{"id":8280,"date":"2020-09-01T08:53:58","date_gmt":"2020-09-01T08:53:58","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8280"},"modified":"2021-10-04T07:45:19","modified_gmt":"2021-10-04T07:45:19","slug":"fda-software-documentation-for-medical-devices","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/","title":{"rendered":"\u00a0\u533b\u7642\u6a5f\u5668\u306e\u305f\u3081\u306eFDA\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30fb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3"},"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-69f19e3449aad\" 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-69f19e3449aad\"><\/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\/fda-software-documentation-for-medical-devices\/#How_to_classify_your_medical_device_software\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u3069\u306e\u3088\u3046\u306b\u5206\u985e\u3059\u308b\u304b\uff1f\u00a0\">\u533b\u7642\u6a5f\u5668\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u3069\u306e\u3088\u3046\u306b\u5206\u985e\u3059\u308b\u304b\uff1f\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\/fda-software-documentation-for-medical-devices\/#FDA_software_documents_for_medical_devices\" title=\"\u533b\u7642\u6a5f\u5668\u306eFDA\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u6587\u66f8\">\u533b\u7642\u6a5f\u5668\u306eFDA\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u6587\u66f8<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/#What_are_the_documents_to_be_submitted\" title=\"\u63d0\u51fa\u3059\u3079\u304d\u66f8\u985e\u306f\u4f55\u3067\u3059\u304b\uff1f\">\u63d0\u51fa\u3059\u3079\u304d\u66f8\u985e\u306f\u4f55\u3067\u3059\u304b\uff1f<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/#Description_of_the_documents\" title=\"\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u8aac\u660e\u00a0\">\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u8aac\u660e\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\/fda-software-documentation-for-medical-devices\/#1_Level_of_Concern\" title=\"1.\u6c17\u306b\u306a\u308b\u30ec\u30d9\u30eb\u00a0\">1.\u6c17\u306b\u306a\u308b\u30ec\u30d9\u30eb\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/#2_Software_Description\" title=\"2.\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u8aac\u660e\">2.\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u8aac\u660e<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/#3_Device_Hazard_Analysis\" title=\"3.\u30c7\u30d0\u30a4\u30b9\u306e\u30cf\u30b6\u30fc\u30c9\u5206\u6790\u00a0\">3.\u30c7\u30d0\u30a4\u30b9\u306e\u30cf\u30b6\u30fc\u30c9\u5206\u6790\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/#4_Software_Requirements_Specification\" title=\"4.\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8981\u6c42\u4ed5\u69d8\">4.\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8981\u6c42\u4ed5\u69d8<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/#5_Architecture_Design_Chart\" title=\"5.\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u8a2d\u8a08\u56f3\">5.\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u8a2d\u8a08\u56f3<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/#6_Software_Design_Specifications_SDS\" title=\"6.\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8a2d\u8a08\u4ed5\u69d8\u66f8\uff08SDS\">6.\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8a2d\u8a08\u4ed5\u69d8\u66f8\uff08SDS<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/#7_Traceability_Analysis\" title=\"7.\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u5206\u6790\">7.\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u5206\u6790<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/#8_Software_Development_Environment_Description_SDED\" title=\"8.\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u958b\u767a\u74b0\u5883\u8a18\u8ff0\uff08SDED\">8.\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u958b\u767a\u74b0\u5883\u8a18\u8ff0\uff08SDED<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/#9_Verification_and_Validation_Documentation\" title=\"9.\u691c\u8a3c\u304a\u3088\u3073\u59a5\u5f53\u6027\u78ba\u8a8d\u306e\u305f\u3081\u306e\u6587\u66f8\">9.\u691c\u8a3c\u304a\u3088\u3073\u59a5\u5f53\u6027\u78ba\u8a8d\u306e\u305f\u3081\u306e\u6587\u66f8<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/#10_Revision_Level_History\" title=\"10.\u30ea\u30d3\u30b8\u30e7\u30f3\u30ec\u30d9\u30eb\u5c65\u6b74\">10.