{"id":7693,"date":"2020-06-01T09:23:19","date_gmt":"2020-06-01T09:23:19","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7693"},"modified":"2020-06-01T13:59:13","modified_gmt":"2020-06-01T13:59:13","slug":"clinical-trials-for-medical-devices-5-expert-tips","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-trials-for-medical-devices-5-expert-tips\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u30025\u3064\u306e\u30a2\u30c9\u30d0\u30a4\u30b9"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">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\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f53d3814539\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><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><\/label><input  type=\"checkbox\" id=\"item-69f53d3814539\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-trials-for-medical-devices-5-expert-tips\/#1_Blinding\" title=\"1.\u30d6\u30e9\u30a4\u30f3\u30c9\">1.\u30d6\u30e9\u30a4\u30f3\u30c9<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-trials-for-medical-devices-5-expert-tips\/#2_Outsourcing_work_to_experts\" title=\"2.\u5c02\u9580\u5bb6\u3078\u306e\u696d\u52d9\u59d4\u8a17\u00a0\">2.\u5c02\u9580\u5bb6\u3078\u306e\u696d\u52d9\u59d4\u8a17\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-trials-for-medical-devices-5-expert-tips\/#3_Outcome_assessment_for_clinical_trials_on_Medical_Devices\" title=\"3.\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u30a2\u30a6\u30c8\u30ab\u30e0\u8a55\u4fa1\">3.\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u30a2\u30a6\u30c8\u30ab\u30e0\u8a55\u4fa1<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-trials-for-medical-devices-5-expert-tips\/#4_Early_scientific_advice_and_expert_panels\" title=\"4.\u521d\u671f\u306e\u79d1\u5b66\u7684\u52a9\u8a00\u3068\u5c02\u9580\u5bb6\u30d1\u30cd\u30eb\">4.\u521d\u671f\u306e\u79d1\u5b66\u7684\u52a9\u8a00\u3068\u5c02\u9580\u5bb6\u30d1\u30cd\u30eb<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-trials-for-medical-devices-5-expert-tips\/#5_FDAMDR_regulatory_requirements_for_medical_device_clinical_trials\" title=\"5.\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u95a2\u3059\u308bFDA\/MDR\u898f\u5236\u8981\u4ef6\">5.\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u95a2\u3059\u308bFDA\/MDR\u898f\u5236\u8981\u4ef6<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-trials-for-medical-devices-5-expert-tips\/#US_FDA_regulations_for_medical_devices\" title=\"\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u7c73\u56fdFDA\u898f\u5236 \">\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u7c73\u56fdFDA\u898f\u5236 <\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-trials-for-medical-devices-5-expert-tips\/#EU_MDR_regulations_for_medical_devices\" title=\"\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308bEU MDR\u898f\u5236 \">\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308bEU MDR\u898f\u5236 <\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Shrinidh Joshi\u3001\u7d4c\u9a13\u8005 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-research?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">\u81e8\u5e8a\u7814\u7a76\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u3068\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u304c\u3001\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u884c\u3046\u969b\u306b\u7559\u610f\u3059\u3079\u304d5\u3064\u306e\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002\u00a0<\/em><\/p>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306f\u3001\u4e16\u754c\u4e2d\u306e\u4f55\u767e\u4e07\u4eba\u3082\u306e\u4eba\u3005\u306e\u751f\u6d3b\u3068\u5065\u5eb7\u306b\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u3044\u307e\u3059\u3002\u53e3\u8154\u4f53\u6e29\u8a08\u306e\u3088\u3046\u306a\u65e5\u5e38\u7684\u306a\u5bb6\u5ead\u7528\u54c1\u304b\u3089\u3001\u6df1\u90e8\u8133\u523a\u6fc0\u88c5\u7f6e\u306e\u3088\u3046\u306a\u8907\u96d1\u306a\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u88fd\u54c1\u307e\u3067\u3001\u60a3\u8005\u3084\u4e00\u822c\u5e02\u6c11\u306f\u3001\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u304c\u5b89\u5168\u3067\u52b9\u679c\u7684\u3067\u3042\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u898f\u5236\u5f53\u5c40\u306b\u4f9d\u5b58\u3057\u3066\u3044\u307e\u3059\u3002\u305d\u306e <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">\u533b\u7642\u6a5f\u5668<\/a> \u306e\u5206\u91ce\u306f\u3001\u5e02\u6c11\u306e\u5065\u5eb7\u7ba1\u7406\u306e\u305f\u3081\u306b\u307e\u3059\u307e\u3059\u91cd\u8981\u306b\u306a\u3063\u3066\u304a\u308a\u3001\u652f\u51fa\u306b\u3082\u591a\u5927\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u3066\u3044\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u6b27\u5dde\u9023\u5408\uff08EU\uff09\u3060\u3051\u3092\u898b\u3066\u3082\u3001\u3053\u306e\u5206\u91ce\u306f\u7d04675,000\u4eba\u3092\u96c7\u7528\u3057\u30011,100\u5104\u30e6\u30fc\u30ed\u306e\u58f2\u4e0a\u9ad8\u3092\u751f\u307f\u51fa\u3057\u300125,000\u793e\u4ee5\u4e0a\u306e\u4f01\u696d\u3092\u4ee3\u8868\u3057\u3066\u304a\u308a\u3001\u305d\u306e\u3046\u306195%\u304c\u4e2d\u5c0f\u4f01\u696d\u3067\u3042\u308b[1]\u3002\u533b\u85ac\u54c1\u306b\u306f\u53b3\u683c\u306a\u898f\u5236\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u3084EU\u306e\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff08MDD\uff09\u3067\u306f\u3001\u30af\u30e9\u30b9IIb\u304a\u3088\u3073\u30af\u30e9\u30b9III\u306e\u533b\u7642\u6a5f\u5668\uff08\u690d\u8fbc\u307f\u578b\u533b\u7642\u6a5f\u5668\u3084\u4f53\u5916\u8a3a\u65ad\u7528\u6a5f\u5668\u306a\u3069\u306e\u4e2d\u30fb\u9ad8\u30ea\u30b9\u30af\u306e\u533b\u7642\u6a5f\u5668\uff09\u306b\u5bfe\u3057\u3066\u306e\u307f\u3001\u53b3\u683c\u306a\u898f\u5236\u304c\u5b9a\