{"id":6539,"date":"2019-12-09T05:42:45","date_gmt":"2019-12-09T05:42:45","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=6539"},"modified":"2020-03-17T08:14:56","modified_gmt":"2020-03-17T08:14:56","slug":"how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u4f5c\u6210\u3092\u4f9d\u983c\u3059\u308b\u306b\u306f"},"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-6a69e265084aa\" 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-6a69e265084aa\"><\/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\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#1_Experienced_in_implementing_the_new_EU_regulations\" title=\"1.\u65b0\u305f\u306aEU\u898f\u5236\u306e\u5c0e\u5165\u7d4c\u9a13\u304c\u3042\u308b\u3053\u3068\">1.\u65b0\u305f\u306aEU\u898f\u5236\u306e\u5c0e\u5165\u7d4c\u9a13\u304c\u3042\u308b\u3053\u3068<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#A_Clinical_Evaluation_Report_writer_compiles_the_CER_using_the_below_guidance_documents\" title=\"\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u4f5c\u6210\u8005\u306f\u3001\u4ee5\u4e0b\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u7528\u3044\u3066CER\u3092\u307e\u3068\u3081\u307e\u3059\u3002\">\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u4f5c\u6210\u8005\u306f\u3001\u4ee5\u4e0b\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u7528\u3044\u3066CER\u3092\u307e\u3068\u3081\u307e\u3059\u3002<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#2_Effective_industry_insider\" title=\"2.\u696d\u754c\u306b\u7cbe\u901a\u3057\u3066\u3044\u308b\u3053\u3068\">2.\u696d\u754c\u306b\u7cbe\u901a\u3057\u3066\u3044\u308b\u3053\u3068<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#3_Well-versed_with_scientific_literature\" title=\"3.\u79d1\u5b66\u6587\u732e\u306b\u7cbe\u901a\u3057\u3066\u3044\u308b\u3053\u3068\">3.\u79d1\u5b66\u6587\u732e\u306b\u7cbe\u901a\u3057\u3066\u3044\u308b\u3053\u3068<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#4_Familiar_with_the_Economic_Operators_Regime\" title=\"4.\u30a8\u30b3\u30ce\u30df\u30c3\u30af\u30fb\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u30ba\u30fb\u30ec\u30b8\u30fc\u30e0\u306b\u7cbe\u901a\u3057\u3066\u3044\u308b\u3053\u3068\">4.\u30a8\u30b3\u30ce\u30df\u30c3\u30af\u30fb\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u30ba\u30fb\u30ec\u30b8\u30fc\u30e0\u306b\u7cbe\u901a\u3057\u3066\u3044\u308b\u3053\u3068<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#5_Strong_analytical_and_report_writing_skills\" title=\"5.\u512a\u308c\u305f\u5206\u6790\u80fd\u529b\u3068\u30ec\u30dd\u30fc\u30c8\u4f5c\u6210\u80fd\u529b\">5.\u512a\u308c\u305f\u5206\u6790\u80fd\u529b\u3068\u30ec\u30dd\u30fc\u30c8\u4f5c\u6210\u80fd\u529b<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/#6_Experience_with_regulatory_affairs_RA\" title=\"6.\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30a2\u30d5\u30a7\u30a2\u30fc\u30ba\uff08RA\uff09\u306e\u7d4c\u9a13\">6.\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30a2\u30d5\u30a7\u30a2\u30fc\u30ba\uff08RA\uff09\u306e\u7d4c\u9a13<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Kolabtree\u306e\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u3067\u3042\u308bMahasweta Pal\u6c0f\u304c\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u6c42\u3081\u308b\u4eba\u6750\u306e\u5fc5\u9808\u30b9\u30ad\u30eb\u306b\u3064\u3044\u3066\u66f8\u3044\u3066\u3044\u307e\u3059\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=How-to-hire-CER-writer\"> \u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u4f5c\u6210<\/a>.\u00a0<\/em><\/p>\n<p>European Medical Writers' Association\u306e\u8457\u540d\u306a\u30e1\u30f3\u30d0\u30fc\u3067\u3042\u308bGillian Pritchard\u535a\u58eb\u306f\u3001\"\u81e8\u5e8a\u8a55\u4fa1\u3068\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u9023\u3059\u308b\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3057\u3001\u8a55\u4fa1\u3057\u3001\u5206\u6790\u3059\u308b\u305f\u3081\u306e\u69cb\u9020\u5316\u3055\u308c\u305f\u7d99\u7d9a\u7684\u306a\u624b\u9806\u3067\u3042\u308b \"\u3068\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u306f\u3001\u524d\u81e8\u5e8a\u8a66\u9a13\u3001\u81e8\u5e8a\u8a66\u9a13\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3001\u4f7f\u7528\u8aac\u660e\u66f8\u306a\u3069\u306e\u30c7\u30fc\u30bf\u3092\u542b\u307f\u3001\u6a5f\u5668\u306e\u7533\u8acb\u306e\u59a5\u5f53\u6027\u3092\u88cf\u4ed8\u3051\u308b\u3082\u306e\u3067\u3059\u3002<\/p>\n<p>\u524d\u56de\u306e\u8a18\u4e8b\u306e\u7d9a\u304d\u3067\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/what-is-a-clinical-evaluation-report\/\">\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8<\/a>\u305d\u3053\u3067\u4eca\u56de\u306f\u3001\u304a\u5ba2\u69d8\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u6700\u9069\u306aCER\u30e9\u30a4\u30bf\u30fc\u304c\u6301\u3064\u3079\u304d\u30b9\u30ad\u30eb\u3092\u3054\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Experienced_in_implementing_the_new_EU_regulations\"><\/span>1.