{"id":8126,"date":"2020-07-28T10:59:55","date_gmt":"2020-07-28T10:59:55","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8126"},"modified":"2020-07-28T11:08:36","modified_gmt":"2020-07-28T11:08:36","slug":"a-guide-to-fda-design-controls-for-your-medical-device","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/a-guide-to-fda-design-controls-for-your-medical-device\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u305f\u3081\u306eFDA\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\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-69f4732774382\" 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-69f4732774382\"><\/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\/a-guide-to-fda-design-controls-for-your-medical-device\/#Applicability\" title=\"\u9069\u7528\u6027\u00a0\">\u9069\u7528\u6027\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-guide-to-fda-design-controls-for-your-medical-device\/#Device_Design_Phases\" title=\"\u30c7\u30d0\u30a4\u30b9\u8a2d\u8a08\u306e\u30d5\u30a7\u30fc\u30ba\">\u30c7\u30d0\u30a4\u30b9\u8a2d\u8a08\u306e\u30d5\u30a7\u30fc\u30ba<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-guide-to-fda-design-controls-for-your-medical-device\/#D_D_Planning_Phase\" title=\"D&amp;D\u8a08\u753b\u6bb5\u968e\">D&amp;D\u8a08\u753b\u6bb5\u968e<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_Input_Phase\" title=\"\u8a2d\u8a08\u5165\u529b\u6bb5\u968e\">\u8a2d\u8a08\u5165\u529b\u6bb5\u968e<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_Output_Phase\" title=\"\u8a2d\u8a08\u51fa\u529b\u6bb5\u968e\">\u8a2d\u8a08\u51fa\u529b\u6bb5\u968e<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_Review_Phase\" title=\"\u30c7\u30b6\u30a4\u30f3\u30ec\u30d3\u30e5\u30fc\u6bb5\u968e\">\u30c7\u30b6\u30a4\u30f3\u30ec\u30d3\u30e5\u30fc\u6bb5\u968e<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_Verification_Phase\" title=\"\u8a2d\u8a08\u691c\u8a3c\u6bb5\u968e\">\u8a2d\u8a08\u691c\u8a3c\u6bb5\u968e<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_Validation_Phase\" title=\"\u30c7\u30b6\u30a4\u30f3\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6bb5\u968e\">\u30c7\u30b6\u30a4\u30f3\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6bb5\u968e<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_Transfer_Phase\" title=\"\u8a2d\u8a08\u79fb\u7ba1\u30d5\u30a7\u30fc\u30ba\">\u8a2d\u8a08\u79fb\u7ba1\u30d5\u30a7\u30fc\u30ba<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_Changes_Phase\" title=\"\u8a2d\u8a08\u5909\u66f4\u30d5\u30a7\u30fc\u30ba\">\u8a2d\u8a08\u5909\u66f4\u30d5\u30a7\u30fc\u30ba<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-guide-to-fda-design-controls-for-your-medical-device\/#Design_History_File_DHF\" title=\"\u30c7\u30b6\u30a4\u30f3\u30d2\u30b9\u30c8\u30ea\u30fc\u30d5\u30a1\u30a4\u30eb\uff08DHF\uff09\u00a0\">\u30c7\u30b6\u30a4\u30f3\u30d2\u30b9\u30c8\u30ea\u30fc\u30d5\u30a1\u30a4\u30eb\uff08DHF\uff09\u00a0<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Shreya Chenni, <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDADesignControl\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u898f\u5236\u95a2\u9023\u30e9\u30a4\u30bf\u30fc<\/a> \u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u305f\u3081\u306eFDA\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306b\u3064\u3044\u3066\u300110\u5206\u3067\u308f\u304b\u308b\u30ac\u30a4\u30c9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u00a0\u00a0<\/em><\/p>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b3\u30fc\u30eb\u306e\u4e3b\u306a\u539f\u56e0\u306e\u4e00\u3064\u306f\u3001FDA\u304c\u6307\u6458\u3057\u305f\u8a2d\u8a08\u7ba1\u7406\u306e\u4e0d\u5099\u3067\u3059[3,3a]\u3002\u305d\u306e\u5f8c\u3001\u88fd\u9020\u524d\u306e\u7ba1\u7406\u304c\u6a5f\u5668GMP\u898f\u5236\u306b\u8ffd\u52a0\u3055\u308c\u307e\u3057\u305f\u3002\u8a2d\u8a08\u7ba1\u7406\u3068\u306f\u3001\u8a2d\u8a08\u30fb\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306b\u7d44\u307f\u8fbc\u307e\u308c\u305f\u3001\u76f8\u4e92\u306b\u95a2\u9023\u3059\u308b\u4e00\u9023\u306e\u5b9f\u52d9\u3068\u624b\u9806\u3001\u3059\u306a\u308f\u3061\u30c1\u30a7\u30c3\u30af\u30a2\u30f3\u30c9\u30d0\u30e9\u30f3\u30b9\u306e\u30b7\u30b9\u30c6\u30e0\u3067\u3059\u3002\u8a2d\u8a08\u7ba1\u7406\u306f\u3001\u88fd\u9020\u306b\u79fb\u3055\u308c\u305f\u8a2d\u8a08\u304c\u3001\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u306b\u9069\u3057\u305f\u6a5f\u5668\u306b\u306a\u308b\u53ef\u80fd\u6027\u3092\u9ad8\u3081\u308b\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Applicability\"><\/span><b>\u9069\u7528\u6027\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u3059\u3079\u3066\u306e\u30af\u30e9\u30b9II\u3001III\u304a\u3088\u3073\u4ee5\u4e0b\u306e\u30af\u30e9\u30b9I\u6a5f\u5668\u306f\u3001\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3067\u81ea\u52d5\u5316\u3055\u308c\u305f\u30c7\u30d0\u30a4\u30b9<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">868.6810 \u6c17\u7ba1\u6c17\u7ba1\u652f\u5438\u5f15\u7528\u30ab\u30c6\u30fc\u30c6\u30eb\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">878.4460 \u624b\u888b\u3001\u5916\u79d1\u533b\u7528\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">880.6760 \u62d8\u675f\u3001\u4fdd\u8b77\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">892.5650 \u30b7\u30b9\u30c6\u30e0\u3001\u30a2\u30d7\u30ea\u30b1\u30fc\u30bf\u3001\u653e\u5c04\u6027\u6838\u7a2e\u3001\u624b\u52d5\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">892.5740 \u7dda\u6e90\u3001\u653e\u5c04\u6027\u6838\u7a2e\u306b\u3088\u308b\u9060\u9694\u6cbb\u7642<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3067\u81ea\u52d5\u5316\u3055\u308c\u305f\u30c7\u30d0\u30a4\u30b9<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u6c17\u7ba1\u6c17\u7ba1\u652f\u5438\u5f15\u30ab\u30c6\u30fc\u30c6\u30eb<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30b5\u30fc\u30b8\u30f3\u30b0\u30ed\u30fc\u30d6<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u4fdd\u8b77\u62d8\u675f<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30b7\u30b9\u30c6\u30e0\u3001\u653e\u5c04\u6027\u6838\u7a2e\u3001\u30a2\u30d7\u30ea\u30b1\u30fc\u30bf\u30fc\u3001\u30de\u30cb\u30e5\u30a2\u30eb<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u7dda\u6e90\u3001\u653e\u5c04\u6027\u6838\u7a2e\u306b\u3088\u308b\u9060\u9694\u6cbb\u7642<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Design controls apply to all D&amp;D activities \u2013 for novel or improved devices being developed in the pre-market phase, as well as for changes to existing, marketed devices. Design controls do not apply to <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> activities conducted during the proof of concept stage.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u8a2d\u8a08\u7ba1\u7406\u306f\u3001\u3069\u306e\u3088\u3046\u306a\u88fd\u54c1\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306b\u3082\u9069\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u4ee5\u4e0b\u306e\u30d5\u30ed\u30fc\u30c1\u30e3\u30fc\u30c8\u306f\u3001\u5f93\u6765\u306e\u30a6\u30a9\u30fc\u30bf\u30fc\u30d5\u30a9\u30fc\u30eb\u8a2d\u8a08\u30d7\u30ed\u30bb\u30b9\u3068\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff08SW\uff09\u306eV\u30e2\u30c7\u30eb\u30d7\u30ed\u30bb\u30b9\u306b\u9069\u7528\u3055\u308c\u308b\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u4f8b\u3067\u3059\u3002<\/span><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-8136 size-full\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1.png\" alt=\"\" width=\"1316\" height=\"940\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1.png 1316w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1-300x214.png 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1-1024x731.png 1024w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1-768x549.png 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1-1080x771.png 1080w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1-269x192.png 269w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1-300x214@2x.png 600w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/MD1-269x192@2x.png 538w\" sizes=\"(max-width: 1316px) 100vw, 1316px\" \/><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/media\/116573\/download\"><i><span style=\"font-weight: 