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u898f\u5236\u5f53\u5c40\u306f\u3001\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304b\u3089\u63d0\u4f9b\u3055\u308c\u308b\u30c7\u30fc\u30bf\u304c\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3092\u53cd\u6620\u3057\u305f\u3082\u306e\u3067\u3042\u308b\u3053\u3068\u3092\u671f\u5f85\u3057\u3066\u304a\u308a\u3001\u5e02\u5834\u627f\u8a8d\u306e\u524d\u306b\u3001\u3088\u308a\u91cd\u8981\u306a\u81e8\u5e8a\u8a55\u4fa1\u3092\u5fc5\u8981\u3068\u3057\u3066\u3044\u307e\u3059[2]\u3002\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u6a5f\u5668\u3068\u9769\u65b0\u7684\u306a\u4e2d\u7a0b\u5ea6\u306e\u30ea\u30b9\u30af\u306e\u6a5f\u5668\uff08\u533b\u7642\u6a5f\u5668\u5168\u4f53\u306e\u7d044%\uff09\u306f\u3001\u4e00\u822c\u7684\u306b\u6280\u8853\u306e\u5229\u70b9\u304c\u305d\u306e\u30ea\u30b9\u30af\u3092\u4e0a\u56de\u308b\u3053\u3068\u3092\u793a\u3059\u81e8\u5e8a\u7684\u8a3c\u62e0\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u3053\u306e\u8a18\u4e8b\u3067\u306f\u305d\u306e\u70b9\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u306f\u3001\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u793a\u3059\u3060\u3051\u3067\u306a\u304f\u3001\u5e02\u5834\u3067\u306e\u81e8\u5e8a\u74b0\u5883\u306b\u304a\u3051\u308b\u6a5f\u5668\u306e\u597d\u307e\u3057\u3044\u4f7f\u7528\u65b9\u6cd5\u3092\u81e8\u5e8a\u533b\u3084\u60a3\u8005\u306b\u4f1d\u3048\u308b\u305f\u3081\u306b\u3082\u3001\u3057\u3070\u3057\u3070\u91cd\u8981\u3068\u306a\u308a\u307e\u3059\u3002\u898f\u5236\u5f53\u5c40\u306f\u3001\u5e02\u5834\u627f\u8a8d\u3092\u884c\u3046\u524d\u306b\u3001\u3088\u308a\u591a\u304f\u306e\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u78ba\u8a8d\u3057\u305f\u3044\u3068\u8003\u3048\u3001\u3088\u308a\u591a\u304f\u306e\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u8981\u6c42\u3057\u3066\u3044\u307e\u3059\u3002\u898f\u5236\u5f53\u5c40\u3060\u3051\u3067\u306a\u304f\u3001\u652f\u6255\u8005\u3082\u88fd\u54c1\u4fa1\u5024\u306e\u4e3b\u5f35\u3092\u7acb\u8a3c\u3057\u3001\u511f\u9084\u3092\u627f\u8a8d\u3059\u308b\u305f\u3081\u306b\u3001\u3088\u308a\u591a\u304f\u306e\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u8981\u6c42\u3057\u3066\u3044\u307e\u3059\u3002\u533b\u7642\u6a5f\u95a2\u3084\u533b\u5e2b\u3067\u3055\u3048\u3001\u8cfc\u5165\u306e\u610f\u601d\u6c7a\u5b9a\u3092\u3059\u308b\u969b\u306b\u3001\u3088\u308a\u591a\u304f\u306e\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306b\u3001\u69d8\u3005\u306a\u30b9\u30c6\u30fc\u30af\u30db\u30eb\u30c0\u30fc\u304b\u3089\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u308b\u3053\u3068\u304b\u3089\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u81ea\u793e\u88fd\u54c1\u306b\u95a2\u3059\u308b\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u3053\u308c\u307e\u3067\u4ee5\u4e0a\u306b\u84c4\u7a4d\u3059\u308b\u5fc5\u8981\u306b\u8feb\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u4f01\u696d\u306f\u3053\u306e\u30d7\u30ec\u30c3\u30b7\u30e3\u30fc\u306b\u5fdc\u3048\u308b\u305f\u3081\u3001\u3088\u308a\u591a\u304f\u306e\u81e8\u5e8a\u8a66\u9a13\u3084\u30d5\u30a9\u30fc\u30ab\u30b9\u30b0\u30eb\u30fc\u30d7\u8abf\u67fb\u3092\u5b9f\u65bd\u3057\u3001\u533b\u7642\u6a5f\u5668\u306e\u30d9\u30fc\u30bf\u7248\u306b\u5909\u66f4\u3092\u52a0\u3048\u308b\u3053\u3068\u3067\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u3059\u3002\u6700\u8fd1\u306e\u50be\u5411\u3068\u3057\u3066\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u307e\u3059\u307e\u3059 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">\u81e8\u5e8a\u8a66\u9a13<\/a> \u7af6\u5408\u88fd\u54c1\u3068\u306e\u5dee\u5225\u5316\u3092\u56f3\u308a\u3001\u5e02\u5834\u3067\u306e\u63a1\u7528\u78ba\u7387\u3092\u9ad8\u3081\u308b\u305f\u3081\u306b <\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3092\u884c\u3046\u305f\u3081\u306b\u5fc5\u8981\u306a5\u3064\u306e\u30dd\u30a4\u30f3\u30c8\u3092\u3054\u7d39\u4ecb\u3057\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13<\/a>.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Blinding\"><\/span><b>1.\u30d6\u30e9\u30a4\u30f3\u30c9<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u76f2\u691c\u5316\u306f\u3001\u3059\u3079\u3066\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u8981\u7d20\u3067\u3042\u308a\u3001\u89b3\u5bdf\u8005\u3001\u533b\u5e2b\u3001\u60a3\u8005\u306e\u4e3b\u89b3\u306b\u8d77\u56e0\u3059\u308b\u6e2c\u5b9a\u30d0\u30a4\u30a2\u30b9\u3092\u4f4e\u6e1b\u3059\u308b\u3002\u502b\u7406\u7684\u307e\u305f\u306f\u5b9f\u7528\u7684\u306a\u7406\u7531\u304b\u3089\u3001\u533b\u7642\u6a5f\u5668\u306e\u7121\u4f5c\u70ba\u5316\u81e8\u5e8a\u8a66\u9a13\u3067\u306f\u3001\u85ac\u7406\u5b66\u7684\u306a\u7121\u4f5c\u70ba\u5316\u81e8\u5e8a\u8a66\u9a13\u3068\u6bd4\u8f03\u3057\u3066\u3001\u76f2\u691c\u5316\u3092\u884c\u3046\u3053\u3068\u304c\u56f0\u96e3\u306a\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u533b\u7642\u5f93\u4e8b\u8005\u306e\u76f2\u691c\u5316\u304c\u4e0d\u53ef\u80fd\u306a\u5834\u5408\u3001\u7d4c\u9a13\u3068\u8a13\u7df4\u3092\u53d7\u3051\u305f\u30b9\u30bf\u30c3\u30d5\u3092\u7d50\u679c\u8a55\u4fa1\u8005\u3068\u3057\u3066\u3001\u7d50\u679c\u306e\u76f2\u691c\u8a55\u4fa1\u3092\u8a08\u753b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u3092\u899a\u3048\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u30c7\u30fc\u30bf\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3001\u88c1\u5b9a\u59d4\u54e1\u4f1a\u3001\u72ec\u7acb\u30c7\u30fc\u30bf\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u5b89\u5168\u6027\u59d4\u54e1\u4f1a\u3001\u7d71\u8a08\u5bb6\u3001\u7d50\u8ad6\u4f5c\u6210\u8005\u3082\u76f2\u691c\u5316\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059[3]\u3002\u76f2\u691c\u5316\u3092\u884c\u308f\u306a\u3044\u5834\u5408\u3001\u533b\u7642\u6a5f\u5668\u4f01\u696d\u3068\u305