{"id":73,"date":"2026-05-05T00:29:59","date_gmt":"2026-05-05T00:29:59","guid":{"rendered":"http:\/\/4.190.161.227\/?p=73"},"modified":"2026-05-05T00:56:44","modified_gmt":"2026-05-05T00:56:44","slug":"need-a-clinical-evaluation-plan-kolabtree-connects-you-with-the-experts-who-can-deliver-it","status":"publish","type":"post","link":"https:\/\/www.kolabtree.jp\/blog\/?p=73","title":{"rendered":"\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b\uff08CEP\uff09\u306e\u4f5c\u6210\u3067\u304a\u56f0\u308a\u3067\u3059\u304b\uff1f\u3000Kolabtree\u306a\u3089\u533b\u7642\u6a5f\u5668\u30fb\u898f\u5236\u5bfe\u5fdc\u306e\u5c02\u9580\u5bb6\u306b\u4f9d\u983c\u3067\u304d\u307e\u3059"},"content":{"rendered":"\n<p 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MDR\uff08\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u898f\u5247\uff09\u3092\u306f\u3058\u3081\u3068\u3059\u308b\u898f\u5236\u8981\u4ef6\u304c\u53b3\u683c\u5316\u3057\u3066\u304a\u308a\u3001\u958b\u767a\u30c1\u30fc\u30e0\u3084\u85ac\u4e8b\u30fb\u54c1\u8cea\u4fdd\u8a3c\u90e8\u9580\u306b\u3068\u3063\u3066\u3001\u95a2\u9023\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u6574\u5099\u306f\u3053\u308c\u307e\u3067\u4ee5\u4e0a\u306b\u91cd\u8981\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u306a\u304b\u3067\u3082\u3001\u591a\u304f\u306e\u4f01\u696d\u304c\u65e9\u3044\u6bb5\u968e\u3067\u8ab2\u984c\u306b\u611f\u3058\u3084\u3059\u3044\u306e\u304c\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b\uff08CEP\uff1aClinical Evaluation Plan\uff09\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">CEP\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u30fb\u6027\u80fd\u30fb\u81e8\u5e8a\u7684\u6709\u52b9\u6027\u3092\u3069\u306e\u3088\u3046\u306b\u8a55\u4fa1\u3057\u3066\u3044\u304f\u304b\u3092\u793a\u3059\u3001\u3044\u308f\u3070\u81e8\u5e8a\u8a55\u4fa1\u306e\u8a2d\u8a08\u56f3\u3067\u3059\u3002\u3053\u3053\u304c\u66d6\u6627\u3060\u3068\u3001\u305d\u306e\u5f8c\u306e\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER\uff09\u3084\u898f\u5236\u5f53\u5c40\u3078\u306e\u8aac\u660e\u306b\u3082\u4e00\u8cab\u6027\u304c\u51fa\u306b\u304f\u304f\u306a\u308a\u307e\u3059\u3002\u9006\u306b\u3001\u3057\u3063\u304b\u308a\u3057\u305fCEP\u304c\u3042\u308c\u3070\u3001\u81e8\u5e8a\u8a55\u4fa1\u5168\u4f53\u3092\u30b9\u30e0\u30fc\u30ba\u304b\u3064\u6226\u7565\u7684\u306b\u9032\u3081\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">Kolabtree\u3067\u306f\u3001\u3053\u3046\u3057\u305f\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b\u306e\u4f5c\u6210\u652f\u63f4\u3084\u533b\u7642\u6a5f\u5668\u898f\u5236\u5bfe\u5fdc\u306b\u5f37\u3044\u5c02\u9580\u5bb6\u3068\u3064\u306a\u304c\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>\u306a\u305c\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b\uff08CEP<\/strong><strong>\uff09\u304c\u91cd\u8981