{"id":9944,"date":"2022-02-22T09:43:37","date_gmt":"2022-02-22T09:43:37","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=9944"},"modified":"2022-02-22T10:02:12","modified_gmt":"2022-02-22T10:02:12","slug":"medical-device-technical-file-checklist-the-ultimate-guide","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-technical-file-checklist-the-ultimate-guide\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3002\u7a76\u6975\u306e\u30ac\u30a4\u30c9"},"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-69f333b978294\" 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-69f333b978294\"><\/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\/medical-device-technical-file-checklist-the-ultimate-guide\/#Download_the_Medical_Device_Technical_File_Checklist\" title=\"\u533b\u7642\u6a5f\u5668\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\">\u533b\u7642\u6a5f\u5668\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e\u30c0\u30a6\u30f3\u30ed\u30fc\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\/medical-device-technical-file-checklist-the-ultimate-guide\/#Device_description_specifications\" title=\"\u30c7\u30d0\u30a4\u30b9\u306e\u8aac\u660e\u3068\u4ed5\u69d8\u00a0\">\u30c7\u30d0\u30a4\u30b9\u306e\u8aac\u660e\u3068\u4ed5\u69d8\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\/medical-device-technical-file-checklist-the-ultimate-guide\/#Information_to_be_supplied_by_the_manufacturer\" title=\"\u30e1\u30fc\u30ab\u30fc\u304c\u63d0\u4f9b\u3059\u3079\u304d\u60c5\u5831\">\u30e1\u30fc\u30ab\u30fc\u304c\u63d0\u4f9b\u3059\u3079\u304d\u60c5\u5831<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-technical-file-checklist-the-ultimate-guide\/#Design_manufacturing_information\" title=\"\u8a2d\u8a08\u30fb\u88fd\u9020\u60c5\u5831\">\u8a2d\u8a08\u30fb\u88fd\u9020\u60c5\u5831<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-technical-file-checklist-the-ultimate-guide\/#General_safety_performance_requirements\" title=\"\u4e00\u822c\u7684\u306a\u5b89\u5168\u6027\u3068\u6027\u80fd\u306b\u95a2\u3059\u308b\u8981\u6c42\u4e8b\u9805\">\u4e00\u822c\u7684\u306a\u5b89\u5168\u6027\u3068\u6027\u80fd\u306b\u95a2\u3059\u308b\u8981\u6c42\u4e8b\u9805<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-technical-file-checklist-the-ultimate-guide\/#Verification_validation_information\" title=\"\u691c\u8a3c\u30fb\u78ba\u8a8d\u60c5\u5831\">\u691c\u8a3c\u30fb\u78ba\u8a8d\u60c5\u5831<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-technical-file-checklist-the-ultimate-guide\/#Risk_assessment\" title=\"\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u00a0\">\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-technical-file-checklist-the-ultimate-guide\/#Declaration_of_Conformity\" title=\"\u9069\u5408\u6027\u5ba3\u8a00\">\u9069\u5408\u6027\u5ba3\u8a00<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-technical-file-checklist-the-ultimate-guide\/#Need_help_with_your_technical_documentation_and_MDR_compliance_Consult_medical_device_CER_writers_medical_device_regulatory_experts_and_MDR_consultants_on_Kolabtree\" title=\"\u6280\u8853\u6587\u66f8\u3084MDR\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3067\u304a\u56f0\u308a\u3067\u3059\u304b\uff1fKolabtree\u306e\u533b\u7642\u6a5f\u5668CER\u30e9\u30a4\u30bf\u30fc\u3001\u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u5c02\u9580\u5bb6\u3001MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002\">\u6280\u8853\u6587\u66f8\u3084MDR\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3067\u304a\u56f0\u308a\u3067\u3059\u304b\uff1fKolabtree\u306e\u533b\u7642\u6a5f\u5668CER\u30e9\u30a4\u30bf\u30fc\u3001\u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u5c02\u9580\u5bb6\u3001MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u5fc5\u8981\u4e0d\u53ef\u6b20\u306a\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3067\u3059\u30021\u30da\u30fc\u30b8\u306e\u30ac\u30a4\u30c9\u3092\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u3057\u3066\u3001MDR\u6e96\u62e0\u3068CE\u30de\u30fc\u30af\u53d6\u5f97\u306b\u5fc5\u8981\u306a\u3082\u306e\u304c\u3059\u3079\u3066\u63c3\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<\/em><\/p>\n<p><span