d\u306e\u81e8\u5e8a\u8a66\u9a13\u62c5\u5f53\u8005\u306f\u3001\u76f2\u691c\u5316\u3092\u884c\u308f\u306a\u3044\u7406\u7531\u3092\u8aac\u660e\u3057\u3001\u7d50\u679c\u3092\u5831\u544a\u3059\u308b\u969b\u306b\u305d\u306e\u9650\u754c\u3092\u8b70\u8ad6\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4e00\u90e8\u306e\u533b\u7642\u6a5f\u5668\u8a66\u9a13\u3067\u306f\u3001\u60a3\u8005\u3068\u8a66\u9a13\u62c5\u5f53\u8005\u306e\u76f2\u691c\u5316\u304c\u9054\u6210\u3067\u304d\u306a\u3044\u5834\u5408\u304c\u3042\u308b\u305f\u3081\u3001\u5ba2\u89b3\u7684\u306a\u7d50\u679c\u3092\u9078\u629e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u8fd1\u5e74\u3001\u898f\u5236\u5f53\u5c40\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u5bfe\u3057\u3001\u81e8\u5e8a\u8a66\u9a13\u3067\u500b\u4eba\u3092\u76f2\u691c\u5316\u3059\u308b\u305f\u3081\u306e\u72ec\u5275\u7684\u306a\u65b9\u6cd5\u3092\u6a21\u7d22\u3059\u308b\u3088\u3046\u5f37\u8abf\u3057\u3066\u3044\u308b\u304c\u3001\u3082\u3057\u65b0\u3057\u3044\u6280\u8853\u3092\u53d6\u308a\u5165\u308c\u308b\u3053\u3068\u3092\u9078\u629e\u3057\u305f\u5834\u5408\u306f\u3001\u76f2\u691c\u5316\u30d7\u30ed\u30bb\u30b9\u81ea\u4f53\u304c\u7d50\u679c\u3092\u6b63\u78ba\u306b\u8a55\u4fa1\u3059\u308b\u80fd\u529b\u3092\u640d\u306a\u3046\u3053\u3068\u3067\u30d0\u30a4\u30a2\u30b9\u3092\u5c0e\u5165\u3057\u306a\u3044\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u65b0\u3057\u3044\u76f2\u691c\u5316\u6280\u8853\u306f3\u3064\u306e\u54c1\u8cea\u3092\u5099\u3048\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u30021.\u7fa4\u5272\u3092\u3046\u307e\u304f\u96a0\u3059\u30012.\u7d50\u679c\u3092\u6b63\u78ba\u306b\u8a55\u4fa1\u3059\u308b\u80fd\u529b\u306b\u969c\u5bb3\u3092\u4e0e\u3048\u306a\u3044\u30013.\u7d50\u679c\u3092\u8a55\u4fa1\u3059\u308b\u500b\u4eba\u306b\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u3001\u3068\u3044\u30463\u3064\u306e\u54c1\u8cea\u304c\u5fc5\u8981\u3067\u3042\u308b[4]\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u306e\u500b\u4eba\u3092\u76f2\u691c\u5316\u3059\u308b\u65b9\u6cd5\u3092\u614e\u91cd\u306b\u691c\u8a0e\u3057\u305f\u306b\u3082\u304b\u304b\u308f\u3089\u305a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13<\/a>\u3057\u304b\u3057\u3001\u502b\u7406\u7684\u306b\u76f2\u691c\u5316\u3067\u304d\u306a\u3044\u30b0\u30eb\u30fc\u30d7\u304c\u5fc5\u305a\u51fa\u3066\u304d\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3053\u306e\u73fe\u5b9f\u3092\u53d7\u3051\u5165\u308c\u3001\u76f2\u691c\u5316\u304c\u4e0d\u53ef\u80fd\u306a\u5834\u5408\u306b\u306f\u30d0\u30a4\u30a2\u30b9\u3092\u6700\u5c0f\u5316\u3059\u308b\u305f\u3081\u306e\u5225\u306e\u6226\u7565\u3092\u53d6\u308a\u5165\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Outsourcing_work_to_experts\"><\/span><b>2.\u5c02\u9580\u5bb6\u3078\u306e\u696d\u52d9\u59d4\u8a17\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<blockquote><p><span style=\"font-weight: 400;\">\u696d\u754c\u5168\u4f53\u306e\u50be\u5411\u3068\u3057\u3066\u3001\u307b\u3068\u3093\u3069\u306e\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u793e\u5185\u3067\u5b8c\u5168\u306a\u81e8\u5e8a\u8a66\u9a13\u3092\u904b\u55b6\u3059\u308b\u305f\u3081\u306e\u30ea\u30bd\u30fc\u30b9\u3084\u5c02\u9580\u77e5\u8b58\u3092\u6301\u3063\u3066\u3044\u307e\u305b\u3093\u3002\u5927\u898f\u6a21\u306a\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3067\u3042\u308c\u3070\u3001\u793e\u5185\u306b\u81e8\u5e8a\u958b\u767a\u30c1\u30fc\u30e0\u304c\u3042\u308a\u3001\u81e8\u5e8a\u8a66\u9a13\u3092\u5186\u6ed1\u306b\u9032\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u304c\u3001\u5e2f\u57df\u5e45\u3084\u7d4c\u9a13\u304c\u5c11\u306a\u304f\u3001\u4f59\u88d5\u306e\u306a\u3044\u5c0f\u898f\u6a21\u306a\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u6210\u5426\u304c\u975e\u5e38\u306b\u91cd\u8981\u3067\u3042\u308a\u3001\u6642\u306b\u306f\u81e8\u5e8a\u8a66\u9a13\u304c\u5c0f\u898f\u6a21\u306a\u4f01\u696d\u306e\u751f\u6b7b\u3092\u5de6\u53f3\u3059\u308b\u3053\u3068\u3082\u3042\u308b\u306e\u3067\u3059\u3002<\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">As a result, we are witnessing a corresponding rise in the outsourcing of clinical services to contract <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30ea\u30b5\u30fc\u30c1<\/a> organizations (CROs). Medical device companies are turning to CROs for assistance with clinical operations management, investigator recruitment, clinical monitoring, data management, <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">\u751f\u7269\u7d71\u8a08\u5b66\u7684\u5206\u6790<\/a>\u5065\u5eb7\u7d4c\u6e08\u30fb\u6210\u679c\u6226\u7565\u3001\u54c1\u8cea\u4fdd\u8a3c\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">\u85ac\u4e8b\u627f\u8a8d<\/a>\u306a\u3069\u306e\u30cb\u30fc\u30ba\u304c\u3042\u308a\u307e\u3059\u3002\u81e8\u5e8a\u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u3084CRO\u3092\u9078\u629e\u3059\u308b\u969b\u306b\u6700\u3082\u91cd\u8981\u306a\u306e\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u7d4c\u9a13\u3084\u305d\u306e\u5206\u91ce\u306e\u5c02\u9580\u77e5\u8b58\u3067\u3059\u3002<\/span><\/p>\n<blockquote><p>\u65b0\u3057\u3044\u50cd\u304d\u65b9\u3068\u3057\u3066\u3001\u30aa\u30f3\u30c7\u30de\u30f3\u30c9\u306e\u5c02\u9580\u5bb6\u306b\u4ed5\u4e8b\u3092\u59d4\u8a17\u3059\u308b\u65b9\u6cd5\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u3001CRO\u3084\u5f93\u6765\u306e\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u4f1a\u793e\u3068\u306e\u9023\u643a\u306b\u91cd\u3044\u30b3\u30b9\u30c8\u3084\u7ba1\u7406\u8cbb\u3092\u304b\u3051\u3089\u308c\u306a\u3044\u5c0f\u898f\u6a21\u306a\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u7279\u306b\u6709\u76ca\u3067\u3059\u3002\u500b\u4eba\u306e\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3092