400;\">\u51fa\u5178\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u5411\u3051\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u30ac\u30a4\u30c0\u30f3\u30b9\u3001CDRH-FDA<\/span><\/i><\/a><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Device_Design_Phases\"><\/span><b>\u30c7\u30d0\u30a4\u30b9\u8a2d\u8a08\u306e\u30d5\u30a7\u30fc\u30ba<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"D_D_Planning_Phase\"><\/span><b>D&amp;D\u8a08\u753b\u6bb5\u968e<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">D&amp;D\u8a08\u753b\u306f\u78ba\u7acb\u3055\u308c\u3001\u7dad\u6301\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u3053\u306e\u8a08\u753b\u306f\u3001\u8a2d\u8a08\u30fb\u958b\u767a\u6d3b\u52d5\u3092\u8a18\u8ff0\u307e\u305f\u306f\u53c2\u7167\u3057\u3001\u5b9f\u65bd\u306e\u305f\u3081\u306e\u8cac\u4efb\u3092\u5272\u308a\u5f53\u3066\u308b\u3053\u3068\u3002\u6700\u4f4e\u9650\u3001FDA\u306f\u4ee5\u4e0b\u306e\u5185\u5bb9\u3092\u8a08\u753b\u306b\u76db\u308a\u8fbc\u3080\u3053\u3068\u3092\u63a8\u5968\u3057\u3066\u3044\u308b\u3002\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">D&amp;D\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u76ee\u6a19\u3068\u76ee\u7684<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30c7\u30b6\u30a4\u30f3\u6d3b\u52d5\u306e\u8cac\u4efb\u306e\u660e\u78ba\u5316<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u4e3b\u8981\u306a\u30bf\u30b9\u30af\u3001\u6210\u679c\u7269\u3092\u7279\u5b9a\u3057\u3001\u5404\u30bf\u30b9\u30af\u306e\u8cac\u4efb\u8005\u3092\u5272\u308a\u5f53\u3066\u308b\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u4e3b\u306a\u958b\u767a\u671f\u9593\u306b\u5408\u308f\u305b\u305f\u4e3b\u8981\u30bf\u30b9\u30af\u306e\u30b9\u30b1\u30b8\u30e5\u30fc\u30ea\u30f3\u30b0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u4e3b\u8981\u306a\u30ec\u30d3\u30e5\u30fc\u3068\u6c7a\u5b9a\u30dd\u30a4\u30f3\u30c8\u306e\u7279\u5b9a\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u67fb\u8aad\u8005\u3001\u67fb\u8aad\u30c1\u30fc\u30e0\u3001\u67fb\u8aad\u8005\u304c\u5f93\u3046\u3079\u304d\u624b\u9806\u306e\u78ba\u8a8d<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u8a2d\u8a08\u66f8\u306e\u7ba1\u7406<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u544a\u77e5\u6d3b\u52d5<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u8a08\u753b\u306f\u3001\u30c7\u30b6\u30a4\u30f3\u3084\u958b\u767a\u306e\u9032\u5c55\u306b\u5fdc\u3058\u3066\u898b\u76f4\u3057\u3001\u66f4\u65b0\u3057\u3001\u627f\u8a8d\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Design_Input_Phase\"><\/span><b>\u8a2d\u8a08\u5165\u529b\u6bb5\u968e<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u3053\u308c\u304c\u88fd\u54c1\u8a2d\u8a08\u306e\u51fa\u767a\u70b9\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u306e\u8981\u6c42\u3092\u6e80\u305f\u3059\u3088\u3046\u306b\u8a2d\u8a08\u30fb\u958b\u767a\u3055\u308c\u307e\u3059\u3002\u9867\u5ba2\u30a2\u30f3\u30b1\u30fc\u30c8\u3001\u533b\u5e2b\u304b\u3089\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3001\u82e6\u60c5\u306a\u3069\u3001\u3055\u307e\u3056\u307e\u306a\u60c5\u5831\u6e90\u304b\u3089\u30e6\u30fc\u30b6\u30fc\u306e\u8981\u6c42\u3092\u53ce\u96c6\u3059\u308b\u3002\u3053\u308c\u3089\u306e\u8981\u6c42\u306f\u3001\u8a2d\u8a08\u306e\u30a4\u30f3\u30d7\u30c3\u30c8\u306b\u79fb\u3055\u308c\u307e\u3059\u3002\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30c7\u30b6\u30a4\u30f3\u306e\u5165\u529b\u3067\u3059\u3002<\/span> <span style=\"font-weight: 400;\">\u3053\u308c\u3089\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u8a2d\u8a08\u306b\u4f7f\u7528\u3055\u308c\u308b\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u7269\u7406\u7684\u304a\u3088\u3073\u6027\u80fd\u4e0a\u306e\u8981\u6c42\u4e8b\u9805\u3067\u3059\u3002\u8a2d\u8a08\u5165\u529b\u6bb5\u968e\u3067\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u306e\u8981\u6c42\u3092\u88fd\u54c1\u306e\u8981\u6c42\u306b\u5909\u63db\u3057\u307e\u3059\u3002\u8a2d\u8a08\u5165\u529b\u3092\u5b9a\u7fa9\u3059\u308b\u969b\u306b\u306f\u3001\u898f\u5236\u8981\u4ef6\u304c\u8003\u616e\u3055\u308c\u307e\u3059\u3002\u8a2d\u8a08\u5165\u529b\u8981\u4ef6\u306f\u3001\u5305\u62ec\u7684\u3067\u3001\u66d6\u6627\u3055\u304c\u306a\u304f\u3001\u5ba2\u89b3\u7684\u306b\u691c\u8a3c\u53ef\u80fd\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u5165\u529b\u8981\u4ef6\u306f\u30013\u3064\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u307e\u3068\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0<\/span>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u6a5f\u80fd\u7684\u8981\u6c42\u4e8b\u9805\u3068\u306f\u3001\u305d\u306e\u6a5f\u5668\u304c\u4f55\u3092\u3059\u308b\u306e\u304b\u3092\u8aac\u660e\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u4f8b\u3048\u3070\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u3067\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u30