\u65b0\u305f\u306aEU\u898f\u5236\u306e\u5c0e\u5165\u7d4c\u9a13\u304c\u3042\u308b\u3053\u3068<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u7279\u306b\u3001EU\u306eMDR\u306b\u6e96\u62e0\u3057\u305f\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u3067\u306f\u3001\u898f\u5236\u5f53\u5c40\u306e\u30e9\u30a4\u30bf\u30fc\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u3084\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306e\u6587\u66f8\u306e\u5206\u6790\u306b\u95a2\u3057\u3066\u3001\u904e\u53bb\u306e\u5831\u544a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3088\u308a\u3082\u6539\u5584\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u8a8d\u8b58\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002CER \u306e\u5c02\u9580\u5bb6\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u3001\u5185\u90e8\u5b89\u5168\u6027\u8a55\u4fa1\u3001\u304a\u3088\u3073\u54c1\u8cea\u7ba1\u7406\u30c7\u30fc\u30bf\u306e\u8907\u96d1\u3055\u3092\u7406\u89e3\u3059\u308b\u5c02\u9580\u77e5\u8b58\u3092\u57fa\u306b\u63a1\u7528\u3055\u308c\u307e\u3059\u3002\u3055\u3089\u306b\u3001CER\u30e9\u30a4\u30bf\u30fc\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3001\u8a2d\u8a08\u54c1\u8cea\u3001\u88fd\u9020\u8a8d\u8a3c\u3001\u30e1\u30fc\u30ab\u30fc\u306e\u4f7f\u7528\u8aac\u660e\u66f8\u3001\u305d\u306e\u4ed6\u306e\u95a2\u9023\u3059\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u4ef6\u306b\u95a2\u3059\u308b\u554f\u3044\u5408\u308f\u305b\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u6b27\u5dde\u9023\u5408\u304c\u767a\u8868\u3057\u305f <a href=\"https:\/\/ec.europa.eu\/growth\/sectors\/medical-devices\/new-regulations_en\">\u65b0\u533b\u7642\u6a5f\u5668\u898f\u5236<\/a> \u30922017\u5e744\u6708\u306b\u767a\u8868\u3057\u305f\u3002MEDDEV 2.7\/1 Rev.4\u306b\u95a2\u3057\u3066\u306f\u3001CER\u3092\u30b7\u30fc\u30e0\u30ec\u30b9\u306b\u51e6\u7406\u3057\u3066\u63d0\u4f9b\u3067\u304d\u308b\u3088\u3046\u3001CER\u30e9\u30a4\u30bf\u30fc\u306f5\u6bb5\u968e\u306e\u81e8\u5e8a\u8a55\u4fa1\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u5f93\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<ul>\n<li><strong>\u30b9\u30c6\u30fc\u30b80 - \u65b0\u3057\u3044CER\u306e\u7bc4\u56f2\u3068\u8a08\u753b<\/strong><\/li>\n<li><strong>\u30b9\u30c6\u30fc\u30b81 - \u8907\u6570\u306e\u60c5\u5831\u6e90\u304b\u3089\u306e\u95a2\u9023\u30c7\u30fc\u30bf\u306e\u53ce\u96c6\uff08\u6587\u732e\u8abf\u67fb\u3001\u81e8\u5e8a\u6587\u66f8\u3001\u30e1\u30fc\u30ab\u30fc\u306e\u8a18\u9332\u3001\u5e02\u8ca9\u5f8c\u306e\u6587\u66f8\u306a\u3069\uff09<\/strong><\/li>\n<li><strong>\u30b9\u30c6\u30fc\u30b82 - \u53ce\u96c6\u3057\u305f\u30c7\u30fc\u30bf\u306e\u8a55\u4fa1\u3068\u5206\u6790<\/strong><\/li>\n<li><strong>\u30b9\u30c6\u30fc\u30b83 - \u7af6\u5408\u4ed6\u793e\u306e\u5206\u6790\u3001\u540c\u7b49\u6027\u306e\u5206\u6790<\/strong><\/li>\n<li><strong>\u30b9\u30c6\u30fc\u30b84 - \u5e02\u8ca9\u5f8c\u8abf\u67fb\uff08PMS\uff09\u30c7\u30fc\u30bf\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\uff08PMCF\uff09\u30c7\u30fc\u30bf\u306b\u3088\u308bCER\u306e\u66f4\u65b0<\/strong><\/li>\n<\/ul>\n<p>\u6700\u3082\u91cd\u8981\u306a\u3053\u3068\u306f\u3001\u65b0\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3088\u308b\u3068\u3001\u57f7\u7b46\u8005\u306f\u300c\u5341\u5206\u306a\u81e8\u5e8a\u8a3c\u62e0\u300d\u306e\u8981\u4ef6\u306b\u7279\u306b\u6ce8\u610f\u3092\u6255\u3046\u5fc5\u8981\u304c\u3042\u308b\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u3064\u307e\u308a\u3001EU MDR\u306b\u6e96\u62e0\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u958b\u767a\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306b\u95a2\u9023\u3059\u308b\u6a5f\u4f1a\u3001\u30ea\u30b9\u30af\u3001\u304a\u3088\u3073\u8ab2\u984c\u3092\u63d0\u793a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002<\/p>\n<h5><span