style=\"font-weight: 400;\">\u304a\u5ba2\u69d8\u304c\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3067\u3001\u6b27\u5dde\u5e02\u5834\u3067\u88fd\u54c1\u3092\u8ca9\u58f2\u3057\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u6b27\u5dde\u9023\u5408\u533b\u7642\u6a5f\u5668\u898f\u52472017\/745 ANNEX IX\uff5eXI\uff08EU MDR 2017\/745\uff09\u306b\u5f93\u3063\u3066\u9069\u5408\u6027\u3092\u78ba\u7acb\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/span><b>1<\/b><span style=\"font-weight: 400;\">.\u533b\u7642\u6a5f\u5668\u3092\u8ca9\u58f2\u3059\u308b\u969b\u306b\u306f\u3001\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3068\u547c\u3070\u308c\u308b\u66f8\u985e\u3092\u4f5c\u6210\u3057\u3066\u627f\u8a8d\u3092\u5f97\u308b\u3053\u3068\u3067\u3001\u3053\u306e\u9069\u5408\u6027\u3092\u8a3c\u660e\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Download_the_Medical_Device_Technical_File_Checklist\"><\/span>\u533b\u7642\u6a5f\u5668\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<div class='mailmunch-forms-short-code mailmunch-forms-widget-1073033' style='display: none !important;'><\/div>\n<p><span style=\"font-weight: 400;\">MDR\u306b\u3088\u308b\u3068\u3001\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306f\u3001\u3059\u3079\u3066\u306e\u7a2e\u985e\u306e\u533b\u7642\u6a5f\u5668\u306b\u5fc5\u9808\u306e\u6587\u66f8\u3067\u3042\u308a\u3001\u660e\u78ba\u306b\u7406\u89e3\u3067\u304d\u308b\u8a00\u8a9e\u3067\u4f5c\u6210\u3055\u308c\u3001\u3088\u304f\u6574\u7406\u3055\u308c\u3001\u5bb9\u6613\u306b\u691c\u7d22\u3067\u304d\u308b\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306f\u3001\u88fd\u54c1\u304c\u4f7f\u7528\u76ee\u7684\u306b\u5bfe\u3057\u3066\u5b89\u5168\u3067\u3042\u308a\u3001\u8981\u6c42\u3055\u308c\u305f\u76ee\u7684\u3092\u52b9\u679c\u7684\u306b\u679c\u305f\u3059\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u6587\u66f8\u5316\u3055\u308c\u305f\u8a3c\u62e0\u3068\u3057\u3066\u6a5f\u80fd\u3057\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u306e\u3067\u3059\u3002 <\/span><b>EU MDR 2017\/745 <\/b><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u8981\u6c42\u4e8b\u9805\u3092\u8aac\u660e\u30fb\u5b9a\u7fa9\u3059\u308b\uff08\u9644\u5c5e\u66f8I\uff09<\/span><b>2<\/b><span style=\"font-weight: 400;\"> \u307e\u305f\u3001\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\uff08\u4ed8\u5c5e\u66f8II\uff09\u306e\u8981\u4ef6\u3082\u5b9a\u7fa9\u3057\u3066\u3044\u307e\u3059\u3002<\/span><b>3<\/b><span style=\"font-weight: 400;\">.\u3053\u306e\u9069\u5408\u6027\u3092\u30d1\u30b9\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><a href=\"https:\/\/www.johner-institute.com\/articles\/regulatory-affairs\/and-more\/conformity-assessment\/\"> <span style=\"font-weight: 400;\">\u8a55\u4fa1<\/span><\/a><span style=\"font-weight: 400;\"> \u6280\u8853\u8cc7\u6599\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3053\u3068\u3067\u3001\u975e\u5e38\u306b\u7c21\u5358\u306b\u533b\u7642\u6a5f\u5668\u306e\u627f\u8a8d\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u57fa\u672c\u7684\u306b\u3001\u6280\u8853\u8cc7\u6599\u306b\u306f\u4ee5\u4e0b\u306e\u8981\u7d20\u304c\u542b\u307e\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Device_description_specifications\"><\/span><b>\u30c7\u30d0\u30a4\u30b9\u306e\u8aac\u660e\u3068\u4ed5\u69d8\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u305d\u306e\u76ee\u7684\u306f\u3001\u88fd\u54c1\u3001\u305d\u306e\u76ee\u7684\u3001\u4ed5\u69d8\u3001\u69cb\u6210\u8981\u7d20\u3001\u6750\u6599\u3092\u5b8c\u5168\u306b\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u3053\u306e\u6587\u66f8\u3067\u306f\u3001\u57fa\u672c\u7684\u306aUDI-DI\u3092\u5272\u308a\u5f53\u3066\u308b\u30b7\u30b9\u30c6\u30e0\u3001\u4ed8\u5c5e\u66f8VIII\u306e\u898f\u5247\u306b\u57fa\u3065\u304f\u88fd\u54c1\u306e\u5206\u985e\u306e\u8aac\u660e\u3001\u304a\u3088\u3073\u4ee5\u4e0b\u306e\u65b9\u6cd5\u3068\u3068\u3082\u306b\u3001\u88fd\u54c1\u3092\u5b8c\u5168\u306b\u8aac\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <\/span><a