\u306a\u306e\u304b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b\uff08CEP\uff09\u306f\u3001\u5358\u306a\u308b\u5f62\u5f0f\u7684\u306a\u6587\u66f8\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<br>\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u304b\u3089\u5e02\u8ca9\u5f8c\u307e\u3067\u3092\u898b\u636e\u3048\u3001\u3069\u306e\u3088\u3046\u306a\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3057\u3001\u3069\u306e\u3088\u3046\u306a\u57fa\u6e96\u3067\u8a55\u4fa1\u3057\u3001\u3069\u306e\u3088\u3046\u306b\u5b89\u5168\u6027\u3068\u6027\u80fd\u3092\u7acb\u8a3c\u3057\u3066\u3044\u304f\u306e\u304b\u3092\u6574\u7406\u3059\u308b\u91cd\u8981\u306a\u6587\u66f8\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"u-mb-ctrl u-mb-0 wp-block-paragraph\">\u4e00\u822c\u7684\u306bCEP\u306b\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u5185\u5bb9\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u306e\u9032\u3081\u65b9<\/li>\n\n\n\n<li>\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u8a55\u4fa1\u57fa\u6e96<\/li>\n\n\n\n<li>\u5b89\u5168\u6027\u30fb\u6027\u80fd\u306b\u95a2\u3059\u308b\u8a55\u4fa1\u65b9\u91dd<\/li>\n\n\n\n<li>\u81e8\u5e8a\u8a66\u9a13\u3084\u8abf\u67fb\u306e\u8003\u3048\u65b9<\/li>\n\n\n\n<li>\u81e8\u5e8a\u8a55\u4fa1\u306e\u5168\u4f53\u6226\u7565<\/li>\n<\/ul>\n\n\n\n<p class=\"u-mb-ctrl u-mb-0 wp-block-paragraph\">\u8cea\u306e\u9ad8\u3044CEP\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u3067\u3001\u6b21\u306e\u3088\u3046\u306a\u30e1\u30ea\u30c3\u30c8\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u65e2\u5b58\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u4e0d\u8db3\u3084\u30ae\u30e3\u30c3\u30d7\u3092\u628a\u63e1\u3067\u304d\u308b<\/li>\n\n\n\n<li>\u88fd\u54c1\u306e\u4e3b\u5f35\u3092\u79d1\u5b66\u7684\u306b\u88cf\u3065\u3051\u3084\u3059\u304f\u306a\u308b<\/li>\n\n\n\n<li>\u898f\u5236\u8981\u4ef6\u306b\u6cbf\u3063\u305f\u81e8\u5e8a\u8a55\u4fa1\u306e\u6d41\u308c\u3092\u4f5c\u308c\u308b<\/li>\n\n\n\n<li>\u5f8c\u7d9a\u306eCER\u4f5c\u6210\u3084\u5f53\u5c40\u5bfe\u5fdc\u304c\u9032\u3081\u3084\u3059\u304f\u306a\u308b<\/li>\n<\/ul>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">\u7279\u306bEU MDR\u306b\u5bfe\u5fdc\u3059\u308b\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001CEP\u306e\u5b8c\u6210\u5ea6\u306f\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u5f8c\u5de5\u7a0b\u3067\u5e33\u5c3b\u3092\u5408\u308f\u305b\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u6700\u521d\u306b\u8a55\u4fa1\u65b9\u91dd\u3092\u304d\u3061\u3093\u3068\u8a2d\u8a08\u3057\u3066\u304a\u304f\u3053\u3068\u304c\u3001\u7d50\u679c\u7684\u306b\u52b9\u7387\u306e\u826f\u3044\u898f\u5236\u5bfe\u5fdc\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>\u533b\u7642\u6a5f\u5668\u306eCEP<\/strong><strong>\u4f5c\u6210\u304c\u96e3\u3057\u3044\u7406\u7531<