e6\u30fc\u30b6\u30fc\u306e\u6307\u793a\u306b\u3088\u308a\u3001\u8eca\u6905\u5b50\u304c\u524d\u65b9\u306b\u79fb\u52d5\u3059\u308b\u3053\u3068<\/span><\/i><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u6027\u80fd\u8981\u4ef6\uff1a\u305d\u306e\u6a5f\u5668\u304c\u3069\u306e\u7a0b\u5ea6\u3001\u3069\u306e\u3088\u3046\u306a\u6027\u80fd\u3092\u6301\u3064\u3079\u304d\u304b\u3092\u898f\u5b9a\u3057\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u3067\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u8eca\u6905\u5b50\u306f\u3001\u524d\u9032\u65b9\u5411\u306b2m\/s\u306e\u901f\u5ea6\u3067\u52d5\u304f\u3053\u3068<\/span><\/i><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u8981\u4ef6\uff1a\u30e6\u30fc\u30b6\u30fc\uff0f\u60a3\u8005\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u306a\u3069\u3001\u5916\u90e8\u30b7\u30b9\u30c6\u30e0\u3068\u306e\u4e92\u63db\u6027\u306b\u91cd\u8981\u306a\u30c7\u30d0\u30a4\u30b9\u306e\u7279\u6027\u3092\u6307\u5b9a\u3057\u307e\u3059\u3002\u4f8b\u3048\u3070 <\/span><i><span style=\"font-weight: 400;\">\u8eca\u6905\u5b50\u306b\u306f\u3001\u65b9\u5411\u3092\u793a\u3059\u30b7\u30f3\u30dc\u30eb\u306e\u30dc\u30bf\u30f3\u304c\u4ed8\u3044\u3066\u3044\u308b\u3053\u3068\u3002<\/span><\/i><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u3053\u3053\u3067\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u306e\u30cb\u30fc\u30ba\u3092\u5b9a\u7fa9\u3057\u3001\u305d\u308c\u3092\u30c7\u30b6\u30a4\u30f3\u306e\u30a4\u30f3\u30d7\u30c3\u30c8\u306b\u5909\u63db\u3057\u305f\u4f8b\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002\u00a0<\/span>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30e6\u30fc\u30b6\u30fc\u30cb\u30fc\u30ba<br \/>\n<\/span>\u30c7\u30d0\u30a4\u30b9\u306f\u30dd\u30fc\u30bf\u30d6\u30eb\u3067\u3001\u30d6\u30eb\u30fc\u30c8\u30a5\u30fc\u30b9\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u308b\u3053\u3068<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30c7\u30b6\u30a4\u30f3\u5165\u529b\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><i><span style=\"font-weight: 400;\">\u6e96\u62e0\u3059\u3079\u304d\u9069\u7528\u53ef\u80fd\u306aFDA\u627f\u8a8d\u307e\u305f\u306f\u56fd\u969b\u898f\u683c\u3092\u7279\u5b9a\u3059\u308b\u3002\u306a\u3069\u3067\u3059\u3002<\/span><\/i><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">IEEE ANSI C63.27-2017 \u7121\u7dda\u306e\u5171\u5b58\u6027\u306e\u8a55\u4fa1\u306b\u95a2\u3059\u308b\u7c73\u56fd\u56fd\u5bb6\u898f\u683c<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">AAMI TIR 69: Association for Advancement of Medical Instrumentation - Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems (2017)\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">IEC 60601-1-2 Edition 3: 2007:\u533b\u7642\u7528\u96fb\u6c17\u6a5f\u5668 - \u30d1\u30fc\u30c8 1-2:\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u4e00\u822c\u8981\u6c42\u4e8b\u9805 - \u4ed8\u5e2f\u898f\u683c\u96fb\u78c1\u4e21\u7acb\u6027-\u8981\u6c42\u4e8b\u9805\u3068\u8a66\u9a13<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">UL 2054 - \u5bb6\u5ead\u7528\u304a\u3088\u3073\u5546\u696d\u7528\u30d0\u30c3\u30c6\u30ea\u30fc\u306e\u898f\u683c<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><i><span style=\"font-weight: 400;\">\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3084\u305d\u306e\u4ed6\u306e\u5177\u4f53\u7684\u306a\u30a4\u30f3\u30d7\u30c3\u30c8\u3092\u30ea\u30b9\u30c8\u30a2\u30c3\u30d7\u3057\u307e\u3059\u3002\u306a\u3069\u3067\u3059\u3002\u00a0<\/span><\/i><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30c7\u30d0\u30a4\u30b9\u306fDC\u96fb\u6e90\u3067\u3042\u308b\u3053\u3068<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Bluetooth\u30e2\u30b8\u30e5\u30fc\u30eb\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u91cd\u91cf\uff1a\u7d046lbs\u307e\u305f\u306f6lbs+\/-2lbs(<\/span><i><span style=\"font-weight: 