href=\"https:\/\/advisera.com\/13485academy\/mdr\/classification-of-devices\/\"><span style=\"font-weight: 400;\">\u7b2c51\u6761<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<ol>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>\u4ed5\u69d8<\/b><span style=\"font-weight: 400;\"> \u57fa\u672c\u7684\u306aUDI-DI\u307e\u305f\u306f\u660e\u78ba\u306a\u8b58\u5225\u60c5\u5831\u306b\u52a0\u3048\u3066\u3001\u88fd\u54c1\u540d\u307e\u305f\u306f\u5546\u6a19\u540d\u3092\u542b\u3081\u308b\u3002<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>\u30c7\u30d0\u30a4\u30b9\u306e\u8aac\u660e<\/b><span style=\"font-weight: 400;\"> \u306f\u3001\u4e00\u822c\u7684\u306a\u8aac\u660e\u3001\u52d5\u4f5c\u539f\u7406\u3001\u6280\u8853\u4ed5\u69d8\u3001\u4ed8\u5c5e\u54c1\u3084\u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u306e\u8aac\u660e\u3001\u4e3b\u8981\u306a\u6a5f\u80fd\u8981\u7d20\/\u90e8\u54c1\/\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\/\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3001\u69cb\u6210\u3067\u3059\u3002<\/span><\/li>\n<\/ol>\n<h2><span class=\"ez-toc-section\" id=\"Information_to_be_supplied_by_the_manufacturer\"><\/span><b>\u30e1\u30fc\u30ab\u30fc\u304c\u63d0\u4f9b\u3059\u3079\u304d\u60c5\u5831<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ol>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>\u4f7f\u7528\u8aac\u660e\u66f8\uff08Ifu\uff09 -<\/b><span style=\"font-weight: 400;\"> \u3053\u306e\u6587\u66f8\u306b\u306f\u3001\u6a5f\u5668\u306e\u8aac\u660e\u3068\u4ed5\u69d8\u3001\u76ee\u7684\u3001\u8b66\u544a\u3068\u6ce8\u610f\u4e8b\u9805\u304c\u542b\u307e\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u6a5f\u5668\u306e\u76ee\u7684\u306f\u3001IFU \u306e\u91cd\u8981\u306a\u8981\u7d20\u3067\u3059\u3002\u3053\u306e\u6587\u66f8\u306b\u306f\u3001\u5bfe\u8c61\u3068\u306a\u308b\u60a3\u8005\u3001\u8a3a\u65ad\uff0f\u6cbb\u7642\uff0f\u76e3\u8996\u306e\u5bfe\u8c61\u3068\u306a\u308b\u72b6\u614b\u3001\u9069\u5fdc\u75c7\u3001\u7981\u5fcc\u75c7\u3001\u8b66\u544a\u3001\u6ce8\u610f\u4e8b\u9805\u3001\u5371\u967a\u6027\u306a\u3069\u3001\u5bfe\u8c61\u3068\u306a\u308b\u30e6\u30fc\u30b6\u30fc\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>\u30d1\u30c3\u30b1\u30fc\u30b8\u30f3\u30b0\uff06\u30e9\u30d9\u30ea\u30f3\u30b0\u60c5\u5831-\u3002 <\/b><span style=\"font-weight: 400;\">MDR\u3067\u306f\u3001\u3053\u306e\u6587\u66f8\u306e\u4e2d\u3067\u3001\u5b8c\u5168\u306a\u30e9\u30d9\u30eb\u3068\u30d1\u30c3\u30b1\u30fc\u30b8\u306e\u60c5\u5831\u3092\u8aac\u660e\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u307e\u305f\u3001\u5358\u54c1\u8ca9\u58f2\u306b\u95a2\u3059\u308b\u8aac\u660e\u3001\u7279\u5b9a\u306e\u7ba1\u7406\u6761\u4ef6\u306e\u5834\u5408\u306e\u8f38\u9001\u7528\u5305\u88c5\u3001\u3059\u3079\u3066\u306e\u5371\u967a\u6027\u3001\u8b66\u544a\u3001\u53d6\u308a\u6271\u3044\u65b9\u6cd5\u3001\u88fd\u9020\u5e74\u6708\u65e5\u3001\u4f7f\u7528\u671f\u9650\u3092\u793a\u3059\u8a18\u53f7\u3092\u8a18\u8f09\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">\u6ce8\uff1a\u3053\u308c\u3089\u306e\u60c5\u5831\u306f\u516c\u958b\u3055\u308c\u305f\u6587\u66f8\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u305a\u3001EU\u306e\u516c\u7528\u8a9e\u306e\u4e00\u3064\u3068\u52a0\u76df\u56fd\u304c\u8981\u6c42\u3059\u308b\u8a00\u8a9e\u3067\u66f8\u304b\u308c\u3066\u3044\u308b\u3053\u3068\u304c\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Design_manufacturing_information\"><\/span><b>\u8a2d\u8a08\u30fb\u88fd\u9020\u60c5\u5831<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u6587\u66f8\u3067\u306f\u3001\u6982\u8981\u3092\u8aac\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<ol>\n<li><span