\u30ea\u30d3\u30b8\u30e7\u30f3\u30ec\u30d9\u30eb\u5c65\u6b74<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/#11_Unresolved_Anomalies\" title=\"11.\u672a\u89e3\u6c7a\u306e\u30a2\u30ce\u30de\u30ea\u30fc\u00a0\">11.\u672a\u89e3\u6c7a\u306e\u30a2\u30ce\u30de\u30ea\u30fc\u00a0<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDA-Doc\">\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30e9\u30a4\u30bf\u30fc<\/a> Shreya Chenni\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u305f\u3081\u306eFDA\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30fb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u306e\u30ac\u30a4\u30c9\u3092\u63d0\u4f9b\u3057\u3066\u304a\u308a\u3001\u5206\u985e\u306b\u57fa\u3065\u304f\u8981\u4ef6\u306e\u5185\u8a33\u3082\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u00a0<\/em><\/p>\n<p><span style=\"font-weight: 400;\">\u306e\u3067\u3059\u3002 <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> industry is seeing rapid technological advancement and a high rate of innovation.\u00a0 Nowadays, many devices are AI-enabled, which allows early detection of disease, identification of different patterns of a biological activity, and improved diagnostic accuracy. Some examples of AI-enabled applications or devices include Arterys Application, Philips WSI and QuantX by Quantitative Insights. The software has to be verified and validated, to ensure its safety and effectiveness.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u542b\u3080\u3059\u3079\u3066\u306e\u30c7\u30d0\u30a4\u30b9\u3067 <a href=\"https:\/\/www.kolabtree.com\/blog\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/\">510(k)\u30eb\u30fc\u30c8<\/a>\u305d\u306e\u305f\u3081\u306b\u306f\u3001\u7279\u5b9a\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u95a2\u9023\u306e\u66f8\u985e\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u4ee5\u4e0b\u306e\u5834\u5408\u306b\u5fc5\u8981\u306a\u66f8\u985e\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/510-k-submissions\">510(k)\u306e\u63d0\u51fa\u7269<\/a> \u307e\u305f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u5206\u985e\u306b\u57fa\u3065\u3044\u3066\u3001\u3069\u306e\u3088\u3046\u306b\u8d77\u8349\u3059\u308b\u304b\u3092\u7406\u89e3\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u00a0\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_to_classify_your_medical_device_software\"><\/span><b>\u533b\u7642\u6a5f\u5668\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u3069\u306e\u3088\u3046\u306b\u5206\u985e\u3059\u308b\u304b\uff1f\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u8a72\u5f53\u3059\u308b\u61f8\u5ff5\u30ec\u30d9\u30eb\uff08LoC\uff09\u3092\u7279\u5b9a\u3059\u308b\u30023\u3064\u306e\u30ec\u30d9\u30eb\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u91cd\u5927\uff1a\u6545\u969c\u3084\u6f5c\u5728\u7684\u306a\u6b20\u9665\u304c\u3001\u60a3\u8005\u3084\u64cd\u4f5c\u8005\u306e\u6b7b\u4ea1\u3084\u91cd\u50b7\u306b\u76f4\u7d50\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3082\u306e\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">OR\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0\u6545\u969c\u3084\u6f5c\u5728\u7684\u306a\u6b20\u9665\u306f\u3001\u8aa4\u3063\u305f\u60c5\u5831\u3084\u9045\u308c\u305f\u60c5\u5831\u3001\u3042\u308b\u3044\u306f\u533b\u7642\u5f93\u4e8b\u8005\u306e\u884c\u52d5\u306b\u3088\u3063\u3066\u3001\u9593\u63a5\u7684\u306b\u60a3\u8005\u3084\u64cd\u4f5c\u8005\u306e\u6b7b\u4ea1\u3084\u91cd\u50b7\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u4e2d\u7a0b\u5ea6\uff1a\u6545\u969c\u3084\u6f5c\u5728\u7684\u306a\u8a2d\u8a08\u4e0a\u306e\u6b20\u9665\u306b\u3088\u308a\u3001\u60a3\u8005\u3084\u64cd\u4f5c\u8005\u304c\u76f4\u63a5\u8efd\u50b7\u3092\u8ca0\u3046\u53ef\u80fd\u6027\u304c\u3042\u308b\u3082\u306e\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u00a0OR\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u8aa4\u3063\u305f\u60c5\u5831\u3084\u9045\u308c\u305f\u60c5\u5831\u3001\u3042\u308b\u3044\u306f\u533b\u7642\u5f93\u4e8b\u8005\u306e\u884c\u52d5\u306b\u3088\u3063\u3066\u3001\u6545\u969c\u3084\u6f5c\u5728\u7684\u306a\u6b20\u9665\u304c\u9593\u63a5\u7684\u306b\u60a3\u8005\u3084\u64cd\u4f5c\u8005\u306b\u8efd\u50b7\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u8efd\u5ea6\uff1a\u6545\u969c\u3084\u6f5c\u5728\u7684\u306a\u8a2d\u8a08\u4e0a\u306e\u6b20\u9665\u304c\u3042\u3063\u3066\u3082\u3001\u60a3\u8005\u3084\u64cd\u4f5c\u8005\u306b\u50b7\u5bb3\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u4f4e\u3044\u5834\u5408\u3002\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u306e\u88681\u3068\u88682\u3092\u4f7f\u7528\u3057\u307e\u3059\u3002 <\/span><a href=\"https:\/\/www.fda.gov\/media\/73065\/download\"><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306b\u642d\u8f09\u3055\u308c\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u5e02\u8ca9\u524d\u63d0\u51fa\u66f8\u985e\u306e\u5185\u5bb9\u306b\u95a2\u3059\u308bFDA\u30ac\u30a4\u30c0\u30f3\u30b9<\/span><\/a><span style=\"font-weight: 400;\"> \u3092\u30af\u30ea\u30c3\u30af\u3057\u3066\u8cea\u554f\u306b\u7b54\u3048\u3001\u3042\u306a\u305f\u306e\u300c\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u61f8\u5ff5\u30ec\u30d9\u30eb\u300d\u3092\u6c7a\u5b9a\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"FDA_software_documents_for_medical_devices\"><\/span><b>\u533b\u7642\u6a5f\u5668\u306eFDA\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u6587\u66f8<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"What_are_the_documents_to_be_submitted\"><\/span><span style=\"font-weight: 400;\">\u63d0\u51fa\u3059\u3079\u304d\u66f8\u985e\u306f\u4f55\u3067\u3059\u304b\uff1f<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u4e2d\u7a0b\u5ea6\u306e\u61f8\u5ff5\u30ec\u30d9\u30eb\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3068\u5927\u898f\u6a21\u306a\u61f8\u5ff5\u30ec\u30d9\u30eb\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3067\u306f\u300111\u7a2e\u985e\u306e\u6587\u66f8\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4e00\u65b9\u3001\u8efd\u5fae\u306a\u61f8\u5ff5\u30ec\u30d9\u30eb\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3067\u306f\u30017\u7a2e\u985e\u306e\u6587\u66f8\u304c\u5fc5\u8981\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u6587\u66f8\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u5185\u5bb9\u306e\u7bc4\u56f2\u3068\u7a0b\u5ea6\u306f\u3001\u305d\u306eLoC\u306b\u5fdc\u3058\u3066\u7570\u306a\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u6b21\u306e\u8868\u306f\u3001\u61f8\u5ff5\u3055\u308c\u308b\u30ec\u30d9\u30eb\u3054\u3068\u306b\u5fc5\u8981\u306a\u66f8\u985e\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><b>\u30de\u30a4\u30ca\u30fc<\/b><\/td>\n<td><b>\u30e2\u30c7\u30ec\u30fc\u30c8<\/b><\/td>\n<td><b>\u30e1\u30b8\u30e3\u30fc<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u60a9\u307f\u306e\u30ec\u30d9\u30eb<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u60a9\u307f\u306e\u30ec\u30d9\u30eb<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u60a9\u307f\u306e\u30ec\u30d9\u30eb<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u8aac\u660e<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u8aac\u660e<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u8aac\u660e<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u30c7\u30d0\u30a4\u30b9\u306e\u30cf\u30b6\u30fc\u30c9\u5206\u6790<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30c7\u30d0\u30a4\u30b9\u306e\u30cf\u30b6\u30fc\u30c9\u5206\u6790<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30c7\u30d0\u30a4\u30b9\u306e\u30cf\u30b6\u30fc\u30c9\u5206\u6790<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8981\u6c42\u4ed5\u69d8\u66f8\uff08SRS<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8981\u6c42\u4ed5\u69d8\u66f8\uff08SRS<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8981\u6c42\u4ed5\u69d8\u66f8\uff08SRS<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u5206\u6790<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u5206\u6790<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u5206\u6790<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u691c\u8a3c\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u691c\u8a3c\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u691c\u8a3c\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u30ea\u30d3\u30b8\u30e7\u30f3\u30ec\u30d9\u30eb\u5c65\u6b74\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30ea\u30d3\u30b8\u30e7\u30f3\u30ec\u30d9\u30eb\u5c65\u6b74\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30ea\u30d3\u30b8\u30e7\u30f3\u30ec\u30d9\u30eb\u5c65\u6b74\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">&#8212;&#8212;&#8212;&#8212;<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u5efa\u7bc9\u8a2d\u8a08\u56f3<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u