class=\"ez-toc-section\" id=\"A_Clinical_Evaluation_Report_writer_compiles_the_CER_using_the_below_guidance_documents\"><\/span>\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u4f5c\u6210\u8005\u306f\u3001\u4ee5\u4e0b\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u7528\u3044\u3066CER\u3092\u307e\u3068\u3081\u307e\u3059\u3002<span class=\"ez-toc-section-end\"><\/span><\/h5>\n<ul>\n<li><strong>MEDDEV 2.7\/1 Rev.4 Annex 1\uff082016\u5e746\u6708\u767a\u884c\u3001\u5b89\u5168\u6027\u30fb\u6027\u80fd\u8a55\u4fa1\u306b\u4fc2\u308b2020\u5e745\u6708\u5b9f\u65bd\uff09<\/strong><\/li>\n<li><strong>EN ISO 14155:2011 (\u4eba\u3092\u5bfe\u8c61\u3068\u3057\u305f\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u3068GCP)<\/strong><\/li>\n<li><strong>EN ISO 14971:2012 (\u533b\u7642\u6a5f\u5668\u3078\u306e\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u81e8\u5e8a\u5fdc\u7528)<\/strong><\/li>\n<li><strong>MEDDEV 2.12\/2 rev2 Post Market Clinical Follow-up - A guide for manufacturers and Notified Bodies (January 2012; to be superseded by MDR Annex XIV)\u3092\u53c2\u7167\u306e\u3053\u3068\u3002<\/strong><\/li>\n<li><strong>NB Med 2.12 Rec1 - Post Marketing Surveillance\uff082000\u5e742\u6708\u3001MDR\u9644\u5c5e\u66f8III\u306b\u53d6\u3063\u3066\u4ee3\u308f\u3089\u308c\u308b\u4e88\u5b9a\uff09\u3002<\/strong><\/li>\n<\/ul>\n<p>\u533b\u7642\u6a5f\u5668\u306e\u7a2e\u985e\u306b\u3088\u3063\u3066\u306f\u3001CER\u30e9\u30a4\u30bf\u30fc\u306fMEDDEV 2.1\/6 Quantification and Classification Software\u3092\u4f7f\u7528\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002EU MDR\u306b\u5f93\u3063\u3066CER\u3092\u66f4\u65b0\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u53e4\u3044\u6a5f\u5668\u306e\u5834\u5408\u306f\u3001\u6a5f\u5668\u306e\u8a2d\u8a08\u4ed5\u69d8\u66f8\u3068\u3068\u3082\u306b\u3001\u81e8\u5e8a\u8a66\u9a13\u5831\u544a\u66f8\u306e\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u30c6\u30b9\u30c8\u30c7\u30fc\u30bf\u3092\u5831\u544a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002CER\u30e9\u30a4\u30bf\u30fc\u306b\u6c42\u3081\u3089\u308c\u308b\u306e\u306f\u3001\u9078\u629e\u3057\u305f\u533b\u7642\u6a5f\u5668\u306e\u904e\u53bb\u306e\u3059\u3079\u3066\u306eCER\u306e\u5206\u6790\u3001\u7af6\u5408\u6a5f\u5668\u3068\u306e\u6bd4\u8f03\u7814\u7a76\u3001\u30ae\u30e3\u30c3\u30d7\u5206\u6790\u306e\u5b9f\u65bd\u3001\u65b0\u898f\u533b\u7642\u6a5f\u5668\u306e\u5e02\u5834\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u306e\u53ef\u80fd\u6027\u306e\u78ba\u7acb\u3067\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Effective_industry_insider\"><\/span>2.\u696d\u754c\u306b\u7cbe\u901a\u3057\u3066\u3044\u308b\u3053\u3068<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>When CER Specialists are industry veterans, their expertise in medical device approvals eases the regulatory journey for manufacturers. A qualified CER expert with a background in Clinical <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> Methodology across all therapeutic areas is the manufacturer&#8217;s bigwig. An established CER specialist would be a strong networker privy to regulatory meetings. In light of EU\u2019s complex regulatory landscape, the need of the hour is to select CER specialists with experience of dealing with the multitude of regulatory challenges. They would also be best fit for device manufacturers treading into crowded therapeutic areas, e.g., Cardiology, Endocrinology, Oncology, etc.<\/p>\n<p>CER \u30b9\u30da\u30b7\u30e3\u30ea\u30b9\u30c8\u306f\u3001\u533b\u7642\u6a5f\u5668\u5b89\u5168\u898f\u5236\u306e\u8ab2\u984c\u3092\u8b70\u8ad6\u3059\u308b Regulatory &amp; Compliance \u30ab\u30f3\u30d5\u30a1\u30ec\u30f3\u30b9\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u3001\u304a\u3088\u3073\u30bb\u30df\u30ca\u30fc\u306b\u3001\u4f01\u696d\u306e\u4ee3\u8868\u3068\u3057\u3066\u5b9a\u671f\u7684\u306b\u53c2\u52a0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3067\u306f\u3001CER\u30e9\u30a4\u30bf\u30fc\u304c\u898f\u5236\u30d1\u30cd\u30eb\u306bCER\u3092\u63d0\u793a\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3067\u306f\u3001CER\u306e\u63d0\u51fa\u3068\u30ec\u30d3\u30e5\u30fc\u3092\u30b9\u30e0\u30fc\u30ba\u306b\u884c\u3046\u305f\u3081\u306b\u3001CER\u30e9\u30a4\u30bf\u30fc\u306b\u306f\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u3068\u306e\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u3067\u826f\u3044\u8a55\u5224\u3092\u5f97\u3066\u3044\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u5834\u5408\u3001CER\u30e9\u30a4\u30bf\u30fc\u306b\u306f\u5b8c\u74a7\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u30b9\u30ad\u30eb\u3