\u96c7\u3046\u3053\u3068\u3067\u3001\u6642\u9593\u3068\u30b3\u30b9\u30c8\u3092\u524a\u6e1b\u3057\u3001\u5c02\u9580\u5bb6\u3068\u76f4\u63a5\u4ed5\u4e8b\u3092\u3057\u3066\u6210\u679c\u7269\u3092\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3088\u308a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">FDA\u63d0\u51fa\u7269\u306e\u5c02\u9580\u5bb6<\/a> \u306b\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-content-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">\u30e1\u30c7\u30a3\u30ab\u30eb\u30fb\u30b3\u30f3\u30c6\u30f3\u30c4\u30fb\u30e9\u30a4\u30bf\u30fc<\/a>\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u5c02\u9580\u5bb6\u304c\u3001\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u3067\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002<\/p><\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"3_Outcome_assessment_for_clinical_trials_on_Medical_Devices\"><\/span><b>3.\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u30a2\u30a6\u30c8\u30ab\u30e0\u8a55\u4fa1<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u95a2\u9023\u3059\u308b\u30a2\u30a6\u30c8\u30ab\u30e0\u306e\u5b9a\u7fa9\u306f\u8907\u96d1\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u30da\u30fc\u30b9\u30e1\u30fc\u30ab\u30fc\u3001\u30a4\u30f3\u30b9\u30ea\u30f3\u30dd\u30f3\u30d7\u3001\u624b\u8853\u5ba4\u30e2\u30cb\u30bf\u30fc\u3001\u9664\u7d30\u52d5\u5668\u3001\u624b\u8853\u5668\u5177\u306a\u3069\u3001\u533b\u7642\u6a5f\u5668\u306e\u7a2e\u985e\u306b\u3088\u3063\u3066\u8907\u96d1\u3055\u3084\u7528\u9014\u304c\u5927\u304d\u304f\u7570\u306a\u308b\u3053\u3068\u3084\u3001\u6f5c\u5728\u7684\u306b\u95a2\u9023\u6027\u306e\u3042\u308b\u30a2\u30a6\u30c8\u30ab\u30e0\u304c\u591a\u7a2e\u591a\u69d8\u3067\u3042\u308b\u3053\u3068\u304c\u4e00\u56e0\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u7279\u306b\u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u95a2\u9023\u3059\u308b\u969c\u58c1\u306f\u3001\u30a2\u30a6\u30c8\u30ab\u30e0\u306e\u6982\u5ff5\u306b\u5bfe\u3059\u308b\u5171\u901a\u306e\u7406\u89e3\u304c\u6b20\u3051\u3066\u3044\u308b\u3053\u3068\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u3067\u306f\u3001\u751f\u5b58\u7387\u3084\u5408\u4f75\u75c7\u306e\u767a\u751f\u7387\u306a\u3069\u306e\u4f1d\u7d71\u7684\u306a\u30a2\u30a6\u30c8\u30ab\u30e0\u3001\u3042\u308b\u3044\u306f\u30b5\u30ed\u30b2\u30fc\u30c8(<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biomarkers\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc<\/a>\u307e\u305f\u3001QOL\u3001\u81ea\u5f8b\u6027\u3001\u4e0d\u5feb\u611f\u3001\u969c\u5bb3\u3001\u751f\u6d3b\u6e80\u8db3\u5ea6\u306a\u3069\u306e\u3088\u308a\u9069\u5207\u306a\u89e3\u91c8\u4e0a\u306e\u7d50\u679c\u6307\u6a19\u306e\u4ee3\u308f\u308a\u306b\u3001\u753b\u50cf\u6280\u8853\u3001\u30aa\u30df\u30c3\u30af\u30b9\uff09\u304c\u4f7f\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u6a5f\u5668\u306e\u6545\u969c\u3001\u6a5f\u5668\u306e\u7834\u640d\u3001\u6a5f\u5668\u306e\u6ed1\u308a\u3001\u6a5f\u5668\u306e\u79fb\u52d5\u3001\u30cd\u30b8\u306e\u7de9\u307f\u306a\u3069\u3001\u533b\u7642\u6a5f\u5668\u306e\u6a5f\u80fd\u306b\u95a2\u3059\u308b\u7279\u5b9a\u306e\u30a2\u30a6\u30c8\u30ab\u30e0\u3092\u9664\u5916\u3059\u308b\u3053\u3068\u3092\u610f\u5473\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u89e3\u91c8\u7684\u306a\u30a2\u30a6\u30c8\u30ab\u30e0\u6307\u6a19\u306f\u3001\u6a5f\u68b0\u7684\u306a\u5b9a\u7fa9\u3092\u6301\u3064\u5358\u306a\u308b\u7528\u8a9e\u3067\u306f\u306a\u304f\u3001\u6982\u5ff5\u3067\u3042\u308b\u3053\u3068\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3042\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u7523\u696d\u754c\u304c\u8cc7\u91d1\u63d0\u4f9b\u3057\u305f\u533b\u7642\u6a5f\u5668\u306e\u8a66\u9a13\u306f\u3001\u30dd\u30b8\u30c6\u30a3\u30d6\u306a\u7d50\u679c\u3092\u5831\u544a\u3057\u305f\u308a\u3001\u6709\u610f\u3067\u306a\u3044\u8a66\u9a13\u7d50\u679c\u3092\u5f97\u305f\u5834\u5408\u306b\u5b9f\u9a13\u7684\u4ecb\u5165\u3092\u652f\u6301\u3059\u308b\u7d50\u8ad6\u3092\u51fa\u3059\u50be\u5411\u304c\u3042\u308b[5]\u3002\u6280\u8853\u3092\u5411\u4e0a\u3055\u305b\u3001\u533b\u7642\u6a5f\u5668\u306e\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3092\u63a8\u9032\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u7523\u696d\u754c\u306e\u95a2\u4e0e\u304c\u5fc5\u8981\u3067\u3042\u308b\u304c\u3001\u305d\u308c\u306f\u79d1\u5b66\u7684\u6839\u62e0\u306b\u57fa\u3065\u304d\u3001\u5b8c\u5168\u306b\u900f\u660e\u6027\u306e\u3042\u308b\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_Early_scientific_advice_and_expert_panels\"><\/span><b>4.\u521d\u671f\u306e\u79d1\u5b66\u7684\u52a9\u8a00\u3068\u5c02\u9580\u5bb6\u30d1\u30cd\u30eb<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u306e\u3067\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-technology\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">\u533b\u7642\u6280\u8853<\/a> \u306e\u696d\u754c\u306f\u3001\u591a\u6570\u306e\u4e3b\u984c\u5c02\u9580\u5bb6\uff08SME\uff09\u306b\u3088\u3063\u3066\u5360\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u5f7c\u3089\u306f\u3001\u8a66\u9a13\u306e\u5b9f\u65bd\u3084\u8a66\u9a13\u65b9\u6cd5\u306e\u8a13\u7df4\u3092\u53d7\u3051\u3066\u3044\u307e\u305b\u3093\u304c\u3001\u591a\u69d8\u3067\u9769\u65b0\u7684\u306a\u88fd\u54c1\u3092\u5927\u91cf\u306b\u751f\u307f\u51fa\u3057\u3066\u3044\u307e\u3059\u3002\u521d\u671f\u306e\u79d1\u5b66\u7684\u30a2\u30c9\u30d0\u30a4\u30b9\u3078\u306e\u30a2\u30af\u30bb\u30b9\u306f\u3001\u7279\u306b\u4e2d\u5c0f\u4f01\u696d\u3084\u30a2\u30ab\u30c7\u30df\u30a2\u306b\u3068\u3063\u3066\u3001\u3067\u304d\u308b\u3060\u3051\u7c21\u5358\u3067\u624b\u9803\u306a\u3082\u306e\u3067\u3042\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u81ea\u793e\u306e\u30c7\u30d0\u30a4\u30b9\u306e\u81e8\u5e8a\u958b\u767a\u6226\u7565\u3084\u81e8\u5e8a\u8a66\u9a13\u306b\u95a2\u3059\u308b\u65e9\u671f\u306e\u79d1\u5b66\u7684\u30a2\u30c9\u30d0\u30a4\u30b9\u304c\u671b\u307e\u308c\u3066\u3044\u308b\u3002\u65e9\u671f\u306b\u610f\u5473\u306e\u3042\u308b\u5f62\u3067\u95a2\u4fc2\u3092\u7bc9\u304f\u3053\u3068\u3067\u3001SOP\uff08\u6a19\u6e96\u4f5c\u696d\u624b\u9806\uff09\u3084\u6280\u8853\u306b\u95a2\u3059\u308b\u8abf\u6574\u304c\u53ef\u80fd\u306b\u306a\u308b\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_FDAMDR_regulatory_requirements_for_medical_device_clinical_trials\"><\/span><b>5.