5efa\u7bc9\u8a2d\u8a08\u56f3<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">&#8212;&#8212;&#8212;&#8212;<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8a2d\u8a08\u4ed5\u69d8\u66f8<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8a2d\u8a08\u4ed5\u69d8\u66f8<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">&#8212;&#8212;&#8212;&#8212;<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u958b\u767a\u74b0\u5883\u306e\u8aac\u660e\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u958b\u767a\u74b0\u5883\u306e\u8aac\u660e\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">&#8212;&#8212;&#8212;&#8212;<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u672a\u89e3\u6c7a\u306e\u7570\u5e38\uff08\u30d0\u30b0\u3084\u30c7\u30a3\u30d5\u30a7\u30af\u30c8\uff09\u306b\u3064\u3044\u3066<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u672a\u89e3\u6c7a\u306e\u7570\u5e38\uff08\u30d0\u30b0\u3084\u30c7\u30a3\u30d5\u30a7\u30af\u30c8\uff09\u306b\u3064\u3044\u3066<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Description_of_the_documents\"><\/span><b>\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u8aac\u660e\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"1_Level_of_Concern\"><\/span><b>1.\u6c17\u306b\u306a\u308b\u30ec\u30d9\u30eb\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u306e\u88681\u3068\u88682\u306e\u8cea\u554f\u306b\u5bfe\u3059\u308b\u7b54\u3048\u3092\u8a18\u9332\u3059\u308b\u3002 <\/span><a href=\"https:\/\/www.fda.gov\/media\/73065\/download\"><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306b\u642d\u8f09\u3055\u308c\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u5e02\u8ca9\u524d\u63d0\u51fa\u66f8\u985e\u306e\u5185\u5bb9\u306b\u95a2\u3059\u308bFDA\u30ac\u30a4\u30c0\u30f3\u30b9<\/span><\/a><span style=\"font-weight: 400;\">\u00a0 \u3053\u306e\u6587\u66f8\u3067\u306f\u6c7a\u5b9a\u3055\u308c\u305f\u61f8\u5ff5\u306e\u30ec\u30d9\u30eb\u306e\u6839\u62e0\u3092\u542b\u3080\u3002\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"2_Software_Description\"><\/span><b>2.\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u8aac\u660e<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u7d39\u4ecb\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u305d\u306e\u7279\u5fb4\u3001\u6a5f\u80fd\u6027\u3001\u4f7f\u7528\u76ee\u7684\u306b\u3064\u3044\u3066\u306e\u5305\u62ec\u7684\u306a\u6982\u8981\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u3001\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0\u8a00\u8a9e\u3001\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u30fb\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3001\u30aa\u30da\u30ec\u30fc\u30c6\u30a3\u30f3\u30b0\u30fb\u30b7\u30b9\u30c6\u30e0\u3001\u65e2\u88fd\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u4f7f\u7528\u306b\u3064\u3044\u3066\u3082\u8a18\u8f09\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u307e\u305f\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u56f3\u3084\u8868\u3092\u63b2\u8f09\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u65e2\u88fd\u54c1\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u4f7f\u7528\u3059\u308b\u5834\u5408\u306f\u3001FDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/shelf-software-use-medical-devices\">\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u65e2\u88fd\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u4f7f\u7528\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>.\"\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"3_Device_Hazard_Analysis\"><\/span><b>3.\u30c7\u30d0\u30a4\u30b9\u306e\u30cf\u30b6\u30fc\u30c9\u5206\u6790\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u00a0\u6a5f\u5668\u306e\u30cf\u30b6\u30fc\u30c9\u5206\u6790\u306f\u5fc5\u9808\u3067\u3059\u3002\u610f\u56f3\u3055\u308c\u305f\u30c7\u30d0\u30a4\u30b9\uff08\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u304a\u3088\u3073\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\uff09\u306e\u4f7f\u7528\u306b\u95a2\u9023\u3059\u308b\u3059\u3079\u3066\u306e\u4e88\u898b\u53ef\u80fd\u306a\u30cf\u30b6\u30fc\u30c9\u3092\u628a\u63e1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30ea\u30b9\u30af\u5206\u6790\u306f\u3001ISO 14971\u306b\u6e96\u62e0\u3057\u3066\u5b9f\u65bd\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u30cf\u30b6\u30fc\u30c9\u5206\u6790\u3067\u306f\u3001\u30cf\u30b6\u30fc\u30c9\u3001\u5371\u967a\u6027\u3001\u30cf\u30b6\u30fc\u30c9\u306e\u91cd\u5927\u5ea6\u3001\u30cf\u30b6\u30fc\u30c9\u306e\u539f\u56e0\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u624b\u6bb5\u3001\u7ba1\u7406\u624b\u6bb5\u306e\u691c\u8a3c\u3092\u7279\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"4_Software_Requirements_Specification\"><\/span><b>4.