400;\">\u5165\u529b\u306f\u691c\u8a3c\u3092\u78ba\u5b9f\u306b\u3059\u308b\u305f\u3081\u306b\u5b9a\u91cf\u7684\u306a\u5236\u9650\u3092\u8a2d\u3051\u308b\u3079\u304d\u3067\u3042\u308b)<\/span><\/i><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"Design_Output_Phase\"><\/span><b>\u8a2d\u8a08\u51fa\u529b\u6bb5\u968e<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u30c7\u30b6\u30a4\u30f3\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\u3068\u306f\u3001\u5404\u8a2d\u8a08\u6bb5\u968e\u306b\u304a\u3051\u308b\u8a2d\u8a08\u4f5c\u696d\u306e\u7d50\u679c\u3001\u304a\u3088\u3073\u8a2d\u8a08\u4f5c\u696d\u5168\u4f53\u306e\u7d42\u4e86\u6642\u306b\u5f97\u3089\u308c\u308b\u3082\u306e\u3067\u3042\u308b\u3002\u8a2d\u8a08\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\u306e\u4f8b\u3068\u3057\u3066\u306f\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u56f3\u9762\u3001\u30e9\u30d9\u30ea\u30f3\u30b0\u3001\u4f5c\u696d\u6307\u793a\u66f8\u3001\u305d\u306e\u4ed6\u306e\u88fd\u54c1\u4ed5\u69d8\u304c\u3042\u308b\u3002\u305d\u306e\u4ed6\u306e\u8a2d\u8a08\u6210\u679c\u3068\u3057\u3066\u306f\u3001\u30ea\u30b9\u30af\u5206\u6790\u306e\u7d50\u679c\u3001\u691c\u8a3c\u6d3b\u52d5\u306e\u7d50\u679c\u3001\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u306e\u7d50\u679c\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u30bd\u30fc\u30b9\u30b3\u30fc\u30c9\u306a\u3069\u304c\u3042\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u8a2d\u8a08\u51fa\u529b\u306f\u3001\u62c5\u5f53\u8005\u306b\u3088\u308b\u30ec\u30d3\u30e5\u30fc\u3068\u627f\u8a8d\u306e\u524d\u306b\u30ea\u30ea\u30fc\u30b9\u3057\u3066\u306f\u3044\u3051\u307e\u305b\u3093\u3002\u307e\u305f\u3001\u30c7\u30b6\u30a4\u30f3\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\/\u30a4\u30f3\u30d7\u30c3\u30c8\u306e\u627f\u8a8d\u5f8c\u306b\u30c7\u30d0\u30a4\u30b9\u306b\u5909\u66f4\u3092\u52a0\u3048\u308b\u5834\u5408\u306f\u3001\u95a2\u4fc2\u8005\u306b\u3088\u308b\u30ec\u30d3\u30e5\u30fc\u3068\u627f\u8a8d\u3092\u7d4c\u3066\u7ba1\u7406\u3055\u308c\u308b\u3053\u3068\u306b\u7559\u610f\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002  \u3053\u306e\u30d5\u30a7\u30fc\u30ba\u306e\u7d42\u308f\u308a\u306b\u306f\u3001\u30c7\u30b6\u30a4\u30f3\u30ec\u30d3\u30e5\u30fc\u304c\u5fc5\u8981\u3067\u3059\u3002<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Design_Review_Phase\"><\/span><b>\u30c7\u30b6\u30a4\u30f3\u30ec\u30d3\u30e5\u30fc\u6bb5\u968e<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u30c7\u30b6\u30a4\u30f3\u30ec\u30d3\u30e5\u30fc\u306f\u3001\u8a2d\u8a08\u51fa\u529b\u30d5\u30a7\u30fc\u30ba\u306e\u5f8c\u306b\u884c\u308f\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u30c7\u30b6\u30a4\u30f3\u30ec\u30d3\u30e5\u30fc\u306f\u3001\u78ba\u7acb\u3055\u308c\u305f\u624b\u9806\u306b\u5f93\u3044\u3001\u8a2d\u8a08\u5c65\u6b74\u30d5\u30a1\u30a4\u30eb\uff08DHF\uff09\u306b\u6587\u66f8\u5316\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u5404\u30c7\u30b6\u30a4\u30f3\u30ec\u30d3\u30e5\u30fc\u306e\u53c2\u52a0\u8005\u306f\u3001\u3059\u3079\u3066\u306e\u6a5f\u80fd\u30b0\u30eb\u30fc\u30d7\u306e\u4ee3\u8868\u8005\u3067\u3042\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u6b63\u5f0f\u306a\u30ec\u30d3\u30e5\u30fc\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u91cd\u8981\u306a\u30de\u30a4\u30eb\u30b9\u30c8\u30fc\u30f3\u306e\u7d42\u308f\u308a\u306b\u5b9f\u65bd\u3059\u308b\u3053\u3068\u304c\u63a8\u5968\u3055\u308c\u307e\u3059\u3002\u4e00\u822c\u7684\u306b\u3001\u30c7\u30b6\u30a4\u30f3\u30ec\u30d3\u30e5\u30fc\u306f\u3001\u30c7\u30b6\u30a4\u30f3\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\u30d5\u30a7\u30fc\u30ba\u3001V&amp;V\u30d5\u30a7\u30fc\u30ba\u3001\u30c7\u30b6\u30a4\u30f3\u30c8\u30e9\u30f3\u30b9\u30d5\u30a1\u30fc\u30d5\u30a7\u30fc\u30ba\u306e\u5f8c\u306b\u884c\u308f\u308c\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u958b\u767a\u306e\u8907\u96d1\u3055\u306b\u3082\u3088\u308a\u307e\u3059\u3002FDA\u306f\u5c11\u306a\u304f\u3068\u30821\u56de\u306e\u30c7\u30b6\u30a4\u30f3\u30ec\u30d3\u30e5\u30fc\u3092\u8981\u6c42\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Design_Verification_Phase\"><\/span><b>\u8a2d\u8a08\u691c\u8a3c\u6bb5\u968e<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u8a2d\u8a08\u691c\u8a3c\u3068\u306f\u3001\u8a2d\u8a08\u51fa\u529b\u304c\u8a2d\u8a08\u5165\u529b\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u5ba2\u89b3\u7684\u306a\u8a3c\u62e0\u306b\u3088\u3063\u3066\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3067\u3059\u3002 <\/span><b>\u57fa\u672c\u7684\u306b\u306f\u300c\u8a2d\u8a08\u5165\u529b\uff1d\u8a2d\u8a08\u51fa\u529b\u300d\u3067\u3059\u3002 <\/b><span style=\"font-weight: 400;\">\u691c\u8a3c\u6d3b\u52d5\u306f\u3001\u78ba\u7acb\u3055\u308c\u305f\u624b\u9806\u306b\u5f93\u3063\u3066\u5b9f\u65bd\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u691c\u8a3c\u306e\u4f8b\u3068\u3057\u3066\u306f\u3001EMC\u30fb\u96fb\u6c17\u8a66\u9a13\u3001\u76ee\u8996\u691c\u67fb\u3001\u975e\u81e8\u5e8a\u8a66\u9a13\u6d3b\u52d5\u3001\u30d7\u30ed\u30bb\u30b9\u3084\u8a2d\u8a08\u306e\u30d5\u30a9\u30fc\u30eb\u30c8 \u30c4\u30ea\u30fc\u89e3\u6790\u3001\u6545\u969c\u30e2\u30fc\u30c9\u30fb\u5f71\u97ff\u89e3\u6790\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002\u691c\u8a3c\u306f\u3001\u88fd\u54c1\u4ed5\u69d8\u306e\u6280\u8853\u7684\u8981\u6c42\u4e8b\u9805\u304c\u6e80\u305f\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3059\u3079\u3066\u306e\u691c\u8a3c\u6d3b\u52d5\u306f\u6587\u66f8\u5316\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u00a0<\/span><\/p>\n<p><b>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u30de\u30c8\u30ea\u30c3\u30af\u30b9\u3002<\/b><span style=\"font-weight: 400;\"> \u672c\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306f\u3001\u30c7\u30b6\u30a4\u30f3\u306e\u30a4\u30f3\u30d7\u30c3\u30c8\u3068\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\u3092\u8868\u5f62\u5f0f\u3067\u8a18\u8f09\u3057\u3066\u3044\u307e\u3059\u3002\u5404\u5165\u529b\u306b\u5bfe\u3057\u3066\u3001\u5bfe\u5fdc\u3059\u308b\u51fa\u529b\u304c\u53c2\u7167\u3055\u308c\u308b\u3002\u3053\u306e\u691c\u8a3c\u65b9\u6cd5\u306f\u3001\u30a4\u30f3\u30d7\u30c3\u30c8\u3068\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\u304c\u4e21\u65b9\u3068\u3082\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3067\u3042\u308b\u5834\u5408\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Design_Validation_Phase\"><\/span><b>\u30c7\u30b6\u30a4\u30f3\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6bb5\u968e<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u30c7\u30b6\u30a4\u30f3\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3068\u306f\u3001\u4ed5\u69d8\uff08\u898f\u5b9a\u3055\u308c\u305f\u8981\u6c42\u4e8b\u9805\uff09\u304c\u30e6\u30fc\u30b6\u30fc\u306e\u30cb\u30fc\u30ba\u3084\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u5ba2\u89b3\u7684\u306a\u8a3c\u62e0\u306b\u3088\u3063\u3066\u8a3c\u660e\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3068\u306f\u3001\u3042\u308b\u30d7\u30ed\u30bb\u30b9\u304c\u6240\u5b9a\u306e\u4ed5\u69d8\u3092\u6e80\u305f\u3059\u7d50\u679c\u3084\u88fd\u54c1\u3092\u4e00\u8cab\u3057\u3066\u751f\u307f\u51fa\u3059\u3053\u3068\u3092\u3001\u5ba2\u89b3\u7684\u306a\u8a3c\u62e0\u306b\u3088\u3063\u3066\u8a3c\u660e\u3059\u308b\u3053\u3068\u3002\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30c7\u30b6\u30a4\u30f3\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3068\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u4ed5\u69d8\u304c\u30e6\u30fc\u30b6\u30fc\u306e\u30cb\u30fc\u30ba\u3084\u610f\u56f3\u3057\u305f\u7528\u9014\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u5ba2\u89b3\u7684\u306a\u8a3c\u62e0\u306b\u3088\u3063\u3066\u8a3c\u660e\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306f\u901a\u5e38 <\/span><b>\u5b9f\u969b\u306e\u74b0\u5883\u4e0b\u307e\u305f\u306f\u6a21\u64ec\u74b0\u5883\u4e0b\u3067\u5b9f\u65bd<\/b><span style=\"font-weight: 400;\">.\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u4f8b\u3068\u3057\u3066\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u3001\u81e8\u5e8a\u8a55\u4fa1\u3001\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf \u30fc\u30c6\u30b9\u30c8\u3001\u30a2\u30c9\u30ec\u30b9\u30d1\u30c3\u30b1\u30fc\u30b8\u30f3\u30b0\u3001\u30e9\u30d9\u30ea\u30f3\u30b0\u3001\u5206\u6790\u3001\u691c\u67fb\u306a\u3069\u304c\u3042\u308b\u3002\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6d3b\u52d5\u306e\u7d50\u679c\u304a\u3088\u3073\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u30ec\u30dd\u30fc\u30c8\u306f\u3001\u30c7\u30b6\u30a4\u30f3\u30d2\u30b9\u30c8\u30ea\u30fc\u30d5\u30a1\u30a4\u30eb\uff08DHF\uff09\u306e\u4e00\u90e8\u3068\u3057\u3066\u6587\u66f8\u5316\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Design_Transfer_Phase\"><\/span><b>\u8a2d\u8a08\u79fb\u7ba1\u30d5\u30a7\u30fc\u30ba<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">V&amp;V\u30b9\u30c6\u30fc\u30b8\u306e\u5b8c\u4e86\u5f8c\u3001\u8a2d\u8a08\u79fb\u7ba1\u304c\u884c\u308f\u308c\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u54c1\u8cea\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u8a2d\u8a08\u3092\u88fd\u54c1\u4ed5\u69d8\u306b\u79fb\u3059\u3053\u3068\u3092\u542b\u307f\u307e\u3059\u3002\u3053\u306e\u6bb5\u968e\u306f\