092\u6301\u3063\u305f\u4eba\u3092\u9078\u3076\u3079\u304d\u3067\u3059\u3002\u307e\u305f\u3001CER\u30e9\u30a4\u30bf\u30fc\u306f\u3001CER\u306e\u4f5c\u6210\u3068\u540c\u6642\u306b\u30c7\u30fc\u30bf\u306e\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3084\u9451\u5b9a\u3092\u884c\u3046\u305f\u3081\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u5b8c\u4e86\u76ee\u6a19\u3092\u6bb5\u968e\u7684\u306b\u8a2d\u5b9a\u3057\u3066\u52b9\u7387\u7684\u306b\u4f5c\u696d\u3092\u9032\u3081\u308b\u3053\u3068\u304c\u671b\u307e\u3057\u3044\u3068\u3044\u3048\u307e\u3059\u3002\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u30e9\u30a4\u30bf\u30fc\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u898f\u5236\u4e0a\u306e\u76ee\u6a19\u3092\u6700\u5c0f\u9650\u306e\u6642\u9593\u306e\u30ed\u30b9\u3067\u9054\u6210\u3067\u304d\u308b\u3088\u3046\u306b\u3001\u54c1\u8cea\u7ba1\u7406\u30c1\u30fc\u30e0\u3092\u6307\u5c0e\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/p>\n<p>\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report--cer-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">CER\u30e9\u30a4\u30bf\u30fc\u306e\u63a1\u7528<\/a> \u306f\u3001CER\u30e9\u30a4\u30bf\u30fc\u304c\u30c7\u30d0\u30a4\u30b9\u306e\u30ea\u30b9\u30af\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306b\u57fa\u3065\u3044\u3066\u300c\u30a2\u30af\u30c6\u30a3\u30d6\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u300d\u30ec\u30dd\u30fc\u30c8\u3092\u63d0\u4f9b\u3067\u304d\u308b\u3088\u3046\u306b\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3054\u3068\u306b\u7d0d\u54c1\u5f8c\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3092\u8a2d\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002\u7d4c\u9a13\u8c4a\u5bcc\u306aCER\u30e9\u30a4\u30bf\u30fc\u306f\u3001\u65e5\u5e38\u7684\u306b\u6587\u732e\u8abf\u67fb\u3092\u884c\u3044\u3001\u898f\u5236\u5f53\u5c40\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u30c1\u30a7\u30c3\u30af\u3057\u3001\u533b\u7642\u6a5f\u5668\u898f\u5236\u306b\u95a2\u3059\u308b\u4f1a\u8b70\u306b\u51fa\u5e2d\u3057\u3001\u60c5\u5831\u3092\u5931\u3046\u3053\u3068\u306a\u304fCER\u3092\u51e6\u7406\u3059\u308b\u305f\u3081\u306e\u3088\u308a\u30b9\u30de\u30fc\u30c8\u306a\u65b9\u6cd5\u3092\u958b\u767a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002EU\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u8981\u4ef6\u304c\u62e1\u5927\u3057\u3066\u3044\u308b\u305f\u3081\u3001MDR\u3068MEDDEV\u306e\u7d71\u5408\u6307\u4ee4\u3092\u5206\u6790\u3057\u3066\u52b9\u679c\u7684\u306a\u81e8\u5e8a\u8a55\u4fa1\u6226\u7565\u3092\u5b9f\u65bd\u3059\u308bCER\u30e9\u30a4\u30bf\u30fc\u306f\u3001\u9577\u671f\u7684\u306b\u898b\u3066\u9078\u629e\u3059\u3079\u304d\u3067\u3057\u3087\u3046\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Well-versed_with_scientific_literature\"><\/span>3.\u79d1\u5b66\u6587\u732e\u306b\u7cbe\u901a\u3057\u3066\u3044\u308b\u3053\u3068<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>EU\u306eMDR\u3067\u306f\u3001\u540c\u7b49\u307e\u305f\u306f\u985e\u4f3c\u306e\u6a5f\u5668\u306e\u30c7\u30fc\u30bf\u3092\u7528\u3044\u3066CER\u3092\u8a55\u4fa1\u3057\u3001\u533b\u7642\u6a5f\u5668\u3092\u7528\u3044\u305f\u89b3\u5bdf\u30fb\u81e8\u5e8a\u30fb\u5b9f\u9a13\u7814\u7a76\u306e\u5b9a\u671f\u7684\u306a\u66f4\u65b0\u3092\u884c\u3046\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u6b27\u5dde\u306eCER\u5c02\u9580\u5bb6\u304c\u5f93\u3046\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u3001\u5ba2\u89b3\u7684\u3067\u504f\u308a\u306e\u306a\u3044\u30b7\u30b9\u30c6\u30de\u30c6\u30a3\u30c3\u30af\u306a\u691c\u7d22\u3068\u3001\u60a3\u8005\u306e\u7279\u6027\u3001\u4ecb\u5165\u306e\u7a2e\u985e\u3001\u5bfe\u7167\u3001\u304a\u3088\u3073\u7d50\u679c\u306e\u554f\u3044\u5408\u308f\u305b\u306b\u95a2\u3059\u308b\u30ec\u30d3\u30e5\u30fc\u3067\u69cb\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002CER\u30e9\u30a4\u30bf\u30fc\u306f\u3001\u81e8\u5e8a\u6587\u66f8\u3092\u7814\u7a76\u3057\u3001\u30ea\u30b9\u30af\u5206\u6790\u3092\u884c\u3046\u30af\u30ed\u30b9\u30d5\u30a1\u30f3\u30af\u30b7\u30e7\u30ca\u30eb\u30c1\u30fc\u30e0\u3068\u8b70\u8ad6\u3057\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u5b9f\u65bd\u3057\u3001\u6587\u732e\u7814\u7a76\u304b\u3089\u5f97\u3089\u308c\u308b\u3055\u307e\u3056\u307e\u306a\u6d1e\u5bdf\u306b\u57fa\u3065\u3044\u3066\u7814\u7a76\u958b\u767a\u30c1\u30fc\u30e0\u3092\u7c21\u7565\u5316\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u6587\u732e\u691c\u7d22\u3001\u30e1\u30bf\u30a2\u30