{"id":8671,"date":"2025-09-30T22:52:16","date_gmt":"2025-09-30T14:52:16","guid":{"rendered":"https:\/\/be.tworg.app\/knowledge_base\/milestones\/"},"modified":"2025-11-22T10:14:02","modified_gmt":"2025-11-22T02:14:02","slug":"milestones","status":"publish","type":"knowledge_base","link":"https:\/\/behealthventures.com\/ja\/knowledge_base\/milestones\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u958b\u767a\u306e\u4e3b\u8981\u30de\u30a4\u30eb\u30b9\u30c8\u30fc\u30f3\uff08Milestones\uff09"},"content":{"rendered":"<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone wp-image-6489 size-full\" src=\"http:\/\/be.tworg.app\/wp-content\/uploads\/2025\/09\/bddb2813-7260-4ee6-aba9-0d4a455d592a.jpg\" alt=\"\" width=\"740\" height=\"470\" \/><\/p>\n<p data-start=\"10695\" data-end=\"10721\"><strong data-start=\"10695\" data-end=\"10721\">\u6bd4\u7ffc\u751f\u533b\u30d9\u30f3\u30c1\u30e3\u30fc 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data-end=\"12057\">\u54c1\u8cea\u30fb\u30b3\u30b9\u30c8\u30fb\u7d0d\u671f\u306e\u30d0\u30e9\u30f3\u30b9\u304c\u5c06\u6765\u306e\u5546\u696d\u5316\u306b\u8010\u3048\u3046\u308b\u304b\u3069\u3046\u304b<\/strong>\u3092\u542b\u3081\u305f\u7dcf\u5408\u7684\u306a\u691c\u8a0e\u3067\u3059\u3002<\/p>\n<p data-start=\"12074\" data-end=\"12161\">\u3053\u306e\u30d5\u30a7\u30fc\u30ba\u3067\u3001\u521d\u671f\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u3092\u69cb\u7bc9\u3057\u3001\u30b7\u30df\u30e5\u30ec\u30fc\u30b7\u30e7\u30f3\u3084\u30d9\u30f3\u30c1\u30c6\u30b9\u30c8\u306b\u3088\u3063\u3066\u4e00\u5b9a\u306e\u691c\u8a3c\u7d50\u679c\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u308c\u3070\u3001\u305d\u306e\u5f8c\u306e\u81e8\u5e8a\u30fb\u898f\u5236\u30d5\u30a7\u30fc\u30ba\u306b\u5bfe\u3057\u3066\u5f37\u529b\u306a\u88cf\u4ed8\u3051\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<h3 data-start=\"12168\" data-end=\"12193\">3. \u898f\u5236\u6226\u7565\uff1a\u65e9\u671f\u306b\u30eb\u30fc\u30c8\u3092\u6c7a\u3081\u308b\u91cd\u8981\u6027<\/h3>\n<p data-start=\"12195\" data-end=\"12248\">\u6280\u8853\u304c\u5f62\u306b\u306a\u308a\u59cb\u3081\u308b\u3068\u3001\u6b21\u306b\u91cd\u8981\u306b\u306a\u308b\u306e\u304c**\u898f\u5236\u6226\u7565\uff08Regulatory Strategy\uff09**\u3067\u3059\u3002<\/p>\n<p data-start=\"12250\" data-end=\"12362\">\u5404\u56fd\u306b\u306f\u3001\u305d\u308c\u305e\u308c\u7570\u306a\u308b\u533b\u7642\u6a5f\u5668\u30af\u30e9\u30b9\u5206\u985e\u3068\u7533\u8acb\u30eb\u30fc\u30c8\u304c\u5b58\u5728\u3057\u307e\u3059\u3002\u88fd\u54c1\u306e\u7528\u9014\u3084\u30ea\u30b9\u30af\u30ec\u30d9\u30eb\u306b\u5fdc\u3058\u3066\u3001Class I \/ II \/ III \u3068\u3044\u3063\u305f\u30af\u30e9\u30b9\u3092\u7279\u5b9a\u3057\u3001\u305d\u308c\u306b\u5fdc\u3058\u305f\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u3068\u8981\u6c42\u4e8b\u9805\u3092\u6574\u7406\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p