\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8981\u6c42\u4ed5\u69d8<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8981\u6c42\u4ed5\u69d8\u66f8\uff08SRS\uff09\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306b\u5bfe\u3059\u308b\u3059\u3079\u3066\u306e\u8981\u6c42\u4e8b\u9805\u3092\u6587\u66f8\u5316\u3057\u305f\u3082\u306e\u3067\u3059\u3002\u57fa\u672c\u7684\u306b\u3001\u8981\u4ef6\u306f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u304c\u4f55\u3092\u3059\u3079\u304d\u304b\u3092\u8a18\u8ff0\u3059\u308b\u3002\u8981\u4ef6\u306f\u3001\u6a5f\u80fd\u3001\u6027\u80fd\u3001\u30e6\u30fc\u30b6\u30fc\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u3001\u898f\u5236\u306a\u3069\u3001\u3055\u307e\u3056\u307e\u306a\u30d0\u30b1\u30c4\u306b\u5165\u308c\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30de\u30a4\u30ca\u30fc\u306aLoC\u306e\u5834\u5408\u3001SRS\u306f\u6a5f\u80fd\u7684\u306a\u8981\u6c42\u306e\u8981\u7d04\u3067\u3088\u3044\u304c\u3001\u4e2d\u7a0b\u5ea6\u3084\u30e1\u30b8\u30e3\u30fc\u306e\u5834\u5408\u3001\u8981\u6c42\u306f\u8a73\u7d30\u3067\u3042\u308a\u3001\u5178\u578b\u7684\u306a\u30ea\u30b9\u30c8\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u30ea\u30b9\u30c8\u30a2\u30c3\u30d7\u3055\u308c\u305f\u5404\u8981\u4ef6\u306b\u306f\u3001SRS-01\u3001SRS-02\u306a\u3069\u306e\u8981\u4ef6ID\u304c\u5272\u308a\u5f53\u3066\u3089\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3053\u3053\u3067\u306f\u3001SRS\u306e\u4f8b\u3092\u3044\u304f\u3064\u304b\u3054\u7d39\u4ecb\u3057\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u8981\u4ef6\u3002\u306b\u3064\u3044\u3066\u306e\u8981\u4ef6\u3092\u542b\u3081\u308b\u3002\u00a0\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u30de\u30a4\u30af\u30ed\u30d7\u30ed\u30bb\u30c3\u30b5\u30fc\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u30e1\u30e2\u30ea\u30fc\u30c7\u30d0\u30a4\u30b9<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u30bb\u30f3\u30b5\u30fc\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u30a8\u30cd\u30eb\u30ae\u30fc\u6e90\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u5b89\u5168\u6a5f\u80fd<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> \u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0\u8981\u4ef6\u3002\u30d7\u30ed\u30b0\u30e9\u30e0\u30b5\u30a4\u30ba\u306e\u8981\u4ef6\u3001\u5236\u9650\u4e8b\u9805\u306a\u3069\u3092\u542b\u3080\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u8981\u4ef6\u3002\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3068\u30d7\u30ea\u30f3\u30bf\u30fc\u3084\u30e2\u30cb\u30bf\u30fc\u306a\u3069\u306e\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u6a5f\u5668\u3068\u306e\u9593\u306e\u901a\u4fe1\u306b\u3064\u3044\u3066\u306e\u8981\u4ef6\u3092\u542b\u3080\u3002\u305d\u306e\u4ed6\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u304c\u5bfe\u5fdc\u3057\u3066\u3044\u308bOS\u306a\u3069\u306e\u8981\u4ef6\u3082\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u6027\u80fd\u304a\u3088\u3073\u6a5f\u80fd\u8981\u4ef6 \u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u6027\u80fd\u304a\u3088\u3073\u6a5f\u80fd\u8981\u4ef6\u306b\u306f\u3001\u6cbb\u7642\u3001\u8a3a\u65ad\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u30a2\u30e9\u30fc\u30e0\u3001\u5206\u6790\u3001\u304a\u3088\u3073\u89e3\u91c8\u306e\u305f\u3081\u306e\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u307e\u305f\u306f\u5236\u5fa1\u7279\u6027\u304c\u542b\u307e\u308c\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u3001\u5168\u6587\u53c2\u7167\u307e\u305f\u306f\u88cf\u4ed8\u3051\u3068\u306a\u308b\u81e8\u5e8a\u30c7\u30fc\u30bf\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u307e\u305f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u6027\u80fd\u3084\u6a5f\u80fd\u306b\u95a2\u3059\u308b\u8981\u6c42\u4e8b\u9805\u3082\u542b\u307e\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306b\u3088\u308b\u30c7\u30d0\u30a4\u30b9\u306e\u5236\u9650\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u5185\u90e8\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30c6\u30b9\u30c8\u3068\u30c1\u30a7\u30c3\u30af<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30a8\u30e9\u30fc\u30fb\u5272\u8fbc\u307f\u51e6\u7406\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30d5\u30a9\u30fc\u30eb\u30c8\u691c\u51fa\u3001\u8010\u6027\u3001\u56de\u5fa9\u7279\u6027 