{"id":8869,"date":"2021-03-11T15:30:29","date_gmt":"2021-03-11T15:30:29","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8869"},"modified":"2023-04-10T12:35:42","modified_gmt":"2023-04-10T12:35:42","slug":"medical-device-design-the-essential-step-by-step-guide","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-design-the-essential-step-by-step-guide\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u30c7\u30b6\u30a4\u30f3\u3002The Essential, Step-by-Step Guide"},"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-69f19aa900492\" 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-69f19aa900492\"><\/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-design-the-essential-step-by-step-guide\/#Medical_Device_Design_IEC_ISO_regulations_and_compliance\" title=\"\u533b\u7642\u6a5f\u5668\u8a2d\u8a08\u3002IEC\u3068ISO\u306e\u898f\u5236\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\">\u533b\u7642\u6a5f\u5668\u8a2d\u8a08\u3002IEC\u3068ISO\u306e\u898f\u5236\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/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-design-the-essential-step-by-step-guide\/#Medical_Device_Design_ISO_Standards\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u30c7\u30b6\u30a4\u30f3\u3002ISO\u898f\u683c\">\u533b\u7642\u6a5f\u5668\u306e\u30c7\u30b6\u30a4\u30f3\u3002ISO\u898f\u683c<\/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-design-the-essential-step-by-step-guide\/#Medical_Device_Regulations_and_Design_Control\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u3068\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u00a0\">\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u3068\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u00a0<\/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-design-the-essential-step-by-step-guide\/#Medical_Device_Design_Why_Traceability_is_Important\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3002\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u304c\u91cd\u8981\u306a\u7406\u7531\u00a0\">\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3002\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u304c\u91cd\u8981\u306a\u7406\u7531\u00a0<\/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-design-the-essential-step-by-step-guide\/#Medical_Device_Design_Verification_and_Validation\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3002\u691c\u8a3c\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\">\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3002\u691c\u8a3c\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/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-design-the-essential-step-by-step-guide\/#Medical_Device_Design_Risk_Management\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3002\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\">\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3002\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/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-design-the-essential-step-by-step-guide\/#Risk_migration_strategy_vs_Risk_management_plan\" title=\" \u30ea\u30b9\u30af\u79fb\u884c\u6226\u7565vs.\u30ea\u30b9\u30af\u7ba1\u7406\u8a08\u753b\"> \u30ea\u30b9\u30af\u79fb\u884c\u6226\u7565vs.\u30ea\u30b9\u30af\u7ba1\u7406\u8a08\u753b<\/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-design-the-essential-step-by-step-guide\/#Conclusion\" title=\"\u7d50\u8ad6\">\u7d50\u8ad6<\/a><\/li><\/ul><\/nav><\/div>\n<p><em><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/shrinidh-joshi\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">\u30b7\u30e5\u30ea\u30cb\u30fc\u30c9\u30fb\u30b8\u30e7\u30b7<\/a>, <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">\u533b\u7642\u6a5f\u5668\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a>\u00a0on Kolabtree, provides a comprehensive guide to <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u533b\u7642\u6a5f\u5668<\/a> design, design controls, validation &amp; verification, regulatory requirements and risk management.\u00a0 \u00a0<\/em><\/p>\n<p>\u306e\u4e2d\u306b\u3042\u308b\u3002 <a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-development-3-tips-for-success\/\">\u524d\u306e\u8a18\u4e8b<\/a>, we took a look at the overview of the medical device development process from the ideation to the discovery phase. In this article, we will focus more on <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-design\" target=\"_blank\" rel=\"noopener\">medical device design<\/a>, design controls, and compliance.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Medical_Device_Design_IEC_ISO_regulations_and_compliance\"><\/span><b>\u533b\u7642\u6a5f\u5668\u8a2d\u8a08\u3002IEC\u3068ISO\u306e\u898f\u5236\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u4e00\u5b9a\u306e\u898f\u5236\u8981\u4ef6\u3084\u898f\u683c\u306b\u9069\u5408\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u306f\u3001\u3059\u3067\u306b\u3054\u627f\u77e5\u306e\u3068\u304a\u308a\u3067\u3059\u3002\u56fd\u969b\u96fb\u6c17\u6a19\u6e96\u4f1a\u8b70(IEC)\u3084\u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb(ISO)\u306a\u3069\u306e\u533b\u7642\u6a5f\u5668\u898f\u683c\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3001\u8a2d\u8a08\u8005\u3001\u7814\u7a76\u6240\u3001\u305d\u3057\u3066CDMO\u306a\u3069\u306e\u533b\u7642\u6a5f\u5668\u958b\u767a\u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u304c\u3001\u6a5f\u5668\u3084\u88c5\u7f6e\u3092\u4e00\u5b9a\u306e\u54c1\u8cea\u3084\u4f7f\u3044\u3084\u3059\u3055\u306e\u57fa\u6e96\u3067\u691c\u67fb\u3001\u8a55\u4fa1\u3001\u7dad\u6301\u3059\u308b\u3053\u3068\u3092\u53ef\u80fd\u306b\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">IEC\uff09\u306f\u30011970\u5e74\u306b\u521d\u306e\u533b\u7642\u6a5f\u5668\u898f\u683c\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002<\/span><a href=\"https:\/\/webstore.iec.ch\/publication\/22261\"> <span style=\"font-weight: 400;\">IEC 60601<\/span><\/a><span style=\"font-weight: 400;\">-1.IEC 60601-1, \u533b\u7642\u7528\u96fb\u6c17\u6a5f\u5668 - Part 1: \u3053\u308c\u306f\u56fd\u969b\u7684\u306b\u8a8d\u3081\u3089\u308c\u305f\u898f\u683c\u3067\u3042\u308a\uff0c\u533b\u7642\u7528\u96fb\u6c17\u6a5f\u5668\u304a\u3088\u3073\u88c5\u7f6e\u306e\u4e00\u822c\u7684\u306a\u8981\u6c42\u4e8b\u9805\u3092\u898f\u5b9a\u3057\u3066\u304a\u308a\uff0c\u57fa\u672c\u7684\u306a\u5b89\u5168\u6027\u3068\u5fc5\u9808\u6027\u80fd\u306b\u95a2\u3059\u308b\u898f\u683c\u3092\u7db2\u7f85\u3057\u3066\u3044\u308b\u3002 <\/span><b>[4]<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">IEC 60601-1 \u306f\u3001\u533b\u7642\u6a5f\u5668\u5206\u91ce\u306b\u304a\u3051\u308b\u6700\u65b0\u306e\u533b\u5b66\u7684\u767a\u5c55\u3084\u6280\u8853\u7684\u9032\u6b69\u306b\u5408\u308f\u305b\u3066\u3001\u5b9a\u671f\u7684\u306b\u6539\u8a02\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u6700\u65b0\u306e\u6539\u8a02\u306f 2012 \u5e74\u306b\u884c\u308f\u308c\u307e\u3057\u305f\uff08IEC 60601-1 \u306e Amendment 1\uff09\u3002\u3053\u306e\u6539\u8a02\u7248\u3067\u306f\u3001\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u306e\u8003\u616e\u3001\u533b\u7642\u6a5f\u5668\u306e\u5fc5\u9808\u6027\u80fd\u8a55\u4fa1\u3001\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u3001\u30b3\u30de\u30f3\u30c9\u306b\u95a2\u3059\u308b\u8981\u6c42\u4e8b\u9805\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u533b\u7642\u6a5f\u5668\u306b\u542b\u3081\u3001\u6b63\u5f0f\u306a\u958b\u767a\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u63a1\u7528\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001IEC 60601-1 \u306e\u6539\u8a02\u7248\u306e\u7bc4\u56f2\u306b\u306f\u3001\u30cf\u30b6\u30fc\u30c9\uff08\u96fb\u6c17\u7684\u304a\u3088\u3073\u6a5f\u68b0\u7684\uff09\u3001\u533b\u7642\u6a5f\u5668\u306e\u30e9\u30d9\u30ea\u30f3\u30b0\u8981\u4ef6\uff08\u65b0\u3057\u3044\u30e9\u30d9\u30ea\u30f3\u30b0\u898f\u683c\u3092\u542b\u3080\uff09\u3001\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306b\u95a2\u3059\u308b\u6280\u8853\u4ed5\u69d8\u306e\u65b0\u898f\u304a\u3088\u3073\u6539\u8a02\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Medical_Device_Design_ISO_Standards\"><\/span><b>\u533b\u7642\u6a5f\u5668\u306e\u30c7\u30b6\u30a4\u30f3\u3002ISO\u898f\u683c<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u307e\u305f\u3001\u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb\u306b\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u898f\u683c\u306e\u4ed5\u69d8\u304c\u3042\u308a\u307e\u3059\u3002<\/span><a href=\"https:\/\/www.iso.org\/files\/live\/sites\/isoorg\/files\/store\/en\/PUB100377.pdf\"> <span style=\"font-weight: 400;\">ISO 13485<\/span><\/a><span style=\"font-weight: 400;\"> \u305d\u3057\u3066<\/span><a href=\"https:\/\/www.iso.org\/standard\/72704.html\"> <span style=\"font-weight: 400;\">ISO 14971<\/span><\/a><span style=\"font-weight: 400;\"> \u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u305f\u3081\u306b\u4e16\u754c\u4e2d\u3067\u5e83\u304f\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u898f\u683c\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u56fd\u969b\u898f\u683c\u4ee5\u5916\u306b\u3082\u3001\u7279\u5b9a\u306e\u5730\u57df\u306b\u7279\u5316\u3057\u305f\u898f\u683c\u304c\u3042\u308a\u3001\u305d\u308c\u3089\u306f\u3059\u3079\u3066\u56fd\u969b\u898f\u683c\u3092\u82e5\u5e72\u306e\u4fee\u6b63\u3068\u5236\u9650\u3092\u52a0\u3048\u3066\u63a1\u7528\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u7c73\u56fd\u3067\u533b\u7642\u6a5f\u5668\u3092\u88fd\u9020\u30fb\u8ca9\u58f2\u3059\u308b\u5834\u5408\u3001\u305d\u306e\u533b\u7642\u6a5f\u5668\u306fFDA\u306e\u898f\u5236\u3092\u53d7\u3051\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002ANSI\uff08American National Standards Institute\uff09\u306f\u3001\u7c73\u56fd\u306b\u304a\u3051\u308bISO\u898f\u683c\u306e\u4ee3\u8868\u6a5f\u95a2\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3055\u3089\u306b\u4f3c\u305f\u3088\u3046\u306a\u7d44\u7e54\u3068\u3057\u3066\u3001AAMI\uff08Association for the Advancement of Medical Instrumentation\uff09\u3068\u3001\u30a2\u30e1\u30ea\u30ab\u306e\u898f\u683c\u3092\u5b9a\u3081\u308bASQ\uff08American Society for Quality\uff09\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304cISO\u898f\u683c\u3092\u8003\u616e\u3057\u3066\u6a5f\u5668\u3092\u8a2d\u8a08\u3057\u3066\u3044\u305f\u5834\u5408\u3001FDA\u304c\u305d\u306e\u6a5f\u5668\u3092\u627f\u8a8d\u3057\u306a\u3044\u53ef\u80fd\u6027\u3082\u3042\u308a\u307e\u3059\u3002FDA\u306f\u3001\u56fd\u969b\u898f\u683c\u3068\u5730\u57df\u898f\u683c\u306e\u4e21\u65b9\u304b\u3089\u6d3e\u751f\u3057\u305f\u30ea\u30b9\u30af\u7ba1\u7406\u306e\u305f\u3081\u306e\u72ec\u81ea\u306e\u624b\u9806\u3092\u6301\u3063\u3066\u3044\u308b\u305f\u3081\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3053\u3068\u304c\u8003\u3048\u3089\u308c\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.iso.org\/standard\/38193.html\"><span style=\"font-weight: 400;\">ISO 14971:2007\u3001\u533b\u7642\u6a5f\u5668-\u533b\u7642\u6a5f\u5668\u3078\u306e\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u9069\u7528<\/span><\/a><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">(\u56fd\u969b\u898f\u683c\u3002)<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/my.aami.org\/aamiresources\/previewfiles\/149711010_preview.pdf\"><span style=\"font-weight: 400;\">ANSI\/AAMI\/ISO 14971:2007 (R2010), \u533b\u7642\u6a5f\u5668 - \u533b\u7642\u6a5f\u5668\u3078\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u306e\u9069\u7528<\/span><\/a><span style=\"font-weight: 400;\"> (\u53c2\u7167\u3057\u305f\u56fd\u969b\u898f\u683c\u306b\u8ffd\u52a0\u30fb\u4fee\u6b63\u3092\u52a0\u3048\u305f\u5730\u57df\u898f\u683c\uff09\u3002) <\/span><b>[5].<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u898f\u683c\u306e\u5834\u5408\u3001\u56fd\u969b\u7248\u3084\u5730\u57df\u7248\u306eISO 13485\u898f\u683c\u306b\u306f\u6e96\u62e0\u3057\u3066\u3044\u307e\u305b\u3093\u3002\u3053\u308c\u306f\u3001\u7c73\u56fd\u5e02\u5834\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u306b\u3064\u3044\u3066\u3001FDA\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u7570\u306a\u308b\u305f\u3081\u3067\u3042\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u4e00\u65b9\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u6b27\u5dde\u9023\u5408\uff08EU\uff09\u3092\u691c\u8a0e\u3057\u3066\u3044\u308b\u5834\u5408\u3001ISO\u304b\u3089\u63a1\u7528\u3055\u308c\u305f\u898f\u683c\u3067\u3042\u308bCEN\uff08European Committee for Standardization\uff09\u3068\u3001IEC\u304b\u3089\u63a1\u7528\u3055\u308c\u305f\u5730\u57df\u898f\u683c\u3067\u3042\u308bCENELEC\uff08European Committee for Electrotechnical Standardization\uff09\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">CEN\u306f\u3001ISO\u304b\u3089\u306e\u8981\u6c42\u306b\u5fdc\u3058\u3066\u5c11\u3057\u5909\u66f4\u3055\u308c\u3001\u300cEN\u300d\u3068\u3044\u3046\u63a5\u982d\u8f9e\u3092\u4ed8\u3051\u3066\u66f8\u304b\u308c\u3066\u3044\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/ec.europa.eu\/eip\/ageing\/standards\/healthcare\/other-healthcare\/en-iso-134852012_en\"><span style=\"font-weight: 400;\">EN ISO 13485:2012\u3001\u533b\u7642\u6a5f\u5668-\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0-\u898f\u5236\u76ee\u7684\u306e\u305f\u3081\u306e\u8981\u6c42\u4e8b\u9805\u3002<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/standards.cen.eu\/dyn\/www\/f?p=204%3A110%3A0%3A%3A%3A%3AFSP_PROJECT%2CFSP_ORG_ID%3A38201%2C581003&amp;cs=14A047C9499FD595C91B9A9B53DFF1311\"><span style=\"font-weight: 400;\">EN ISO 14971:2012\u3001\u533b\u7642\u6a5f\u5668-\u533b\u7642\u6a5f\u5668\u3078\u306e\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u9069\u7528<\/span><\/a><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u5404\u56fd\u306e\u4f1a\u54e1\u306f\u3001\u3053\u308c\u3089\u306e\u898f\u683c\u3092EU\u304b\u3089\u63a1\u7528\u3057\u3001\u63a5\u982d\u8f9e\u3092\u4ed8\u3051\u3066\u3044\u308b\u3002\u30b9\u30a4\u30b9\u306e\u5834\u5408\u3001\u30b9\u30a4\u30b9\u898f\u683c\u306f\u3001SN EN ISO 13485:2012 \u3084 SN EN ISO 14971:2012 \u306e\u3088\u3046\u306b\u3001\u63a5\u982d\u8f9e\u3068\u3057\u3066 \"SN \"\u3092\u4ed8\u3051\u305f\u898f\u683c\u3092\u767a\u884c\u3057\u3066\u3044\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30ab\u30ca\u30c0\u306e\u5834\u5408\u306f\u3001CSA\uff08Canadian Standards Authority\uff09\u304cISO\u306e\u4ee3\u8868\u6a5f\u95a2\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Medical_Device_Regulations_and_Design_Control\"><\/span><b>\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u3068\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001FDA\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u3001\u30ab\u30ca\u30c0\u4fdd\u5065\u7701\u306a\u3069\u306e\u898f\u5236\u6a5f\u95a2\u304c\u3001\u533b\u7642\u6a5f\u5668\u306e\u8ca9\u58f2\u3092\u958b\u59cb\u3059\u308b\u524d\u306b\u3001\u305d\u306e\u533b\u7642\u6a5f\u5668\u304c\u6f5c\u5728\u7684\u306a\u30e6\u30fc\u30b6\u30fc\u306b\u3068\u3063\u3066\u5b89\u5168\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u305f\u3044\u3068\u8003\u3048\u3066\u3044\u308b\u305f\u3081\u3001\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5f93\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4e0a\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u8ff0\u3079\u305f\u3088\u3046\u306b\u3001FDA\u306f\u54c1\u8cea\u7ba1\u7406\u306b\u5bfe\u3059\u308b\u8981\u6c42\u4e8b\u9805\u304c\u7570\u306a\u308b\u305f\u3081\u3001ISO 