data-start=\"12364\" data-end=\"12369\">\u305f\u3068\u3048\u3070\uff1a<\/p>\n<ul data-start=\"12371\" data-end=\"12470\">\n<li data-start=\"12371\" data-end=\"12421\">\n<p data-start=\"12373\" data-end=\"12421\">\u4e00\u90e8\u306e\u88fd\u54c1\u306f\u3001\u7c73\u56fd\u306e <strong data-start=\"12384\" data-end=\"12394\">510(k)<\/strong> \u306e\u3088\u3046\u306a\u7c21\u6613\u306a\u30eb\u30fc\u30c8\u3067\u7533\u8acb\u53ef\u80fd\u306a\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<\/li>\n<li data-start=\"12422\" data-end=\"12470\">\n<p data-start=\"12424\" data-end=\"12470\">\u4e00\u65b9\u3067\u3001\u9ad8\u30ea\u30b9\u30af\u6a5f\u5668\u306f <strong data-start=\"12436\" data-end=\"12443\">PMA<\/strong> \u3084\u30d5\u30eb\u30b9\u30b1\u30fc\u30eb\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u4f34\u3046\u53b3\u683c\u306a\u5be9\u67fb\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"12472\" data-end=\"12519\">\u52a0\u3048\u3066\u3001\u30bf\u30fc\u30b2\u30c3\u30c8\u5e02\u5834\u306b\u304a\u3051\u308b\u898f\u5236\u52d5\u5411\u3084\u5be9\u67fb\u306e\u30dd\u30a4\u30f3\u30c8\u3082\u614e\u91cd\u306b\u628a\u63e1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001<\/p>\n<ul data-start=\"12521\" data-end=\"12642\">\n<li data-start=\"12521\" data-end=\"12576\">\n<p data-start=\"12523\" data-end=\"12576\">\u6b27\u5dde\u3067\u306f <strong data-start=\"12528\" data-end=\"12535\">MDR<\/strong> \u65bd\u884c\u5f8c\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u533b\u7642\u6a5f\u5668\u3084AI\u3092\u7528\u3044\u305f\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u8981\u6c42\u304c\u4e00\u6bb5\u3068\u53b3\u683c\u5316<\/p>\n<\/li>\n<li data-start=\"12577\" data-end=\"12642\">\n<p data-start=\"12579\" data-end=\"12642\">\u7c73\u56fd\u3084\u5404\u56fd\u5f53\u5c40\u306b\u304a\u3051\u308b AI\/Software as a Medical Device\uff08SaMD\uff09\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u5909\u5316<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"12644\" data-end=\"12654\">\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002<\/p>\n<p data-start=\"12656\" data-end=\"12673\">\u65e9\u671f\u306b\u898f\u5236\u6226\u7565\u3092\u5b9a\u3081\u308b\u3053\u3068\u306b\u3088\u308a\u3001<\/p>\n<ul data-start=\"12675\" data-end=\"12728\">\n<li data-start=\"12675\" data-end=\"12691\">\n<p data-start=\"12677\" data-end=\"12691\">\u5fc5\u8981\u306a\u8a66\u9a13\u9805\u76ee\u306e\u6d17\u3044\u51fa\u3057<\/p>\n<\/li>\n<li data-start=\"12692\" data-end=\"12705\">\n<p data-start=\"12694\" data-end=\"12705\">\u5fc5\u8981\u30ea\u30bd\u30fc\u30b9\u306e\u78ba\u4fdd<\/p>\n<\/li>\n<li data-start=\"12706\" data-end=\"12728\">\n<p data-start=\"12708\" data-end=\"12728\">\u73fe\u5b9f\u7684\u306a\u958b\u767a\u30fb\u7533\u8acb\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u306e\u8a2d\u8a08<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"12730\" data-end=\"12785\">\u3092\u4f53\u7cfb\u7684\u306b\u884c\u3046\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u306e\u6e96\u5099\u5ea6\u5408\u3044\u304c\u3001<strong