style=\"font-weight: 400;\">\u8a2d\u8a08\u56f3\u3001\u56f3\u9762\u3001\u6750\u6599\u3092\u5229\u7528\u3059\u308b\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u88fd\u9020\u306e\u30d7\u30ed\u30bb\u30b9<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u8a2d\u8a08\u304a\u3088\u3073\u88fd\u9020\u6d3b\u52d5\u304c\u884c\u308f\u308c\u3066\u3044\u308b\u3059\u3079\u3066\u306e\u62e0\u70b9\u306b\u95a2\u3059\u308b\u30c7\u30fc\u30bf\u3002\u4f55\u3089\u304b\u306e\u5f62\u3067\u88fd\u9020\u306b\u95a2\u4e0e\u3057\u3066\u3044\u308b\u4ed6\u306e\u3059\u3079\u3066\u306e\u4e0b\u8acb\u3051\u306e\u30b9\u30c6\u30c3\u30d7\u307e\u305f\u306f\u30d7\u30ed\u30bb\u30b9\uff08\u6ec5\u83cc\u3001\u7279\u5b9a\u306e\u90e8\u54c1\u307e\u305f\u306f\u4ed8\u5c5e\u54c1\u306e\u88fd\u9020\u3001\u307e\u305f\u306f\u5305\u88c5\u306a\u3069\uff09\u306f\u3001\u540d\u524d\u3068\u4f4f\u6240\u306b\u95a2\u3059\u308b\u5b8c\u5168\u306a\u60c5\u5831\u306b\u52a0\u3048\u3066\u3001\u30d7\u30ed\u30bb\u30b9\u306e\u3069\u306e\u90e8\u5206\u3092\u5b9f\u884c\u3057\u3066\u3044\u308b\u304b\u3092\u8aac\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u54c1\u8cea\u7ba1\u7406\u306e\u624b\u9806\u3068\u30c1\u30a7\u30c3\u30af<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">This document is prepared in correlation with ISO 13485 and contains information from procedures, <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> plans, protocols, results of verification and validation, production process in detail.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"General_safety_performance_requirements\"><\/span><b>\u4e00\u822c\u7684\u306a\u5b89\u5168\u6027\u3068\u6027\u80fd\u306b\u95a2\u3059\u308b\u8981\u6c42\u4e8b\u9805<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u6587\u66f8\u306f\u3001GSPR\u3068\u3082\u547c\u3070\u308c\u3001MDR\u306e\u9644\u5c5e\u66f81\u3067\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u6587\u66f8\u306f\u3001\u9069\u7528\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u8981\u6c42\u4e8b\u9805\u306b\u5f93\u3063\u3066\u8a2d\u8a08\u304a\u3088\u3073\u88fd\u9020\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u8a3c\u62e0\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u5b89\u5168\u306a\u4f7f\u7528\u3068\u52b9\u679c\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u6587\u66f8\u306f\u3001\u4ee5\u524d\u306f\u5fc5\u9808\u8981\u4ef6\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3068\u547c\u3070\u308c\u3066\u3044\u307e\u3057\u305f\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Verification_validation_information\"><\/span><b>\u691c\u8a3c\u30fb\u78ba\u8a8d\u60c5\u5831<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ol>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>\u30d9\u30ea\u30d5\u30a1\u30a4\uff06\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u30ec\u30dd\u30fc\u30c8 <\/b><span style=\"font-weight: 400;\">\u3053\u3053\u3067\u306f\u3001\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u3001\u5316\u5b66\u6210\u5206\u306b\u95a2\u3059\u308b\u5b89\u5168\u6027\u3001\u96fb\u6c17\u306e\u5b89\u5168\u6027\u3001\u6240\u5b9a\u306e\u6761\u4ef6\u3067\u4fdd\u5b58\u3057\u305f\u5834\u5408\u306e\u5b89\u5b9a\u6027\u3001\u7121\u83cc\u6027\u3001\u4f7f\u7528\u6027\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u3001\u8cc7\u6599\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u8a66\u9a13\u7d50\u679c\u3068\u524d\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u5206\u6790\u7d50\u679c\u304c\u3053\u306e\u5831\u544a\u66f8\u306b\u307e\u3068\u3081\u3089\u308c\u307e\u3059\u3002\u524d\u81e8\u5e8a\u30c7\u30fc\u30bf\u306b\u52a0\u3048\u3066\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u5f97\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3042\u308a\u3001\u305d\u308c\u306f\u81e8\u5e8a\u8a55\u4fa1\u307e\u305f\u306f\u81e8\u5e8a\u8abf\u67fb\u306b\u3088\u3063\u3066\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u6b27\u5dde\u59d4\u54e1\u4f1a\u304c\u91cd\u8996\u3057\u3066\u3044\u308b\u306e\u306f\u3001\u8a2d\u8a08\u30fb\u958b\u767a\u6642\u3060\u3051\u3067\u306a\u304f\u3001\u5e02\u8ca9\u5f8c\u3082\u542b\u3081\u305f\u81e8\u5e8a\u30c7\u30fc\u30bf\u3067\u3042\u308b\u3002<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER\uff09\u306b\u3064\u3044\u3066<\/b><span