ca\u30ea\u30b7\u30b9\u3001\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u53ce\u96c6\u306b\u306f\u591a\u304f\u306e\u8aad\u89e3\u529b\u3068\u5206\u6790\u529b\u304c\u5fc5\u8981\u3067\u3059\u304c\u3001CER\u30e9\u30a4\u30bf\u30fc\u306b\u306f\u305d\u306e\u3059\u3079\u3066\u3092\u7fd2\u5f97\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u3057\u305f\u304c\u3063\u3066\u3001CER\u30e9\u30a4\u30bf\u30fc\u306b\u306f\u3001\u95a2\u9023\u3059\u308b\u30c7\u30fc\u30bf\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u30d7\u30ed\u30bb\u30b9\u3092\u52b9\u7387\u5316\u3067\u304d\u308b\u533b\u5b66\u6587\u732e\u306e\u52b9\u679c\u7684\u306a\u8aad\u307f\u624b\u3067\u3042\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306e\u4f5c\u6210\u7d4c\u9a13\u304c\u3042\u308a\u3001\u81e8\u5e8a\u8a3c\u62e0\u306e\u30ae\u30e3\u30c3\u30d7\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u30c7\u30fc\u30bf\u3001\u524d\u81e8\u5e8a\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u306e\u8a55\u4fa1\u306b\u95a2\u9023\u3059\u308b\u8cea\u554f\u306b\u5bfe\u51e6\u3057\u305f\u7d4c\u9a13\u304c\u3042\u308b\u65b9\u304c\u671b\u307e\u3057\u3044\u3067\u3059\u3002<\/p>\n<p>\u307e\u305f\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u3001CER\u30e9\u30a4\u30bf\u30fc\u306b\u3001\u6a5f\u5668\u306e\u6a5f\u80fd\u6027\u3092\u793a\u3059\u30d4\u30a2\u30ec\u30d3\u30e5\u30fc\u3055\u308c\u305f\u79d1\u5b66\u7684\u30fb\u81e8\u5e8a\u7684\u306a\u5831\u544a\u66f8\u3092\u4f5c\u6210\u3057\u3066\u3082\u3089\u3044\u3001\u305d\u306e\u5f8c\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306e\u30c7\u30fc\u30bf\u3092\u793a\u3059\u5831\u544a\u66f8\u3092\u4f5c\u6210\u3057\u3066\u3082\u3089\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/services\/clinical-evaluation-report-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">\u30d7\u30ed\u306eCER\u30e9\u30a4\u30bf\u30fc<\/a> \u306f\u3001\u4e16\u754c\u7684\u306b\u6709\u540d\u306a\u3042\u3089\u3086\u308b\u79d1\u5b66\u6587\u732e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u5bfe\u8c61\u3068\u3057\u305f\u6587\u732e\u691c\u7d22\u306b\u3082\u7cbe\u901a\u3057\u3066\u3044\u307e\u3059\u3002MEDLINE\u3001Index Medicus\u3001EMBASE\/Excerpta Medica\u3001Cochrane Database of Systematic Reviews\u306a\u3069\u3092\u99c6\u4f7f\u3057\u3066\u3001\u52b9\u7387\u7684\u306a\u30c7\u30fc\u30bf\u30b9\u30ab\u30a6\u30c6\u30a3\u30f3\u30b0\u3092\u884c\u3044\u307e\u3059\u3002CER\u30e9\u30a4\u30bf\u30fc\u304c\u4f7f\u7528\u3059\u308b\u4e3b\u8981\u306a\u691c\u7d22\u6226\u7565\u306f\u3001\u30ec\u30dd\u30fc\u30c8\u306e\u8cea\u3092\u5de6\u53f3\u3057\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"4_Familiar_with_the_Economic_Operators_Regime\"><\/span>4.\u30a8\u30b3\u30ce\u30df\u30c3\u30af\u30fb\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u30ba\u30fb\u30ec\u30b8\u30fc\u30e0\u306b\u7cbe\u901a\u3057\u3066\u3044\u308b\u3053\u3068<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>EU MDR\u306b\u306f\u3001\u7d4c\u6e08\u4e8b\u696d\u8005\uff08EO\uff09\u306b\u95a2\u3059\u308b\u8ffd\u52a0\u5236\u5ea6\u304c\u3042\u308a\u3001CE\u30de\u30fc\u30ad\u30f3\u30b0\u306e\u524d\u306b\u6cd5\u5f8b\u9867\u554f\u3068\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002EO\u5236\u5ea6\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u6b27\u5dde\u9023\u5408\uff08EU\uff09\u6cd5\u306e\u898f\u5236\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u8a73\u8ff0\u3057\u305f\u65e7\u898f\u5247\uff08765\/2008\uff09\u306b\u57fa\u3065\u3044\u3066\u304a\u308a\u3001CE\u30de\u30fc\u30ad\u30f3\u30b0\u5236\u5ea6\u306e\u6a5f\u80fd\u306b\u304a\u3051\u308b\u6982\u5ff5\u3084\u3001\u300c\u5e02\u5834\u306b\u51fa\u3059\u300d\u300c\u5165\u624b\u53ef\u80fd\u306b\u3059\u308b\u300d\u3068\u3044\u3063\u305f\u4e2d\u6838\u6982\u5ff5\u3001\u88fd\u54c1\u306e\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u304a\u3051\u308b\u7d4c\u6e08\u4e8b\u696d\u8005\u3068\u305d\u306e\u7fa9\u52d9\u306a\u3069\u3001\u7d4c\u6e08\u4e8b\u696d\u8005\u306b\u95a2\u9023\u3059\u308b\u3059\u3079\u3066\u306e\u6982\u5ff5\u3092\u8003\u616e\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u3055\u3089\u306b\u3001MDR\u304a\u3088\u3073IVDR\u3067\u306f\u3001\u88fd\u9020\u696d\u8005\u3001\u8a8d\u5b9a\u4ee3\u7406\u5e97\u3001\u8f38\u5165\u696d\u8005\u3001\u8ca9\u58f2\u696d\u8005\uff08MAID\uff09\u306b\u5bfe\u3059\u308b\u8981\u6c42\u4e8b\u9805\u3092\u660e\u78ba\u306b\u5b9a\u7fa9\u3057\u3066\u3044\u307e\u3059\u3002\u305d\u306e <a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2019\/10\/implementation-of-shared-mdr-economic-operator-res\">MAID\u30d1\u30e9\u30c0\u30a4\u30e0<\/a> \u306f\u3001\u3053\u308c\u307e\u3067\u306eMEDDEV\u6307\u4ee4\u3092\u66f4\u65b0\u3057\u305f\u3082\u306e\u3067\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3092\u518d\u89e3\u91c8\u3057\u3001\u533b\u7642\u6a5f\u5668\u306e\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u304a\u3051\u308b\u5404\u4eba\u306e\u5f79\u5272\u306e\u7406\u89e3\u3092\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306b\u660e\u78ba\u306b\u63d0\u793a\u3059\u308b\u7fa9\u52d9\u3092\u8a73\u8ff0\u3057\u3066\u3044\u307e\u3059\u3002\u30d6\u30eb\u30fc\u30ac\u30a4\u30c9\uff08\u6b27\u5dde\u59d4\u54e1\u4f1a\u767a\u884c\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\uff09\u306b\u3088\u308b\u3068\u3001\u300cMAID\u306e\u5404\u5f79\u5272\u306f\u3001\u300e\u5e02\u5834\u306b\u51fa\u3059\u300f\u304a\u3088\u3073\u300e\u5165\u624b\u53ef\u80fd\u306b\u3059\u308b\u300f\u3068\u3044\u3046\u91cd\u8981\u306a\u6982\u5ff5\u3068\u3068\u3082\u306b\u3001MDR\u304a\u3088\u3073IVDR\u306b\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u6982\u5ff5\u306f\u3001MDR\u304a\u3088\u3073IVDR\u304c\u533b\u7642\u6a5f\u5668\u306e\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u304a\u3051\u308b\u69d8\u3005\u306aEO\u306b\u8ab2\u3059\u898f\u5236\u4e0a\u306e\u8cac\u4efb\u3092\u6c7a\u5b9a\u3065\u3051\u308b\u3082\u306e\u3067\u3042\u308b\u300d\u3068\u3057\u3066\u3044\u308b\u3002<\/p>\n<p>\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u306e\u4f5c\u6210\u8005\u306f\u3001EO\u4f53\u5236\u306e\u7fa9\u52d9\u3092\u6271\u3046\u6cd5\u5f8b\u5c02\u9580\u5bb6\u3068\u306e\u4f1a\u8a71\u3092\u30ea\u30fc\u30c9\u3057\u3001\u30e1\u30fc\u30ab\u30fc\u5074\u306e\u95a2\u9023\u6587\u66f8\u3084\u3001\u88fd\u54c1\u627f\u8a8d\u306e\u904e\u7a0b\u3067\u906d\u9047\u3059\u308b\u3042\u3089\u3086\u308b\u72b6\u6cc1\u306b\u5bfe\u5fdc\u3057\u3066\u767a\u884c\u3055\u308c\u305f\u95a2\u9023\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u63d0\u4f9b\u3059\u308b\u7d4c\u9a13\u304c\u5fc5\u8981\u3067\u3059\u3002\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u88fd\u54c1\u304c\u3044\u3064RoHS\u306b\u6e96\u62e0\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u304b\u3092\u5206\u6790\u30fb\u89e3\u91c8\u3067\u304d\u308bCER\u5c02\u9580\u5bb6\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/ec.europa.eu\/environment\/waste\/rohs_eee\/legis_en.htm\">Restriction of Hazardous Substances RoHS Directive (2011\/65\/EC)<\/a>\u306e\u7b2c4\u7248\u304c\u767a\u884c\u3055\u308c\u305f\u5834\u5408\u306a\u3069\uff09\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.medicaldesignbriefs.com\/component\/content\/article\/mdb\/features\/articles\/33060\">\u533b\u7642\u7528\u96fb\u6c17\uff08ME\uff09\u6a5f\u5668\u306e\u898f\u683c\u3001IEC\/EN 60601-1-2:2018<\/a> \u304c2018\u5e7412\u670830\u65e5\u304b\u3089\u4e0a\u5e02\u3055\u308c\u305f\u533b\u7528\u96fb\u6c17\u88fd\u54c1\u306b\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u307e\u3057\u305f\uff09\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_Strong_analytical_and_report_writing_skills\"><\/span>5.\u512a\u308c\u305f\u5206\u6790\u80fd\u529b\u3068\u30ec\u30dd\u30fc\u30c8\u4f5c\u6210\u80fd\u529b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>CER\u30e9\u30a4\u30bf\u30fc\u306f\u3001\u65b0\u3057\u3044MDR\u6307\u4ee4\u306b\u3088\u3063\u3066\u6a5f\u5668\u306e\u5206\u985e\u306e\u57fa\u6e96\u304c\u5909\u66f4\u3055\u308c\u305f\u305f\u3081\u3001\u4ee5\u524d\u306eCE\u30de\u30fc\u30af\u306e\u6587\u66f8\u306b\u3064\u3044\u3066\u3082\u30e1\u30fc\u30ab\u30fc\u306e\u983c\u307f\u306e\u7db1\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u3057\u305f\u304c\u3063\u3066\u3001CER <a href=\"https:\/\/www.kolabtree.com\/services\/medical-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a> \u307e\u305f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304b\u3089\u306f\u3001\u6a5f\u5668\u306e\u518d\u5206\u985e\u3084\u8ca9\u58f2\u30fb\u6d41\u901a\u30d7\u30ed\u30bb\u30b9\u306e\u5909\u66f4\u306b\u95a2\u3059\u308b\u5831\u544a\u66f8\u306e\u63d0\u51fa\u3092\u6c42\u3081\u3089\u308c\u308b\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u307e\u305f\u3001\u81e8\u5e8a\u8a55\u4fa1\u3067\u306f\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u6bb5\u968e\u7684\u306b\u5be9\u67fb\u3057\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u5831\u544a\u66f8\u306e\u30c7\u30fc\u30bf\u3092\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u305f\u3081\u3001CER\u30e9\u30a4\u30bf\u30fc\u306f\u81e8\u5e8a\u30c7\u30fc\u30bf\u5206\u6790\u306e\u7d4c\u9a13\u304c\u5fc5\u8981\u3067\u3059\u3002\u7406\u60f3\u7684\u306aCER\u30e9\u30a4\u30bf\u30fc\u306f\u3001\u3059\u3079\u3066\u306e\u4e3b\u8981\u306a\u6cbb\u7642\u5206\u91ce\u306b\u304a\u3044\u3066\u5c11\u306a\u304f\u3068\u308250\u4ef6\u306eCER\u3092\u63d0\u4f9b\u3057\u305f\u7d4c\u9a13\u304c\u3042\u308a\u3001\u3042\u3089\u3086\u308b\u7a2e\u985e\u306e\u533b\u7642\u6a5f\u5668\u306eCER\u6210\u679c\u7269\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u306b\u7cbe\u901a\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"6_Experience_with_regulatory_affairs_RA\"><\/span>6.