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5b9f\u969b\u306b\u306f\u3001\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b\u306e\u4f5c\u6210\u306f\u6c7a\u3057\u3066\u7c21\u5358\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<br>\u793e\u5185\u306b\u958b\u767a\u3001\u85ac\u4e8b\u3001\u81e8\u5e8a\u3001\u54c1\u8cea\u4fdd\u8a3c\u306e\u77e5\u898b\u304c\u63c3\u3063\u3066\u3044\u3066\u3082\u3001\u305d\u308c\u3089\u3092\u4e00\u3064\u306e\u898f\u5236\u6587\u66f8\u3068\u3057\u3066\u6574\u7406\u3059\u308b\u306e\u306f\u304b\u306a\u308a\u9ad8\u5ea6\u306a\u4f5c\u696d\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"u-mb-ctrl u-mb-0 wp-block-paragraph\">\u305f\u3068\u3048\u3070\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u60a9\u307f\u306f\u3088\u304f\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u3069\u3053\u307e\u3067\u6587\u732e\u8abf\u67fb\u3092\u884c\u3048\u3070\u5341\u5206\u306a\u306e\u304b\u5206\u304b\u3089\u306a\u3044<\/li>\n\n\n\n<li>\u81ea\u793e\u88fd\u54c1\u306e intended purpose \u3084 claims \u306e\u6574\u7406\u304c\u96e3\u3057\u3044<\/li>\n\n\n\n<li>CER\u3084PMCF\u3068\u306e\u95a2\u4fc2\u3092\u8e0f\u307e\u3048\u3066CEP\u3092\u8a2d\u8a08\u3057\u305f\u3044<\/li>\n\n\n\n<li>EU MDR\u3084MEDDEV 2.7\/1 Rev.4\u3078\u306e\u6574\u5408\u6027\u306b\u4e0d\u5b89\u304c\u3042\u308b<\/li>\n\n\n\n<li>\u793e\u5185\u30ea\u30bd\u30fc\u30b9\u304c\u8db3\u308a\u305a\u3001\u5c02\u9580\u5bb6\u306e\u652f\u63f4\u304c\u5fc5\u8981<\/li>\n<\/ul>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a55\u4fa1\u3067\u306f\u3001\u5358\u306b\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u57cb\u3081\u308b\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3059\u3002<br>\u88fd\u54c1\u306e\u7279\u6027\u3001\u5bfe\u8c61\u60a3\u8005\u3001\u65e2\u5b58\u30c7\u30fc\u30bf\u3001\u30ea\u30b9\u30af\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3001\u898f\u5236\u8981\u4ef6\u3092\u8e0f\u307e\u3048\u305f\u3046\u3048\u3067\u3001\u300c\u306a\u305c\u3053\u306e\u8a55\u4fa1\u65b9\u91dd\u306a\u306e\u304b\u300d\u307e\u3067\u8aac\u660e\u3067\u304d\u308b\u69cb\u6210\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>Kolabtree<\/strong><strong>\u304c\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b\uff08CEP<\/strong><strong>\uff09\u306e\u652f\u63f4\u306b\u5411\u3044\u3066\u3044\u308b\u7406\u7531<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Kolabtree\u306f\u3001\u79d1\u5b66\u30fb\u533b\u7642\u30fb\u898f\u5236\u5206\u91ce\u306b\u7279\u5316\u3057\u305f\u5c02\u9580\u5bb6\u3078\u4f9d\u983c\u3067\u304d\u308b\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3059\u3002<br>CEP\u4f5c\u6210\u652f\u63f4\u3001CER\u4f5c\u6210\u3001\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u6587\u66f8\u4f5c\u6210\u3001\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u3001\u7d71\u8a08\u89e3\u6790\u306a\u3069\u3001\u5c02\u9580\u6027\u306e\u9ad8\u3044\u6848\u4ef6\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u4eba\u6750\u304c\u63c3\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"u-mb-ctrl