{"id":8820,"date":"2026-02-09T16:47:13","date_gmt":"2026-02-09T08:47:13","guid":{"rendered":"https:\/\/www.thy-precision.com\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ae%e8%a8%ad%e8%a8%88%e3%83%bb%e9%96%8b%e7%99%ba%e3%81%a8%e3%81%af%ef%bc%9f%e8%a3%bd%e5%93%81%e4%bc%81%e7%94%bb%e3%81%8b%e3%82%89%e8%a9%a6%e4%bd%9c%e3%83%bb\/"},"modified":"2026-10-08T01:54:42","modified_gmt":"2026-10-07T17:54:42","slug":"design-for-medical-devices-turning-concepts-into-market-launch","status":"publish","type":"post","link":"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u3068\u306f\uff1f\u88fd\u54c1\u4f01\u753b\u304b\u3089\u8a66\u4f5c\u30fb\u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c\u3092\u89e3\u8aac"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306e\u30a2\u30a4\u30c7\u30a2\u3092\u5b9f\u969b\u306e\u88fd\u54c1\u3068\u3057\u3066\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u307e\u3067\u306b\u306f\u3001\u7dbf\u5bc6\u306a\u8a08\u753b\u3001\u6cd5\u898f\u5236\u3078\u306e\u5bfe\u5fdc\u3001\u305d\u3057\u3066\u9ad8\u5ea6\u306a\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u6280\u8853\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u307e\u305f\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306e\u5404\u6bb5\u968e\u306b\u304a\u3044\u3066\u3001\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u898f\u5236\u8981\u4ef6\u3084\u60a3\u8005\u306e\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u57fa\u6e96\u3092\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u9069\u5207\u306b\u69cb\u7bc9\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u6cd5\u898f\u5236\u3078\u306e\u9069\u5408\u3060\u3051\u3067\u306a\u304f\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u3084\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3046\u3048\u3067\u3082\u91cd\u8981\u3067\u3059\u3002  <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u672c\u8a18\u4e8b\u3067\u306f\u3001\u9ad8\u54c1\u8cea\u306a\u533b\u7642\u6a5f\u5668\u3092\u958b\u767a\u3057\u3001\u5e02\u5834\u6295\u5165\u306b\u3064\u306a\u3052\u308b\u305f\u3081\u306b\u91cd\u8981\u3068\u306a\u308b\u8a2d\u8a08\u306e\u57fa\u672c\u539f\u5247\u3068\u88fd\u9020\u6226\u7565\u306b\u3064\u3044\u3066\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_85 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AE%E8%A8%AD%E8%A8%88%E3%83%BB%E9%96%8B%E7%99%BA%E3%81%AB%E3%81%8A%E3%81%84%E3%81%A6%E5%93%81%E8%B3%AA%E3%81%8C%E9%87%8D%E8%A6%81%E3%81%AA%E7%90%86%E7%94%B1\" >\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u306b\u304a\u3044\u3066\u54c1\u8cea\u304c\u91cd\u8981\u306a\u7406\u7531<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AE%E8%A8%AD%E8%A8%88%E3%83%BB%E9%96%8B%E7%99%BA%E3%81%8B%E3%82%89%E5%B8%82%E5%A0%B4%E6%8A%95%E5%85%A5%E3%81%BE%E3%81%A7%E3%81%AE%E6%B5%81%E3%82%8C\" >\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u304b\u3089\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#1_%E8%A3%BD%E5%93%81%E4%BC%81%E7%94%BB%E3%83%BB%E3%82%A2%E3%82%A4%E3%83%87%E3%82%A2%E3%81%AE%E6%A4%9C%E8%A8%8E\" >1. \u88fd\u54c1\u4f01\u753b\u30fb\u30a2\u30a4\u30c7\u30a2\u306e\u691c\u8a0e<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#2_%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AE%E3%82%AF%E3%83%A9%E3%82%B9%E5%88%86%E9%A1%9E\" >2. \u533b\u7642\u6a5f\u5668\u306e\u30af\u30e9\u30b9\u5206\u985e<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#3_%E8%A8%AD%E8%A8%88%E3%82%A4%E3%83%B3%E3%83%97%E3%83%83%E3%83%88%EF%BC%88Design_Input%EF%BC%89\" >3. \u8a2d\u8a08\u30a4\u30f3\u30d7\u30c3\u30c8\uff08Design Input\uff09<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#4_%E8%A8%AD%E8%A8%88%E3%83%BB%E8%A9%A6%E4%BD%9C\" >4. \u8a2d\u8a08\u30fb\u8a66\u4f5c<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#5_%E8%A8%AD%E8%A8%88%E3%82%A2%E3%82%A6%E3%83%88%E3%83%97%E3%83%83%E3%83%88%EF%BC%88Design_Output%EF%BC%89\" >5. \u8a2d\u8a08\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\uff08Design Output\uff09<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#6_%E6%A4%9C%E8%A8%BC%E3%83%BB%E5%A6%A5%E5%BD%93%E6%80%A7%E7%A2%BA%E8%AA%8D%EF%BC%88Verification_Validation%EF%BC%89\" >6. \u691c\u8a3c\u30fb\u59a5\u5f53\u6027\u78ba\u8a8d\uff08Verification &amp; Validation\uff09<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#7_%E8%A6%8F%E5%88%B6%E5%BD%93%E5%B1%80%E3%81%B8%E3%81%AE%E7%94%B3%E8%AB%8B%E3%83%BB%E6%89%BF%E8%AA%8D\" >7. \u898f\u5236\u5f53\u5c40\u3078\u306e\u7533\u8acb\u30fb\u627f\u8a8d<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#8_%E9%87%8F%E7%94%A3%E3%83%BB%E5%B8%82%E5%A0%B4%E6%8A%95%E5%85%A5\" >8. \u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E8%A8%AD%E8%A8%88%E3%81%A7%E9%87%8D%E8%A6%81%E3%81%A8%E3%81%AA%E3%82%8B5%E3%81%A4%E3%81%AE%E3%83%9D%E3%82%A4%E3%83%B3%E3%83%88\" >\u533b\u7642\u6a5f\u5668\u8a2d\u8a08\u3067\u91cd\u8981\u3068\u306a\u308b5\u3064\u306e\u30dd\u30a4\u30f3\u30c8<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#1_%E5%AE%89%E5%85%A8%E6%80%A7\" >1. \u5b89\u5168\u6027<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#2_%E3%83%88%E3%83%AC%E3%83%BC%E3%82%B5%E3%83%93%E3%83%AA%E3%83%86%E3%82%A3\" >2. \u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#3_%E4%BD%8E%E6%B6%88%E8%B2%BB%E9%9B%BB%E5%8A%9B%E8%A8%AD%E8%A8%88\" >3. \u4f4e\u6d88\u8cbb\u96fb\u529b\u8a2d\u8a08<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#4_%E3%83%AA%E3%82%B9%E3%82%AF%E3%83%9E%E3%83%8D%E3%82%B8%E3%83%A1%E3%83%B3%E3%83%88\" >4. \u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#5_%E3%83%A6%E3%83%BC%E3%82%B6%E3%83%BC%E4%B8%AD%E5%BF%83%E8%A8%AD%E8%A8%88\" >5. \u30e6\u30fc\u30b6\u30fc\u4e2d\u5fc3\u8a2d\u8a08<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AE%E8%A3%BD%E9%80%A0%E3%83%91%E3%83%BC%E3%83%88%E3%83%8A%E3%83%BC%E3%82%92%E9%81%B8%E3%81%B6%E9%9A%9B%E3%81%AE%E3%83%9D%E3%82%A4%E3%83%B3%E3%83%88\" >\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u9078\u3076\u969b\u306e\u30dd\u30a4\u30f3\u30c8<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#1_ISO_13485%E8%AA%8D%E8%A8%BC%E3%82%92%E5%8F%96%E5%BE%97%E3%81%97%E3%81%A6%E3%81%84%E3%82%8B%E3%81%8B\" >1. ISO 13485\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u308b\u304b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#2_%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E8%A6%8F%E5%88%B6%E8%A6%81%E6%B1%82%E3%82%92%E7%90%86%E8%A7%A3%E3%81%97%E3%81%A6%E3%81%84%E3%82%8B%E3%81%8B\" >2. \u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u898f\u5236\u8981\u6c42\u3092\u7406\u89e3\u3057\u3066\u3044\u308b\u304b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#3_%E9%96%8B%E7%99%BA%E3%81%8B%E3%82%89%E9%87%8F%E7%94%A3%E3%81%BE%E3%81%A7%E4%B8%80%E8%B2%AB%E3%81%97%E3%81%A6%E5%AF%BE%E5%BF%9C%E3%81%A7%E3%81%8D%E3%82%8B%E3%81%8B\" >3. \u958b\u767a\u304b\u3089\u91cf\u7523\u307e\u3067\u4e00\u8cab\u3057\u3066\u5bfe\u5fdc\u3067\u304d\u308b\u304b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-21\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#4_%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E8%A3%BD%E9%80%A0%E3%81%AB%E5%AF%BE%E5%BF%9C%E3%81%97%E3%81%A6%E3%81%84%E3%82%8B%E3%81%8B\" >4. \u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u308b\u304b<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-22\" href=\"https:\/\/www.thy-precision.com\/ja\/design-for-medical-devices-turning-concepts-into-market-launch\/#THY%E7%B2%BE%E5%AF%86%E5%B7%A5%E6%A5%AD%E3%81%8C%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E8%A3%BD%E9%80%A0%E3%82%92%E3%82%B5%E3%83%9D%E3%83%BC%E3%83%88\" >THY\u7cbe\u5bc6\u5de5\u696d\u304c\u533b\u7642\u6a5f\u5668\u88fd\u9020\u3092\u30b5\u30dd\u30fc\u30c8<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AE%E8%A8%AD%E8%A8%88%E3%83%BB%E9%96%8B%E7%99%BA%E3%81%AB%E3%81%8A%E3%81%84%E3%81%A6%E5%93%81%E8%B3%AA%E3%81%8C%E9%87%8D%E8%A6%81%E3%81%AA%E7%90%86%E7%94%B1\"><\/span><strong>\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u306b\u304a\u3044\u3066\u54c1\u8cea\u304c\u91cd\u8981\u306a\u7406\u7531<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2026\/02\/\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u3068\u306f\uff1f\u88fd\u54c1\u4f01\u753b\u304b\u3089\u8a66\u4f5c\u30fb\u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c\u3092\u89e3\u8aac01.jpg\" alt=\"\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u3068\u306f\uff1f\u88fd\u54c1\u4f01\u753b\u304b\u3089\u8a66\u4f5c\u30fb\u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c\u3092\u89e3\u8aac\u3002\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u306b\u304a\u3044\u3066\u54c1\u8cea\u304c\u91cd\u8981\u306a\u7406\u7531\" class=\"wp-image-8826\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2026\/02\/\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u3068\u306f\uff1f\u88fd\u54c1\u4f01\u753b\u304b\u3089\u8a66\u4f5c\u30fb\u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c\u3092\u89e3\u8aac01.jpg 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2026\/02\/\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u3068\u306f\uff1f\u88fd\u54c1\u4f01\u753b\u304b\u3089\u8a66\u4f5c\u30fb\u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c\u3092\u89e3\u8aac01-768x422.jpg 