data-start=\"12754\" data-end=\"12774\">\u4e88\u5b9a\u901a\u308a\u306b\u5e02\u5834\u53c2\u5165\u3067\u304d\u308b\u304b\u3069\u3046\u304b<\/strong> \u3092\u5927\u304d\u304f\u5de6\u53f3\u3057\u307e\u3059\u3002<\/p>\n<h3 data-start=\"12792\" data-end=\"12826\">4. \u8a2d\u8a08\u691c\u8a3c\u3068\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff1a\u5b89\u5168\u306a\u30b7\u30b9\u30c6\u30e0\u3092\u69cb\u7bc9\u3059\u308b<\/h3>\n<p data-start=\"12828\" data-end=\"12891\">\u898f\u5236\u30eb\u30fc\u30c8\u304c\u56fa\u307e\u308b\u3068\u3001\u6b21\u306f<strong data-start=\"12841\" data-end=\"12880\">\u8a2d\u8a08\u691c\u8a3c\uff08Design Verification\uff09\u3068\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/strong>\u306e\u30d5\u30a7\u30fc\u30ba\u306b\u9032\u307f\u307e\u3059\u3002<\/p>\n<p data-start=\"12893\" data-end=\"12981\">\u3053\u3053\u3067\u306f\u3001\u4e8b\u524d\u306b\u5b9a\u7fa9\u3057\u305f <strong data-start=\"12906\" data-end=\"12930\">Design Input\uff08\u8a2d\u8a08\u5165\u529b\u8981\u4ef6\uff09<\/strong> \u3068 <strong data-start=\"12933\" data-end=\"12956\">Design Output\uff08\u8a2d\u8a08\u51fa\u529b\uff09<\/strong> \u306b\u57fa\u3065\u304d\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u5404\u7a2e\u8a66\u9a13\u30fb\u8a55\u4fa1\u3092\u884c\u3044\u307e\u3059\uff1a<\/p>\n<ul data-start=\"12983\" data-end=\"13034\">\n<li data-start=\"12983\" data-end=\"12998\">\n<p data-start=\"12985\" data-end=\"12998\">\u6a5f\u69cb\u8a2d\u8a08\u30fb\u69cb\u9020\u5f37\u5ea6\u8a66\u9a13<\/p>\n<\/li>\n<li data-start=\"12999\" data-end=\"13014\">\n<p data-start=\"13001\" data-end=\"13014\">\u96fb\u6c17\u7684\u30fb\u6a5f\u80fd\u7684\u6027\u80fd\u8a66\u9a13<\/p>\n<\/li>\n<li data-start=\"13015\" data-end=\"13034\">\n<p data-start=\"13017\" data-end=\"13034\">\u751f\u7269\u5b66\u7684\u5b89\u5168\u6027\u30fb\u751f\u4f53\u9069\u5408\u6027\u8a55\u4fa1<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"13036\" data-end=\"13114\">\u3042\u308f\u305b\u3066\u3001<strong data-start=\"13041\" data-end=\"13060\">FMEA\uff08\u6545\u969c\u30e2\u30fc\u30c9\u5f71\u97ff\u89e3\u6790\uff09<\/strong> \u306a\u3069\u306e\u30ea\u30b9\u30af\u5206\u6790\u30c4\u30fc\u30eb\u3092\u7528\u3044\u3066\u3001\u5b9f\u4f7f\u7528\u6642\u306b\u767a\u751f\u3057\u5f97\u308b\u4e0d\u5177\u5408\u30b7\u30ca\u30ea\u30aa\u3092\u4e88\u6e2c\u3057\u3001\u305d\u306e\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3057\u3066\u3044\u304d\u307e\u3059\u3002<\/p>\n<p data-start=\"13116\" data-end=\"13181\">\u3053\u306e\u30d5\u30a7\u30fc\u30ba\u3067\u306f\u3001\u6280\u8853\u529b\u3060\u3051\u3067\u306a\u304f\u3001\u30c1\u30fc\u30e0\u304c**\u30b7\u30b9\u30c6\u30e0\u5168\u4f53\u3092\u4fef\u77b0\u3059\u308b\u529b\uff08\u30b7\u30b9\u30c6\u30e0\u601d\u8003\uff09**\u3092\u6301\u3063\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u304c\u554f\u308f\u308c\u307e\u3059\u3002<\/p>\n<p