u-mb-0 wp-block-paragraph\">Kolabtree\u3067\u4f9d\u983c\u3057\u3084\u3059\u3044\u5c02\u9580\u9818\u57df\u306b\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul 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wp-block-paragraph\">\u3053\u3046\u3057\u305f\u5c02\u9580\u5bb6\u306e\u652f\u63f4\u3092\u53d7\u3051\u308b\u3053\u3068\u3067\u3001\u793e\u5185\u3060\u3051\u3067\u306f\u6574\u7406\u3057\u304d\u308c\u306a\u3044\u60c5\u5831\u3092\u3001\u898f\u5236\u5bfe\u5fdc\u306b\u8010\u3048\u3046\u308b\u5f62\u3067\u69cb\u9020\u5316\u3057\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>Kolabtree<\/strong><strong>\u3067\u4f9d\u983c\u3067\u304d\u308b\u533b\u7642\u6a5f\u5668\u30fb\u81e8\u5e8a\u8a55\u4fa1\u95a2\u9023\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Kolabtree\u3067\u5bfe\u5fdc\u3067\u304d\u308b\u306e\u306f\u3001\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b\uff08CEP\uff09\u3060\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<br>\u5b9f\u969b\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u3084\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u5206\u91ce\u306e\u4f01\u696d\u304c\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u95a2\u9023\u696d\u52d9\u3092\u307e\u3068\u3081\u3066\u4f9d\u983c\u3059\u308b\u30b1\u30fc\u30b9\u3082\u591a\u304f\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"u-mb-ctrl u-mb-0 wp-block-paragraph\">\u81e8\u5e8a\u8a55\u4fa1\u95a2\u9023\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u4f5c\u6210\u652f\u63f4<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b\uff08CEP\uff09<\/li>\n\n\n\n<li>\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER\uff09<\/li>\n\n\n\n<li>PMCF\u8a08\u753b<\/li>\n\n\n\n<li>\u30c7\u30fc\u30bf\u8a55\u4fa1\u30de\u30c8\u30ea\u30af\u30b9<\/li>\n\n\n\n<li>\u30b7\u30b9\u30c6\u30de\u30c6\u30a3\u30c3\u30af\u30ec\u30d3\u30e5\u30fc<\/li>\n<\/ul>\n\n\n\n<p class=\"u-mb-ctrl u-mb-0 wp-block-paragraph\">\u81e8\u5e8a\u8a66\u9a13\u30fb\u8abf\u67fb\u6e96\u5099\u306e\u652f\u63f4<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Clinical Investigation Plan\uff08CIP\uff09<\/li>\n\n\n\n<li>\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb<\/li>\n\n\n\n<li>\u6cbb\u9a13\u8cac\u4efb\u8005\u5411\u3051\u8cc7\u6599<\/li>\n\n\n\n<li>\u502b\u7406\u5be9\u67fb\u59d4\u54e1\u4f1a\u63d0\u51fa\u8cc7\u6599<\/li>\n\n\n\n<li>\u30d5\u30a3\u30fc\u30b8\u30d3\u30ea\u30c6\u30a3\u8a55\u4fa1<\/li>\n<\/ul>\n\n\n\n<p class=\"u-mb-ctrl u-mb-0 