\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30a2\u30d5\u30a7\u30a2\u30fc\u30ba\uff08RA\uff09\u306e\u7d4c\u9a13<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u85ac\u4e8b\u306e\u5c02\u9580\u5bb6\u3067\u306a\u3051\u308c\u3070\u3001Clinical Evaluation Report\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002CER\u30e9\u30a4\u30bf\u30fc\u306f\u3001\u898f\u5236\u30b7\u30b9\u30c6\u30e0\u306e\u5909\u66f4\u3001\u66f4\u65b0\u3001\u6539\u826f\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u306b\u9577\u3051\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/MEMO_17_848\">\u6b27\u5dde\u59d4\u54e1\u4f1a<\/a>, <a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/regulation-of-medical-devices\/medical-device-regulation_online-guide.html\">\u30b9\u30a4\u30b9\u30e1\u30c7\u30a3\u30c3\u30af<\/a>, <a href=\"https:\/\/www.ansm.sante.fr\/Activites\/Surveillance-du-marche-des-dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMDIV\/Dispositifs-medicaux-Operations-d-evaluation-et-de-controle-du-marche\/(offset)\/3#dm\">ANSM<\/a>, etc.) in their deliverables. Essentially, a Clinical Evaluation Report writer should be an expert on regulatory affairs. With documentation requirements rising, the scope for CER writers keeps diversifying. CER writers are expected to inform manufacturers when their products can have a clinically exempt CER (in case of equivalent manufacturing and supply methodologies, similar <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/spotlight-kolabtrees-research-consultant-and-data-scientist-dr-cidila-d\/\">\u6587\u732e\u691c\u7d22<\/a>, and reporting requirements as listed in MEDDEV 2.7\/1 Rev 4).<\/p>\n<p>\u3059\u3079\u3066\u306eCER\u30d5\u30a1\u30a4\u30eb\u306f\u3001\u6a5f\u5668\u306e\u30c7\u30b6\u30a4\u30f3\u3001\u7279\u5fb4\u3001\u610f\u56f3\u3055\u308c\u305f\u4f7f\u7528\u60c5\u5831\u3001\u8b66\u544a\u3001\u7981\u5fcc\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u30c7\u30fc\u30bf\u3001\u304a\u3088\u3073\u30c7\u30fc\u30bf\u30bd\u30fc\u30b9\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u660e\u793a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002EU\u306eMDR\u8981\u4ef6\u306b\u306f\u3001\u5171\u6709\u3055\u308c\u305f\u7d4c\u6e08\u4e8b\u696d\u8005\u8cc7\u6e90\u306e\u5951\u7d04\u304a\u3088\u3073QMS\u4e3b\u5c0e\u306e\u5b9f\u65bd\u3001UDI\u304a\u3088\u3073\u30e9\u30d9\u30ea\u30f3\u30b0\u306e\u9075\u5b88\u3001\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u30c7\u30fc\u30bf\u306e\u53ce\u96c6\u3001Brexit\u30b7\u30d5\u30c8\u3068\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306e\u6e1b\u5c11\u306e\u5f71\u97ff\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n<p><strong>\u3092\u63a1\u7528\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/services\/clinical-evaluation-report-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306eCER\u30e9\u30a4\u30bf\u30fc<\/a>?Kolabtree\u3067\u8cc7\u683c\u3092\u6301\u3063\u305f\u5c02\u9580\u5bb6\u306b\u76f8\u8ac7\u3057\u307e\u3057\u3087\u3046\u3002\u3042\u306a\u305f\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6295\u7a3f\u3057\u3066\u3001\u7121\u6599\u3067\u898b\u7a4d\u3082\u308a\u3092\u5165\u624b\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n<p><\/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=How-to-hire-CER-writer\">\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=How-to-hire-CER-writer\">\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=How-to-hire-CER-writer\">\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=How-to-hire-CER-writer\">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=How-to-hire-CER-writer\">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=How-to-hire-CER-writer\">\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=How-to-hire-CER-writer\">\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=How-to-hire-CER-writer\">\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=How-to-hire-CER-writer\">\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=How-to-hire-CER-writer\">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=How-to-hire-CER-writer\">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=How-to-hire-CER-writer\">\u00a0\u751f\u7269\u7d71\u8a08\u5b66\u306e\u5c02\u9580\u5bb6<\/a> |<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-development?