13485\u306b\u306f\u5f93\u3063\u3066\u3044\u307e\u305b\u3093\u3002\u8a2d\u8a08\u7ba1\u7406\u306f\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u3002<\/span><a href=\"https:\/\/www.fda.gov\/files\/drugs\/published\/Design-Controls---Devices.pdf\"> <span style=\"font-weight: 400;\">FDA 21 CFR 820.30<\/span><\/a><span style=\"font-weight: 400;\"> \u3053\u308c\u306f\u3001ISO 13485 \u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b 7.3 \u8a2d\u8a08\u30fb\u958b\u767a\u306e\u9805\u3068\u540c\u69d8\u306e\u8da3\u65e8\u3067\u3042\u308b\u3002\u307e\u305f\u3001FDA \u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u306b\u304a\u3051\u308b\u9069\u6b63\u54c1\u8cea\u57fa\u6e96\u3092\u9075\u5b88\u3059\u308b\u305f\u3081\u306b\u3001\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u898f\u5236\u306b cGMP\uff08Current Good Manufacturing Practice\uff09\u306e\u8981\u6c42\u4e8b\u9805\u3092\u7d44\u307f\u8fbc\u3093\u3067\u3044\u308b\u3002 <\/span><b>[6]<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u898f\u5236\u306f\u3001\u591a\u7a2e\u591a\u69d8\u306a\u6a5f\u5668\u306b\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u3053\u306e\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306f\u3001\u6cd5\u898f\u5236\u3078\u306e\u5bfe\u5fdc\u3060\u3051\u3067\u306a\u304f\u3001\u793e\u5185\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306b\u3082\u67d4\u8edf\u306b\u5bfe\u5fdc\u3057\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3092\u6210\u529f\u3055\u305b\u308b\u305f\u3081\u306b\u306f\u3001\u7d4c\u55b6\u5b66\u3001\u751f\u547d\u79d1\u5b66\u3001\u5de5\u5b66\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30b5\u30a4\u30a8\u30f3\u30b9\u3001\u82b8\u8853\u306a\u3069\u3001\u6280\u8853\u7684\u306a\u30d0\u30c3\u30af\u30b0\u30e9\u30a6\u30f3\u30c9\u3068\u975e\u6280\u8853\u7684\u306a\u30d0\u30c3\u30af\u30b0\u30e9\u30a6\u30f3\u30c9\u306e\u4e21\u65b9\u3092\u6301\u3064\u5c02\u9580\u5bb6\u304c\u5fc5\u8981\u3067\u3059\u3002<\/span><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-8875\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-science-cycle.png\" alt=\"\" width=\"1066\" height=\"674\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-science-cycle.png 1066w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-science-cycle-300x190.png 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-science-cycle-1024x647.png 1024w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-science-cycle-768x486.png 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-science-cycle-326x205.png 326w\" sizes=\"(max-width: 1066px) 100vw, 1066px\" \/><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-8877\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-regulatory-cycle.png\" alt=\"\" width=\"1102\" height=\"684\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-regulatory-cycle.png 1102w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-regulatory-cycle-300x186.png 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-regulatory-cycle-1024x636.png 1024w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-regulatory-cycle-768x477.png 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-regulatory-cycle-1080x670.png 1080w\" sizes=\"(max-width: 1102px) 100vw, 1102px\" \/><\/p>\n<p><b>\u56f31: <\/b><span style=\"font-weight: 400;\">\u88fd\u54c1\u306e\u30c8\u30fc\u30bf\u30eb\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3002\u30b5\u30a4\u30a8\u30f3\u30b9\u30fb\u30b5\u30a4\u30af\u30eb\u3068\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30b5\u30a4\u30af\u30eb (Adapted from <\/span><b>[7]<\/b><span style=\"font-weight: 400;\">).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u6280\u8853\u9769\u65b0\u304b\u3089\u85ac\u4e8b\u627f\u8a8d\u3001\u5546\u696d\u5316\u307e\u3067\u306e\u533b\u7642\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306f\u3001\u6a5f\u5668\u958b\u767a\u3092\u63a8\u9032\u3059\u308b\u76f8\u4e92\u306b\u95a2\u9023\u3057\u305f\u4e00\u9023\u306e\u30b9\u30c6\u30c3\u30d7\u3067\u3042\u308b\u3053\u3068\u306f\u6ce8\u76ee\u306b\u5024\u3057\u307e\u3059\uff08\u56f31\uff1a\u30c8\u30fc\u30bf\u30eb\u30d7\u30ed\u30c0\u30af\u30c8\u30b5\u30a4\u30af\u30eb\u3092\u53c2\u7167\uff09\u3002\u521d\u671f\u6bb5\u968e\u3067\u306f\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u304c\u8a2d\u8a08\u3057\u305f\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u3092\u30d9\u30f3\u30c1\u30c6\u30b9\u30c8\u3057\u3066\u8a2d\u8a08\u3092\u6700\u9069\u5316\u3057\u3001\u751f\u4f53\u9069\u5408\u6027\u3001\u62bd\u51fa\u7269\u3001\u6d78\u51fa\u7269\u3001\u67d4\u8edf\u6027\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u5168\u4f53\u7684\u306a\u5f37\u5ea6\u306a\u3069\u3092\u30c6\u30b9\u30c8\u3057\u307e\u3059\u3002\u85ac\u4e8b\u30a2\u30c9\u30d0\u30a4\u30b6\u30fc\u306e\u5f79\u5272\u306f\u3001\u898f\u5236\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u95b2\u89a7\u3057\u3066\u3001\u88fd\u54c1\u304c\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u898f\u5236\u3055\u308c\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u63d0\u6848\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u4f7f\u7528\u76ee\u7684\u3068\u305d\u306e\u52d5\u4f5c\u3084\u4f5c\u7528\u306e\u69d8\u5f0f\u306f\u3001\u6a5f\u5668\u8a2d\u8a08\u306e\u6307\u91dd\u3068\u306a\u308a\u3001510(k)\u3001PMA\u3001De Novo\u3001Pre-sub\u3001IDE\u3001HDE\u3001\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\u306a\u3069\u306e\u898f\u5236\u7d4c\u8def\u3082\u6c7a\u5b9a\u3057\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u56f31\u306b\u793a\u3059\u3088\u3046\u306b\u3001\u79d1\u5b66\u7684\u30d7\u30ed\u30bb\u30b9\u3068\u898f\u5236\u7684\u30d7\u30ed\u30bb\u30b9\u306e\u4e21\u65b9\u304c\u3001\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066\u76f8\u4e92\u306b\u7d61\u307f\u5408\u3063\u3066\u3044\u307e\u3059\u3002\u79d1\u5b66\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u3055\u307e\u3056\u307e\u306a\u90e8\u5206\u304c\u76f8\u4e92\u306b\u95a2\u9023\u3057\u3066\u3044\u308b\u3088\u3046\u306b\u3001\u79d1\u5b66\u3068\u898f\u5236\u8981\u4ef6\u306f\u76f8\u4e92\u306b\u95a2\u9023\u3057\u3066\u304a\u308a\u3001\u305d\u308c\u305e\u308c\u304c\u4ed6\u65b9\u306b\u60c5\u5831\u3092\u63d0\u4f9b\u3057\u3001\u6c7a\u5b9a\u3057\u307e\u3059\u3002\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u4e00\u90e8\u304c\u5358\u72ec\u3067\u691c\u8a0e\u3055\u308c\u308b\u5371\u967a\u6027\u304c\u306a\u3044\u3088\u3046\u306b\u3001FDA\u3068\u30e1\u30fc\u30ab\u30fc\u306e\u4e21\u65b9\u3067\u3064\u306a\u304c\u308a\u3092\u69cb\u7bc9\u3059\u308b\u6a5f\u4f1a\u304c\u3042\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u985e\u4f3c\u88fd\u54c1\u306e\u5e02\u8ca9\u5f8c\u306e\u7d4c\u9a13\u3092\u8003\u616e\u305b\u305a\u306b\u3001\u5e02\u8ca9\u524d\u306e\u7533\u8acb\u66f8\u304c\u5be9\u67fb\u3055\u308c\u308b\u3053\u3068\u306f\u73cd\u3057\u304f\u3042\u308a\u307e\u305b\u3093\u3002<\/span><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-8873 size-full\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-1.png\" alt=\"\" width=\"977\" height=\"628\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-1.png 977w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-1-300x193.png 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-1-768x494.png 768w\" sizes=\"(max-width: 977px) 100vw, 977px\" \/><\/p>\n<p><b>\u56f32: <\/b><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u305f\u3081\u306e\u30a6\u30a9\u30fc\u30bf\u30fc\u30d5\u30ed\u30fc\u30c7\u30b6\u30a4\u30f3\u30d7\u30ed\u30bb\u30b9\uff08Adapted from <\/span><b>[8]<\/b><span style=\"font-weight: 400;\">).