data-start=\"13183\" data-end=\"13188\">\u3059\u306a\u308f\u3061\uff1a<\/p>\n<ul data-start=\"13190\" data-end=\"13246\">\n<li data-start=\"13190\" data-end=\"13212\">\n<p data-start=\"13192\" data-end=\"13212\">\u5b89\u5168\u6027\u30fb\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u4fdd\u3057\u3064\u3064<\/p>\n<\/li>\n<li data-start=\"13213\" data-end=\"13246\">\n<p data-start=\"13215\" data-end=\"13246\">\u30d7\u30ed\u30c0\u30af\u30c8\u306e\u9769\u65b0\u6027\u3084\u81e8\u5e8a\u73fe\u5834\u3067\u306e\u4f7f\u3044\u3084\u3059\u3055\u3092\u640d\u306a\u308f\u306a\u3044\u3053\u3068<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"13248\" data-end=\"13256\">\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n<p data-start=\"13258\" data-end=\"13334\">\u8a2d\u8a08\u691c\u8a3c\u306e\u5145\u5b9f\u5ea6\u306f\u3001\u305d\u306e\u5f8c\u306e\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u5be9\u67fb\u306b\u304a\u3044\u3066\u3001<strong data-start=\"13286\" data-end=\"13307\">\u627f\u8a8d\u53ef\u5426\u3092\u5de6\u53f3\u3059\u308b\u4e2d\u6838\u7684\u306a\u5224\u65ad\u6750\u6599<\/strong>\u3068\u306a\u308b\u305f\u3081\u3001\u6c7a\u3057\u3066\u5f62\u5f0f\u7684\u306b\u6e08\u307e\u305b\u308b\u3079\u304d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n<h3 data-start=\"13341\" data-end=\"13372\">5. \u81e8\u5e8a\u8a55\u4fa1\uff1a\u5b9f\u81e8\u5e8a\u74b0\u5883\u3067\u306e\u5b89\u5168\u6027\u30fb\u6709\u52b9\u6027\u3092\u8a3c\u660e\u3059\u308b<\/h3>\n<p data-start=\"13374\" data-end=\"13439\">\u81e8\u5e8a\u8a55\u4fa1\uff08Clinical Validation\uff09\u306f\u3001\u88fd\u54c1\u304c<strong data-start=\"13404\" data-end=\"13429\">\u5b9f\u969b\u306e\u4f7f\u7528\u74b0\u5883\u306b\u304a\u3044\u3066\u5b89\u5168\u304b\u3064\u6709\u52b9\u3067\u3042\u308b\u304b<\/strong>\u3092\u78ba\u8a8d\u3059\u308b\u6bb5\u968e\u3067\u3059\u3002<\/p>\n<p data-start=\"13441\" data-end=\"13475\">\u88fd\u54c1\u306e\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u306b\u5fdc\u3058\u3066\u3001\u5fc5\u8981\u3068\u306a\u308b\u81e8\u5e8a\u8a55\u4fa1\u306e\u30ec\u30d9\u30eb\u306f\u7570\u306a\u308a\u307e\u3059\u3002<\/p>\n<ul data-start=\"13477\" data-end=\"13528\">\n<li data-start=\"13477\" data-end=\"13499\">\n<p data-start=\"13479\" data-end=\"13499\">\u7c21\u6613\u306a\u89b3\u5bdf\u7814\u7a76\u3067\u8db3\u308a\u308b\u5834\u5408\u3082\u3042\u308c\u3070\u3001<\/p>\n<\/li>\n<li data-start=\"13500\" data-end=\"13528\">\n<p data-start=\"13502\" data-end=\"13528\">\u30d5\u30eb\u30b9\u30b1\u30fc\u30eb\u306e\u81e8\u5e8a\u8a66\u9a13\u304c\u5fc5\u9808\u3068\u306a\u308b\u30b1\u30fc\u30b9\u3082\u3042\u308a\u307e\u3059\u3002<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"13530\" data-end=\"13538\">\u81e8\u5e8a\u8a66\u9a13\u8a08\u753b\u306f\u3001<\/p>\n<ul data-start=\"13540\" data-end=\"13563\">\n<li data-start=\"13540\" data-end=\"13554\">\n<p