style=\"font-weight: 400;\"> \u3053\u306e\u5831\u544a\u66f8\u3067\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u30c7\u30b6\u30a4\u30f3\u3068\u69cb\u6210\u3001\u304a\u3088\u3073\u610f\u56f3\u3055\u308c\u305f\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306e\u5305\u62ec\u7684\u306a\u6982\u8981\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u6587\u66f8\u3067\u306f\u3001\u672c\u88c5\u7f6e\u306b\u985e\u4f3c\u3057\u305f\u88c5\u7f6e\u3068\u306e\u6700\u5148\u7aef\u306e\u3001\u81e8\u5e8a\u7684\u3001\u751f\u7269\u5b66\u7684\u3001\u6280\u8853\u7684\u306a\u6bd4\u8f03\u3092\u8a73\u3057\u304f\u8aac\u660e\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u985e\u4f3c\u306e\u6a5f\u5668\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u516c\u8868\u3055\u308c\u3066\u3044\u308b\u81e8\u5e8a\u30c7\u30fc\u30bf\u3084\u95a2\u9023\u6587\u732e\u306e\u30ec\u30d3\u30e5\u30fc\u3092\u307e\u3068\u3081\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u305d\u306e\u6a5f\u5668\u304c\u65b0\u898f\u306e\u3082\u306e\u3067\u3042\u308b\u5834\u5408\u3001\u88fd\u9020\u8005\u306f\u6280\u8853\u7684\u3001\u81e8\u5e8a\u7684\u3001\u751f\u7269\u5b66\u7684\u306a\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u78ba\u7acb\u3059\u308b\u305f\u3081\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<br \/>\n<\/span><\/li>\n<li><b style=\"font-size: 14px;\">\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u5831\u544a\u66f8\uff08ber\uff09-\u3002<\/b><span style=\"font-weight: 400;\"> \u3053\u308c\u306f\u3001\u4eba\u4f53\u306e\u7121\u50b7\u306e\u76ae\u819a\u3084\u7d44\u7e54\u3068\u63a5\u89e6\u3059\u308b\u5404\u6750\u6599\u306e\u751f\u4f53\u9069\u5408\u6027\u3092\u307e\u3068\u3081\u305f\u3082\u306e\u3067\u3059\u3002\u3053\u306e\u30ec\u30dd\u30fc\u30c8\u306f\u3001ISO 10993-1\u751f\u4f53\u9069\u5408\u6027\u898f\u683c\u306b\u57fa\u3065\u3044\u3066\u7de8\u96c6\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/li>\n<li><b>ISO 10993-1:2021\u306b\u5bfe\u3059\u308bHS COMPLIANCE MATRIX<\/b><b>4<\/b><b> - <\/b><span style=\"font-weight: 400;\">\u3053\u306e\u6587\u66f8\u306f\u3001\u3053\u306e\u751f\u4f53\u9069\u5408\u6027\u898f\u683c\u306e\u4e0b\u3067\u9069\u7528\u3055\u308c\u308b\u8981\u4ef6\u3092\u78ba\u7acb\u3059\u308b\u305f\u3081\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3068\u3057\u3066\u4f5c\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001ISO 10993\u306b\u57fa\u3065\u3044\u3066\u30c7\u30d0\u30a4\u30b9\u306b\u9069\u7528\u3055\u308c\u308b\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u3092\u78ba\u7acb\u3059\u308b\u3002<\/span><\/li>\n<li><b>\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\uff08PMCF\uff09-\u3002<\/b><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a55\u4fa1\u3092\u7d99\u7d9a\u7684\u306b\u66f4\u65b0\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3001\u6a5f\u5668\u306e\u8ca9\u58f2\u5f8c\u3082\u7a4d\u6975\u7684\u306b\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3057\u3001\u305d\u306e\u8a55\u4fa1\u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff08\u4ed8\u5c5e\u66f8XIV\u306e\u30d1\u30fc\u30c82\u306b\u8a18\u8f09\uff09\u3002<\/span><b>5<\/b><span style=\"font-weight: 400;\">.