\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u95a2\u3059\u308bFDA\/MDR\u898f\u5236\u8981\u4ef6<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u4e0a\u8a18\u306e\u30d2\u30f3\u30c8\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u306e\u307b\u3093\u306e\u4e00\u90e8\u306b\u904e\u304e\u307e\u305b\u3093\u3002\u3053\u308c\u3089\u306e\u91cd\u8981\u306a\u30d2\u30f3\u30c8\u3068\u306f\u5225\u306b\u3001\u898f\u5236\u3084\u502b\u7406\u7684\u8981\u4ef6\u306e\u9075\u5b88\u3082\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u898f\u5236\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3001\u6b63\u898f\u4ee3\u7406\u5e97\u3001\u8f38\u5165\u696d\u8005\u3001\u8ca9\u58f2\u696d\u8005\u306a\u3069\u3001\u7d4c\u6e08\u7684\u306b\u95a2\u4fc2\u3059\u308b\u3059\u3079\u3066\u306e\u5229\u5bb3\u95a2\u4fc2\u8005\u306e\u8cac\u4efb\u304c\u5897\u52a0\u3057\u3001\u76f8\u4e92\u95a2\u4fc2\u304c\u660e\u78ba\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u6b27\u5dde\u3084\u5317\u7c73\u306e\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u591a\u304f\u306f\u3001\u3053\u308c\u3089\u306e\u7fa9\u52d9\u306b\u5b8c\u5168\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u306e\u30a4\u30f3\u30d5\u30e9\u304c\u4e0d\u8db3\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"US_FDA_regulations_for_medical_devices\"><\/span><span style=\"font-weight: 400;\"><strong>\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u7c73\u56fdFDA\u898f\u5236<\/strong> <\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u7c73\u56fd\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u306fFDA\u306b\u3088\u3063\u3066\u898f\u5236\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u7c73\u56fd\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306f\u3001\u91cd\u8981\u306a\u30ea\u30b9\u30af\u3092\u4f34\u3046\u8a66\u9a13\uff08SR\uff09\u3068\u91cd\u8981\u3067\u306a\u3044\u30ea\u30b9\u30af\u3092\u4f34\u3046\u8a66\u9a13\uff08NSR\uff09\u306b\u5206\u3051\u3089\u308c\u307e\u3059\u3002SR\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306b\u306f\u3001IDE\uff08Investigational Device Exemption\uff09\u306e\u7533\u8acb\u304c\u5fc5\u8981\u3068\u306a\u308b\u3002\u30b9\u30dd\u30f3\u30b5\u30fc\u306f\u3001\u8a66\u9a13\u958b\u59cb\u524d\u306bFDA\u3068IRB\uff08Institutional Review Board\uff09\u306e\u4e21\u65b9\u304b\u3089\u627f\u8a8d\u3092\u5f97\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002NSR\u30c7\u30d0\u30a4\u30b9\u306e\u7814\u7a76\u3067\u306f\u3001IRB\u306e\u627f\u8a8d\u306e\u307f\u304c\u5fc5\u8981\u3067\u3059\u304c\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u306f\u3001\u30e9\u30d9\u30eb\u8868\u793a\u3001\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u7814\u7a76\u4e2d\u306e\u8a18\u9332\u4fdd\u6301\u306a\u3069\u3001\u7701\u7565\u3055\u308c\u305fIDE\u306e\u8981\u4ef6\u3092\u9075\u5b88\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30c7\u30d0\u30a4\u30b9\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u305f\u3081\u306b\u3001FDA\u306b\u306f2\u3064\u306e\u57fa\u672c\u7684\u306a\u898f\u5236\u7d4c\u8def\u304c\u3042\u308a\u307e\u3059\u3002\u5e02\u8ca9\u524d\u627f\u8a8d\uff08PMA\uff09\u3068510(k)\u3067\u3059\u3002510(k)\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u305d\u306e\u30c7\u30d0\u30a4\u30b9\u304c\u5148\u884c\u30c7\u30d0\u30a4\u30b9\u3068\u300c\u5b9f\u8cea\u7684\u306b\u540c\u7b49\u300d\u3067\u3042\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4e00\u65b9\u3001PMA\u30c7\u30d0\u30a4\u30b9\u306e\u627f\u8a8d\u306b\u306f\u3001\u4e00\u822c\u7684\u306b\u30e1\u30fc\u30ab\u30fc\u306f\u30d4\u30dc\u30bf\u30eb\u8a66\u9a13\u306e\u30c7\u30fc\u30bf\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4e00\u65b9\u3001PMA\u30c7\u30d0\u30a4\u30b9\u306e\u627f\u8a8d\u306b\u306f\u3001\u4e00\u822c\u7684\u306b\u30e1\u30fc\u30ab\u30fc\u306f\u30d4\u30dc\u30bf\u30eb\u8a66\u9a13\u306e\u30c7\u30fc\u30bf\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u8a66\u9a13\u306b\u306f\u6570\u767e\u4eba\u304b\u3089\u6570\u5343\u4eba\u306e\u60a3\u8005\u304c\u53c2\u52a0\u3057\u3001\u305d\u306e\u8cbb\u7528\u306f\u6570\u5343\u4e07\u30c9\u30eb\u306b\u3082\u53ca\u3073\u307e\u3059\u3002<\/span><\/p>\n<p><strong>\u3082\u8aad\u3093\u3067\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">FDA\u306e\u8fc5\u901f\u306a\u627f\u8a8d\u3092\u5f97\u308b\u305f\u3081\u306b510(k)\u7533\u8acb\u3067\u907f\u3051\u308b\u3079\u304d13\u306e\u30df\u30b9\u00a0<\/a><\/strong><\/p>\n<h3><span class=\"ez-toc-section\" id=\"EU_MDR_regulations_for_medical_devices\"><\/span><span style=\"font-weight: 400;\"><strong>\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308bEU