7684\u3067\u3059\u3002\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u304a\u3088\u3073\u30d0\u30a4\u30aa\u30c6\u30c3\u30af\u9818\u57df\u306b\u304a\u3044\u3066\u3001\u8fc5\u901f\u306b\u5e02\u5834\u6295\u5165\u3092\u5b9f\u73fe\u3057\u3001\u304b\u3064\u9577\u671f\u7684\u306b\u5b58\u7d9a\u3067\u304d\u308b\u30c1\u30fc\u30e0\u306f\u3001\u5fc5\u305a\u3057\u3082\u30e2\u30c7\u30eb\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u306e\u8aac\u660e\u306b\u9577\u3051\u305f\u30c1\u30fc\u30e0\u3067\u306f\u306a\u304f\u3001\u3080\u3057\u308d\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30ac\u30d0\u30ca\u30f3\u30b9\u3092\u78ba\u5b9f\u306b\u5b9f\u88c5\u3067\u304d\u308b\u30c1\u30fc\u30e0\u3067\u3042\u308b\u30b1\u30fc\u30b9\u304c\u5927\u534a\u3067\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">AI\u3092Software\u00a0Item\u3068\u3057\u3066\u660e\u78ba\u306b\u5b9a\u7fa9\u3067\u304d\u3066\u3044\u308b\u304b\u3001\u4e0d\u78ba\u5b9f\u6027\u3092\u691c\u8a3c\u53ef\u80fd\u306a\u30b7\u30b9\u30c6\u30e0\u6319\u52d5<\/span><span data-contrast=\"auto\">\u3078\u3068\u5909\u63db\u3067\u304d\u3066\u3044\u308b\u304b\u3001Retraining\u3092\u30c8\u30ec\u30fc\u30b5\u30d6\u30eb\u306a\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u66f4\u65b0\u3068\u3057\u3066\u5b89\u5b9a\u7684\u306b\u7ba1\u7406\u3067\u304d\u3066\u3044\u308b\u304b\u3001\u3055\u3089\u306b\u6700\u5c0f\u9650\u306eTraceability\u306b\u3088\u3063\u3066\u30ea\u30b9\u30af\u304b\u3089\u30a8\u30d3\u30c7\u30f3\u30b9\u307e\u3067\u306e\u9023\u9396\u3092\u78ba\u5b9f\u306b\u69cb\u7bc9\u3067\u304d\u3066\u3044\u308b\u304b\u3002\u3053\u308c\u3089\u306f\u3044\u305a\u308c\u3082\u3001\u958b\u767a\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u306e\u4e88\u6e2c\u53ef\u80fd\u6027\u3001\u81e8\u5e8a\u304a\u3088\u3073\u898f\u5236\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u7a4d\u307f\u4e0a\u3052\u306e\u78ba\u5b9f\u6027\u3001\u3055\u3089\u306b\u306f\u5c06\u6765\u7684\u306aM&amp;A\u3084\u30a8\u30b0\u30b8\u30c3\u30c8\u6642\u306e\u30c7\u30e5\u30fc\u30c7\u30ea\u30b8\u30a7\u30f3\u30b9\u306b\u304a\u3044\u3066\u3001\u300c\u3053\u306e\u512a\u308c\u305f\u7d50\u679c\u304c\u3069\u306e\u30e2\u30c7\u30eb\u30d0\u30fc\u30b8\u30e7\u30f3\u304b\u3089\u5f97\u3089\u308c\u305f\u3082\u306e\u304b\u300d\u3092\u5373\u5ea7\u306b\u8aac\u660e\u3067\u304d\u308b\u304b\u3069\u3046\u304b\u3092\u76f4\u63a5\u7684\u306b\u5de6\u53f3\u3057\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u6295\u8cc7\u5bb6\u306e\u8996\u70b9\u304b\u3089\u898b\u308c\u3070\u3001\u3053\u306e\u6700\u5c0f\u53ef\u884c\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u306b\u3088\u3063\u3066\u5f97\u3089\u308c\u308b\u4fa1\u5024\u306f\u3001\u5358\u306a\u308b\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u6574\u5099\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u305d\u308c\u306f\u300c\u78ba\u5b9f\u6027\u300d\u3067\u3059\u3002\u3059\u306a\u308f\u3061\u3001\u898f\u5236\u30ea\u30b9\u30af\u304a\u3088\u3073\u958b\u767a\u30fb\u30c7\u30ea\u30d0\u30ea\u30fc\u30ea\u30b9\u30af\u3092\u3001\u7ba1\u7406\u53ef\u80fd\u306a\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30ea\u30b9\u30af\u3078\u3068\u53ce\u675f\u3055\u305b\u308b\u80fd\u529b\u3067\u3042\u308a\u3001\u305d\u306e\u7d50\u679c\u3068\u3057\u3066\u6642\u9593\u304a\u3088\u3073\u8cc7\u672c\u306e\u6d88\u8cbb\u66f2\u7dda\u3092\u9ad8\u3044\u7cbe\u5ea6\u3067\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u53ef\u80fd\u306b\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u308c\u3053\u305d\u304c\u3001AI\u00a0<\/span><span data-contrast=\"auto\">SaMD<\/span><span data-contrast=\"auto\">\u306e\u4f01\u696d\u4fa1\u5024\uff08\u30d0\u30ea\u30e5\u30a8\u30fc\u30b7\u30e7\u30f3\uff09\u3092\u6301\u7d9a\u7684\u306b\u652f\u3048\u308b\u6839\u672c\u7684\u306a\u30ed\u30b8\u30c3\u30af\u3068\u8a00\u3048\u307e\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u8a73\u7d30\u306b\u3064\u3044\u3066\u306f\u3001<\/span><span data-contrast=\"auto\">Joseph.Shen@behealthventures.com\u00a0<\/span><span data-contrast=\"auto\">\u307e\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/span><span data-contrast=\"auto\">\u3002<\/span><span data-ccp-props=\"{&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134245417&quot;:false}\">\u00a0<\/span><\/p>\n","protected":false},"featured_media":11426,"parent":0,"menu_order":0,"template":"","class_list":["post-11431","knowledge_base","type-knowledge_base","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/knowledge_base\/11431","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/knowledge_base"}],"about":[{"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/types\/knowledge_base"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/media\/11426"}],"wp:attachment":[{"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/media?parent=11431"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}