12 \u975e\u62d8\u675f\u306e\u63a8\u5968\u4e8b\u9805\u3092\u542b\u3080\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u5b89\u5168\u6027\u306b\u3064\u3044\u3066<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30bf\u30a4\u30df\u30f3\u30b0\u3068\u30e1\u30e2\u30ea\u306e\u8981\u6c42\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u9069\u5207\u3067\u3042\u308c\u3070\u3001\u65e2\u88fd\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u8b58\u5225\u3002\u00a0<\/span><\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"5_Architecture_Design_Chart\"><\/span><b>5.\u30a2\u30fc\u30ad\u30c6\u30af\u30c1\u30e3\u8a2d\u8a08\u56f3<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u00a0\u3053\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u4e3b\u8981\u306a\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u307e\u305f\u306f\u6a5f\u80fd\u30d6\u30ed\u30c3\u30af\u9593\u306e\u95a2\u4fc2\u3001\u30c7\u30fc\u30bf\u306e\u6d41\u308c\u3001\u304a\u3088\u3073\u76f8\u4e92\u4f5c\u7528\u3092\u660e\u78ba\u306b\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u901a\u5e38\u3001\u30d5\u30ed\u30fc\u30c1\u30e3\u30fc\u30c8\u3084\u30d6\u30ed\u30c3\u30af\u30c0\u30a4\u30a2\u30b0\u30e9\u30e0\u306a\u3069\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u305f\u5f62\u5f0f\u3067\u63cf\u304b\u308c\u308b\u3002\u4e2d\u7a0b\u5ea6\u306e\u61f8\u5ff5\u30ec\u30d9\u30eb\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u304a\u3088\u3073\u4e3b\u8981\u306a\u61f8\u5ff5\u30ec\u30d9\u30eb\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306b\u3064\u3044\u3066\u306f\u3001\u30c7\u30b6\u30a4\u30f3\u30c1\u30e3\u30fc\u30c8\u306b\u72b6\u614b\u56f3\u3092\u542b\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"6_Software_Design_Specifications_SDS\"><\/span><b>6.\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u8a2d\u8a08\u4ed5\u69d8\u66f8\uff08SDS<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u8981\u4ef6\u306e\u5b9f\u65bd\u306b\u3064\u3044\u3066\u306f\u3001\u672c\u6587\u66f8\u3067\u8a73\u8ff0\u3059\u308b\u3002\u5404 SDS \u306b\u306f\u3001SRS \u3068\u540c\u69d8\u306b SDS-01 \u306e\u3088\u3046\u306a\u756a\u53f7\u3092\u4ed8\u3051\u308b\u3002SRS\u306b\u542b\u307e\u308c\u308b\u5404\u8981\u4ef6\u306b\u306f\u3001\u5bfe\u5fdc\u3059\u308b\u8a2d\u8a08\u4ed5\u69d8\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002\u305f\u3060\u3057\u30011\u3064\u306e\u8a2d\u8a08\u4ed5\u69d8\u304c\u4e00\u7fa4\u306e\u8981\u4ef6\u306b\u5bfe\u5fdc\u3059\u308b\u3053\u3068\u3082\u53ef\u80fd\u3067\u3042\u308b\u3002\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"7_Traceability_Analysis\"><\/span><b>7.\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u5206\u6790<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306f\u3001\u8981\u6c42\u4e8b\u9805\u3001\u8a2d\u8a08\u4ed5\u69d8\u3001\u30cf\u30b6\u30fc\u30c9\u3001V&amp;V\u30c6\u30b9\u30c8\u3092\u30ea\u30f3\u30af\u3057\u3066\u3044\u307e\u3059\u3002\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30de\u30c8\u30ea\u30af\u30b9\u306f\u4ee5\u4e0b\u306e\u3088\u3046\u306b\u4f5c\u6210\u3055\u308c\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u8a73\u7d30\u3092\u8ffd\u52a0\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><span style=\"font-weight: 400;\">\u30e6\u30fc\u30b6\u30fc\u30cb\u30fc\u30ba\uff08\u30aa\u30d7\u30b7\u30e7\u30f3<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SRS<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SDS<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u5371\u967a\u6027<\/span><\/td>\n<td><span style=\"font-weight: 400;\">V&amp;V\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">UND-001<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SRS-001<\/span><\/p>\n<p><span style=\"font-weight: 400;\">SRS-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SDS-001<\/span><\/td>\n<td><span style=\"font-weight: 400;\">HAZ-001<\/span><\/td>\n<td><span style=\"font-weight: 400;\">TC-001<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">UND-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SRS-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SDS-001<\/span><\/p>\n<p><span style=\"font-weight: 400;\">SDS-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">HAZ-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">TC-002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">TC-004<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h3><span class=\"ez-toc-section\" id=\"8_Software_Development_Environment_Description_SDED\"><\/span><b>8.