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u306f\u3001\u5358\u306b\u5916\u89b3\u3084\u6a5f\u80fd\u3092\u6c7a\u3081\u308b\u3060\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u60a3\u8005\u306e\u5b89\u5168\u6027\u3084\u81e8\u5e8a\u7d50\u679c\u3001\u3055\u3089\u306b\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u627f\u8a8d\u306b\u3082\u76f4\u63a5\u5f71\u97ff\u3057\u307e\u3059\u3002\u8a2d\u8a08\u306b\u554f\u984c\u304c\u3042\u308b\u5834\u5408\u3001\u91cd\u5927\u306a\u4e8b\u6545\u3084\u898f\u5236\u5bfe\u5fdc\u306e\u9045\u308c\u3001\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002 <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8a2d\u8a08\u7ba1\u7406\uff08Design Control\uff09\u3068\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u6d3b\u52d5\u3092\u4f53\u7cfb\u7684\u306b\u7ba1\u7406\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002<a href=\"https:\/\/www.fda.gov\/\">\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09<\/a>\u3084<a href=\"https:\/\/www.ema.europa.eu\/en\/homepage\">\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA: European Medicines Agency\uff09<\/a>\u306a\u3069\u306e\u898f\u5236\u5f53\u5c40\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3058\u3066\u4e00\u8cab\u3057\u305f\u54c1\u8cea\u3092\u78ba\u4fdd\u3057\u3001\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3059\u308b\u305f\u3081\u306e\u8a2d\u8a08\u7ba1\u7406\u4f53\u5236\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002<br>\u7c73\u56fd\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u5bfe\u3057\u3066\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306e\u4e2d\u3067\u8a2d\u8a08\u30fb\u958b\u767a\u306b\u95a2\u3059\u308b\u7ba1\u7406\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002 <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA\u306e21 <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-820#820.30\">CFR Part 820.30<\/a>\u306f\u3001\u898f\u5236\u3078\u306e\u9069\u5408\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u3001\u88fd\u9020\u696d\u8005\u306b\u5bfe\u3057\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306b\u304a\u3044\u3066\u8a2d\u8a08\u7ba1\u7406\u3092\u5c0e\u5165\u3059\u308b\u3053\u3068\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AE%E8%A8%AD%E8%A8%88%E3%83%BB%E9%96%8B%E7%99%BA%E3%81%8B%E3%82%89%E5%B8%82%E5%A0%B4%E6%8A%95%E5%85%A5%E3%81%BE%E3%81%A7%E3%81%AE%E6%B5%81%E3%82%8C\"><\/span><strong>\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u304b\u3089\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2026\/02\/\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u3068\u306f\uff1f\u88fd\u54c1\u4f01\u753b\u304b\u3089\u8a66\u4f5c\u30fb\u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c\u3092\u89e3\u8aac03.jpg\" alt=\"\" class=\"wp-image-8829\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2026\/02\/\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u3068\u306f\uff1f\u88fd\u54c1\u4f01\u753b\u304b\u3089\u8a66\u4f5c\u30fb\u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c\u3092\u89e3\u8aac03.jpg 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2026\/02\/\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u3068\u306f\uff1f\u88fd\u54c1\u4f01\u753b\u304b\u3089\u8a66\u4f5c\u30fb\u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c\u3092\u89e3\u8aac03-768x422.jpg 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u3092\u30a2\u30a4\u30c7\u30a2\u304b\u3089\u88fd\u54c1\u5316\u3057\u3001\u5e02\u5834\u3078\u6295\u5165\u3059\u308b\u307e\u3067\u306b\u306f\u3001\u7dbf\u5bc6\u306a\u8a08\u753b\u3068\u6b63\u78ba\u306a\u958b\u767a\u3001\u3055\u3089\u306b\u5404\u5e02\u5834\u306e\u898f\u5236\u8981\u4ef6\u3078\u306e\u5bfe\u5fdc\u304c\u5fc5\u8981\u3067\u3059\u3002<br>\u3053\u3053\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u958b\u767a\u306b\u304a\u3051\u308b\u4e3b\u306a8\u3064\u306e\u30b9\u30c6\u30c3\u30d7\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002 <br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"1_%E8%A3%BD%E5%93%81%E4%BC%81%E7%94%BB%E3%83%BB%E3%82%A2%E3%82%A4%E3%83%87%E3%82%A2%E3%81%AE%E6%A4%9C%E8%A8%8E\"><\/span><strong>1. \u88fd\u54c1\u4f01\u753b\u30fb\u30a2\u30a4\u30c7\u30a2\u306e\u691c\u8a0e<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u306f\u3001\u533b\u7642\u73fe\u5834\u306b\u304a\u3051\u308b\u672a\u89e3\u6c7a\u306e\u30cb\u30fc\u30ba\u3084\u3001\u65e2\u5b58\u88fd\u54c1\u306e\u6539\u5584\u70b9\u3092\u767a\u898b\u3059\u308b\u3053\u3068\u304b\u3089\u59cb\u307e\u308a\u307e\u3059\u3002<br>\u3053\u306e\u6bb5\u968e\u3067\u306f\u3001\u5e02\u5834\u8abf\u67fb\u3001\u30e6\u30fc\u30b6\u30fc\u3078\u306e\u30d2\u30a2\u30ea\u30f3\u30b0\u3001\u533b\u7642\u73fe\u5834\u3067\u306e\u89b3\u5bdf\u306a\u3069\u3092\u901a\u3058\u3066\u88fd\u54c1\u30b3\u30f3\u30bb\u30d7\u30c8\u3092\u660e\u78ba\u306b\u3057\u307e\u3059\u3002\u958b\u767a\u521d\u671f\u306b\u88fd\u54c1\u306e\u76ee\u7684\u3084\u8981\u4ef6\u3092\u660e\u78ba\u306b\u3057\u3066\u304a\u304f\u3053\u3068\u3067\u3001\u5f8c\u5de5\u7a0b\u306b\u304a\u3051\u308b\u5927\u5e45\u306a\u8a2d\u8a08\u5909\u66f4\u3084\u8ffd\u52a0\u30b3\u30b9\u30c8\u3092\u6291\u3048\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002<br>\u4e3b\u306a\u691c\u8a0e\u9805\u76ee\u306b\u306f\u4ee5\u4e0b\u304c\u3042\u308a\u307e\u3059\u3002   <\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30e6\u30fc\u30b6\u30fc\u30cb\u30fc\u30ba\u306e\u628a\u63e1\uff1a \u533b\u5e2b\u3001\u770b\u8b77\u5e2b\u3001\u305d\u306e\u4ed6\u306e\u533b\u7642\u5f93\u4e8b\u8005\u3084\u60a3\u8005\u306a\u3069\u306e\u30cb\u30fc\u30ba\u3092\u78ba\u8a8d\u3057\u3001\u88fd\u54c1\u306e\u76ee\u7684\u3092\u660e\u78ba\u306b\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u7af6\u5408\u88fd\u54c1\u306e\u5206\u6790\uff1a \u65e2\u5b58\u88fd\u54c1\u3092\u8abf\u67fb\u3057\u3001\u5e02\u5834\u306b\u304a\u3051\u308b\u8ab2\u984c\u3084\u6539\u5584\u306e\u4f59\u5730\u3092\u5206\u6790\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5b9f\u73fe\u53ef\u80fd\u6027\u306e\u691c\u8a0e\uff1a \u6280\u8853\u9762\u3001\u30b3\u30b9\u30c8\u9762\u3001\u898f\u5236\u9762\u306a\u3069\u304b\u3089\u88fd\u54c1\u5316\u306e\u53ef\u80fd\u6027\u3092\u8a55\u4fa1\u3057\u307e\u3059\u3002<br><br><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"2_%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AE%E3%82%AF%E3%83%A9%E3%82%B9%E5%88%86%E9%A1%9E\"><\/span><strong>2. \u533b\u7642\u6a5f\u5668\u306e\u30af\u30e9\u30b9\u5206\u985e<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u7c73\u56fd\u3067\u306fFDA\u304c\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u30fb\u6d41\u901a\u3092\u76e3\u7763\u3057\u3066\u304a\u308a\u3001\u30ea\u30b9\u30af\u30ec\u30d9\u30eb\u306b\u5fdc\u3058\u3066\u533b\u7642\u6a5f\u5668\u3092Class I\u3001Class II\u3001Class III\u306e3\u3064\u306b\u5206\u985e\u3057\u3066\u3044\u307e\u3059\u3002 <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Class I\u306f\u6bd4\u8f03\u7684\u30ea\u30b9\u30af\u306e\u4f4e\u3044\u533b\u7642\u6a5f\u5668\u3001Class II\u306f\u4e2d\u7a0b\u5ea6\u306e\u30ea\u30b9\u30af\u3092\u6301\u3064\u533b\u7642\u6a5f\u5668\u3001Class III\u306f\u751f\u547d\u7dad\u6301\u88c5\u7f6e\u306a\u3069\u3092\u542b\u3080\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u533b\u7642\u6a5f\u5668\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002<br>\u88fd\u54c1\u306e\u30af\u30e9\u30b9\u306b\u3088\u3063\u3066\u5fc5\u8981\u3068\u306a\u308b\u898f\u5236\u5bfe\u5fdc\u3084\u5e02\u8ca9\u524d\u624b\u7d9a\u304d\u304c\u7570\u306a\u308b\u305f\u3081\u3001\u958b\u767a\u306e\u65e9\u3044\u6bb5\u968e\u3067\u5bfe\u8c61\u5e02\u5834\u306b\u304a\u3051\u308b\u88fd\u54c1\u5206\u985e\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002 <br><br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"3_%E8%A8%AD%E8%A8%88%E3%82%A4%E3%83%B3%E3%83%97%E3%83%83%E3%83%88%EF%BC%88Design_Input%EF%BC%89\"><\/span><strong>3. \u8a2d\u8a08\u30a4\u30f3\u30d7\u30c3\u30c8\uff08Design Input\uff09<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u8a2d\u8a08\u30a4\u30f3\u30d7\u30c3\u30c8\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u7528\u9014\u3084\u8981\u6c42\u4e8b\u9805\u3092\u5177\u4f53\u7684\u306a\u8a2d\u8a08\u8981\u4ef6\u3078\u843d\u3068\u3057\u8fbc\u3080\u5de5\u7a0b\u3067\u3059\u3002<br>\u306a\u304b\u3067\u3082\u6750\u6599\u9078\u5b9a\u306f\u91cd\u8981\u3067\u3042\u308a\u3001\u751f\u4f53\u9069\u5408\u6027\u3001\u8010\u4e45\u6027\u3001\u6ec5\u83cc\u65b9\u6cd5\u3068\u306e\u9069\u5408\u6027\u306a\u3069\u3092\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u307e\u305f\u3001\u88fd\u54c1\u306e\u6027\u80fd\u3084\u4fe1\u983c\u6027\u3092\u5de6\u53f3\u3059\u308b\u6a5f\u80fd\u8981\u4ef6\u306b\u3064\u3044\u3066\u3082\u691c\u8a0e\u3057\u307e\u3059\u3002\u5bf8\u6cd5\u7cbe\u5ea6\u3001\u6d88\u8cbb\u96fb\u529b\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3068\u306e\u9023\u643a\u3001\u5b89\u5168\u6a5f\u69cb\u306a\u3069\u3001\u88fd\u54c1\u306b\u5fc5\u8981\u3068\u306a\u308b\u8981\u7d20\u3092\u660e\u78ba\u306b\u3057\u3001\u305d\u308c\u305e\u308c\u304c\u9069\u5207\u306b\u6a5f\u80fd\u3059\u308b\u3088\u3046\u8a2d\u8a08\u3057\u307e\u3059\u3002 <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f8b\u3048\u3070\u3001\u30d0\u30c3\u30c6\u30ea\u30fc\u99c6\u52d5\u578b\u306e\u533b\u7642\u6a5f\u5668\u3067\u306f\u6d88\u8cbb\u96fb\u529b\u304c\u4f7f\u7528\u53ef\u80fd\u6642\u9593\u306b\u76f4\u63a5\u5f71\u97ff\u3057\u307e\u3059\u3002\u307e\u305f\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u7d44\u307f\u8fbc\u3080\u3053\u3068\u3067\u3001\u81ea\u52d5\u5236\u5fa1\u3084\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306a\u3069\u306e\u6a5f\u80fd\u3092\u5b9f\u73fe\u3067\u304d\u307e\u3059\u3002<br><br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"4_%E8%A8%AD%E8%A8%88%E3%83%BB%E8%A9%A6%E4%BD%9C\"><\/span><strong>4. \u8a2d\u8a08\u30fb\u8a66\u4f5c<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u8a2d\u8a08\u30fb\u958b\u767a\u6bb5\u968e\u3067\u306f\u3001\u88fd\u54c1\u30b3\u30f3\u30bb\u30d7\u30c8\u3092\u5b9f\u969b\u306b\u6a5f\u80fd\u3059\u308b\u5f62\u3078\u5177\u4f53\u5316\u3057\u3066\u3044\u304d\u307e\u3059\u3002<br>\u307e\u305a\u30b9\u30b1\u30c3\u30c1\u3084CAD\u30e2\u30c7\u30eb\u3092\u4f5c\u6210\u3057\u3001\u88fd\u54c1\u306e\u69cb\u9020\u3084\u6a5f\u68b0\u8a2d\u8a08\u3092\u691c\u8a0e\u3057\u307e\u3059\u3002\u57fa\u672c\u8a2d\u8a08\u304c\u5b8c\u6210\u3057\u305f\u5f8c\u306f\u30013D\u30d7\u30ea\u30f3\u30c8\u3001CNC\u52a0\u5de5\u3001\u5c04\u51fa\u6210\u5f62\u306a\u3069\u306e\u65b9\u6cd5\u3092\u5229\u7528\u3057\u3066\u8a66\u4f5c\u54c1\u3092\u88fd\u4f5c\u3057\u3001\u8a55\u4fa1\u3084\u8a2d\u8a08\u6539\u5584\u3092\u884c\u3044\u307e\u3059\u3002  <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8a66\u4f5c\u6bb5\u968e\u304b\u3089\u91cf\u7523\u6027\u3092\u8003\u616e\u3057\u305fDFM\uff08Design for Manufacturability\uff1a\u88fd\u9020\u6027\u3092\u8003\u616e\u3057\u305f\u8a2d\u8a08\uff09\u3092\u884c\u3046\u3053\u3068\u3067\u3001\u91cf\u7523\u79fb\u884c\u5f8c\u306e\u8a2d\u8a08\u5909\u66f4\u3084\u88fd\u9020\u4e0a\u306e\u554f\u984c\u3092\u4f4e\u6e1b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<br><br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"5_%E8%A8%AD%E8%A8%88%E3%82%A2%E3%82%A6%E3%83%88%E3%83%97%E3%83%83%E3%83%88%EF%BC%88Design_Output%EF%BC%89\"><\/span><strong>5. \u8a2d\u8a08\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\uff08Design Output\uff09<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u8a2d\u8a08\u5185\u5bb9\u304c\u78ba\u5b9a\u3059\u308b\u3068\u3001\u88fd\u9020\u306b\u5fc5\u8981\u3068\u306a\u308b\u56f3\u9762\u3001\u4ed5\u69d8\u66f8\u3001\u6750\u6599\u4ed5\u69d8\u3001\u88fd\u9020\u6761\u4ef6\u306a\u3069\u306e\u8a2d\u8a08\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002<br>\u3053\u308c\u3089\u306f\u91cf\u7523\u6642\u306e\u88fd\u9020\u3084\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u3068\u306a\u308b\u91cd\u8981\u306a\u60c5\u5831\u3067\u3059\u3002<br>\u8a2d\u8a08\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\u306f\u9069\u5207\u306b\u6587\u66f8\u5316\u3057\u3001\u8a2d\u8a08\u30a4\u30f3\u30d7\u30c3\u30c8\u3068\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u78ba\u4fdd\u3057\u305f\u3046\u3048\u3067\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306e\u4e2d\u3067\u7ba1\u7406\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002  <br><br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"6_%E6%A4%9C%E8%A8%BC%E3%83%BB%E5%A6%A5%E5%BD%93%E6%80%A7%E7%A2%BA%E8%AA%8D%EF%BC%88Verification_Validation%EF%BC%89\"><\/span><strong>6. \u691c\u8a3c\u30fb\u59a5\u5f53\u6027\u78ba\u8a8d\uff08Verification &amp; Validation\uff09<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u8a2d\u8a08\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\u304c\u78ba\u5b9a\u3057\u305f\u5f8c\u306f\u3001\u533b\u7642\u6a5f\u5668\u304c\u8a2d\u8a08\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3001\u5b9f\u969b\u306e\u4f7f\u7528\u74b0\u5883\u306b\u304a\u3044\u3066\u610f\u56f3\u3057\u305f\u3068\u304a\u308a\u306b\u6a5f\u80fd\u3059\u308b\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002Verification\uff08\u691c\u8a3c\uff09\u3067\u306f\u3001\u88fd\u54c1\u304c\u8a2d\u8a08\u4ed5\u69d8\u3084\u6280\u8853\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002 <br><br>\u4e00\u65b9\u3001Validation\uff08\u59a5\u5f53\u6027\u78ba\u8a8d\uff09\u3067\u306f\u3001\u5b9f\u969b\u307e\u305f\u306f\u60f3\u5b9a\u3055\u308c\u308b\u4f7f\u7528\u6761\u4ef6\u306b\u304a\u3044\u3066\u3001\u88fd\u54c1\u304c\u30e6\u30fc\u30b6\u30fc\u306e\u30cb\u30fc\u30ba\u3084\u610f\u56f3\u3057\u305f\u7528\u9014\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<br>\u3053\u306e\u5de5\u7a0b\u306f\u91cf\u7523\u524d\u306b\u6f5c\u5728\u7684\u306a\u554f\u984c\u3092\u767a\u898b\u3057\u3001\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3068\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u91cd\u8981\u3067\u3059\u3002<br><br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"7_%E8%A6%8F%E5%88%B6%E5%BD%93%E5%B1%80%E3%81%B8%E3%81%AE%E7%94%B3%E8%AB%8B%E3%83%BB%E6%89%BF%E8%AA%8D\"><\/span><strong>7. \u898f\u5236\u5f53\u5c40\u3078\u306e\u7533\u8acb\u30fb\u627f\u8a8d<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u691c\u8a3c\u30fb\u59a5\u5f53\u6027\u78ba\u8a8d\u3092\u7d4c\u305f\u5f8c\u3001\u5e02\u5834\u3078\u6295\u5165\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u898f\u5236\u4e0a\u306e\u624b\u7d9a\u304d\u3092\u884c\u3044\u307e\u3059\u3002<br>\u5fc5\u8981\u3068\u306a\u308b\u624b\u7d9a\u304d\u306f\u8ca9\u58f2\u3059\u308b\u56fd\u3084\u5730\u57df\u3001\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002<br>\u7c73\u56fd\u3067\u306f\u3001\u5bfe\u8c61\u3068\u306a\u308b\u88fd\u54c1\u306b\u3064\u3044\u3066510(k)\u5e02\u8ca9\u524d\u5c4a\u51fa\u3084PMA\uff08\u5e02\u8ca9\u524d\u627f\u8a8d\uff09\u306a\u3069\u306e\u624b\u7d9a\u304d\u304c\u5fc5\u8981\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<br>EU\u5e02\u5834\u3067\u306f\u3001EU\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08MDR 2017\/745\uff09\u306a\u3069\u306e\u9069\u7528\u8981\u4ef6\u3092\u78ba\u8a8d\u3057\u3001\u8a72\u5f53\u3059\u308b\u5834\u5408\u306fNotified Body\uff08\u8a8d\u8a3c\u6a5f\u95a2\uff09\u306b\u3088\u308b\u9069\u5408\u6027\u8a55\u4fa1\u306a\u3069\u3092\u7d4c\u3066CE\u30de\u30fc\u30ad\u30f3\u30b0\u306b\u5fc5\u8981\u306a\u624b\u7d9a\u304d\u3092\u884c\u3044\u307e\u3059\u3002 <\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA\u627f\u8a8d\uff08\u7c73\u56fd\uff09\uff1a\u30cf\u30a4\u30ea\u30b9\u30af\u306e\u533b\u7642\u6a5f\u5668\u306b\u3064\u3044\u3066\u306f\u3001<a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions-selecting-and-preparing-correct-submission\/premarket-notification-510k\">510(k)<\/a>\u627f\u8a8d\uff08\u5b9f\u8cea\u7684\u540c\u7b49\u6027\u306b\u57fa\u3065\u304f\u627f\u8a8d\uff09\u307e\u305f\u306f\u5e02\u8ca9\u524d\u627f\u8a8d\uff08PMA\uff09\u304c\u5fc5\u8981\u3067\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>CE\u30de\u30fc\u30af\uff08EU\uff09\uff1a<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32017R0745&amp;qid=1742263908178\">MDR 2017\/745<\/a>\u3078\u306e\u9069\u5408\u304a\u3088\u3073\u30ce\u30fc\u200b\u200b\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\uff08\u901a\u77e5\u6a5f\u95a2\uff09\u306b\u3088\u308b\u627f\u8a8d\u304c\u5fc5\u8981\u3067\u3059\u3002<br><br><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"8_%E9%87%8F%E7%94%A3%E3%83%BB%E5%B8%82%E5%A0%B4%E6%8A%95%E5%85%A5\"><\/span><strong>8. \u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5fc5\u8981\u306a\u624b\u7d9a\u304d\u304c\u5b8c\u4e86\u3059\u308b\u3068\u3001\u91cf\u7523\u4f53\u5236\u3092\u69cb\u7bc9\u3057\u3001\u88fd\u54c1\u3092\u5e02\u5834\u3078\u6295\u5165\u3057\u307e\u3059\u3002<br>\u3057\u304b\u3057\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u306f\u5e02\u5834\u6295\u5165\u3067\u7d42\u308f\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<br>\u5e02\u5834\u6295\u5165\u5f8c\u3082\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\uff08Post-Market Surveillance\uff09\u3092\u901a\u3058\u3066\u88fd\u54c1\u306e\u6027\u80fd\u3084\u4e0d\u5177\u5408\u3001\u6709\u5bb3\u4e8b\u8c61\u306a\u3069\u3092\u7d99\u7d9a\u7684\u306b\u78ba\u8a8d\u3057\u3001\u5b89\u5168\u6027\u3068\u54c1\u8cea\u3092\u7dad\u6301\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E8%A8%AD%E8%A8%88%E3%81%A7%E9%87%8D%E8%A6%81%E3%81%A8%E3%81%AA%E3%82%8B5%E3%81%A4%E3%81%AE%E3%83%9D%E3%82%A4%E3%83%B3%E3%83%88\"><\/span><strong>\u533b\u7642\u6a5f\u5668\u8a2d\u8a08\u3067\u91cd\u8981\u3068\u306a\u308b5\u3064\u306e\u30dd\u30a4\u30f3\u30c8<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2026\/02\/\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u3068\u306f\uff1f\u88fd\u54c1\u4f01\u753b\u304b\u3089\u8a66\u4f5c\u30fb\u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c\u3092\u89e3\u8aac02.jpg\" alt=\"\" class=\"wp-image-8832\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2026\/02\/\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u3068\u306f\uff1f\u88fd\u54c1\u4f01\u753b\u304b\u3089\u8a66\u4f5c\u30fb\u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c\u3092\u89e3\u8aac02.jpg 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2026\/02\/\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u3068\u306f\uff1f\u88fd\u54c1\u4f01\u753b\u304b\u3089\u8a66\u4f5c\u30fb\u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c\u3092\u89e3\u8aac02-768x422.jpg 