{"id":6878,"date":"2020-02-07T13:14:07","date_gmt":"2020-02-07T13:14:07","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=6878"},"modified":"2021-04-06T12:36:40","modified_gmt":"2021-04-06T12:36:40","slug":"writing-a-clinical-evaluation-report-5-quick-tips","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/writing-a-clinical-evaluation-report-5-quick-tips\/","title":{"rendered":"\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306e\u66f8\u304d\u65b9\u30025\u3064\u306e\u30d2\u30f3\u30c8"},"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-6a14a5f42e448\" 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-6a14a5f42e448\"><\/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\/writing-a-clinical-evaluation-report-5-quick-tips\/#1_Define_a_CER_protocol_and_strategy\" title=\"1.CER\u30d7\u30ed\u30c8\u30b3\u30eb\u304a\u3088\u3073\u6226\u7565\u306e\u5b9a\u7fa9\">1.CER\u30d7\u30ed\u30c8\u30b3\u30eb\u304a\u3088\u3073\u6226\u7565\u306e\u5b9a\u7fa9<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/writing-a-clinical-evaluation-report-5-quick-tips\/#2_Demonstrate_equivalence\" title=\"2.\u540c\u7b49\u6027\u3092\u8a3c\u660e\u3059\u308b\">2.\u540c\u7b49\u6027\u3092\u8a3c\u660e\u3059\u308b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/writing-a-clinical-evaluation-report-5-quick-tips\/#3_Evaluate_literature_review_data\" title=\"3.\u6587\u732e\u8abf\u67fb\u30c7\u30fc\u30bf\u306e\u8a55\u4fa1\">3.\u6587\u732e\u8abf\u67fb\u30c7\u30fc\u30bf\u306e\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\/writing-a-clinical-evaluation-report-5-quick-tips\/#4_Determine_requirement_for_clinical_investigation\" title=\"4.\u81e8\u5e8a\u8a66\u9a13\u306e\u5fc5\u8981\u6027\u306e\u5224\u65ad\">4.\u81e8\u5e8a\u8a66\u9a13\u306e\u5fc5\u8981\u6027\u306e\u5224\u65ad<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/writing-a-clinical-evaluation-report-5-quick-tips\/#5_Monitor_post-market_activities\" title=\"5.\u5e02\u8ca9\u5f8c\u6d3b\u52d5\u306e\u76e3\u8996\">5.\u5e02\u8ca9\u5f8c\u6d3b\u52d5\u306e\u76e3\u8996<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Sophie Laurenson, <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30d8\u30eb\u30b9\u30b1\u30a2<\/a> &amp; technology innovator\u00a0on Kolabtree, shares 5 tips for writing a clinical evaluation report and defining a CER strategy.<\/em><\/p>\n<p>EU MDR\u306f\u3001\u6b27\u5dde\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u3042\u308a\u65b9\u306b\u5927\u304d\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u3066\u3044\u307e\u3059\u3002\u898f\u5236\u9075\u5b88\u306e\u4e00\u74b0\u3068\u3057\u3066\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306fCE\u30de\u30fc\u30ad\u30f3\u30b0\u306e\u305f\u3081\u306b\u4e0d\u53ef\u6b20\u306a\u6587\u66f8\u3067\u3042\u308b\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER\uff09\u3092\u4f5c\u6210\u3057\u3001\u7dad\u6301\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u3053\u3067\u306f\u3001\u5805\u7262\u306aCER\u6226\u7565\u3092\u5b9a\u7fa9\u3059\u308b\u305f\u3081\u306b\u8003\u616e\u3059\u3079\u304d\u70b9\u306b\u3064\u3044\u3066\u3001\u5c02\u9580\u5bb6\u306e\u30d2\u30f3\u30c8\u3092\u3054\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Define_a_CER_protocol_and_strategy\"><\/span>1.CER\u30d7\u30ed\u30c8\u30b3\u30eb\u304a\u3088\u3073\u6226\u7565\u306e\u5b9a\u7fa9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u88cf\u4ed8\u3051\u304c\u5fc5\u8981\u306a\u5fc5\u9808\u8981\u4ef6\uff08MDR\u306b\u304a\u3051\u308b\u5b89\u5168\u6027\u53ca\u3073\u6027\u80fd\u8981\u4ef6\uff09\u3092\u7279\u5b9a\u3059\u308b\u3002\u6027\u80fd\u3001\u5b89\u5168\u6027\u3001\u30ea\u30b9\u30af\/\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306e\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u306b\u95a2\u9023\u3059\u308b\u6307\u6a19\u3092\u5b9a\u7fa9\u3059\u308b\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Demonstrate_equivalence\"><\/span><strong>2.