data-start=\"13542\" data-end=\"13554\">\u502b\u7406\u59d4\u54e1\u4f1a\uff08IRB\uff09<\/p>\n<\/li>\n<li data-start=\"13555\" data-end=\"13563\">\n<p data-start=\"13557\" data-end=\"13563\">\u898f\u5236\u5f53\u5c40<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"13565\" data-end=\"13621\">\u306e\u627f\u8a8d\u3092\u53d7\u3051\u3001<strong data-start=\"13572\" data-end=\"13603\">GCP\uff08Good Clinical Practice\uff09<\/strong> \u306b\u5247\u3063\u3066\u5b9f\u65bd\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n<p data-start=\"13623\" data-end=\"13683\">\u8a66\u9a13\u5b8c\u4e86\u5f8c\u3001\u30c7\u30fc\u30bf\u304c\u88fd\u54c1\u306e\u5b89\u5168\u6027\u30fb\u6709\u52b9\u6027\u3092\u652f\u6301\u3059\u308b\u3082\u306e\u3067\u3042\u308c\u3070\u3001\u305d\u306e\u7d50\u679c\u3092\u898f\u5236\u7533\u8acb\u66f8\u985e\u306e\u91cd\u8981\u306a\u69cb\u6210\u8981\u7d20\u3068\u3057\u3066\u7d71\u5408\u3057\u307e\u3059\u3002<\/p>\n<p data-start=\"13685\" data-end=\"13717\">\u3053\u306e\u30d5\u30a7\u30fc\u30ba\u306e\u8ab2\u984c\u306f\u3001\u79d1\u5b66\u7684\u306a\u691c\u8a3c\u306b\u3068\u3069\u307e\u308a\u307e\u305b\u3093\u3002\u5b9f\u52d9\u7684\u306b\u3082\u3001<\/p>\n<ul data-start=\"13719\" data-end=\"13773\">\n<li data-start=\"13719\" data-end=\"13734\">\n<p data-start=\"13721\" data-end=\"13734\">\u533b\u7642\u6a5f\u95a2\u3068\u306e\u9023\u643a\u30fb\u5951\u7d04<\/p>\n<\/li>\n<li data-start=\"13735\" data-end=\"13749\">\n<p data-start=\"13737\" data-end=\"13749\">\u5bfe\u8c61\u60a3\u8005\u306e\u30ea\u30af\u30eb\u30fc\u30c8<\/p>\n<\/li>\n<li data-start=\"13750\" data-end=\"13773\">\n<p data-start=\"13752\" data-end=\"13773\">\u81e8\u5e8a\u8a66\u9a13\u306e\u904b\u55b6\u30b3\u30b9\u30c8\u30fb\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u7ba1\u7406<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"13775\" data-end=\"13791\">\u306a\u3069\u591a\u304f\u306e\u30cf\u30fc\u30c9\u30eb\u304c\u5b58\u5728\u3057\u307e\u3059\u3002<\/p>\n<p data-start=\"13793\" data-end=\"13841\">\u6226\u7565\u7684\u306a\u81e8\u5e8a\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u65e9\u671f\u306b\u78ba\u4fdd\u3067\u304d\u308c\u3070\u3001\u81e8\u5e8a\u8a55\u4fa1\u306e\u52b9\u7387\u3068\u4fe1\u983c\u6027\u3092\u5927\u304d\u304f\u9ad8\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<h3 data-start=\"13848\" data-end=\"13878\">6. \u898f\u5236\u7533\u8acb\u3068\u627f\u8a8d\uff1a\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u304b\u3089\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u3078<\/h3>\n<p data-start=\"13880\" data-end=\"13942\">\u4e0a\u5e02\u524d\u306b\u306f\u3001\u4e3b\u7ba1\u5f53\u5c40\u306b\u5bfe\u3057\u3066 <strong data-start=\"13895\" data-end=\"13906\">\u767b\u9332\u30fb\u627f\u8a8d\u7533\u8acb<\/strong> \u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u969b\u3001\u4ee5\u4e0b\u3092\u542b\u3080\u5305\u62ec\u7684\u306a\u6280\u8853\u6587\u66f8\u3092\u63d0\u51fa\u3057\u307e\u3059\uff1a<\/p>\n<ul data-start=\"13944\" data-end=\"14056\">\n<li