wp-block-paragraph\">\u6587\u732e\u8abf\u67fb\u30fb\u30a8\u30d3\u30c7\u30f3\u30b9\u7d71\u5408<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u7cfb\u7d71\u7684\u6587\u732e\u30ec\u30d3\u30e5\u30fc<\/li>\n\n\n\n<li>\u30e1\u30bf\u30a2\u30ca\u30ea\u30b7\u30b9<\/li>\n\n\n\n<li>\u69cb\u9020\u5316\u691c\u7d22<\/li>\n\n\n\n<li>\u30d0\u30a4\u30a2\u30b9\u8a55\u4fa1<\/li>\n\n\n\n<li>\u30a8\u30d3\u30c7\u30f3\u30b9\u30ae\u30e3\u30c3\u30d7\u5206\u6790<\/li>\n<\/ul>\n\n\n\n<p class=\"u-mb-ctrl u-mb-0 wp-block-paragraph\">\u7d71\u8a08\u89e3\u6790\u30fb\u30c7\u30fc\u30bf\u30b5\u30dd\u30fc\u30c8<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u8a2d\u8a08<\/li>\n\n\n\n<li>Statistical Analysis Plan\uff08SAP\uff09\u4f5c\u6210<\/li>\n\n\n\n<li>\u4e2d\u9593\u89e3\u6790\u30fb\u6700\u7d42\u89e3\u6790<\/li>\n\n\n\n<li>\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u8a55\u4fa1\u652f\u63f4<\/li>\n<\/ul>\n\n\n\n<p class=\"u-mb-ctrl u-mb-0 wp-block-paragraph\">\u898f\u5236\u7533\u8acb\u30fb\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0\u652f\u63f4<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>510(k)\u3084PMA\u306b\u95a2\u9023\u3059\u308b\u6587\u66f8\u4f5c\u6210\u652f\u63f4<\/li>\n\n\n\n<li>\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb<\/li>\n\n\n\n<li>\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u6587\u66f8<\/li>\n\n\n\n<li>\u767d\u66f8\u3084\u5b66\u8853\u539f\u7a3f\u306e\u4f5c\u6210<\/li>\n\n\n\n<li>\u6559\u80b2\u8cc7\u6599\u3084\u6280\u8853\u8cc7\u6599\u306e\u6574\u5099<\/li>\n<\/ul>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">\u3064\u307e\u308aKolabtree\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a55\u4fa1\u30fb\u898f\u5236\u5bfe\u5fdc\u3092\u90e8\u5206\u7684\u306b\u3082\u5305\u62ec\u7684\u306b\u3082\u652f\u63f4\u3067\u304d\u308b\u306e\u304c\u5f37\u307f\u3067\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>Kolabtree<\/strong><strong>\u306e\u5c02\u9580\u5bb6\u306fCEP<\/strong><strong>\u4f5c\u6210\u3092\u3069\u306e\u3088\u3046\u306b\u652f\u63f4\u3059\u308b\u306e\u304b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b\uff08CEP\uff09\u306e\u4f5c\u6210\u3067\u306f\u3001\u79d1\u5b66\u7684\u306a\u59a5\u5f53\u6027\u3068\u898f\u5236\u4e0a\u306e\u6574\u5408\u6027\u3001\u305d\u306e\u4e21\u65b9\u304c\u5fc5\u8981\u3067\u3059\u3002Kolabtree\u306e\u5c02\u9580\u5bb6\u306f\u3001\u6563\u5728\u3057\u3066\u3044\u308b\u6280\u8853\u60c5\u5831\u3084\u793e\u5185\u8cc7\u6599\u3092\u6574\u7406\u3057\u3001\u7b4b\u306e\u901a\u3063\u305f\u8a55\u4fa1\u6226\u7565\u3078\u843d\u3068\u3057\u8fbc\u3080\u30b5\u30dd\u30fc\u30c8\u3092\u884c\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"u-mb-ctrl u-mb-0 wp-block-paragraph\">\u5177\u4f53\u7684\u306b\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u652f\u63f4\u304c\u53ef\u80fd\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u6587\u66f8\u3001\u6280\u8853\u8cc7\u6599\u3001\u521d\u671f\u30c7\u30fc\u30bf\u306e\u30ec\u30d3\u30e5\u30fc<\/li>\n\n\n\n<li>intended purpose \u3084\u6027\u80fd\u4e3b\u5f35\u306e\u6574\u7406<\/li>\n\n\n\n<li>\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u6226\u7565\u306e\u8a2d\u8a08<\/li>\n\n\n\n<li>\u5b89\u5168\u6027\u30fb\u6027\u80fd\u306b\u95a2\u3059\u308b\u8a55\u4fa1\u89b3\u70b9\u306e\u660e\u78ba\u5316<\/li>\n\n\n\n<li>\u4e0d\u8db3\u3057\u3066\u3044\u308b\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u7279\u5b9a<\/li>\n\n\n\n<li>CER\u3084\u5e02\u8ca9\u5f8c\u8a55\u4fa1\u3092\u898b\u636e\u3048\u305f\u4e00\u8cab\u6027\u306e\u3042\u308b\u8a2d\u8a08<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u7279\u306b\u3001MEDDEV 2.7\/1 Rev.4\u306b\u6cbf\u3063\u305f\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u8a2d\u8a08\u3084\u3001\u5c06\u6765\u306eCER\u4f5c\u6210\u3082\u898b\u8d8a\u3057\u305fCEP\u69cb\u6210\u306f\u3001\u7d4c\u9a13\u306e\u3042\u308b\u5c02\u9580\u5bb6\u304c\u5165\u308b\u3053\u3068\u3067\u7cbe\u5ea6\u304c\u5927\u304d\u304f\u5909\u308f\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">\u3053\u308c\u306f\u5358\u306a\u308b\u300c\u6587\u66f8\u4f5c\u6210\u4ee3\u884c\u300d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<br>\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u958b\u767a\u3068\u898f\u5236\u5bfe\u5fdc\u3092\u524d\u306b\u9032\u3081\u308b\u305f\u3081\u306e\u3001\u5b9f\u52d9\u7684\u306a\u652f\u63f4\u3067\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\">Kolabtree\u306e\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u30e2\u30c7\u30eb\u304c\u4f7f\u3044\u3084\u3059\u3044\u7406\u7531<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5927\u624b\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u4f1a\u793e\u306b\u4f9d\u983c\u3059\u308b\u65b9\u6cd5\u3082\u3042\u308a\u307e\u3059\u304c\u3001\u6848\u4ef6\u306b\u3088\u3063\u3066\u306f\u30aa\u30fc\u30d0\u30fc\u30b9\u30da\u30c3\u30af\u306b\u306a\u3063\u305f\u308a\u3001\u8cbb\u7528\u3084\u5951\u7d04\u306e\u786c\u3055\u304c\u30cd\u30c3\u30af\u306b\u306a\u3063\u305f\u308a\u3059\u308b\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kolabtree\u306f\u3001\u5fc5\u8981\u306a\u5c02\u9580\u6027\u3092\u5fc5\u8981\u306a\u7bc4\u56f2\u3067\u6d3b\u7528\u3057\u3084\u3059\u3044\u306e\u304c\u7279\u5fb4\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"u-mb-ctrl u-mb-0 wp-block-paragraph\">\u4e3b\u306a\u30e1\u30ea\u30c3\u30c8\u306f\u6b21\u306e\u901a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5fc5\u8981\u306a\u30c6\u30fc\u30de\u306b\u5408\u3063\u305f\u5c02\u9580\u5bb6\u3092\u63a2\u3057\u3084\u3059\u3044<\/li>\n\n\n\n<li>\u77ed\u671f\u306e\u30b9\u30dd\u30c3\u30c8\u652f\u63f4\u304b\u3089\u7d99\u7d9a\u652f\u63f4\u307e\u3067\u67d4\u8edf\u306b\u4f9d\u983c\u3067\u304d\u308b<\/li>\n\n\n\n<li>\u5c02\u9580\u5bb6\u306e\u7d4c\u6b74\u3084\u5b9f\u7e3e\u3092\u78ba\u8a8d\u3057\u3084\u3059\u3044<\/li>\n\n\n\n<li>\u30bb\u30ad\u30e5\u30a2\u306a\u74b0\u5883\u3067\u3084\u308a\u53d6\u