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u306a\u305c\u306a\u3089\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u751f\u7523\u304c\u59cb\u307e\u308b\u3068\u3001\u8a2d\u8a08\u5909\u66f4\u7ba1\u7406\u306e\u5bfe\u8c61\u3068\u306a\u308a\u3001\u554f\u984c\u304c\u767a\u751f\u3059\u308b\u3068\u91d1\u92ad\u7684\u306a\u640d\u5931\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u304b\u3089\u3067\u3059\u3002\u8a2d\u8a08\u79fb\u7ba1\u306f\u3001\u78ba\u7acb\u3055\u308c\u305f\u624b\u9806\u306b\u5f93\u3063\u3066\u884c\u308f\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u307e\u305f\u3001\u8a2d\u8a08\u79fb\u7ba1\u3092\u958b\u59cb\u3059\u308b\u524d\u306b\u3001\u88fd\u54c1\u4ed5\u69d8\u3092\u542b\u3080\u6587\u66f8\u304c\u30ec\u30d3\u30e5\u30fc\u3055\u308c\u3001\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Design_Changes_Phase\"><\/span><b>\u8a2d\u8a08\u5909\u66f4\u30d5\u30a7\u30fc\u30ba<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u8a2d\u8a08\u5909\u66f4\u306e\u7ba1\u7406\u306f\u3001\u8a2d\u8a08\u79fb\u7ba1\u6642\u306b\u59cb\u307e\u308a\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066\u7d99\u7d9a\u3055\u308c\u307e\u3059\u3002\u8a2d\u8a08\u79fb\u7ba1\u5f8c\u306e\u8a2d\u8a08\u5909\u66f4\u306f\u3001\u78ba\u7acb\u3055\u308c\u305f\u624b\u9806\u306b\u5f93\u3063\u3066\u5b9f\u65bd\u3055\u308c\u308b\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30fb\u30c1\u30a7\u30f3\u30b8\u30fb\u30ce\u30fc\u30c6\u30a3\u30b9\uff08ECN\uff09\u306e\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u3002\u8a2d\u8a08\u5909\u66f4\u306e\u969b\u306b\u306f\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30ec\u30dd\u30fc\u30c8\u3001\u4f7f\u7528\u8aac\u660e\u66f8\u3001\u691c\u8a3c\u30fb\u59a5\u5f53\u6027\u78ba\u8a8d\u30ec\u30dd\u30fc\u30c8\u306a\u3069\u306e\u95a2\u9023\u6587\u66f8\u3092\u518d\u691c\u8a0e\u3057\u3001\u66f4\u65b0\u3059\u308b\u3053\u3068\u304c\u5fc5\u8981\u3067\u3059\u3002\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Design_History_File_DHF\"><\/span><b>\u30c7\u30b6\u30a4\u30f3\u30d2\u30b9\u30c8\u30ea\u30fc\u30d5\u30a1\u30a4\u30eb\uff08DHF\uff09\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">DHF \u306f\u3001\u7c73\u56fd FDA \u306b\u56fa\u6709\u306e\u3082\u306e\u3067\u3059\u3002ISO 13486:2016 \u306f\u3001\u88fd\u9020\u8005\u304c DHF \u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u3092\u8981\u6c42\u3057\u3066\u3044\u306a\u3044\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3054\u3068\u306b\u3001\u5404\u30d5\u30a7\u30fc\u30ba\u306e\u6210\u679c\u7269\u3092\u307e\u3068\u3081\u305f\u300c\u30c7\u30b6\u30a4\u30f3\u30d2\u30b9\u30c8\u30ea\u30fc\u30d5\u30a1\u30a4\u30eb\u300d\u3092\u4f5c\u6210\u3057\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u6700\u65b0\u306e\u88fd\u54c1\u60c5\u5831\u3082\u542b\u307e\u308c\u3066\u3044\u308b\u3002\u8a2d\u8a08\u30fb\u958b\u767a\u6587\u66f8\u306f\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u5bb9\u6613\u306b\u5165\u624b\u30fb\u30a2\u30af\u30bb\u30b9\u3067\u304d\u308b\u3082\u306e\u3068\u3059\u308b\u3002\u8a2d\u8a08\u30fb\u958b\u767a\u5951\u7d04\u3067\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u306e\u8a2d\u8a08\u60c5\u5831\u306b\u5bfe\u3059\u308b\u6a29\u5229\u3092\u660e\u793a\u3057\u3001\u8a2d\u8a08\u6587\u66f8\u306e\u5f62\u5f0f\u3068\u5185\u5bb9\u306b\u95a2\u3059\u308b\u57fa\u6e96\u3092\u5b9a\u3081\u308b\u3079\u304d\u3067\u3042\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u5b9f\u969b\u306b\u306f\u3001\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306b\u3088\u3063\u3066\u3001\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3068\u30c7\u30b6\u30a4\u30ca\u30fc\u306f\u30c7\u30b6\u30a4\u30f3\u30d7\u30ed\u30bb\u30b9\u306e\u53ef\u8996\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u8996\u8a8d\u6027\u306e\u5411\u4e0a\u306b\u3088\u308a\uff0c\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306f\u8a2d\u8a08\u30d7\u30ed\u30bb\u30b9\u3092\u3088\u308a\u52b9\u679c\u7684\u306b\u6307\u63ee\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308b\uff0e\u3059\u306a\u308f\u3061\uff0c\u554f\u984c\u3092\u65e9\u671f\u306b\u8a8d\u8b58\u3057\uff0c\u4fee\u6b63\u3092\u884c\u3044\uff0c\u30ea\u30bd\u30fc\u30b9\u306e\u5272\u308a\u5f53\u3066\u3092\u8abf\u6574\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308b\uff0e\u8a2d\u8a08\u8005\u306f\uff0c\u30e6\u30fc\u30b6\u30fc\u3084\u60a3\u8005\u306e\u30cb\u30fc\u30ba