\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u958b\u767a\u74b0\u5883\u8a18\u8ff0\uff08SDED<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u4e2d\u7a0b\u5ea6\u306e\u61f8\u5ff5\u30ec\u30d9\u30eb\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u958b\u767a\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u8a08\u753b\u3001\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u6d3b\u52d5\u3092\u8a18\u8f09\u3057\u305fSDED\u306e\u63d0\u51fa\u304c\u5fc5\u8981\u3067\u3059\u3002\u4e2d\u7a0b\u5ea6\u3068\u30e1\u30b8\u30e3\u30fc\u3067\u306f\u8a73\u7d30\u306e\u30ec\u30d9\u30eb\u304c\u7570\u306a\u308b\u3002EN 62304 Table 1: Table A.1 - Summary of requirements by software safety class\u3092\u53c2\u7167\u306e\u3053\u3068\u3002\u3053\u308c\u306f\u3001\u30af\u30e9\u30b9\u3054\u3068\u306b\u542b\u307e\u308c\u308b\u3079\u304d\u8981\u7d20\u3068\u6587\u66f8\u5316\u3055\u308c\u308b\u3079\u304d\u6d3b\u52d5\u3092\u7279\u5b9a\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3067\u304d\u308b\u3002A\u3001B\u3001C\u306e3\u3064\u306e\u30af\u30e9\u30b9\u306f\u3001FDA\u306e\u61f8\u5ff5\u30ec\u30d9\u30eb\u3068\u4e00\u81f4\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"9_Verification_and_Validation_Documentation\"><\/span><b>9.\u691c\u8a3c\u304a\u3088\u3073\u59a5\u5f53\u6027\u78ba\u8a8d\u306e\u305f\u3081\u306e\u6587\u66f8<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u30de\u30a4\u30ca\u30fc\u306aLoC\u3002\u30c7\u30d0\u30a4\u30b9\u30ec\u30d9\u30eb\u306e\u30c6\u30b9\u30c8\u3068\u7d71\u5408\u30c6\u30b9\u30c8\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09\u3092\u6587\u66f8\u5316\u3059\u308b\u3002\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9\u306b\u306f\u3001\u53d7\u3051\u5165\u308c\u57fa\u6e96\u3068\u30c6\u30b9\u30c8\u7d50\u679c\u306e\u6982\u8981\u304c\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u4e2d\u7a0b\u5ea6\u306eLoC\u3002\u59a5\u5f53\u6027\u78ba\u8a8d\u3068\u691c\u8a3c\u306e\u6d3b\u52d5\u3068\u305d\u306e\u7d50\u679c\u3092\u307e\u3068\u3081\u305f\u6587\u66f8\u3002\u53d7\u3051\u5165\u308c\u57fa\u6e96\u3092\u542b\u3081\u308b\u3002\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc\u5206\u6790\u304c\u30c6\u30b9\u30c8\u30b1\u30fc\u30b9ID\u3092\u53c2\u7167\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30e1\u30b8\u30e3\u30fc\u306aLoC\u3002\u4e0a\u8a18\uff08Moderate LoC\uff09\u306e\u60c5\u5831\u306b\u52a0\u3048\u3066\u3001\u5931\u6557\u3057\u305f\u30c6\u30b9\u30c8\u3068\u305d\u308c\u306b\u5bfe\u3059\u308b\u5909\u66f4\u306e\u8a18\u8ff0\u3092\u6587\u66f8\u5316\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"10_Revision_Level_History\"><\/span><b>10.\u30ea\u30d3\u30b8\u30e7\u30f3\u30ec\u30d9\u30eb\u5c65\u6b74<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3078\u306e\u4e3b\u306a\u5909\u66f4\u70b9\u3092\u6587\u66f8\u5316\u3057\u3001\u6700\u7d42\u30e9\u30a4\u30f3\u306e\u6642\u9593\/\u30a8\u30f3\u30c8\u30ea\u304c\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u6700\u65b0\u30d0\u30fc\u30b8\u30e7\u30f3\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002\u30d0\u30fc\u30b8\u30e7\u30f3\u756a\u53f7\u3001\u65e5\u4ed8\u3092\u7279\u5b9a\u3057\u3001\u65e7\u30d0\u30fc\u30b8\u30e7\u30f3\u306b\u5bfe\u3059\u308b\u5909\u66f4\u70b9\u3092\u8aac\u660e\u3059\u308b\u3002\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"11_Unresolved_Anomalies\"><\/span><b>11.\u672a\u89e3\u6c7a\u306e\u30a2\u30ce\u30de\u30ea\u30fc\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u30ea\u30ea\u30fc\u30b9\u3055\u308c\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306b\u5b58\u5728\u3059\u308b\u672a\u89e3\u6c7a\u306e\u30d0\u30b0\u3092\u6587\u66f8\u5316\u3059\u308b\u3002\u305d\u308c\u305e\u308c\u306e\u30d0\u30b0\u306b\u3064\u3044\u3066\u4ee5\u4e0b\u306e\u3053\u3068\u3092\u628a\u63e1\u3059\u308b\u3002\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u554f\u984c\u70b9<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u30c7\u30d0\u30a4\u30b9\u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3078\u306e\u5f71\u97ff\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u3053\u308c\u3089\u306e\u30d0\u30b0\u3092\u4fee\u6b63\u3059\