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u304c\u958b\u59cb\u3055\u308c\u308b\u6700\u521d\u306e\u6bb5\u968e\u306f\u3001\u751f\u7523\u6bb5\u968e\u3067\u5b9f\u65bd\u3055\u308c\u308b\u30c7\u30d0\u30a4\u30b9\u8a2d\u8a08\u3068\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u304b\u3089\u306a\u308bDesign Input\u306e\u958b\u767a\u3068\u627f\u8a8d\u3067\u3059\u3002\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306f\u5168\u4f53\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3067\u3042\u308a\u3001\u30c7\u30b6\u30a4\u30f3\u304c\u6700\u7d42\u7684\u306b\u6c7a\u5b9a\u3055\u308c\u305f\u5f8c\u3001\u751f\u7523\u6bb5\u968e\u306b\u30c7\u30b6\u30a4\u30f3\u3092\u79fb\u3059\u3060\u3051\u3067\u306f\u7d42\u308f\u308a\u307e\u305b\u3093\u3002\u8a2d\u8a08\u6bb5\u968e\u3067\u306e\u5909\u66f4\u3001\u3042\u308b\u3044\u306f\u88fd\u9020\u5f8c\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u306b\u5fdc\u3058\u3066\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306b\u3082\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3059\u3002\u30e6\u30fc\u30b6\u30fc\u306b\u3068\u3063\u3066\u4f7f\u3044\u3084\u3059\u3044\u88fd\u54c1\u3092\u958b\u767a\u3059\u308b\u3053\u3068\u306f\u7d99\u7d9a\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308b\u305f\u3081\u3001\u6539\u826f\u3055\u308c\u305f\u88fd\u54c1\u3067\u306f\u3001\u4f7f\u7528\u30d1\u30bf\u30fc\u30f3\u304b\u3089\u306e\u9769\u547d\u7684\u306a\u5909\u5316\u3084\u3001\u5931\u6557\u3057\u305f\u88fd\u54c1\u306e\u5206\u6790\u3082\u8003\u616e\u3055\u308c\u307e\u3059\u3002\u56f32\u306f\u3001\u30a6\u30a9\u30fc\u30bf\u30fc\u30d5\u30a9\u30fc\u30eb\u578b\u306e\u8a2d\u8a08\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3044\u3066\u3001\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u304c\u3069\u306e\u3088\u3046\u306b\u884c\u308f\u308c\u308b\u304b\u3092\u793a\u3057\u305f\u3082\u306e\u3067\u3042\u308b\u3002<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>\u30e6\u30fc\u30b6\u30fc\u30cb\u30fc\u30ba:-\u3002 <\/b><span style=\"font-weight: 400;\">\u5e02\u5834\u306e\u30cb\u30fc\u30ba\u3092\u8003\u616e\u3057\u3066\u8981\u4ef6\u3092\u5b9a\u7fa9\u3057\u3001\u305d\u306e\u30cb\u30fc\u30ba\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u30c7\u30d0\u30a4\u30b9\u3092\u8a2d\u8a08\u3057\u307e\u3059\u3002\u9032\u5316\u3092\u91cd\u306d\u305f\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u306f\u3001\u6700\u7d42\u7684\u306b\u30d7\u30ed\u30c0\u30af\u30b7\u30e7\u30f3\u306b\u79fb\u7ba1\u3055\u308c\u3001\u88fd\u9020\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306e\u5404\u6bb5\u968e\u3067\u306f\u3001\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>\u30c7\u30b6\u30a4\u30f3\u5165\u529b\u3002<\/b><span style=\"font-weight: 400;\"> \u3053\u308c\u306f\u53cd\u5fa9\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002\u7d44\u7e54\u304c\u7279\u5b9a\u306e\u30cb\u30fc\u30ba\u306b\u5bfe\u5fdc\u3059\u308b\u3053\u3068\u3092\u6c7a\u5b9a\u3059\u308b\u3068\u3001\u30cb\u30fc\u30ba\u304b\u3089\u6d3e\u751f\u3057\u305f\u8a2d\u8a08\u5165\u529b\u306e\u53d7\u3051\u5165\u308c\u53ef\u80fd\u6027\u3092\u691c\u8a0e\u3057\u3001\u30c6\u30b9\u30c8\u3057\u307e\u3059\u3002\u305d\u306e\u6642\u70b9\u3067\u3001\u8981\u6c42\u3092\u6a5f\u5668\u8a2d\u8a08\u306b\u5909\u63db\u3059\u308b\u53cd\u5fa9\u30d7\u30ed\u30bb\u30b9\u304c\u59cb\u307e\u308a\u307e\u3059\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>\u30c7\u30b6\u30a4\u30f3\u30d7\u30ed\u30bb\u30b9\u3002<\/b><span style=\"font-weight: 400;\"> \u3053\u308c\u3089\u306e\u8a2d\u8a08\u30a4\u30f3\u30d7\u30c3\u30c8\u306f\u3001\u305d\u308c\u3089\u306e\u8981\u6c42\u3092\u9ad8\u30ec\u30d9\u30eb\u306e\u4ed5\u69d8\uff08\u8a2d\u8a08\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\uff09\u306b\u5909\u63db\u3059\u308b\u3053\u3068\u3067\u3001\u8a2d\u8a08\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\u306b\u5909\u63db\u3055\u308c\u307e\u3059\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>\u8a2d\u8a08\u51fa\u529b\u3002<\/b><span style=\"font-weight: 400;\"> \u691c\u8a3c\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u4ed5\u69d8\u66f8\u304c\u8981\u6c42\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u8a2d\u8a08\u51fa\u529b\u304c\u8a2d\u8a08\u5165\u529b\u3068\u4e00\u81f4\u3059\u308b\u307e\u3067\u7d9a\u304d\u307e\u3059\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>\u533b\u7642\u6a5f\u5668\u3002<\/b><span style=\"font-weight: 400;\"> \u6700\u7d42\u7684\u306a\u30c7\u30b6\u30a4\u30f3\u306e\u6e96\u5099\u304c\u6574\u3046\u3068\u3001\u305d\u306e\u30c7\u30b6\u30a4\u30f3\u306f\u5927\u91cf\u751f\u7523\u306e\u305f\u3081\u306b\u751f\u7523\u65bd\u8a2d\u306b\u9001\u3089\u308c\u307e\u3059\u3002\u8a2d\u8a08\u7ba1\u7406\u898f\u5b9a\u3067\u306f\u3001\u8a2d\u8a08\u5c65\u6b74\u30d5\u30a1\u30a4\u30eb\uff08DHF\uff09\u306e\u4f5c\u6210\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u3002DHF\u306f\u3001\u3059\u3079\u3066\u306e\u8a2d\u8a08\u7ba1\u7406\u306e\u9593\u306e\u30ea\u30f3\u30af\u3068\u95a2\u4fc2\u3092\u793a\u3057\u3001\u88fd\u54c1\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\u306e\u3059\u3079\u3066\u306e\u5909\u66f4\u3092\u8ffd\u8de1\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3002<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3067\u306f\u3001\u7d19\u30d9\u30fc\u30b9\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u3068\u3001\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u7528\u306b\u958b\u767a\u3055\u308c\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30d9\u30fc\u30b9\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u3068\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u30c7\u30b6\u30a4\u30f3\u30d2\u30b9\u30c8\u30ea\u30fc\u30d5\u30a1\u30a4\u30eb\u306f\u8ffd\u8de1\u53ef\u80fd\u3067\u3042\u308a\u3001\u3059\u3079\u3066\u306e\u30c1\u30fc\u30e0\u30e1\u30f3\u30d0\u30fc\u304c\u30a2\u30af\u30bb\u30b9\u3067\u304d\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u4e0b\u306e\u30d5\u30ed\u30fc\u30c1\u30e3\u30fc\u30c8\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u30b1\u30fc\u30b9\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-8874\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-example.png\" alt=\"\" width=\"983\" height=\"753\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-example.png 983w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-example-300x230.png 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-example-768x588.png 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-design-example-600x460.png 600w\" sizes=\"(max-width: 983px) 100vw, 983px\" \/><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Medical_Device_Design_Why_Traceability_is_Important\"><\/span><b>\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3002\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u304c\u91cd\u8981\u306a\u7406\u7531\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u73fe\u5728\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u3067\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u30cb\u30fc\u30ba\u3001\u8a2d\u8a08\u306e\u30a4\u30f3\u30d7\u30c3\u30c8\u3068\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\u3001\u8a2d\u8a08\u306e\u691c\u8a3c\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u9593\u306e\u30ea\u30f3\u30af\u3068\u95a2\u4fc2\u6027\u3092\u793a\u3059\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30de\u30c8\u30ea\u30af\u30b9\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u304c\u7406\u60f3\u7684\u3067\u3059\u3002\u30c7\u30d0\u30a4\u30b9\u958b\u767a\u306e\u521d\u671f\u6bb5\u968e\u3067\u306f\u3001\u30b9\u30d7\u30ec\u30c3\u30c9\u30b7\u30fc\u30c8\u3084\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3092\u4f7f\u3063\u3066\u30c7\u30d0\u30a4\u30b9\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u304c\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u304c\u9032\u3080\u306b\u3064\u308c\u3066\u3001Microsoft