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306e\u6027\u80fd\u3001\u5b89\u5168\u6027\u3001\u4f7f\u3044\u3084\u3059\u3055\u3092\u5de6\u53f3\u3059\u308b\u4ee3\u8868\u7684\u306a5\u3064\u306e\u8a2d\u8a08\u8981\u7d20\u306b\u3064\u3044\u3066\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"1_%E5%AE%89%E5%85%A8%E6%80%A7\"><\/span><strong>1. \u5b89\u5168\u6027<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u60a3\u8005\u306e\u5b89\u5168\u6027\u306f\u3001\u533b\u7642\u6a5f\u5668\u958b\u767a\u306b\u304a\u3044\u3066\u6700\u3082\u91cd\u8981\u306a\u8981\u7d20\u306e\u4e00\u3064\u3067\u3059\u3002<br>\u533b\u7642\u6a5f\u5668\u306e\u6545\u969c\u3084\u8aa4\u4f5c\u52d5\u306f\u91cd\u5927\u306a\u30ea\u30b9\u30af\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u958b\u767a\u521d\u671f\u304b\u3089\u5b89\u5168\u6027\u3092\u8003\u616e\u3057\u305f\u8a2d\u8a08\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002  <\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u751f\u4f53\u9069\u5408\u6027<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u4eba\u4f53\u3084\u7d44\u7e54\u306b\u63a5\u89e6\u3059\u308b\u6750\u6599\u306b\u3064\u3044\u3066\u306f\u3001\u7528\u9014\u3084\u63a5\u89e6\u6761\u4ef6\u306b\u5fdc\u3058\u3066\u751f\u4f53\u9069\u5408\u6027\u3092\u8a55\u4fa1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002ISO 10993\u30b7\u30ea\u30fc\u30ba\u306a\u3069\u306e\u898f\u683c\u306b\u57fa\u3065\u304d\u3001\u751f\u7269\u5b66\u7684\u30ea\u30b9\u30af\u3092\u8a55\u4fa1\u3057\u307e\u3059\u3002 <\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u96fb\u6c17\u7684\u30fb\u6a5f\u68b0\u7684\u5b89\u5168\u6027<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7528\u96fb\u6c17\u6a5f\u5668\u3067\u306f\u3001IEC 60601\u30b7\u30ea\u30fc\u30ba\u306a\u3069\u3001\u5bfe\u8c61\u3068\u306a\u308b\u88fd\u54c1\u306b\u9069\u7528\u3055\u308c\u308b\u5b89\u5168\u898f\u683c\u3078\u306e\u5bfe\u5fdc\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002 <\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6ec5\u83cc\u30fb\u611f\u67d3\u7ba1\u7406<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u518d\u4f7f\u7528\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u306a\u3069\u3067\u306f\u3001\u88fd\u54c1\u306e\u6750\u6599\u3084\u6027\u80fd\u3092\u640d\u306a\u308f\u305a\u3001\u9069\u5207\u306a\u6d17\u6d44\u30fb\u6d88\u6bd2\u30fb\u6ec5\u83cc\u3092\u884c\u3048\u308b\u3088\u3046\u8a2d\u8a08\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30d5\u30a7\u30a4\u30eb\u30bb\u30fc\u30d5\u6a5f\u69cb<br>\u91cd\u5927\u306a\u6545\u969c\u3092\u9632\u3050\u305f\u3081\u3001\u88fd\u54c1\u306b\u5fdc\u3058\u3066\u5197\u9577\u5316\u3001\u7dca\u6025\u505c\u6b62\u6a5f\u80fd\u3001\u8b66\u5831\u6a5f\u80fd\u306a\u3069\u306e\u5b89\u5168\u6a5f\u69cb\u3092\u8a2d\u8a08\u6bb5\u968e\u304b\u3089\u691c\u8a0e\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><br>\u5b89\u5168\u5bfe\u7b56\u3092\u8a2d\u8a08\u521d\u671f\u304b\u3089\u7d44\u307f\u8fbc\u3080\u3053\u3068\u3067\u3001\u958b\u767a\u5f8c\u534a\u3067\u306e\u5927\u5e45\u306a\u5909\u66f4\u3092\u6291\u3048\u306a\u304c\u3089\u3001\u88fd\u54c1\u30ea\u30b9\u30af\u306e\u4f4e\u6e1b\u306b\u3064\u306a\u3052\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"2_%E3%83%88%E3%83%AC%E3%83%BC%E3%82%B5%E3%83%93%E3%83%AA%E3%83%86%E3%82%A3\"><\/span><strong>2. \u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306f\u3001\u54c1\u8cea\u7ba1\u7406\u3001\u898f\u5236\u5bfe\u5fdc\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\u306a\u3069\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u6301\u3061\u307e\u3059\u3002\u88fd\u54c1\u3084\u90e8\u54c1\u3001\u88fd\u9020\u60c5\u5831\u306a\u3069\u3092\u9069\u5207\u306b\u8ffd\u8de1\u3067\u304d\u308b\u4f53\u5236\u3092\u69cb\u7bc9\u3059\u308b\u3053\u3068\u3067\u3001\u54c1\u8cea\u554f\u984c\u304c\u767a\u751f\u3057\u305f\u969b\u306e\u539f\u56e0\u7a76\u660e\u3084\u5bfe\u8c61\u88fd\u54c1\u306e\u7279\u5b9a\u3092\u8fc5\u901f\u306b\u884c\u3046\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ee3\u8868\u7684\u306a\u7ba1\u7406\u9805\u76ee\u306b\u306f\u4ee5\u4e0b\u304c\u3042\u308a\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>UDI\uff08Unique Device Identification\uff09\uff1a<br> \u5bfe\u8c61\u3068\u306a\u308b\u533b\u7642\u6a5f\u5668\u3092\u8b58\u5225\u30fb\u8ffd\u8de1\u3059\u308b\u305f\u3081\u306e\u8b58\u5225\u30b7\u30b9\u30c6\u30e0 <br><\/li>\n\n\n\n<li>DHF\uff08Design History File\uff09\uff1a<br>\u8a2d\u8a08\u30fb\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u3059\u308b\u8a18\u9332<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>DMR\uff08Device