\u306b\u5bfe\u3059\u308b\u8a2d\u8a08\u306e\u9069\u5408\u6027\u306b\u3064\u3044\u3066\u306e\u7406\u89e3\u3092\u6df1\u3081\u308b\u3053\u3068\u304c\u3067\u304d\uff0c\u307e\u305f\uff0c\u8a2d\u8a08\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u3059\u3079\u3066\u306e\u53c2\u52a0\u8005\u9593\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3084\u8abf\u6574\u304c\u6539\u5584\u3055\u308c\u308b\u3068\u3044\u3046\u5229\u70b9\u304c\u3042\u308b\uff0e<\/span><\/p>\n<blockquote><p><strong>\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308bFDA\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u7406\u89e3\u3068\u5c0e\u5165\u306b\u304a\u56f0\u308a\u3067\u3059\u304b\uff1f\u7d4c\u9a13\u8c4a\u5bcc\u306a <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDADesignControl\">\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u3092Kolabtree\u306b\u63b2\u8f09\u3057\u307e\u3057\u305f\u3002\u00a0\u00a0<\/strong><\/p><\/blockquote>\n<p><b>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9\u00a0<\/b><\/p>\n<ol>\n<li style=\"font-weight: 400;\"><a href=\"https:\/\/www.fda.gov\/media\/116573\/download\"><span style=\"font-weight: 400;\">FDA\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u5411\u3051\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u30ac\u30a4\u30c0\u30f3\u30b9<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30e1\u30c7\u30a3\u30ab\u30eb\u30fb\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3001\u30a4\u30f3\u30bf\u30fc\u30ca\u30b7\u30e7\u30ca\u30eb\u30fb\u30d1\u30fc\u30b9\u30da\u30af\u30c6\u30a3\u30d6\u3001Val Theisz\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><a href=\"https:\/\/www.fda.gov\/media\/116762\/download\"><span style=\"font-weight: 400;\">\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\uff08Joseph Tartal\u6c0f\u306b\u3088\u308b\u30d7\u30ec\u30bc\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3<\/span><\/a><br \/>\n3a. <a href=\"https:\/\/www.govinfo.gov\/content\/pkg\/FR-1996-10-07\/pdf\/96-25720.pdf\"><span style=\"font-weight: 400;\">\u30d5\u30a7\u30c7\u30e9\u30eb\u30ec\u30b8\u30b9\u30bf\u30fc \/ Vol.61, No.195<\/span><\/a><\/li>\n<\/ol>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Shreya Chenni, freelance regulatory writer for medical devices, provides a 10-minute guide to FDA design controls for your medical device.\u00a0\u00a0 One of the major causes of medical device recalls is the lack of design control as identified by the FDA [3,3a]. The pre-production controls were then added to the device GMP regulations. Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process, i.e., a system of checks and balances. Design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use.\u00a0 Applicability\u00a0 All Class II, III and the following Class<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-guide-to-fda-design-controls-for-your-medical-device\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":8131,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[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>A guide to FDA Design Controls for your medical device<\/title>\n<meta name=\"description\" content=\"How to ensure you meet FDA Design Controls for your medical device development. Understand user needs, design input, design output, verification, and more.\" \/>\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\/a-guide-to-fda-design-controls-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=\"A guide to FDA Design Controls for your medical device\" \/>\n<meta property=\"og:description\" content=\"How to ensure you meet FDA Design Controls for your medical device development. Understand user needs, design input, design output, verification, and more.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-guide-to-fda-design-controls-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=\"2020-07-28T10:59:55+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-07-28T11:08:36+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/07\/FDA-design-controls.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=\"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=\"7\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"A guide to FDA Design Controls for your medical device","description":"How to ensure you meet FDA Design Controls for your medical device development. 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