Teams\u3001Asana\u3001Trello\u306a\u3069\u3001\u7d44\u7e54\u306b\u9069\u3057\u305f\u30af\u30e9\u30a6\u30c9\u30d9\u30fc\u30b9\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u7ba1\u7406\u304a\u3088\u3073\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u5171\u6709\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u4f7f\u7528\u3059\u308b\u306e\u304c\u826f\u3044\u3067\u3057\u3087\u3046\u3002\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u304c\u9032\u3080\u306b\u3064\u308c\u3001\u6642\u9593\u3092\u7bc0\u7d04\u3067\u304d\u308b\u65b9\u6cd5\u3092\u898b\u3064\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u306a\u305c\u306a\u3089\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30de\u30c8\u30ea\u30af\u30b9\u3092\u7dad\u6301\u3059\u308b\u65e7\u6765\u306e\u65b9\u6cd5\u3067\u306f\u3001\u8a2d\u8a08\u306e\u691c\u8a3c\u3068\u59a5\u5f53\u6027\u78ba\u8a8d\u306b\u96c6\u4e2d\u3059\u3079\u304d\u591a\u304f\u306e\u6642\u9593\u3092\u6d88\u8cbb\u3057\u3066\u3057\u307e\u3046\u304b\u3089\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30de\u30c8\u30ea\u30c3\u30af\u30b9\u306f\u3001\u88fd\u54c1\u958b\u767a\u30c1\u30fc\u30e0\u3001\u7279\u306b\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306b\u3068\u3063\u3066\u4e0d\u53ef\u6b20\u306a\u3082\u306e\u3067\u3042\u308b\u3002\u306a\u305c\u306a\u3089\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306f\u3059\u3079\u3066\u306e\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u9593\u306e\u95a2\u4fc2\u3068\u3064\u306a\u304c\u308a\u3092\u793a\u3057\u3066\u3044\u308b\u304b\u3089\u3067\u3042\u308b\u3002\u30e6\u30fc\u30b6\u30fc\u30cb\u30fc\u30ba\u306f\u30c7\u30b6\u30a4\u30f3\u30a4\u30f3\u30d7\u30c3\u30c8\u3068\u3069\u306e\u3088\u3046\u306b\u95a2\u9023\u3057\u3066\u3044\u308b\u304b\uff1f\u8a2d\u8a08\u51fa\u529b\u306f\u8a2d\u8a08\u5165\u529b\u3068\u3069\u306e\u3088\u3046\u306b\u95a2\u9023\u3057\u3066\u3044\u308b\u304b\uff1f\u8a2d\u8a08\u691c\u8a3c\u306f\u8a2d\u8a08\u5165\u529b\u3068\u8a2d\u8a08\u51fa\u529b\u306b\u3069\u306e\u3088\u3046\u306b\u95a2\u9023\u3059\u308b\u304b\uff1f\u8a2d\u8a08\u691c\u8a3c\u306f\u3069\u306e\u3088\u3046\u306b\u30e6\u30fc\u30b6\u30fb\u30cb\u30fc\u30ba\u3068\u95a2\u9023\u3057\u3066\u3044\u308b\u304b\uff1f\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u30de\u30c8\u30ea\u30c3\u30af\u30b9\u306f\u3001\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u306e\u958b\u767a\u306e\u6700\u521d\u304b\u3089\u6700\u5f8c\u307e\u3067\u306e\u6d41\u308c\u3092\u30cf\u30a4\u30ec\u30d9\u30eb\u306a\u8996\u70b9\u3067\u793a\u3059\u8cb4\u91cd\u306a\u30c4\u30fc\u30eb\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u306e\u88fd\u54c1\u958b\u767a\u8005\u306f\u3001\u4f55\u5e74\u3082\u4f55\u5e74\u3082\u524d\u304b\u3089\u30c7\u30b6\u30a4\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306b\u4f9d\u5b58\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u305d\u3057\u3066\u4eca<\/span><a href=\"https:\/\/13485store.com\/medical-device-standards\/what-is-iso-13485\/\"> <span style=\"font-weight: 400;\">ISO 13485:2016<\/span><\/a><span style=\"font-weight: 400;\"> \u3082\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u8981\u6c42\u3057\u3066\u3044\u307e\u3059\u3002ISO 13485:2016 \u306b\u5f15\u7528\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u30017.1 \u88fd\u54c1\u5b9f\u73fe\u306e\u8a08\u753b\u30011.c) \u88fd\u54c1\u306b\u7279\u6709\u306e\u8981\u6c42\u3055\u308c\u308b\u691c\u8a3c\u3001\u59a5\u5f53\u6027\u78ba\u8a8d\u3001\u76e3\u8996\u3001\u6e2c\u5b9a\u3001\u691c\u67fb\u53ca\u3073\u8a66\u9a13\u3001\u53d6\u6271\u3044\u3001\u4fdd\u7ba1\u3001\u6d41\u901a\u53ca\u3073\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u6d3b\u52d5\u3092\u3001\u88fd\u54c1\u53d7\u3051\u5165\u308c\u306e\u57fa\u6e96\u3068\u3068\u3082\u306b\u3001\u307e\u305f\u30017.3.2 \u8a2d\u8a08\u53ca\u3073\u958b\u767a\u306e\u8a08\u753b\u30011.e) \u8a2d\u8a08\u53ca\u3073\u958b\u767a\u306e\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\u304b\u3089\u8a2d\u8a08\u53ca\u3073\u958b\u767a\u306e\u30a4\u30f3\u30d7\u30c3\u30c8\u3078\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u78ba\u5b9f\u306b\u3059\u308b\u65b9\u6cd5\u3002 <\/span><b>[9]<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Medical_Device_Design_Verification_and_Validation\"><\/span><b>\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3002\u691c\u8a3c\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u304c\u5e02\u5834\u3067\u6210\u529f\u3092\u53ce\u3081\u308b\u305f\u3081\u306b\u306f\u3001\u6a5f\u80fd\u6027\u3001\u64cd\u4f5c\u6027\u3001\u4fe1\u983c\u6027\u306a\u3069\u306e\u76ee\u6a19\u3092\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3055\u3089\u306b\u3001\u5229\u5bb3\u95a2\u4fc2\u8005\uff08\u60a3\u8005\u3001\u51e6\u65b9\u8005\u3001\u898f\u5236\u5f53\u5c40\u3001\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\uff09\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306b\u3082\u6ce8\u76ee\u3059\u308b\u3067\u3057\u3087\u3046\u3002\u4f8b\u3048\u3070\u3001\u4eba\u5de5\u547c\u5438\u5668\u3084\u5fc3\u81d3\u75c5\u3092\u691c\u51fa\u3059\u308b\u8a3a\u65ad\u88c5\u7f6e\u306a\u3069\u3001\u751f\u547d\u7dad\u6301\u306b\u4e0d\u53ef\u6b20\u306a\u30a2\u30f3\u30e1\u30c3\u30c8\u30cb\u30fc\u30ba\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u8a2d\u8a08\u3055\u308c\u305f\u30c7\u30d0\u30a4\u30b9\u3067\u3042\u308b\u53ef\u80fd\u6027\u304c\u9ad8\u3044\u3067\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u691c\u8a3c\u3068\u59a5\u5f53\u6027\u78ba\u8a8d\u3092\u4f34\u3046\u30c7\u30d0\u30a4\u30b9\u306e\u53cd\u5fa9\u7684\u306a\u30c6\u30b9\u30c8\u306f\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u8a2d\u8a08\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u3053\u306e2\u3064\u306e\u30b9\u30c6\u30c3\u30d7\u306f\u3001\u533b\u7642\u6a5f\u5668\u304c\u30e6\u30fc\u30b6\u30fc\u306e\u8981\u6c42\u306b\u5408\u81f4\u3057\u3066\u3044\u308b\u304b\u3001\u307e\u305f\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u901a\u308a\u306b\u6a5f\u80fd\u3057\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u7c21\u5358\u306b\u8a00\u3048\u3070\u3001\u8a2d\u8a08\u306e\u691c\u8a3c\u3068\u59a5\u5f53\u6027\u78ba\u8a8d\u306f\u3001\u3042\u306a\u305f\u306e\u30c7\u30d0\u30a4\u30b9\u304c\u5b9f\u969b\u306b\u60f3\u5b9a\u3055\u308c\u305f\u901a\u308a\u306b\u52d5\u4f5c\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u307e\u305f\u3001\u8a2d\u8a08\u691c\u8a3c\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u8981\u4ef6\u3001\u898f\u683c\u3001\u88fd\u54c1\u54c1\u8cea\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3067\u3082\u3042\u308a\u307e\u3059\u3002\u8a2d\u8a08\u691c\u8a3c\u3067\u306f\u3001\u8a2d\u8a08\u51fa\u529b\u304c\u3001\u8a2d\u8a08\u5165\u529b\u3067\u6307\u5b9a\u3055\u308c\u305f\u8981\u4ef6\u3001\u4ed5\u69d8\u3001\u307e\u305f\u306f\u898f\u5236\u8981\u4ef6\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u8a55\u4fa1\u3057\u307e\u3059\u3002\u4e00\u65b9\u3001\u8a2d\u8a08\u691c\u8a3c\u306f\u3001\u533b\u7642\u6a5f\u5668\u304c\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u306e\u30cb\u30fc\u30ba\u306b\u57fa\u3065\u3044\u3066\u5229\u76ca\u3092\u3082\u305f\u3089\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u8a55\u4fa1\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30c7\u30b6\u30a4\u30f3 <\/span><b>\u691c\u8a3c<\/b><span style=\"font-weight: 400;\"> \u3092\u5c0b\u306d\u307e\u3059\u3002\"\u30c7\u30d0\u30a4\u30b9\u306e\u8a2d\u8a08\u306f\u6b63\u3057\u304b\u3063\u305f\u306e\u304b\uff1f\"<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30c7\u30b6\u30a4\u30f3 <\/span><b>\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/b><span style=\"font-weight: 400;\"> \u3092\u554f\u3044\u304b\u3051\u307e\u3059\u3002\"Did we design the right device?