\u3053\u308c\u3089\u306e\u30b9\u30c6\u30c3\u30d7\u3092\u8e0f\u3080\u3053\u3068\u3067\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u4e88\u60f3\u3055\u308c\u308b\u30e9\u30a4\u30d5\u30bf\u30a4\u30e0\u3092\u901a\u3057\u3066\u3001\u5b89\u5168\u6027\u3068\u6027\u80fd\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u307e\u305f\u3001\u65e2\u306b\u78ba\u8a8d\u3055\u308c\u3066\u3044\u308b\u30ea\u30b9\u30af\u306e\u53d7\u5bb9\u6027\u3092\u78ba\u8a8d\u3057\u3001\u4e8b\u5b9f\u306b\u57fa\u3065\u304f\u65b0\u305f\u306a\u30ea\u30b9\u30af\u3092\u691c\u51fa\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><\/li>\n<li><b>\u5e02\u8ca9\u5f8c\u8abf\u67fb\uff08PMS\uff09\u306e\u8a08\u753b\u3068\u5831\u544a\u66f8<\/b><span style=\"font-weight: 400;\">MDR\u3067\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u3068\u3057\u3066\u3001\u627f\u8a8d\/CE\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u3084\u5e02\u5834\u53c2\u5165\u5f8c\u3082\u3001\u81e8\u5e8a\u304a\u3088\u3073\u5b89\u5168\u6027\u95a2\u9023\u306e\u30c7\u30fc\u30bf\u3092\u307e\u3068\u3081\u3066\u7dad\u6301\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002  \u3053\u308c\u306b\u3088\u308a\u3001\u8cb4\u793e\u304a\u3088\u3073\u8cb4\u793e\u306e\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u306f\u3001\u30ea\u30b9\u30af\u3092\u4f53\u7cfb\u7684\u306b\u7279\u5b9a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 <\/span><a href=\"https:\/\/decomplix.com\/intended-purpose-medical-device\/\"><span style=\"font-weight: 400;\">\u88fd\u54c1\u306e\u5b9f\u7528\u5316\u306b\u5411\u3051\u3066<\/span><\/a><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u3092\u4f7f\u7528\u3001\u4fdd\u7ba1\u3001\u8f38\u9001\u3001\u6d17\u6d44\u3057\u305f\u3068\u304d\u306b\u521d\u3081\u3066\u660e\u3089\u304b\u306b\u306a\u308b\u30ea\u30b9\u30af\u3082\u3042\u308b\u304b\u3089\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3057\u3001\u6b20\u9665\u3084\u672a\u767a\u898b\u306e\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u554f\u984c\u306a\u3069\u306e\u5236\u5fa1\u3067\u304d\u306a\u3044\u30ea\u30b9\u30af\u304c\u306a\u3044\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u6709\u76ca\u306a\u30b9\u30c6\u30c3\u30d7\u3067\u3059\u3002<\/span><\/li>\n<\/ol>\n<h2><span class=\"ez-toc-section\" id=\"Risk_assessment\"><\/span><b>\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u304a\u5ba2\u69d8\u306e\u6a5f\u5668\u306e\u4f7f\u7528\u306b\u3088\u308a\u5371\u967a\u304c\u751f\u3058\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u6545\u969c\u3092\u7279\u5b9a\u3057\u3001\u7406\u89e3\u3057\u3001\u5236\u5fa1\u3057\u3001\u9632\u6b62\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3092\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3068\u3044\u3044\u307e\u3059\u3002\u540c\u898f\u5247\u306e\u7b2c10\/2\u6761\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3057\u3066\u3001\u88fd\u54c1\u5b89\u5168\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3092\u78ba\u7acb\u3057\u3001\u6587\u66f8\u5316\u3057\u3001\u5b9f\u65bd\u3057\u3001\u7dad\u6301\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002<\/span><span style=\"font-weight: 400;\"> MDR\u306f\u3001EN ISO 14971:2012\u304a\u3088\u3073EN ISO 13485:2016\u306b\u6e96\u62e0\u3057\u3066\u3044\u307e\u3059\u3002<\/span><b>6<\/b><span style=\"font-weight: 400;\">.\u3053\u306e2\u3064\u306eISO\u898f\u683c\u306b\u6e96\u62e0\u3057\u305f\u30ea\u30b9\u30af\u5206\u6790\u8a08\u753b\u30fb\u5831\u544a\u66f8\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u3067\u3001MDR\u3092\u9075\u5b88\u3057\u3001\u30ea\u30b9\u30af\u30fb\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u5206\u6790\u3092\u78ba\u7acb\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n<ol>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30ec\u30dd\u30fc\u30c8<\/span><\/li>\n<\/ol>\n<h2><span class=\"ez-toc-section\" id=\"Declaration_of_Conformity\"><\/span><b>\u9069\u5408\u6027\u5ba3\u8a00<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u3053\u308c\u306f\u3001\u304a\u5ba2\u69d8\u306b\u3068\u3063\u3066\u5fc5\u9808\u306e\u66f8\u985e\u3067\u3042\u308a\u3001\u9069\u5408\u6027\u8a55\u4fa1\u306b\u5411\u3051\u305f\u91cd\u8981\u306a\u30b9\u30c6\u30c3\u30d7\u3067\u3059\u3002MDR\u7b2c19\u6761\u306b\u57fa\u3065\u304d\u3001\u88fd\u9020\u8005\u307e\u305f\u306f\u8a8d\u5b9a\u3055\u308c\u305f\u4ee3\u7406\u4eba\u304c\u7f72\u540d\u3057\u3001\u88fd\u54c1\u304c\u9069\u7528\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u6cd5\u5f8b\u304a\u3088\u3073ISO\u8abf\u548c\u898f\u683c\u3092\u542b\u3080EU\u8981\u6c42\u4e8b\u9805\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u5ba3\u8a00\u3057\u307e\u3059\u3002\u3053\u306e\u6587\u66f8\u306b\u306f\u4ee5\u4e0b\u306e\u60c5\u5831\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<ol>\n<li><b><\/b><span