\u540c\u7b49\u6027\u3092\u8a3c\u660e\u3059\u308b<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u540c\u7b49\u6027\u306f\u3001\u533b\u7642\u6a5f\u5668\u3068\u65e2\u5b58\u306e\u985e\u4f3c\u306eCE\u30de\u30fc\u30af\u4ed8\u304d\u6a5f\u5668\u3068\u306e\u6bd4\u8f03\u306b\u57fa\u3065\u3044\u3066\u5224\u65ad\u3055\u308c\u307e\u3059\u3002\u540c\u7b49\u6027\u306e\u8a3c\u660e\u306f\u3001\u88fd\u9020\u8005\u304c\u5b9a\u7fa9\u3059\u308b\u95a2\u9023\u30d1\u30e9\u30e1\u30fc\u30bf\u3067\u8a55\u4fa1\u3055\u308c\u307e\u3059\u3002\u540c\u7b49\u6027\u306e\u6839\u62e0\u306f\u3001CER\u306e\u4e2d\u3067\u5341\u5206\u306b\u8aac\u660e\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u540c\u7b49\u6027\u306e\u57fa\u6e96\u306f\u8907\u96d1\u304b\u3064\u53b3\u3057\u304f\u306a\u3063\u3066\u304a\u308a\u3001\u5fc5\u9808\u8981\u4ef6\u3068\u306e\u95a2\u9023\u6027\u3082\u5f37\u304f\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u88fd\u54c1\u306b\u95a2\u9023\u6027\u306e\u306a\u3044\u540c\u7b49\u54c1\u3092\u9078\u629e\u3059\u308b\u3068\u3044\u3046\u3088\u304f\u3042\u308b\u8aa4\u308a\u3092\u907f\u3051\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u5404\u7b49\u4fa1\u6a5f\u5668\u3068\u6a5f\u5668\u9593\u306e\u5dee\u7570\u306b\u3064\u3044\u3066\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u30c7\u30fc\u30bf\u3092\u7279\u5b9a\u3057\u3001\u5206\u6790\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Evaluate_literature_review_data\"><\/span><strong>3.\u6587\u732e\u8abf\u67fb\u30c7\u30fc\u30bf\u306e\u8a55\u4fa1<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">\u540c\u7b49\u6027\u304c\u5341\u5206\u306b\u8a3c\u660e\u3067\u304d\u308c\u3070\u3001\u5148\u884c\u7814\u7a76\u306e\u6587\u732e\u304b\u3089\u62bd\u51fa\u3057\u305f\u81e8\u5e8a\u30c7\u30fc\u30bf\u306f\u3001CER\u3092\u307e\u3068\u3081\u308b\u4e0a\u3067\u8cb4\u91cd\u306a\u30c4\u30fc\u30eb\u3068\u306a\u308b\u3002\u3057\u304b\u3057\u3001\u6587\u732e\u8abf\u67fb\u306f\u7cfb\u7d71\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u884c\u308f\u308c\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3042\u308b\u3002<\/p>\n<p>- \u6587\u732e\u30ec\u30d3\u30e5\u30fc\u306e\u5305\u62ec\u7684\u306a\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f5c\u6210\u3059\u308b\u3002<br \/>\n- \u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3001\u691c\u7d22\u6761\u4ef6\u3001\u9664\u5916\u57fa\u6e96\uff08\u8a00\u8a9e\u3001\u8a66\u9a13\u30bf\u30a4\u30d7\/\u30c7\u30b6\u30a4\u30f3\u3001\u8a66\u9a13\u8a2d\u5b9a\u3001\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\uff09\u306a\u3069\u306e\u5165\u529b\u3084\u30d1\u30e9\u30e1\u30fc\u30bf\u3092\u5b9a\u7fa9\u3059\u308b\u3002<br \/>\n- \u540c\u7b49\u54c1\u3068\u30ea\u30b9\u30af\u5206\u6790\u306b\u57fa\u3065\u304d\u3001\u5fc5\u8981\u306a\u5b89\u5168\u6027\u3068\u6027\u80fd\u306e\u57fa\u6e96\u3092\u5b9a\u7fa9\u3059\u308b\u3002<br \/>\n- \u7570\u306a\u308b\u30c7\u30fc\u30bf\u30bd\u30fc\u30b9\u304b\u3089\u95a2\u9023\u3059\u308b\u8ad6\u6587\u3092\u4f53\u7cfb\u7684\u306b\u53ce\u96c6\u3059\u308b\u3002<br \/>\n- \u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306a\u3069\u306e\u5ba2\u89b3\u7684\u306a\u65b9\u6cd5\u3092\u7528\u3044\u3066\u3001\u8907\u6570\u306e\u30ec\u30d3\u30e5\u30a2\u30fc\u3092\u4f7f\u3063\u3066\u30c7\u30fc\u30bf\u3092\u5206\u6790\u3059\u308b\u3053\u3068\u3001\u3067\u3059\u3002<br \/>\n- CER\u6587\u66f8\u306b\u542b\u3081\u308b\u305f\u3081\u306b\u3001\u6587\u732e\u8a55\u4fa1\u306e\u7d50\u8ad6\u3092\u6587\u66f8\u5316\u3059\u308b\u3002<\/p>\n<p><strong>\u3082\u8aad\u3093\u3067\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u4f5c\u6210\u3092\u4f9d\u983c\u3059\u308b\u65b9\u6cd5<\/a>\u00a0<\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_Determine_requirement_for_clinical_investigation\"><\/span>4.\u81e8\u5e8a\u8a66\u9a13\u306e\u5fc5\u8981\u6027\u306e\u5224\u65ad<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">\u81e8\u5e8a\u8abf\u67fb\u306e\u8981\u4ef6\u306f\u3001\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306b\u3088\u3063\u3066\u6c7a\u5b9a\u3055\u308c\u307e\u3059\u3002\u9ad8\u30ea\u30b9\u30af\u304a\u3088\u3073\u30af\u30e9\u30b9III\u306e\u6a5f\u5668\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u5bfe\u8c61\u3068\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u65b0\u898f\u6027\u3082\u6c7a\u5b9a\u8981\u56e0\u3067\u3042\u308a\u3001\u9769\u65b0\u7684\u306a\u6280\u8853\u306b\u57fa\u3065\u304f\u6a5f\u5668\u3084\u65b0\u3057\u3044\u4f7f\u7528\u76ee\u7684\u306e\u6a5f\u5668\u306b\u306f\u3001\u81e8\u5e8a\u8abf\u67fb\u304c\u5fc5\u8981\u3067\u3059\u3002\u5229\u7528\u53ef\u80fd\u306a\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u306f\u3001\u3059\u3079\u3066\u306e\u95a2\u9023\u3059\u308b ER \u306b\u5bfe\u5fdc\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3053\u308c\u306f\u3001\u5b9f\u65bd\u524d\u306b\u81e8\u5e8a\u8a66\u9a13\u8a08\u753b\u66f8\uff08CIP\uff09\u3092\u95a2\u9023\u3059\u308bNB\u3068\u5171\u6709\u3059\u308b\u3053\u3068\u3067\u4fdd\u8a3c\u3055\u308c\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_Monitor_post-market_activities\"><\/span>5. <strong>\u5e02\u8ca9\u5f8c\u6d3b\u52d5\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">MDR\u3067\u306f\u3001PMS\u306e\u6d3b\u52d5\u306f\u9069\u5207\u306b\u8a08\u753b\u3055\u308c\u3001CER\u306b\u6587\u66f8\u5316\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u307e\u305f\u3001\u7d99\u7d9a\u4e2d\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u8a55\u4fa1\u3068CER\u306e\u66f4\u65b0\u306e\u30d7\u30ed\u30bb\u30b9\u3082\u6587\u66f8\u5316\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066CER\u304c\u9069\u5207\u3067\u3042\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u30d7\u30ed\u30bb\u30b9\u3092\u901a\u3058\u3066\u5b9a\u671f\u7684\u306b\u66f4\u65b0\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3053\u308c\u306b\u306f\u3001\u30c7\u30fc\u30bf\u3092\u8a55\u4fa1\u3057\u3001\u3059\u3079\u3066\u306e\u540c\u7b49\u6a5f\u5668\u306e\u95a2\u9023\u6027\u3092\u79e4\u91cf\u3059\u308b\u3053\u3068\u304c\u542b\u307e\u308c\u308b\u3002<\/p>\n<p><strong>\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306e\u66f8\u304d\u65b9\u3067\u304a\u56f0\u308a\u3067\u3059\u304b\uff1f\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306b\u4f9d\u983c\u3059\u308b <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u533b\u7642\u6a5f\u5668CER\u30e9\u30a4\u30bf\u30fc<\/a> \u3092Kolabtree\u306b\u63b2\u8f09\u3057\u307e\u3057\u305f\u3002\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6295\u7a3f\u3057\u3066\u3001\u898b\u7a4d\u3082\u308a\u3092\u3082\u3089\u3046\u306e\u306f\u7121\u6599\u3067\u3059\u3002<\/strong><\/p>\n<p>\u95a2\u9023\u3059\u308b\u5c02\u9580\u5bb6<\/p>\n<p><strong><a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306eCER\u30e9\u30a4\u30bf\u30fc<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations--mdr-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">EU MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">FDA\u63d0\u51fa\u66f8\u985e<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/services\/literature-search?