MDR\u898f\u5236<\/strong> <\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">EU\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u7c73\u56fd\u306e\u305d\u308c\u3068\u306f\u5927\u304d\u304f\u7570\u306a\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/services\/eu-mdr-consulting\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">\u533b\u7642\u6a5f\u5668\u898f\u5236<\/a> (MDR\uff09\uff082017\/745\uff09\u304a\u3088\u3073IVDR\uff082017\/746\uff09\u3067\u3042\u308a\u3001\u3053\u308c\u3089\u306f\u5f93\u6765\u306e3\u3064\u306eEU\u6307\u4ee490\/385\/EEC\u300c\u80fd\u52d5\u7684\u690d\u8fbc\u307f\u578b\u533b\u7642\u6a5f\u5668\uff08AIMDD\uff09\u300d\u300193\/42\/EEC\u300c\u533b\u7642\u6a5f\u5668\uff08MDD\uff09\u300d\u300198\/79\/EC\u300c\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\uff08IVDMD\uff09\u300d\u3092\u7f6e\u304d\u63db\u3048\u308b\u3082\u306e\u3067\u3059\u3002\u6b27\u5dde\u3067\u306f\u3001\u5171\u901a\u306e\u898f\u5236\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u304c\u5c0e\u5165\u3055\u308c\u3066\u3044\u308b\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u5404\u52a0\u76df\u56fd\u306b\u306f\u533b\u7642\u6a5f\u5668\u306e\u7ba1\u7406\u3092\u62c5\u5f53\u3059\u308b\u6240\u8f44\u5b98\u5e81\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">EU\u306b\u304a\u3051\u308b\u5fc5\u9808\u8981\u4ef6\u306e\u4e00\u74b0\u3068\u3057\u3066\u3001\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u306b\u3064\u3044\u3066\u3001\u6307\u4ee493\/42\/EEC\u4ed8\u5c5e\u66f8X\u307e\u305f\u306f\u6307\u4ee490\/385\/EEC\u4ed8\u5c5e\u66f87\u306b\u57fa\u3065\u3044\u3066\u81e8\u5e8a\u8a55\u4fa1\u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u30022016\u5e747\u67081\u65e5\u306b\u30ea\u30ea\u30fc\u30b9\u3055\u308c\u305fMEDDEV2.7.1\u30ea\u30d3\u30b8\u30e7\u30f34\u306b\u3088\u308b\u3068\u3001\u9ad8\u30ea\u30b9\u30af\u307e\u305f\u306f\u65b0\u898f\u306e\u6a5f\u5668\u306e\u88fd\u9020\u8005\u306f\u3001\u66f4\u65b0\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\uff08CER<\/a> \u4ed6\u306e\u6a5f\u5668\u3067\u306f2\uff5e5\u5e74\u306b\u4e00\u5ea6\u306e\u983b\u5ea6\u3067\u3042\u308b\u306e\u306b\u5bfe\u3057\u30011\u5e74\u306b\u4e00\u5ea6\u3002<\/span><\/p>\n<p><strong>CE\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u30af\u30e9\u30b9III\u306e\u533b\u7642\u6a5f\u5668\u306f\u5b89\u5168\u6027\u3068\u6027\u80fd\u3092\u8a3c\u660e\u3059\u308b\u3060\u3051\u3067\u3088\u304f\u3001\u6709\u52b9\u6027\u3092\u8a3c\u660e\u3059\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u898f\u683c\u3078\u306e\u9069\u5408\u306f\u3001\u901a\u5e38\u3001\u3088\u308a\u7c21\u5358\u3067\u5b89\u4fa1\u306a\u81e8\u5e8a\u8a66\u9a13\u3067\u8a3c\u660e\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 <a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S2452302X16300638\">FDA\u306e\u8981\u6c42\u3088\u308a<\/a> [6].\u3053\u306e\u3088\u3046\u306a\u7406\u7531\u304b\u3089\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u4e00\u822c\u7684\u306b\u3001FDA\u306e\u627f\u8a8d\u3092\u5f97\u308b\u3088\u308a\u3082\u304b\u306a\u308a\u524d\u306b\u88fd\u54c1\u3092EU\u306b\u5c0e\u5165\u3057\u305f\u3044\u3068\u8003\u3048\u3066\u3044\u307e\u3059\u3002<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">\u524d\u8ff0\u3057\u305f\u3088\u3046\u306b\u3001\u3053\u306e\u8a18\u4e8b\u3067\u306f\u533b\u7642\u6a5f\u5668\u3092\u5bfe\u8c61\u3068\u3057\u305f\u81e8\u5e8a\u8a66\u9a13\u306e\u91cd\u8981\u306a\u7559\u610f\u70b9\u306e\u307f\u3092\u53d6\u308a\u4e0a\u3052\u3066\u304a\u308a\u3001\u4e0b\u306e\u8868\u306f\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u91cd\u8981\u306a\u7559\u610f\u70b9\u3092\u307e\u3068\u3081\u305f\u3082\u306e\u3067\u3059\u3002<\/span><\/p>\n<p><b>\u88681\uff0e\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u5c02\u9580\u5bb6\u306e5\u3064\u306e\u30d2\u30f3\u30c8<\/b><\/p>\n<table style=\"width: 701px;\">\n<tbody>\n<tr>\n<td style=\"width: 172px;\"><i><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306e5\u3064\u306e\u91cd\u8981\u306a\u7279\u5fb4<\/span><\/i><\/td>\n<td style=\"width: 499px;\"><i><span style=\"font-weight: 400;\">\u6839\u62e0<\/span><\/i><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 172px;\"><b><i>\u533b\u85ac\u54c1\u306e\u6cbb\u9a13\u306b\u6bd4\u3079\u3066\u767b\u9332\u8005\u6570\u304c\u5c11\u306a\u3044\u3002<\/i><\/b><\/td>\n<td style=\"width: 499px;\"><i><span style=\"font-weight: 400;\">\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u5408\u7406\u7684\u306a\u4fdd\u8a3c\u300d\u3092\u76ee\u7684\u3068\u3057\u305f\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3067\u306f\u3001\u30b5\u30f3\u30d7\u30eb\u6570\u304c\u63a7\u3048\u3081\u306b\u306a\u308b\u50be\u5411\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u73fe\u5b9f\u7684\u306a\u554f\u984c\u3068\u3057\u3066\u3001\u3088\u308a\u5927\u898f\u6a21\u306a\u7814\u7a76\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u304c\u56f0\u96e3\u306a\u5834\u5408\u3082\u3042\u308a\u307e\u3059\u3002<\/span><\/i><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 172px;\"><b><i>\u30c7\u30d0\u30a4\u30b9\u8a66\u9a13\u306f\u3001\u85ac\u7269\u8a66\u9a13\u306b\u6bd4\u3079\u3066\u76f2\u691c\u5316\u3084\u7121\u4f5c\u70ba\u5316\u306e\u53ef\u80fd\u6027\u304c\u4f4e\u3044\u3002<\/i><\/b><\/td>\n<td style=\"width: 499px;\"><i><span style=\"font-weight: 400;\">\u76f2\u691c\u5316\u3084\u7121\u4f5c\u70ba\u5316\u306f\u3001\u6a5f\u5668\u3084\u7814\u7a76\u5bfe\u8c61\u306e\u72b6\u614b\u306e\u6027\u8cea\u4e0a\u3001\u73fe\u5b9f\u7684\u3067\u306f\u306a\u3044\u3002\u305d\u306e\u4ed6\u306e\u7814\u7a76\u306b\u3064\u3044\u3066\u306f\u3001\u305d\u306e\u6a5f\u5668\u306e\u30bf\u30a4\u30d7\u306b\u95a2\u3059\u308bFDA\u306e\u7d4c\u9a13\u304b\u3089\u3001\u5408\u610f\u3055\u308c\u305f\u6027\u80fd\u76ee\u6a19\u307e\u305f\u306f\u78ba\u7acb\u3055\u308c\u305f\u5ba2\u89b3\u7684\u6027\u80fd\u57fa\u6e96\u3068\u7d50\u679c\u3092\u6bd4\u8f03\u3059\u308b\u5358\u4e00\u30b0\u30eb\u30fc\u30d7\u306e\u7814\u7a76\u304c\u53ef\u80fd\u3067\u3042\u308b\u3002<\/span><\/i><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 172px;\"><b><i>\u8a66\u9a13\u4e2d\u306b\u30c7\u30d0\u30a4\u30b9\u306e\u30c7\u30b6\u30a4\u30f3\u3084\u624b\u9806\u304c\u5909\u66f4\u3055\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/i><\/b><\/td>\n<td style=\"width: 499px;\"><i><span style=\"font-weight: 