style=\"font-weight: 400;\">\u540d\u524d\u3068\u5b8c\u5168\u306a\u30d3\u30b8\u30cd\u30b9\u30a2\u30c9\u30ec\u30b9\u3001\u307e\u305f\u306f\u6a29\u9650\u306e\u3042\u308b\u4ee3\u8868\u8005\u306e\u540d\u524d<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\">\u88fd\u54c1\u306e\u30b7\u30ea\u30a2\u30eb\u756a\u53f7\u3001\u30e2\u30c7\u30eb\u307e\u305f\u306f\u30bf\u30a4\u30d7\u306e\u8b58\u5225\u60c5\u5831<\/span><\/li>\n<li><span style=\"font-weight: 400;\">MDR\u4ed8\u5c5e\u66f8VIII\u306b\u57fa\u3065\u304f\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e<\/span><b style=\"font-size: 14px;\">7\/8<\/b><b><\/b><\/li>\n<li><span style=\"font-weight: 400;\">\u58f0\u660e\u3092\u51fa\u3057\u3001\u5168\u8cac\u4efb\u3092\u8ca0\u3046\u3068\u8868\u660e<\/span><b><\/b><\/li>\n<li><span style=\"font-weight: 400;\">\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u3092\u53ef\u80fd\u306b\u3059\u308b\u88fd\u54c1\u306e\u8b58\u5225 - \u3053\u308c\u306b\u306f\u753b\u50cf\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/span><b><\/b><\/li>\n<li><span style=\"font-weight: 400;\">\u3092\u5b9f\u65bd\u3057\u305f\u901a\u77e5\u6a5f\u95a2\u306e\u8a73\u7d30\u3002 <\/span><a href=\"https:\/\/europa.eu\/youreurope\/business\/product-requirements\/compliance\/conformity-assessment\/index_en.htm\"><span style=\"font-weight: 400;\">\u9069\u5408\u6027\u8a55\u4fa1\u624b\u9806<\/span><\/a><span style=\"font-weight: 400;\"> (\u8a72\u5f53\u3059\u308b\u5834\u5408)<\/span><\/li>\n<li>\u672c\u88fd\u54c1\u304c\u6e96\u62e0\u3057\u3066\u3044\u308b\u95a2\u9023\u6cd5\u898f\u3001\u304a\u3088\u3073\u3059\u3079\u3066\u306e <a style=\"font-size: 14px;\" href=\"https:\/\/europa.eu\/youreurope\/business\/product-requirements\/standards\/standards-in-europe\/index_en.htm\">\u30cf\u30fc\u30e2\u30ca\u30a4\u30ba\u30c9\u30b9\u30bf\u30f3\u30c0\u30fc\u30c9<\/a><span style=\"font-weight: 400;\"> \u307e\u305f\u306f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306e\u305d\u306e\u4ed6\u306e\u624b\u6bb5<\/span><\/li>\n<li>\u540d\u524d\u3068\u30b5\u30a4\u30f3<\/li>\n<li><b><\/b><span style=\"font-weight: 400;\">\u5ba3\u8a00\u66f8\u306e\u767a\u884c\u65e5<\/span><b><\/b><\/li>\n<li><span style=\"font-weight: 400;\">\u88dc\u8db3\u60c5\u5831\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">\u7d50\u8ad6\u3068\u3057\u3066\u3001\u6a5f\u5668\u306e\u30af\u30e9\u30b9\u3001\u4f7f\u7528\u76ee\u7684\u3001\u30c7\u30b6\u30a4\u30f3\u3001\u3055\u3089\u306b\u306f\u5b89\u5168\u6027\u306e\u5c65\u6b74\u306b\u95a2\u308f\u3089\u305a\u3001\u88fd\u9020\u8005\u3068\u3057\u3066\u6700\u65b0\u306e\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3092\u6301\u3061\u3001\u7dad\u6301\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u306e\u91cd\u8981\u306a\u8981\u7d20\u3092\u69cb\u6210\u3059\u308b\u3053\u308c\u3089\u306e\u8b70\u8ad6\u3055\u308c\u305f\u5fc5\u9808\u8981\u7d20\u306f\u3001EU MDR 2017\/745\u3078\u306e\u6e96\u62e0\u3092\u78ba\u7acb\u3057\u3001\u8a3c\u660e\u3059\u308b\u305f\u3081\u306e\u6700\u3082\u7c21\u5358\u306a\u65b9\u6cd5\u3067\u3059\u3002<\/span><\/p>\n<blockquote>\n<h4><span class=\"ez-toc-section\" id=\"Need_help_with_your_technical_documentation_and_MDR_compliance_Consult_medical_device_CER_writers_medical_device_regulatory_experts_and_MDR_consultants_on_Kolabtree\"><\/span>\u30c6\u30af\u30cb\u30ab\u30eb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u4f5c\u6210\u3084MDR\u3078\u306e\u5bfe\u5fdc\u3067\u304a\u56f0\u308a\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304b\uff1f\u304a\u554f\u3044\u5408\u308f\u305b <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=TechnicalFileChecklist\">\u533b\u7642\u6a5f\u5668CER\u30e9\u30a4\u30bf\u30fc<\/a>, <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulatory-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=TechnicalFileChecklist\">\u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u5c02\u9580\u5bb6<\/a>\u3068\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations-mdr\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=TechnicalFileChecklist\">MDR\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u3092Kolabtree\u306b\u63b2\u8f09\u3057\u307e\u3057\u305f\u3002<span class=\"ez-toc-section-end\"><\/span><\/h4>\n<\/blockquote>\n<p><strong>\u53c2\u8003\u6587\u732e<\/strong><\/p>\n<ol>\n<li><span style=\"font-weight: 400;\">\u6b27\u5dde\u9023\u5408\u533b\u7642\u6a5f\u5668\u898f\u52472017\/745\u3010https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32017R0745\u3011<\/span><\/li>\n<li><span style=\"font-weight: 400;\">ANNEX I - General safety and performance requirements [https:\/\/www.medical-device-regulation.eu\/2019\/07\/23\/annex-i-general-safety-and-performance-requirements\/]<\/span><\/li>\n<li><span style=\"font-weight: 400;\">https:\/\/www.medical-device-regulation.eu\/2019\/07\/25\/annex-ii-part-2\/<\/span><\/li>\n<li><span style=\"font-weight: 400;\">EN ISO 10993-1:2021 \u533b\u7642\u6a5f\u5668\u306e\u751f\u7269\u5b66\u7684\u8a55\u4fa1-\u7b2c1\u90e8\uff1a\u30ea\u30b9\u30af\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u5185\u3067\u306e\u8a55\u4fa1\u304a\u3088\u3073\u8a66\u9a13<\/span><\/li>\n<li><span style=\"font-weight: 400;\">ANNEX XIV \u81e8\u5e8a\u8a55\u4fa1\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7 [https:\/\/www.medical-device-regulation.eu\/2019\/08\/14\/annex-xiv\/]<\/span><\/li>\n<li><span style=\"font-weight: 400;\">I<\/span><span style=\"font-weight: 400;\">SO 13485:2016 \u533b\u7642\u6a5f\u5668 - \u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0 - \u898f\u5236\u76ee\u7684\u306e\u8981\u6c42\u4e8b\u9805 [https:\/\/www.iso.org\/standard\/59752.html]<\/span><\/li>\n<li><span style=\"font-weight: 400;\">MDCG 2021-24 \u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9 [https:\/\/ec.europa.eu\/health\/system\/files\/2021-10\/mdcg_2021-24_en_0.pdf]<\/span><\/li>\n<li><span style=\"font-weight: 400;\">EU MDR Annex VIII [https:\/\/www.medical-device-regulation.eu\/2019\/08\/08\/annex-viii\/<\/span><\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>The essential Technical File checklist for medical device manufacturers. Download the one-page guide to make sure you&#8217;ve got everything you need to achieve MDR compliance and get a CE mark.\u00a0 If you are a medical device manufacturer and are intending to sell your product in the European Market, than you are required to establish conformity according to the European Union Medical Device Regulation 2017\/745 ANNEX IX to XI (EU MDR 2017\/745)1. You can establish this conformity by compiling documentation, known as a Technical File, to seek approval for selling your medical devices.\u00a0 Download the Medical Device Technical File Checklist According to the MDR, the technical file is a mandatory document<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-technical-file-checklist-the-ultimate-guide\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":9954,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[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>Medical Device Technical File Checklist: The Ultimate Guide<\/title>\n<meta name=\"description\" content=\"Free medical device technical file checklist. Download a one-page checklist to ensure you have everything you need for MDR compliance.\" \/>\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\/medical-device-technical-file-checklist-the-ultimate-guide\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Technical File Checklist: The Ultimate Guide\" \/>\n<meta property=\"og:description\" content=\"Free medical device technical file checklist. 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