data-start=\"13944\" data-end=\"13971\">\n<p data-start=\"13946\" data-end=\"13971\">\u30c6\u30af\u30cb\u30ab\u30eb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\uff08\u4ed5\u69d8\u30fb\u8a2d\u8a08\u30fb\u69cb\u9020\u306a\u3069\uff09<\/p>\n<\/li>\n<li data-start=\"13972\" data-end=\"13987\">\n<p data-start=\"13974\" data-end=\"13987\">\u8a2d\u8a08\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306e\u8a18\u9332<\/p>\n<\/li>\n<li data-start=\"13988\" data-end=\"14003\">\n<p data-start=\"13990\" data-end=\"14003\">\u5404\u7a2e\u8a66\u9a13\u30fb\u691c\u8a3c\u306e\u5831\u544a\u66f8<\/p>\n<\/li>\n<li data-start=\"14004\" data-end=\"14015\">\n<p data-start=\"14006\" data-end=\"14015\">\u81e8\u5e8a\u8a55\u4fa1\u306e\u7d50\u679c<\/p>\n<\/li>\n<li data-start=\"14016\" data-end=\"14033\">\n<p data-start=\"14018\" data-end=\"14033\">\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d5\u30a1\u30a4\u30eb<\/p>\n<\/li>\n<li data-start=\"14034\" data-end=\"14056\">\n<p data-start=\"14036\" data-end=\"14056\">\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u3059\u308b\u8aac\u660e<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"14058\" data-end=\"14137\">\u3053\u306e\u30d5\u30a7\u30fc\u30ba\u306f\u3001<strong data-start=\"14066\" data-end=\"14086\">\u5be9\u67fb\u5b98\u3068\u6b63\u5f0f\u306b\u5bfe\u8a71\u3092\u884c\u3046\u30d7\u30ed\u30bb\u30b9<\/strong>\u3067\u3082\u3042\u308a\u307e\u3059\u3002\u8cea\u554f\u306b\u5bfe\u3059\u308b\u56de\u7b54\u3001\u8ffd\u52a0\u8cc7\u6599\u306e\u63d0\u51fa\u306a\u3069\u3092\u3001\u9069\u5207\u304b\u3064\u8fc5\u901f\u306b\u884c\u3046\u3053\u3068\u304c\u627f\u8a8d\u53d6\u5f97\u306e\u9375\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<p data-start=\"14139\" data-end=\"14168\">\u5be9\u67fb\u6587\u5316\u3084\u30d7\u30ed\u30bb\u30b9\u306f\u56fd\u30fb\u5730\u57df\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u305f\u3068\u3048\u3070\uff1a<\/p>\n<ul data-start=\"14170\" data-end=\"14302\">\n<li data-start=\"14170\" data-end=\"14242\">\n<p data-start=\"14172\" data-end=\"14242\"><strong data-start=\"14172\" data-end=\"14179\">FDA<\/strong> \u306f\u3001\u9769\u65b0\u7684\u6280\u8853\u306b\u5bfe\u3057\u3066 <strong data-start=\"14192\" data-end=\"14218\">Pre-submission Meeting<\/strong> \u3092\u63a8\u5968\u3057\u3001\u65e9\u671f\u306e\u610f\u898b\u4ea4\u63db\u3092\u91cd\u8996\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<\/li>\n<li data-start=\"14243\" data-end=\"14302\">\n<p data-start=\"14245\" data-end=\"14302\"><strong