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u6587\u732e\u691c\u7d22\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-compliance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u898f\u5236\u9075\u5b88\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u30af\u30ea\u30cb\u30ab\u30eb\u30fb\u30c8\u30e9\u30a4\u30a2\u30eb\u30fb\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30e9\u30a4\u30bf\u30fc<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/post-market-surveillance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">PMS\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c4<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/country\/india\/subject\/post-market-clinical-followup?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">PMCF\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c4<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u00a0\u751f\u7269\u7d71\u8a08\u5b66\u306e\u5c02\u9580\u5bb6<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-development?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u00a0\u88fd\u54c1\u958b\u767a\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u00a0<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Sophie Laurenson, healthcare &amp; technology innovator\u00a0on Kolabtree, shares 5 tips for writing a clinical evaluation report and defining a CER strategy. The EU MDR has significantly impacted the way medical devices are regulated in Europe. As part of regulatory compliance, medical device manufacturers need to create and maintain a Clinical Evaluation Report (CER), a document essential for CE Marking. Here are expert tips on what to take into account to defining a robust CER strategy. 1. Define a CER protocol and strategy Identify the Essential Requirements (Safety and Performance Requirements in the MDR) that need to be supported by clinical evidence. Define metrics relative to performance, safety and risk\/benefit endpoints.<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/writing-a-clinical-evaluation-report-5-quick-tips\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":6882,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[247,443,540],"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>Writing a Clinical Evaluation Report: 5 Quick Tips - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"Quick tips on writing a clinical evaluation report (CER) for medical device compliance with the EU MDR.\" \/>\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\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Writing a Clinical Evaluation Report: 5 Quick Tips\" \/>\n<meta property=\"og:description\" content=\"Quick tips on writing a clinical evaluation report (CER) for medical device compliance with the EU MDR.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2020-02-07T13:14:07+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-04-06T12:36:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/02\/writing-a-clinical-evaluation-report.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1280\" \/>\n\t<meta property=\"og:image:height\" content=\"853\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"3\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Writing a Clinical Evaluation Report: 5 Quick Tips - 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