\"<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306f\u3001\u69d8\u3005\u306a\u6280\u8853\u306e\u5f62\u3001\u30b5\u30a4\u30ba\u3001\u305d\u3057\u3066\u7570\u306a\u308b\u30ec\u30d9\u30eb\u306e\u8907\u96d1\u3055\u3067\u69cb\u6210\u3055\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u691c\u8a3c\u30fb\u59a5\u5f53\u6027\u78ba\u8a8d\uff08V&amp;V\uff09\u6d3b\u52d5\u306f\u3001\u898f\u5236\u74b0\u5883\u306b\u3088\u3063\u3066\u63a8\u9032\u3055\u308c\u3001\u56fd\u969b\u6a19\u6e96\u306b\u5f93\u308f\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002V&amp;V\u6d3b\u52d5\u3092\u6a19\u6e96\u5316\u3059\u308b\u3053\u3068\u3067\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3092\u5408\u7406\u5316\u3057\u3001\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u3092\u5411\u4e0a\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u81ea\u52d5\u5316\u3055\u308c\u305f\u30c6\u30b9\u30c8\u3001\u8a3a\u65ad\u6280\u8853\u3001\u30c7\u30fc\u30bf\u53ce\u96c6\u30c4\u30fc\u30eb\u306f\u3001V&amp;V\u30d7\u30ed\u30bb\u30b9\u3092\u5f37\u5316\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 <\/span><b>[10]<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>\u30d7\u30ed\u30c0\u30af\u30c8\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3068\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u8a2d\u8a08\/\u88fd\u54c1\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff1a - \u30e6\u30fc\u30b6\u30fc\u3084\u60a3\u8005\u306e\u30cb\u30fc\u30ba\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3001\u3064\u307e\u308a\u6a5f\u5668\u304c\u6b63\u3057\u304f\u6a5f\u80fd\u3059\u308b\u304b\u3069\u3046\u304b\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff1a\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u304c\u3042\u3089\u304b\u3058\u3081\u8a2d\u5b9a\u3055\u308c\u305f\u4ed5\u69d8\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u5fd8\u308c\u3066\u306f\u306a\u3089\u306a\u3044\u306e\u306f\u3001\u8a2d\u8a08\/\u88fd\u54c1\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u2260\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u898f\u5236\u5f53\u5c40\u306f\u3001\u8a2d\u8a08\/\u88fd\u54c1\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3068\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u4e21\u65b9\u3092\u500b\u5225\u306b\u8981\u6c42\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u85ac\u4e8b\u7533\u8acb\u306e\u969b\u306b\u306f\u4e21\u65b9\u3092\u540c\u7b49\u306b\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306e\u3069\u306e\u6bb5\u968e\u3067\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3092\u8003\u3048\u308b\u3079\u304d\u304b\uff1f\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u4f5c\u696d\u3092\u59cb\u3081\u308b\u306e\u306b\u65e9\u3059\u304e\u308b\u3068\u3044\u3046\u3053\u3068\u306f\u306a\u3044\u3053\u3068\u3092\u7406\u89e3\u3059\u3079\u304d\u3067\u3059\u3002\u4f01\u696d\u306f\u3001\u6b63\u3057\u3044\u9053\u3092\u9032\u3093\u3067\u3044\u308b\u304b\u3001\u6b63\u3057\u3044\u554f\u984c\u3092\u89e3\u6c7a\u3057\u3066\u3044\u308b\u304b\u3092\u628a\u63e1\u3059\u308b\u305f\u3081\u306b\u3001\u9045\u304b\u308c\u65e9\u304b\u308c\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3092\u59cb\u3081\u308b\u3079\u304d\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08V&amp;V\uff09\u306f\u53cd\u5fa9\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308b\u305f\u3081\u3001\u8a08\u753b\u304c\u4e0d\u5341\u5206\u3060\u3068\u826f\u3044\u6295\u8cc7\u304c\u3067\u304d\u307e\u305b\u3093\u3002\u30c6\u30b9\u30c8\u6226\u7565\u3092\u3057\u3063\u304b\u308a\u3068\u5b9a\u7fa9\u3059\u308b\u3053\u3068\u3067\u3001\u30b3\u30b9\u30c8\u3068\u30c6\u30b9\u30c8\u671f\u9593\u3092\u6700\u9069\u5316\u3057\u3001\u88fd\u54c1\u3092\u671f\u9650\u5185\u306b\u5e02\u5834\u6295\u5165\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30c6\u30b9\u30c8\u6226\u7565\u306e\u8907\u96d1\u3055\u306f\u3001\u4f7f\u7528\u3059\u308b\u6280\u8853\u3084\u5730\u7406\u7684\u306a\u30bf\u30fc\u30b2\u30c3\u30c8\u5e02\u5834\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u30c6\u30b9\u30c8\u6226\u7565\u306f\u3001\u5c11\u306a\u304f\u3068\u3082\u4ee5\u4e0b\u306e6\u3064\u306e\u30d1\u30e9\u30e1\u30fc\u30bf\u3092\u30ab\u30d0\u30fc\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u5bfe\u8c61\u3068\u306a\u308b\u5730\u57df\u3068\u95a2\u9023\u3059\u308b\u57fa\u6e96<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Time to market;<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30d0\u30fc\u30b8\u30e7\u30f3\u30a2\u30c3\u30d7\u3057\u3066\u8e0f\u8972\u3059\u308b\u898f\u683c\u3067\u3059\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30c6\u30b9\u30c8\u30e9\u30dc - \u5185\u90e8\u307e\u305f\u306f\u72ec\u7acb\u3057\u305f\u30e9\u30dc\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30c6\u30b9\u30c8\u306e\u9806\u5e8f\u3092\u6c7a\u3081\u308b\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30c6\u30b9\u30c8\u7d50\u679c\u306e\u63d0\u793a<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u3057\u305f\u304c\u3063\u3066\u3001\u691c\u8a3c\u30fb\u59a5\u5f53\u6027\u78ba\u8a8d\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u4f7f\u7528\u3055\u308c\u308b\u30c6\u30b9\u30c8\u3082\u691c\u8a3c\u3055\u308c\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u30c6\u30b9\u30c8\u304c\u9593\u9055\u3063\u3066\u3044\u308b\u3068\u3001\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u3084\u6a5f\u80fd\u6027\u306e\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\u304c\u9593\u9055\u3063\u3066\u3044\u308b\u305f\u3081\u3001\u6e2c\u5b9a\u3059\u3079\u304d\u3082\u306e\u3092\u78ba\u5b9f\u306b\u6e2c\u5b9a\u3059\u308b\u305f\u3081\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u95a2\u9023\u3059\u308b\u898f\u5236\u306b\u6e96\u62e0\u3057\u305f\u3001\u52b9\u679c\u7684\u3067\u6587\u66f8\u5316\u3055\u308c\u305fV&amp;V\u3092\u5fc5\u8981\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Medical_Device_Design_Risk_Management\"><\/span><b>\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3002\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"Risk_migration_strategy_vs_Risk_management_plan\"><\/span><b> \u30ea\u30b9\u30af\u79fb\u884c\u6226\u7565vs.\u30ea\u30b9\u30af\u7ba1\u7406\u8a08\u753b<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u56fd\u969b\u7684\u306b\u8a8d\u3081\u3089\u308c\u305f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u57fa\u6e96\u306b\u57fa\u3065\u304d\u3001\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u3092\u5b9f\u65bd\u3057\u3066\u3044\u307e\u3059\u3002<\/span><a href=\"https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:14971:ed-2:v2:en\"> <span style=\"font-weight: 400;\">ISO 14971:2007 \u533b\u7642\u6a5f\u5668-\u300c\u533b\u7642\u6a5f\u5668\u3078\u306e\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u9069\u7528<\/span><\/a><span style=\"font-weight: 400;\">\".