data-start=\"14245\" data-end=\"14255\">\u6b27\u5dde\uff08EU\uff09<\/strong> \u306f\u3001MDR\u306b\u57fa\u3065\u304d\u3001\u30c6\u30af\u30cb\u30ab\u30eb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u6574\u5408\u6027\u3068\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u4e00\u8cab\u6027\u3092\u91cd\u8996\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"14304\" data-end=\"14371\">\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u306f\u3001\u6570\u30f6\u6708\u304b\u3089\u4e00\u5e74\u4ee5\u4e0a\u304b\u304b\u308b\u5834\u5408\u3082\u3042\u308b\u305f\u3081\u3001\u30c1\u30fc\u30e0\u306f\u65e9\u671f\u304b\u3089\u6e96\u5099\u3092\u9032\u3081\u3001\u67d4\u8edf\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u4f53\u5236\u3092\u6574\u3048\u3066\u304a\u304f\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/p>\n<h3 data-start=\"14378\" data-end=\"14402\">7. \u91cf\u7523\u4f53\u5236\u306e\u69cb\u7bc9\uff1a\u8a66\u4f5c\u304b\u3089\u5b89\u5b9a\u751f\u7523\u3078<\/h3>\n<p data-start=\"14404\" data-end=\"14444\">\u627f\u8a8d\u53d6\u5f97\u5f8c\u306f\u3001\u88fd\u54c1\u3092<strong data-start=\"14414\" data-end=\"14428\">\u5b89\u5b9a\u3057\u305f\u91cf\u7523\u30d5\u30a7\u30fc\u30ba<\/strong>\u3078\u3068\u79fb\u884c\u3055\u305b\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n<p data-start=\"14446\" data-end=\"14451\">\u3053\u308c\u306b\u306f\u3001<\/p>\n<ul data-start=\"14453\" data-end=\"14541\">\n<li data-start=\"14453\" data-end=\"14468\">\n<p data-start=\"14455\" data-end=\"14468\">\u5de5\u5834\u306e\u751f\u7523\u80fd\u529b\u7acb\u3061\u4e0a\u3052<\/p>\n<\/li>\n<li data-start=\"14469\" data-end=\"14483\">\n<p data-start=\"14471\" data-end=\"14483\">\u751f\u7523\u30d7\u30ed\u30bb\u30b9\u306e\u6700\u9069\u5316<\/p>\n<\/li>\n<li data-start=\"14484\" data-end=\"14522\">\n<p data-start=\"14486\" data-end=\"14522\"><strong data-start=\"14486\" data-end=\"14499\">ISO 13485<\/strong> \u306a\u3069\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u6574\u5099\u30fb\u904b\u7528<\/p>\n<\/li>\n<li data-start=\"14523\" data-end=\"14541\">\n<p data-start=\"14525\" data-end=\"14541\">\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"14543\" data-end=\"14552\">\u306a\u3069\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n<p data-start=\"14554\" data-end=\"14578\">\u88fd\u9020\u73fe\u5834\u306f\u3001\u30ed\u30c3\u30c8\u9593\u3067\u306e\u54c1\u8cea\u4e00\u8cab\u6027\u3092\u78ba\u4fdd\u3057\u3064\u3064\u3001<\/p>\n<ul data-start=\"14580\" data-end=\"14628\">\n<li data-start=\"14580\" data-end=\"14588\">\n<p data-start=\"14582\" data-end=\"14588\">\u53d7\u5165\u691c\u67fb<\/p>\n<\/li>\n<li data-start=\"14589\" data-end=\"14598\">\n<p data-start=\"14591\" data-end=\"14598\">\u5de5\u7a0b\u5185\u691c\u67fb<\/p>\n<\/li>\n<li data-start=\"14599\" data-end=\"14628\">\n<p data-start=\"14601\" data-end=\"14628\">\u6700\u7d42\u691c\u67fb\u304a\u3088\u3073\u5e02\u5834\u304b\u3089\u306e\u4e0d\u5177\u5408\u60c5\u5831\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"14630\" data-end=\"14652\">\u3092\u542b\u3080\u54c1\u8cea\u4fdd\u8a3c\u4f53\u5236\u3092\u69cb\u7bc9\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p data-start=\"14654\" data-end=\"14678\">\u307e\u305f\u3001\u4f9b\u7d66\u30ea\u30b9\u30af\u7ba1\u7406\u3082\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\u3002\u305f\u3068\u3048\u3070\u3001<\/p>\n<ul