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=How-to-hire-CER-writer\"> \u88fd\u54c1\u958b\u767a\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u00a0<\/a><\/strong><\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9<\/p>\n<ol>\n<li><a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2019\/9\/challenges-in-clinical-evaluation-for-the-eu-versu\">Hunter J and Yan M. \"Challenges in Clinical Evaluation for the EU Versus China\".Regulatory Focus.2019\u5e749\u6708\u3067\u3059\u3002\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30a2\u30d5\u30a7\u30a2\u30fc\u30ba\u30d7\u30ed\u30d5\u30a7\u30c3\u30b7\u30e7\u30ca\u30eb\u30bd\u30b5\u30a8\u30c6\u30a3<\/a>.<\/li>\n<li><a href=\"http:\/\/www.imdrf.org\/docs\/ghtf\/final\/sg5\/technical-docs\/ghtf-sg5-n2r8-2007-clinical-evaluation-070501.pdf\">Study Group 5. \"Clinical Evaluation - Final Document\".2007\u5e745\u6708\u3002SG5\/N2R8 Global Harmonization Task Force.<\/a><\/li>\n<li><a href=\"https:\/\/journal.emwa.org\/medical-devices\/clinical-evaluation-reports-from-the-medical-writer-s-perspective\/\">Gillian Pritchard\"\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u306e\u8996\u70b9\u304b\u3089\u898b\u305f\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\uff01\"  Journal of Medical Writing; Volume 26, Issue 2 - Medical Devices.2017\u5e746\u6708\u306e\u8a18\u4e8b\u3067\u3059\u3002\u6b27\u5dde\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u5354\u4f1a<\/a>.<\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>Mahasweta Pal, freelance medical writer on Kolabtree, writes about the essential skills medical device companies should look for in a Clinical Evaluation Report writer.\u00a0 Dr. Gillian Pritchard, a distinguished member of the European Medical Writers&#8217; Association says that &#8220;Clinical evaluation is a structured ongoing procedure to collect, appraise and analyze clinical data pertaining to a medical device.&#8221; This clinical data supports the validity of the device applications while including data of the pre-clinical and clinical investigations, risk management, post-market surveillance, and the instructions for use. Continuing on from our previous article on Clinical Evaluation Reports, we take a look at the top skills the best CER writers should have that<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":32,"featured_media":6567,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[317,443,540,319,435],"tags":[498,499,474,482],"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>How to hire a Clinical Evaluation Report writer for your Medical Device<\/title>\n<meta name=\"description\" content=\"A quick guide to choosing a Clinical Evaluation Report writer for your medical device. Read up on top skills you should look for in a CER writer.\" \/>\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\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to Hire a Clinical Evaluation Report writer for your medical device\" \/>\n<meta property=\"og:description\" content=\"A quick guide to choosing a Clinical Evaluation Report writer for your medical device. Read up on top skills you should look for in a CER writer.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/\" \/>\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=\"2019-12-09T05:42:45+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-03-17T08:14:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/12\/hire-a-clinical-evaluation-report-writer.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"667\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Mahasweta Pal\" \/>\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=\"Mahasweta Pal\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"9\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"How to hire a Clinical Evaluation Report writer for your Medical Device","description":"A quick guide to choosing a Clinical Evaluation Report writer for your medical device. 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