400;\">\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u3001\u521d\u671f\u306e\u81e8\u5e8a\u4e8b\u8c61\u3084\u3001\u533b\u5e2b\u3084\u60a3\u8005\u304b\u3089\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u306b\u3088\u308a\u3001\u6a5f\u5668\u3084\u624b\u9806\u306e\u5909\u66f4\u304c\u5fc5\u8981\u306b\u306a\u308b\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002\u5909\u66f4\u70b9\u306e\u691c\u8a3c\u306b\u306f\u3001\u5f53\u521d\u306e\u8a08\u753b\u3092\u4e0a\u56de\u308b\u8ffd\u52a0\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u304c\u5fc5\u8981\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u5f53\u521d\u306e\u6a5f\u5668\u3084\u624b\u9806\u306b\u95a2\u3059\u308b\u30c7\u30fc\u30bf\u3092\u6d3b\u7528\u3059\u308b\u3053\u3068\u304c\u9069\u5207\u3067\u3042\u308b\u3053\u3068\u304c\u793a\u3055\u308c\u305f\u5834\u5408\u306b\u306f\u3001\u5168\u304f\u65b0\u3057\u3044\u7814\u7a76\u3092\u5fc5\u8981\u3068\u3057\u306a\u3044\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002<\/span><\/i><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 172px;\"><b><i>\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u3001\u65e2\u5b58\u306e\u30c7\u30fc\u30bf\u304c\u30d7\u30ed\u30b9\u30da\u30af\u30c6\u30a3\u30d6\u30fb\u30c7\u30fc\u30bf\u306e\u4e00\u90e8\u307e\u305f\u306f\u5168\u90e8\u3092\u4ee3\u66ff\u3067\u304d\u308b\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002 <\/i><\/b><b><i>\u306e\u8a66\u9a13\u30c7\u30fc\u30bf\u3067\u3059\u3002<\/i><\/b><\/td>\n<td style=\"width: 499px;\"><i><span style=\"font-weight: 400;\">FDA\u306a\u3069\u306e\u898f\u5236\u5f53\u5c40\u306f\u3001\u8ca9\u58f2\u7533\u8acb\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u3068\u3044\u3046\u7279\u5b9a\u306e\u76ee\u7684\u306e\u305f\u3081\u306b\u3001\u524d\u5411\u304d\u7814\u7a76\u306e\u5916\u90e8\u304b\u3089\u5165\u624b\u53ef\u80fd\u306a\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u8003\u616e\u3057\u307e\u3059\u3002\u3053\u306e\u3053\u3068\u306f\u3001\u300c\u9069\u5fdc\u5916\u300d\u306e\u4f7f\u7528\u3092\u88cf\u4ed8\u3051\u308b\u8a3c\u62e0\u304c\u3042\u308a\u3001\u53c2\u52a0\u8005\u3092\u7121\u4f5c\u70ba\u306b\u5272\u308a\u5f53\u3066\u308b\u3053\u3068\u304c\u56f0\u96e3\u3067\u3042\u308b\u304b\u3001\u3042\u308b\u3044\u306f\u975e\u502b\u7406\u7684\u3067\u3042\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u5834\u5408\u306b\u3001\u627f\u8a8d\u3055\u308c\u305f\u6a5f\u5668\u306e\u9069\u5fdc\u62e1\u5927\u3092\u691c\u8a0e\u3059\u308b\u969b\u306b\u7279\u306b\u95a2\u4fc2\u3057\u307e\u3059\u3002<\/span><\/i><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 172px;\"><b><i>\u591a\u304f\u306e\u30c7\u30d0\u30a4\u30b9\u8a66\u9a13\u3067\u306f <\/i><\/b><b><i>\u53cd\u5fa9\u7684\u306a\u6539\u5584 <\/i><\/b><b><i>\u524d\u4e16\u4ee3\u3067\u306e <\/i><\/b><b><i>\u30c7\u30d0\u30a4\u30b9\u3092\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u3002<\/i><\/b><\/td>\n<td style=\"width: 499px;\"><i><span style=\"font-weight: 400;\">\u771f\u306b\u65b0\u3057\u3044\u30c7\u30d0\u30a4\u30b9\u3082\u3042\u308a\u307e\u3059\u304c\u3001\u30c7\u30d0\u30a4\u30b9\u958b\u767a\u306e\u672c\u8cea\u306f\u3001\u81e8\u5e8a\u7d4c\u9a13\u306e\u5897\u52a0\u3068\u79d1\u5b66\u306e\u9032\u6b69\u306b\u4f34\u3044\u3001\u65e2\u5b58\u306e\u6280\u8853\u3092\u7e70\u308a\u8fd4\u3057\u6539\u826f\u3057\u3066\u3044\u304f\u3053\u3068\u306b\u3042\u308a\u307e\u3059\u3002\u591a\u304f\u306e\u5834\u5408\u3001\u65b0\u3057\u3044\u30c7\u30d0\u30a4\u30b9\u306e\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u3068\u30ea\u30b9\u30af\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u304c\u3001\u5fc5\u305a\u3057\u3082\u30aa\u30ea\u30b8\u30ca\u30eb\u306e\u30c7\u30d0\u30a4\u30b9\u307b\u3069\u5e83\u7bc4\u56f2\u306b\u53ca\u3076\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/span><\/i><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><b>\u00a0<\/b><\/p>\n<blockquote><p><strong>\u8457\u8005\u306e\u63a1\u7528<\/strong><\/p>\n<p><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/shrinidh-joshi?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid-Meddevices\"><strong><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-7614 alignleft\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-300x300.jpg\" alt=\"\" width=\"215\" height=\"215\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-150x150@2x.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-150x150.jpg 150w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-24x24.jpg 24w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-48x48.jpg 48w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-96x96.jpg 96w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD.jpg 500w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-96x96@2x.jpg 192w\" sizes=\"(max-width: 215px) 100vw, 215px\" \/><\/strong><\/a>Shrinidh Joshi\u306f\u3001\u88fd\u85ac\u3001\u81e8\u5e8a\u3001\u85ac\u4e8b\u3001\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0\u306e\u5206\u91ce\u306710\u5e74\u4ee5\u4e0a\u306e\u7d4c\u9a13\u304c\u3042\u308a\u307e\u3059\u3002University Health Network\u3001Krembil Research Institute\u3001Sun Pharma\u3001Virgilant\u3001CannTrust\u3001ThermoFisher Scientific\u306a\u3069\u306e\u4f01\u696d\u3067\u3001\u5b66\u754c\u5185\u5916\u3067\u6d3b\u8e8d\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u5c02\u9580\u5206\u91ce\u306f\u3001\u6297\u4f53\u3001\u518d\u751f\u533b\u7642\u3001\u7d30\u80de\u30fb\u907a\u4f1d\u5b50\u6cbb\u7642\u3001\u30a6\u30a4\u30eb\u30b9\u88fd\u54c1\u3001\u304c\u3093\u514d\u75ab\u7642\u6cd5\u3001\u9593\u8449\u7cfb\u30b9\u30c8\u30ed\u30fc\u30de\u7d30\u80de\u3001\u30d0\u30a4\u30aa\u30ea\u30a2\u30af\u30bf\u30fc\u3001\u533b\u7642\u6a5f\u5668\u3001\u8db3\u5834\u3001\u30ab\u30f3\u30ca\u30d3\u30ce\u30a4\u30c9\u306a\u3069\u306e\u533b\u85ac\u54c1\u30fb\u30d0\u30a4\u30aa\u30ed\u30b8\u30af\u30b9\u5e02\u5834\u3002\u30db\u30ef\u30a4\u30c8\u30da\u30fc\u30d1\u30fc\u3001\u30ea\u30b5\u30fc\u30c1\u30da\u30fc\u30d1\u30fc\u3001\u30d6\u30c3\u30af\u30c1\u30e3\u30d7\u30bf\u30fc\u306a\u3069\u3092\u57f7\u7b46\u3057\u3066\u3044\u307e\u3059\u3002<br \/>\n<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/shrinidh-joshi\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrials-MD\">\u30b7\u30e5\u30ea\u30cb\u30fc\u30c9\u30fb\u30b8\u30e7\u30b7\u3092\u96c7\u3046<\/a><\/p><\/blockquote>\n<p><b>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9<\/b><\/p>\n<p><span style=\"font-weight: 400;\">1.)