data-start=\"14680\" data-end=\"14724\">\n<li data-start=\"14680\" data-end=\"14700\">\n<p data-start=\"14682\" data-end=\"14700\">\u91cd\u8981\u90e8\u6750\u306e\u4ee3\u66ff\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u78ba\u4fdd<\/p>\n<\/li>\n<li data-start=\"14701\" data-end=\"14724\">\n<p data-start=\"14703\" data-end=\"14724\">\u4f9b\u7d66\u9014\u7d76\u306b\u5099\u3048\u305fBCP\uff08\u4e8b\u696d\u7d99\u7d9a\u8a08\u753b\uff09<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"14726\" data-end=\"14746\">\u306a\u3069\u3092\u4e8b\u524d\u306b\u691c\u8a0e\u3057\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p data-start=\"14748\" data-end=\"14825\">\u7279\u306b\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u306b\u3068\u3063\u3066\u3001\u3053\u306e\u30d5\u30a7\u30fc\u30ba\u306f<strong data-start=\"14769\" data-end=\"14798\">\u7814\u7a76\u958b\u767a\u4e2d\u5fc3\u306e\u7d44\u7e54\u304b\u3089\u300c\u3082\u306e\u3065\u304f\u308a\u4f01\u696d\u300d\u3078\u306e\u8ee2\u63db\u70b9<\/strong>\u3067\u3042\u308a\u3001\u96e3\u6613\u5ea6\u304c\u9ad8\u3044\u4e00\u65b9\u3067\u5927\u304d\u306a\u6210\u9577\u6a5f\u4f1a\u3067\u3082\u3042\u308a\u307e\u3059\u3002<\/p>\n<h3 data-start=\"14832\" data-end=\"14852\">8. \u5e02\u5834\u5c0e\u5165\u3068\u521d\u671f\u55b6\u696d\u30d5\u30a7\u30fc\u30ba<\/h3>\n<p data-start=\"14854\" data-end=\"14887\">\u4e0a\u5e02\u5f8c\u3001\u88fd\u54c1\u306f<strong data-start=\"14861\" data-end=\"14881\">\u5e02\u5834\u5c0e\u5165\u304a\u3088\u3073\u521d\u671f\u5546\u696d\u5316\u30d5\u30a7\u30fc\u30ba<\/strong>\u306b\u5165\u308a\u307e\u3059\u3002<\/p>\n<p data-start=\"14889\" data-end=\"14900\">\u3053\u3053\u3067\u91cd\u8981\u3068\u306a\u308b\u306e\u306f\uff1a<\/p>\n<ul data-start=\"14902\" data-end=\"14991\">\n<li data-start=\"14902\" data-end=\"14934\">\n<p data-start=\"14904\" data-end=\"14934\">\u30ad\u30fc\u30aa\u30d4\u30cb\u30aa\u30f3\u30ea\u30fc\u30c0\u30fc\uff08KOL\uff09\u3068\u306e\u5354\u50cd\u30fb\u30a8\u30d3\u30c7\u30f3\u30b9\u69cb\u7bc9<\/p>\n<\/li>\n<li data-start=\"14935\" data-end=\"14959\">\n<p data-start=\"14937\" data-end=\"14959\">\u533b\u7642\u6a5f\u95a2\u3084\u30e6\u30fc\u30b6\u30fc\u3078\u306e\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u30fb\u6559\u80b2<\/p>\n<\/li>\n<li data-start=\"14960\" data-end=\"14991\">\n<p data-start=\"14962\" data-end=\"14991\">\u5b66\u4f1a\u767a\u8868\u30fb\u30bb\u30df\u30ca\u30fc\u30fb\u30c7\u30e2\u306a\u3069\u3092\u901a\u3058\u305f\u8a8d\u77e5\u62e1\u5927\u30fb\u5553\u767a\u6d3b\u52d5<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"14993\" data-end=\"14998\">\u306a\u3069\u3067\u3059\u3002<\/p>\n<p data-start=\"15000\" data-end=\"15016\">\u4fdd\u967a\u511f\u9084\u5bfe\u8c61\u3068\u306a\u308b\u88fd\u54c1\u306e\u5834\u5408\u306f\u3001<\/p>\n<ul data-start=\"15018\" data-end=\"15060\">\n<li data-start=\"15018\" 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