308a\u3067\u304d\u308b<\/li>\n\n\n\n<li>\u793e\u5185\u30ea\u30bd\u30fc\u30b9\u3092\u88dc\u3044\u306a\u304c\u3089\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u9032\u3081\u3089\u308c\u308b<\/li>\n<\/ul>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3067\u306f\u3001\u300c\u5168\u90e8\u3092\u5916\u90e8\u306b\u4efb\u305b\u305f\u3044\u300d\u3068\u3044\u3046\u30b1\u30fc\u30b9\u3060\u3051\u3067\u306a\u304f\u3001\u300c\u793e\u5185\u6848\u3092\u5c02\u9580\u5bb6\u306b\u30ec\u30d3\u30e5\u30fc\u3057\u3066\u307b\u3057\u3044\u300d\u300c\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u3060\u3051\u624b\u4f1d\u3063\u3066\u307b\u3057\u3044\u300d\u300cCER\u306b\u3064\u306a\u304c\u308b\u5f62\u3067CEP\u3092\u6574\u3048\u305f\u3044\u300d\u3068\u3044\u3063\u305f\u30cb\u30fc\u30ba\u3082\u5c11\u306a\u304f\u3042\u308a\u307e\u305b\u3093\u3002\u305d\u3046\u3057\u305f\u5b9f\u52d9\u306b\u5408\u308f\u305b\u3084\u3059\u3044\u70b9\u3082\u3001Kolabtree\u306e\u5927\u304d\u306a\u5229\u70b9\u3067\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-left is-style-section_ttl u-mb-ctrl u-mb-10\"><strong>\u306a\u305cCEP<\/strong><strong>\u6848\u4ef6\u306fKolabtree<\/strong><strong>\u3068\u76f8\u6027\u304c\u826f\u3044\u306e\u304b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b\uff08CEP\uff09\u306b\u306f\u3001\u8907\u6570\u306e\u5c02\u9580\u9818\u57df\u304c\u4ea4\u5dee\u3057\u307e\u3059\u3002<br>\u81e8\u5e8a\u77e5\u8b58\u3001\u898f\u5236\u7406\u89e3\u3001\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u3001\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0\u3001\u30c7\u30fc\u30bf\u89e3\u91c8\u3002\u305d\u306e\u3069\u308c\u304b\u4e00\u3064\u3060\u3051\u3067\u306f\u5341\u5206\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kolabtree\u3067\u306f\u3001\u3053\u3046\u3057\u305f\u8907\u6570\u30b9\u30ad\u30eb\u3092\u6301\u3064\u5c02\u9580\u5bb6\u3001\u3042\u308b\u3044\u306f\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u5f79\u5272\u3092\u5206\u3051\u305f\u5c02\u9580\u5bb6\u3092\u898b\u3064\u3051\u3084\u3059\u3044\u305f\u3081\u3001CEP\u306e\u3088\u3046\u306a\u8907\u96d1\u306a\u6848\u4ef6\u3068\u76f8\u6027\u304c\u826f\u3044\u306e\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"u-mb-ctrl u-mb-0 wp-block-paragraph\">\u305d\u306e\u7d50\u679c\u3001\u6b21\u306e\u3088\u3046\u306a\u52b9\u679c\u304c\u671f\u5f85\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u898f\u5236\u5f53\u5c40\u3084\u5be9\u67fb\u6a5f\u95a2\u306b\u8aac\u660e\u3057\u3084\u3059\u3044\u6587\u66f8\u306b\u306a\u308b<\/li>\n\n\n\n<li>\u8ffd\u52a0\u8cea\u554f\u3084\u624b\u623b\u308a\u306e\u30ea\u30b9\u30af\u3092\u6e1b\u3089\u3057\u3084\u3059\u3044<\/li>\n\n\n\n<li>\u81e8\u5e8a\u8a55\u4fa1\u95a2\u9023\u6587\u66f8\u306e\u4e00\u8cab\u6027\u3092\u9ad8\u3081\u3084\u3059\u3044<\/li>\n\n\n\n<li>\u81e8\u5e8a\u8a66\u9a13\u3084\u5e02\u8ca9\u5f8c\u8a55\u4fa1\u3078\u306e\u79fb\u884c\u304c\u30b9\u30e0\u30fc\u30ba\u306b\u306a\u308b<\/li>\n<\/ul>\n\n\n\n<p