u308b\u305f\u3081\u306e\u8a08\u753b\u7684\u306a\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u4e0a\u8a1811\u7a2e\u985e\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306b\u5fc5\u8981\u306a\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3092\u3059\u3079\u3066\u7db2\u7f85\u3057\u3066\u3044\u307e\u3059\u3002\u3055\u3089\u306b\u3001FDA\u306f\u3001\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u8a08\u753b\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u3001V&amp;V\u30c6\u30b9\u30c8\u3068\u305d\u306e\u7d50\u679c\u306a\u3069\u306e\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u6587\u66f8\u3092\u8981\u6c42\u3057\u3066\u3044\u308b\u3002\u3053\u306eFDA\u306e\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u8981\u4ef6\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u8a73\u7d30\u306b\u3064\u3044\u3066\u306f\u3001\u4ee5\u4e0b\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002 <\/span><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/content-premarket-submissions-management-cybersecurity-medical-devices\"><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u7ba1\u7406\u306e\u305f\u3081\u306e\u5e02\u8ca9\u7533\u8acb\u66f8\u306e\u5185\u5bb9\u306b\u3064\u3044\u3066<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><a href=\"https:\/\/www.fda.gov\/media\/73065\/download\"><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306b\u642d\u8f09\u3055\u308c\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u5e02\u8ca9\u5f8c\u7533\u8acb\u66f8\u306e\u5185\u5bb9\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9<\/span><\/a><\/li>\n<\/ul>\n<blockquote><p><strong>\u533b\u7642\u6a5f\u5668\u306eFDA\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30fb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u3067\u304a\u56f0\u308a\u3067\u3059\u304b\uff1f\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30e9\u30a4\u30bf\u30fc\u3068\u9023\u7d61\u3092\u53d6\u3063\u3066\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions\">FDA\u7533\u8acb\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/a> \u3092Kolabtree\u306b\u63b2\u8f09\u3057\u307e\u3057\u305f\u3002<\/strong><\/p><\/blockquote>","protected":false},"excerpt":{"rendered":"<p>Freelance regulatory writer Shreya Chenni provides a guide to FDA software documentation for medical devices, including a breakdown of the requirements based on classification.\u00a0 The medical device industry is seeing rapid technological advancement and a high rate of innovation.\u00a0 Nowadays, many devices are AI-enabled, which allows early detection of disease, identification of different patterns of a biological activity, and improved diagnostic accuracy. Some examples of AI-enabled applications or devices include Arterys Application, Philips WSI and QuantX by Quantitative Insights. The software has to be verified and validated, to ensure its safety and effectiveness.\u00a0 For any device that contains software going through the 510(k) route, specific software-related documents have to be<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":8292,"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>\u00a0FDA Software Documentation for Medical Devices - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"A quick guide to FDA software documentation for medical devices including classification and a checklist of documents required.\" \/>\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\/fda-software-documentation-for-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u00a0FDA Software Documentation for Medical Devices\" \/>\n<meta property=\"og:description\" content=\"A quick guide to FDA software documentation for medical devices including classification and a checklist of documents required.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/fda-software-documentation-for-medical-devices\/\" \/>\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=\"2020-09-01T08:53:58+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-10-04T07:45:19+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/09\/medicaldevice-software.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"626\" \/>\n\t<meta property=\"og:image:height\" content=\"417\" \/>\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=\"6\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"\u00a0FDA Software Documentation for Medical Devices - 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