\u307e\u305f\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u65b9\u91dd\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u306e\u3059\u3079\u3066\u306e\u6bb5\u968e\u3067\u53d6\u308a\u5165\u308c\u3089\u308c\u308b\u5fc5\u8981\u304c\u3042\u308a\u3001\u8a2d\u8a08\u7ba1\u7406\u306e\u5074\u9762\u306b\u3082\u95a2\u9023\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002 <\/span><b>[10]<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306b\u7d42\u308f\u308a\u306f\u3042\u308a\u307e\u305b\u3093\uff08\u5c11\u306a\u304f\u3068\u3082\u7406\u8ad6\u4e0a\u306f\uff01\uff09\u3002\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u54f2\u5b66\u306f\u3001\u5805\u82e6\u3057\u3044\u30eb\u30fc\u30eb\u306b\u3053\u3060\u308f\u308b\u3079\u304d\u3067\u306f\u306a\u3044\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3068\u30ea\u30b9\u30af\u79fb\u884c\u6226\u7565\u306f\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u610f\u56f3\u3092\u7406\u89e3\u3057\u3001\u8ad6\u7406\u7684\u304b\u3064\u4f53\u7cfb\u7684\u306b\u30d7\u30ed\u30bb\u30b9\u306b\u30a2\u30d7\u30ed\u30fc\u30c1\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u8a00\u3044\u63db\u3048\u308c\u3070 <\/span><b>\u30eb\u30fc\u30eb\u3092\u5b88\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u8003\u3048\u3066\u304f\u3060\u3055\u3044\u3002<\/b><\/p>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u306e\u8907\u96d1\u3055\u3092\u8003\u616e\u3059\u308b\u3068\u3001\u7126\u70b9\u3092\u7d5e\u3063\u305f\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u5b9f\u8df5\u306f\u3001\u4f7f\u3044\u3084\u3059\u3055\u3001\u5b89\u5168\u6027\u3001\u304a\u3088\u3073\u898f\u5236\u9075\u5b88\u306e\u78ba\u4fdd\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3068\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u306b\u5371\u5bb3\u3092\u53ca\u307c\u3059\u53ef\u80fd\u6027\u306e\u3042\u308b\u6545\u969c\u3092\u7279\u5b9a\u3057\u3001\u5236\u5fa1\u3057\u3001\u9632\u6b62\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002\u307e\u305f\u3001\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3059\u308b\u3053\u3068\u3082\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u56f33\u306f\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u308f\u308b\u3059\u3079\u3066\u306e\u30b9\u30c6\u30c3\u30d7\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u30cf\u30b6\u30fc\u30c9\u306e\u7279\u5b9a\u304b\u3089\u59cb\u307e\u308a\u3001\u30cf\u30b6\u30fc\u30c9\u306e\u7d50\u679c\u3068\u30ea\u30b9\u30af\u306e\u53ef\u80fd\u6027\u306b\u57fa\u3065\u3044\u3066\u3001\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u304c\u6e2c\u5b9a\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\"> <img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-8880\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-risk-management.png\" alt=\"\" width=\"887\" height=\"491\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-risk-management.png 887w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-risk-management-300x166.png 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/03\/medical-device-risk-management-768x425.png 768w\" sizes=\"(max-width: 887px) 100vw, 887px\" \/><\/span><\/p>\n<p><b>\u56f33\uff0e <\/b><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9 (Adapted from) <\/span><b>[11]<\/b><span style=\"font-weight: 400;\">).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u3067\u7279\u5b9a\u3055\u308c\u305f\u30ea\u30b9\u30af\u304c\u3001\u5b9a\u7fa9\u3055\u308c\u305f\u57fa\u6e96\u3092\u8d85\u3048\u3066\u3044\u308b\u5834\u5408\u3001\u30ea\u30b9\u30af\u8efd\u6e1b\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002\u30ea\u30b9\u30af\u306e\u30ec\u30d9\u30eb\u306f\u3001\u6a5f\u5668\u3001\u6280\u8853\u3001\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u8cb4\u793e\u306e\u30ea\u30b9\u30af\u8efd\u6e1b\u30d7\u30ed\u30bb\u30b9\u306e\u6271\u3044\u65b9\u306a\u3069\u3001\u3044\u304f\u3064\u304b\u306e\u30d1\u30e9\u30e1\u30fc\u30bf\u306b\u5de6\u53f3\u3055\u308c\u307e\u3059\u304c\u3001\u3053\u308c\u3089\u306b\u9650\u5b9a\u3055\u308c\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3069\u306e\u3088\u3046\u306a\u898f\u683c\u304c\u9069\u7528\u3067\u304d\u308b\u304b\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306b\u3001\u6a5f\u5668\u306e\u30cf\u30b6\u30fc\u30c9\u5206\u6790\u3092\u884c\u3046\u3053\u3068\u304c\u5e38\u306b\u63a8\u5968\u3055\u308c\u307e\u3059\u3002\u6700\u8fd1\u306eISO 14971\u306e\u6539\u8a02\u3067\u306fInternational Standard for Risk Management of Medical Devices\uff08\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u306b\u95a2\u3059\u308b\u56fd\u969b\u898f\u683c\uff09\u300d\u306e\u6700\u8fd1\u306e\u6539\u8a02\u7248\u3067\u306f\u3001\u30ea\u30b9\u30af\u5206\u6790\u3068\u4e88\u5099\u7684\u30cf\u30b6\u30fc\u30c9\u5206\u6790\uff08PHA\uff09\u304c\u533b\u7642\u6a5f\u5668\u306e\u4e3b\u8981\u306a\u8981\u4ef6\u3068\u3057\u3066\u6319\u3052\u3089\u308c\u3066\u3044\u307e\u3059\u3002 <\/span><b>[12]<\/b><span style=\"font-weight: 400;\">.\u7c21\u5358\u306b\u8a00\u3048\u3070\u3001PHA\u306f\u3001\u30ea\u30b9\u30af\u8a55\u4fa1\u3068\u7ba1\u7406\u306e\u305f\u3081\u306e\u6700\u521d\u306e\u67a0\u7d44\u307f\u3092\u63d0\u4f9b\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001PHA\u306f\u30ea\u30b9\u30af\u5206\u6790\u3068\u30ea\u30b9\u30af\u8a55\u4fa1\u306e\u4e21\u65b9\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u308b\u3002\u5b9a\u7fa9\u306b\u3088\u308c\u3070\u3001PHA\u306f\u3001\u6a5f\u5668\u306e\u69cb\u9020\u6750\u6599\uff08MoC\uff09\u3001\u6a5f\u5668\u306b\u4f7f\u7528\u3055\u308c\u308b\u90e8\u54c1\u3084\u539f\u6750\u6599\u3001\u4eba\u3068\u6a5f\u5668\u307e\u305f\u306f\u624b\u52d5\u306e\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30a4\u30b9\u3001\u4f7f\u7528\u74b0\u5883\u3001\u52d5\u4f5c\u539f\u7406\u3001\u305d\u306e\u4ed6\u306e\u95a2\u9023\u8981\u56e0\u304b\u3089\u5f62\u6210\u3055\u308c\u308b\u30cf\u30b6\u30fc\u30c9\u3001\u6709\u5bb3\u6027\u3001\u3042\u3089\u3086\u308b\u5371\u967a\u306a\u72b6\u6cc1\u306e\u30ea\u30b9\u30c8\u304b\u3089\u69cb\u6210\u3055\u308c\u308b\u3002 <\/span><b>[13]<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><b>\u7d50\u8ad6<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u6700\u5f8c\u306b\u3001\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u304b\u3089\u65e2\u5b58\u306e\u7d44\u7e54\u306b\u81f3\u308b\u307e\u3067\u3001\u898f\u5247\u3092\u8aad\u3080\u3053\u3068\u3067\u5f97\u3089\u308c\u308b\u3082\u306e\u306f\u4f55\u3082\u306a\u3044\u304c\u3001\u54f2\u5b66\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u5f97\u3089\u308c\u308b\u3082\u306e\u306f\u5927\u304d\u3044\u3068\u3044\u3046\u3053\u3068\u3092\u899a\u3048\u3066\u304a\u3044\u3066\u304f\u3060\u3055\u3044\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u809d\u5fc3\u306a\u306e\u306f\u3001\u30ea\u30b9\u30af\u5206\u6790\u3084\u8a08\u753b\u3092\u7acb\u3066\u308b\u3068\u304d\u3067\u3059\u3002<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u8a2d\u8a08\u30fb\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306e\u521d\u671f\u6bb5\u968e\u304b\u3089\u305a\u3063\u3068\u6d3b\u7528\u3059\u3079\u304d\u3067\u3059\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u3057\u3070\u3057\u3070\u65b0\u3057\u3044\u60c5\u5831\u3092\u5f97\u3066\u3001\u8a2d\u8a08\u3084\u958b\u767a\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\uff08\u73fe\u5728\uff0f\u5c06\u6765\u306e\u30c7\u30d0\u30a4\u30b9\u306e\u5834\u5408\uff09\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u3069\u3093\u306a\u306b\u8a08\u753b\u3092\u7acb\u3066\u3066\u3082\u3001\u3059\u3079\u3066\u306e\u5371\u967a\u6027\u3084\u30ea\u30b9\u30af\u3092\u6392\u9664\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002(\u3057\u304b\u3057\u3001\u591a\u304f\u306e\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\uff01\uff08\u3053\u3053\u3067\u8aac\u660e\u3055\u308c\u3066\u3044\u308b\u8a2d\u8a08\u7ba1\u7406\u306e\u8003\u3048\u65b9\u306b\u5f93\u3046\u3053\u3068\u3067\u3001\u81ea\u52d5\u7684\u306b\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u306e\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u30eb\u30fc\u30c8\u306f\u3001\u4f7f\u7528\u30d1\u30bf\u30fc\u30f3\u3001\u7d20\u6750\u3001\u30e6\u30fc\u30b6\u30fc\u30a8\u30af\u30b9\u30da\u30ea\u30a8\u30f3\u30b9\u3001\u898f\u5236\u306a\u3069\u3001\u8003\u616e\u3059\u3079\u304d\u3055\u307e\u3056\u307e\u306a\u8981\u56e0\u306b\u3088\u308a\u8907\u96d1\u3067\u3059\u3002<\/span><\/p>\n<p><strong>\u56f0\u3063\u305f\u3068\u304d\u306f <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-design\" target=\"_blank\" rel=\"noopener\">medical device design<\/a>? Browse experienced <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">\u30e1\u30c9\u30c6\u30c3\u30af\u696d\u754c\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a> \u306eKolabtree\u306b\u767b\u9332\u3057\u305f\u308a\u3001\u7121\u6599\u3067\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6295\u7a3f\u3057\u3066\u63d0\u6848\u3092\u53d7\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0<\/strong><\/p>\n<p><b>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9\uff06\u30ea\u30bd\u30fc\u30b9<\/b><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.welldoc.com\/health-plans\/\"><span style=\"font-weight: 400;\">https:\/\/www.welldoc.com\/health-plans\/<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/10337\/attachments\/1\/translations\"><span style=\"font-weight: 400;\">https:\/\/ec.europa.eu\/docsroom\/documents\/10337\/attachments\/1\/translations<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">FDA, 2005, Total Product Lifecycle, FDA-CDRH Presentation by CDRH Director Dr David Feigal, http:\/\/www.fda.gov\/cdrh\/strategic\/presentations\/ tplc.html.