class=\"u-mb-ctrl u-mb-30 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MDR\uff08\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u898f\u5247\uff09\u3092\u306f\u3058\u3081\u3068\u3059\u308b\u898f\u5236\u8981\u4ef6\u304c\u53b3\u683c\u5316\u3057\u3066\u304a\u308a\u3001\u958b\u767a\u30c1\u30fc\u30e0\u3084\u85ac\u4e8b\u30fb\u54c1\u8cea\u4fdd\u8a3c\u90e8\u9580\u306b\u3068\u3063\u3066\u3001\u95a2\u9023\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u6574\u5099\u306f\u3053\u308c\u307e\u3067\u4ee5\u4e0a\u306b\u91cd\u8981\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u306a\u304b\u3067\u3082\u3001\u591a\u304f\u306e\u4f01\u696d\u304c\u65e9\u3044\u6bb5\u968e\u3067\u8ab2\u984c\u306b\u611f\u3058\u3084\u3059\u3044\u306e\u304c\u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b\uff08CEP\uff1aClinical Evaluation Plan\uff09\u3067\u3059\u3002 CEP\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u30fb\u6027\u80fd\u30fb\u81e8\u5e8a\u7684\u6709\u52b9\u6027\u3092\u3069\u306e\u3088\u3046\u306b\u8a55\u4fa1\u3057\u3066\u3044\u304f\u304b\u3092\u793a\u3059\u3001\u3044\u308f\u3070\u81e8\u5e8a\u8a55\u4fa1\u306e\u8a2d\u8a08\u56f3\u3067\u3059\u3002\u3053\u3053\u304c\u66d6\u6627\u3060\u3068\u3001\u305d\u306e\u5f8c\u306e\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER\uff09\u3084\u898f\u5236\u5f53\u5c40\u3078\u306e\u8aac\u660e\u306b\u3082\u4e00\u8cab\u6027\u304c\u51fa\u306b\u304f\u304f\u306a\u308a\u307e\u3059\u3002\u9006\u306b\u3001\u3057\u3063\u304b\u308a\u3057\u305fCEP\u304c\u3042\u308c\u3070\u3001\u81e8\u5e8a\u8a55\u4fa1\u5168\u4f53\u3092\u30b9\u30e0\u30fc\u30ba\u304b\u3064\u6226\u7565\u7684\u306b\u9032\u3081\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002 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Kolabtree\u306f\u3001\u4f01\u696d\u304c\u305d\u3046\u3057\u305f\u8ab2\u984c\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u3001\u79d1\u5b66\u30fb\u533b\u7642\u30fb\u898f\u5236\u306e\u5c02\u9580\u5bb6\u3068\u306e\u30de\u30c3\u30c1\u30f3\u30b0\u3092\u652f\u63f4\u3057\u3066\u3044\u307e\u3059\u3002\u3088\u308a\u5f37\u3044\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u4f5c\u308a\u305f\u3044\u3001\u3088\u308a\u5206\u304b\u308a\u3084\u3059\u3044\u898f\u5236\u6587\u66f8\u3092\u6574\u3048\u305f\u3044\u3001\u3088\u308a\u52b9\u7387\u7684\u306b\u627f\u8a8d\u6e96\u5099\u3092\u9032\u3081\u305f\u3044\u3002\u305d\u3093\u306a\u3068\u304d\u306b\u3001\u5fc5\u8981\u306a\u5c02\u9580\u77e5\u8b58\u3078\u30a2\u30af\u30bb\u30b9\u3057\u3084\u3059\u3044\u306e\u304cKolabtree\u306e\u4fa1\u5024\u3067\u3059\u3002 \u81e8\u5e8a\u8a55\u4fa1\u8a08\u753b\uff08CEP\uff09\u306e\u4f5c\u6210\u652f\u63f4\u304c\u5fc5\u8981\u306a\u3089 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