<\/span><span style=\"font-weight: 400;\"> \u00a0 <\/span><span style=\"font-weight: 400;\">\u6b27\u5dde\u59d4\u54e1\u4f1a\u6210\u9577\u306e\u305f\u3081\u306b\u57df\u5185\u5e02\u5834\u3001\u7523\u696d\u3001\u4f01\u696d\u5bb6\u7cbe\u795e <\/span><span style=\"font-weight: 400;\">\u3068\u4e2d\u5c0f\u4f01\u696d\uff1b\u533b\u7642\u6a5f\u5668\u30022016.<\/span><a href=\"http:\/\/ec.europa.eu\/growth\/sectors\/medical-devices\/\"> <span style=\"font-weight: 400;\">http:\/\/ec.europa.eu\/growth\/sectors\/medical-devices\/<\/span><\/a><span style=\"font-weight: 400;\">.\u30a2\u30af\u30bb\u30b9\u306f2020\u5e745\u670824\u65e5\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">2.)<\/span><span style=\"font-weight: 400;\"> \u00a0 <\/span><span style=\"font-weight: 400;\">Eikermann M, Gluud C, Perleth M, Wild C, Sauerland S, Gutierrez-Ibarluzea I, et al. Commentary:\u6b27\u5dde\u306f\u3001\u4e2d\u592e\u3001\u900f\u660e\u3001\u304b\u3064\u8a3c\u62e0\u306b\u57fa\u3065\u304f\u6a5f\u5668\u306e\u898f\u5236\u30d7\u30ed\u30bb\u30b9\u3092\u5fc5\u8981\u3068\u3057\u3066\u3044\u307e\u3059\u3002BMJ.2013;346:f2771.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">3.)<\/span><span style=\"font-weight: 400;\"> \u00a0 <\/span><span style=\"font-weight: 400;\">Jarvinen TL, Sihvonen R, Bhandari M, Sprague S, Malmivaara A, Paavola M, et al.\u7814\u7a76\u7d50\u679c\u306e\u76f2\u691c\u89e3\u91c8\u306f\u3001\u89e3\u91c8\u306e\u504f\u308a\u3092\u5b9f\u73fe\u7684\u304b\u3064\u52b9\u679c\u7684\u306b\u6e1b\u5c11\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002J Clin Epidemiol.2014;67(7):769-72.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">4.)<\/span><span style=\"font-weight: 400;\"> \u00a0 <\/span><span style=\"font-weight: 400;\">Karanicolas PJ, Bhandari M, Walter SD, et al. \u80a1\u95a2\u7bc0\u9aa8\u6298\u306eX\u7dda\u5199\u771f\u3092\u30c7\u30b8\u30bf\u30eb\u51e6\u7406\u3057\u3066\u5916\u79d1\u533b\u306b\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u7a2e\u985e\u3092\u96a0\u3059\u3053\u3068\u3067\u3001\u54c1\u8cea\u8a55\u4fa1\u306e\u4fe1\u983c\u6027\u3092\u640d\u306a\u3046\u3053\u3068\u306a\u304f\u3001\u307e\u305f\u8a55\u4fa1\u30d7\u30ed\u30bb\u30b9\u3092\u56f0\u96e3\u306b\u3059\u308b\u3053\u3068\u306a\u304f\u3001\u8a55\u4fa1\u3092\u884c\u3063\u305f\u3002J Clin Epidemiol.2009;62:214-23.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">5.)<\/span><span style=\"font-weight: 400;\"> \u00a0 <\/span><span style=\"font-weight: 400;\">Probst P, Knebel P, Grummich K, Tenckhoff S, Ulrich A, B\u00fcchler MW, Diener MK.\u4e00\u822c\u5916\u79d1\u304a\u3088\u3073\u8179\u90e8\u5916\u79d1\u306b\u304a\u3051\u308b\u7121\u4f5c\u70ba\u5316\u6bd4\u8f03\u8a66\u9a13\u306e\u696d\u754c\u30d0\u30a4\u30a2\u30b9\u3002\u7d4c\u9a13\u7684\u306a\u7814\u7a76\u3067\u3059\u3002Ann Surg.2016;264(1):87-92.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">6.)<\/span><span style=\"font-weight: 400;\"> \u00a0 <\/span><span style=\"font-weight: 400;\">\u7c73\u56fd\u3067\u3082EU\u3067\u3082\u3001\u4e16\u754c\u521d\u306e\u30c7\u30d0\u30a4\u30b9\u306f\u533b\u7642\u4fdd\u967a\u4f1a\u793e\u304b\u3089\u306e\u511f\u9084\u3092\u53d7\u3051\u308b\u3068\u3044\u3046\u30cf\u30fc\u30c9\u30eb\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u4eca\u56de\u8abf\u67fb\u3057\u305f\u30c7\u30d0\u30a4\u30b9\u306f\u7b2c2\u4e16\u4ee3\u3001\u7b2c3\u4e16\u4ee3\u306e\u88fd\u54c1\u3067\u3042\u308b\u305f\u3081\u3001\u5c0e\u5165\u524d\u306b\u3059\u3067\u306b\u9069\u7528\u7bc4\u56f2\u304c\u6c7a\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>Shrinidh Joshi, experienced clinical research consultant and medical writer, provides 5 best practices to keep in mind while conducting clinical trials for medical devices.\u00a0 Medical devices play a critical role in the lives and health of millions of people worldwide. From everyday household items such as oral thermometers to complex implantables such as deep-brain stimulators, patients and the general public rely on regulators to ensure that legally marketed medical devices have been shown to be safe and effective. The Medical Device sector has become increasingly important for the healthcare of citizens, with an immense influence on expenditure. For example, in the European Union (EU) alone, this sector employs approximately 675,000<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/clinical-trials-for-medical-devices-5-expert-tips\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":7706,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[443,540,435],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Clinical Trials for Medical Devices: 5 Expert Tips - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"Conducting clinical trials for medical devices can be challenging. Read these tips to minimize errors, meet FDA\/MDR regulations and get to market quickly.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/zh\/clinical-trials-for-medical-devices-5-expert-tips\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical Trials for Medical Devices: 5 Expert Tips\" \/>\n<meta property=\"og:description\" content=\"Conducting clinical trials for medical devices can be challenging. 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