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Pietzsch, Jan &amp; Shluzas, Lauren &amp; Pat\u00e9-Cornell, Marie-Elisabeth &amp; Yock, Paul &amp; Linehan, John.(2009).Stage-Gate Process for the Development of Medical Devices.Journal of Medical Devices.3(2).<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">IEC 60601-1\u306e\u7b2c3\u7248\u306e\u305f\u3081\u306e\u898f\u5236\u6226\u7565 2020\u5e749\u67089\u65e5\u306b\u53d6\u5f97\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.meddeviceonline.com\/doc\/an-introduction-to-international-medical-device-standards-0001\"><span style=\"font-weight: 400;\">https:\/\/www.meddeviceonline.com\/doc\/an-introduction-to-international-medical-device-standards-0001<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.fda.gov\/files\/drugs\/published\/Design-Controls---Devices.pdf\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/files\/drugs\/published\/Design-Controls&#8212;Devices.pdf<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Feigal DW.\u4ed8\u9332D\u3002Impact of the Regulatory Framework on Medical Device Development and Innovation.\u7c73\u56fd\u533b\u5b66\u7814\u7a76\u6240\uff08Institute of Medicine\uff09\u306e\u300cFDA 510(k)\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u30d7\u30ed\u30bb\u30b9\u306e\u516c\u8846\u885b\u751f\u52b9\u679c\u306b\u95a2\u3059\u308b\u59d4\u54e1\u4f1a\u300d\uff1bWizemann T, editor.FDA 510(k)\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u30d7\u30ed\u30bb\u30b9\u306e\u516c\u8846\u885b\u751f\u4e0a\u306e\u52b9\u679c\u3002Balancing Patient Safety and Innovation:\u30ef\u30fc\u30af\u30b7\u30e7\u30c3\u30d7\u5831\u544a\u66f8\u3002\u30ef\u30b7\u30f3\u30c8\u30f3\uff08DC\uff09\u3002National Academies Press (US); 2010.Appendix D, Impact of the Regulatory Framework on Medical Device Development and Innovation.Available from:<\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK209794\/\"> <span style=\"font-weight: 400;\">https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK209794\/<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/design-control-guidance-medical-device-manufacturers\"><span style=\"font-weight: 400;\">1997\u5e74\u3001FDA CDRH 1997\u5e74\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;\" aria-level=\"1\"><a href=\"https:\/\/starfishmedical.com\/blog\/iso-134852016-section-7\/?doing_wp_cron=1599995964.4528369903564453125000\"><span style=\"font-weight: 400;\">https:\/\/starfishmedical.com\/blog\/iso-134852016-section-7\/?doing_wp_cron=1599995964.4528369903564453125000<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Teixeira, M. B., and Bradley, R., 2003, Design Controls for the Medical Device Industry, Marcel Dekker, New York.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.iso.org\/standard\/72704.html\"><span style=\"font-weight: 400;\">ISO 14971:2019 - \u533b\u7642\u6a5f\u5668 - \u533b\u7642\u6a5f\u5668\u3078\u306e\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u9069\u7528<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.iso.org\/standard\/74437.html\"><span style=\"font-weight: 400;\">ISO\/TR 24971:2020 - \u533b\u7642\u6a5f\u5668 - ISO 14971\u306e\u9069\u7528\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9<\/span><\/a><\/li>\n<\/ol>\n<p><strong>\u3053\u306e\u30b7\u30ea\u30fc\u30ba\u306e\u5168\u8a18\u4e8b<br \/>\n<\/strong><a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-development-and-design-a-definitive-guide\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30fb\u8a2d\u8a08\u306e\u305f\u3081\u306e\u6c7a\u5b9a\u7248\u30ac\u30a4\u30c9<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-development-3-tips-for-success\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">\u533b\u7642\u6a5f\u5668\u958b\u767a\u3002\u6210\u529f\u306e\u305f\u3081\u306e3\u3064\u306e\u30d2\u30f3\u30c8<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">\u533b\u7642\u6a5f\u5668\u306e\u30c7\u30b6\u30a4\u30f3\u3002The Essential, Step-by-Step Guide<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-commercialization-9-steps-from-sketch-to-launch\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">\u533b\u7642\u6a5f\u5668\u306e\u5546\u54c1\u5316\uff1a\u30b9\u30b1\u30c3\u30c1\u304b\u3089\u767a\u58f2\u307e\u3067\u306e9\u3064\u306e\u30b9\u30c6\u30c3\u30d7<\/a><br \/>\n<a href=\"https:\/\/www.biotechnologynewsmagazine.infomeddnews.com\/how-to-overcome-medical-device-commercialization-challenges-best-practices\/\">\u533b\u7642\u6a5f\u5668\u306e\u5546\u696d\u5316\u306e\u8ab2\u984c\u3092\u3069\u3046\u514b\u670d\u3059\u308b\u304b<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-launch-key-steps-when-taking-product-to-market\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">\u533b\u7642\u6a5f\u5668\u306e\u30ed\u30fc\u30f3\u30c1\u88fd\u54c1\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u305f\u3081\u306e\u91cd\u8981\u306a\u30b9\u30c6\u30c3\u30d7<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDDesign\">\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3002\u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c9<\/a><\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Shrinidh Joshi, medical device expert\u00a0on Kolabtree, provides a comprehensive guide to medical device design, design controls, validation &amp; verification, regulatory requirements and risk management.\u00a0 \u00a0 In the previous article, we took a look at the overview of the medical device development process from the ideation to the discovery phase. In this article, we will focus more on medical device design, design controls, and compliance. Medical Device Design: IEC &amp; ISO regulations and compliance By now you know that for market entry your medical device needs to qualify certain regulatory requirements and standards. Medical device standards such as the International Electrotechnical Commission (IEC) or the International Organization for Standardization (ISO) allow<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-design-the-essential-step-by-step-guide\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":8885,"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 Design: The Essential, Step-by-Step Guide<\/title>\n<meta name=\"description\" content=\"The ultimate guide to medical device post-market surveillance: what it should include, proactive &amp; reactive actions, and important timelines.\" \/>\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-design-the-essential-step-by-step-guide\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Design: The Essential, Step-by-Step Guide\" \/>\n<meta property=\"og:description\" content=\"The ultimate guide to medical device post-market surveillance: what it should include, proactive &amp; reactive actions, and important timelines.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-design-the-essential-step-by-step-guide\/\" \/>\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\" 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