Master Record\uff09\uff1a <br>\u88fd\u9020\u4ed5\u69d8\u3084\u5de5\u7a0b\u306a\u3069\u3001\u88fd\u54c1\u3092\u88fd\u9020\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u60c5\u5831<br><\/li>\n\n\n\n<li>PMS\uff08Post-Market Surveillance\uff09\uff1a <br>\u5e02\u8ca9\u5f8c\u306e\u88fd\u54c1\u6027\u80fd\u3001\u4e0d\u5177\u5408\u3001\u5b89\u5168\u6027\u60c5\u5831\u306a\u3069\u306e\u76e3\u8996<br><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"3_%E4%BD%8E%E6%B6%88%E8%B2%BB%E9%9B%BB%E5%8A%9B%E8%A8%AD%E8%A8%88\"><\/span><strong>3. \u4f4e\u6d88\u8cbb\u96fb\u529b\u8a2d\u8a08<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u30d0\u30c3\u30c6\u30ea\u30fc\u3092\u4f7f\u7528\u3059\u308b\u533b\u7642\u6a5f\u5668\u3067\u306f\u3001\u6d88\u8cbb\u96fb\u529b\u3082\u91cd\u8981\u306a\u8a2d\u8a08\u8981\u7d20\u3067\u3059\u3002\u4f4e\u6d88\u8cbb\u96fb\u529b\u5316\u306b\u3088\u3063\u3066\u30d0\u30c3\u30c6\u30ea\u30fc\u99c6\u52d5\u6642\u9593\u3092\u5ef6\u9577\u3067\u304d\u308b\u307b\u304b\u3001\u5145\u96fb\u3084\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u306e\u983b\u5ea6\u3092\u6291\u3048\u3001\u60a3\u8005\u3084\u533b\u7642\u5f93\u4e8b\u8005\u306e\u5229\u4fbf\u6027\u3092\u9ad8\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u7279\u306b\u30a6\u30a7\u30a2\u30e9\u30d6\u30eb\u533b\u7642\u6a5f\u5668\u3084\u643a\u5e2f\u578b\u8a3a\u65ad\u6a5f\u5668\u306a\u3069\u3067\u306f\u3001\u5c0f\u578b\u5316\u3068\u9577\u6642\u9593\u99c6\u52d5\u3092\u4e21\u7acb\u3059\u308b\u305f\u3081\u306e\u96fb\u529b\u8a2d\u8a08\u304c\u91cd\u8981\u3068\u306a\u308a\u307e\u3059\u3002 <\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"4_%E3%83%AA%E3%82%B9%E3%82%AF%E3%83%9E%E3%83%8D%E3%82%B8%E3%83%A1%E3%83%B3%E3%83%88\"><\/span><strong>4. \u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u958b\u767a\u3067\u306f\u3001\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3057\u3001\u898f\u5236\u8981\u6c42\u3092\u6e80\u305f\u3059\u305f\u3081\u306e\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u304c\u6b20\u304b\u305b\u307e\u305b\u3093\u3002<br>ISO 14971\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u9023\u3059\u308b\u30cf\u30b6\u30fc\u30c9\u3092\u7279\u5b9a\u3057\u3001\u30ea\u30b9\u30af\u3092\u8a55\u4fa1\u30fb\u7ba1\u7406\u3059\u308b\u305f\u3081\u306e\u4f53\u7cfb\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u304c\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002 <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ee3\u8868\u7684\u306a\u53d6\u308a\u7d44\u307f\u306b\u306f\u4ee5\u4e0b\u304c\u3042\u308a\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30cf\u30b6\u30fc\u30c9\u306e\u7279\u5b9a\uff1a <br>FMEA\uff08\u6545\u969c\u30e2\u30fc\u30c9\u5f71\u97ff\u89e3\u6790\uff09\u306a\u3069\u3092\u5229\u7528\u3057\u3066\u6f5c\u5728\u7684\u306a\u6545\u969c\u3084\u5371\u967a\u3092\u5206\u6790<br><\/li>\n\n\n\n<li>\u30ea\u30b9\u30af\u4f4e\u6e1b\uff1a <br>\u8a2d\u8a08\u5909\u66f4\u3001\u5b89\u5168\u6a5f\u69cb\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u5bfe\u7b56\u306a\u3069\u306b\u3088\u3063\u3066\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b<br><\/li>\n\n\n\n<li>\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\uff1a <br>\u5206\u304b\u308a\u3084\u3059\u3044\u64cd\u4f5c\u65b9\u6cd5\u3001\u8868\u793a\u3001\u30a8\u30eb\u30b4\u30ce\u30df\u30af\u30b9\u306a\u3069\u3092\u8003\u616e\u3057\u3001\u4f7f\u7528\u4e0a\u306e\u30a8\u30e9\u30fc\u3092\u4f4e\u6e1b<br><br><br><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"5_%E3%83%A6%E3%83%BC%E3%82%B6%E3%83%BC%E4%B8%AD%E5%BF%83%E8%A8%AD%E8%A8%88\"><\/span><strong>5. \u30e6\u30fc\u30b6\u30fc\u4e2d\u5fc3\u8a2d\u8a08<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306f\u3001\u5b9f\u969b\u306b\u88fd\u54c1\u3092\u4f7f\u7528\u3059\u308b\u60a3\u8005\u3084\u533b\u7642\u5f93\u4e8b\u8005\u3092\u8003\u616e\u3057\u3066\u8a2d\u8a08\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<br>\u4f7f\u3044\u3084\u3059\u3044\u88fd\u54c1\u8a2d\u8a08\u306f\u64cd\u4f5c\u30df\u30b9\u306e\u4f4e\u6e1b\u306b\u3064\u306a\u304c\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u60a3\u8005\u306e\u6cbb\u7642\u7d99\u7d9a\u3084\u533b\u7642\u73fe\u5834\u3067\u306e\u4f5c\u696d\u52b9\u7387\u5411\u4e0a\u306b\u3082\u8ca2\u732e\u3057\u307e\u3059\u3002 <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e3b\u306a\u30dd\u30a4\u30f3\u30c8\u306b\u306f\u4ee5\u4e0b\u304c\u3042\u308a\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30a2\u30af\u30bb\u30b7\u30d3\u30ea\u30c6\u30a3\uff1a <br>\u624b\u6307\u306e\u52d5\u304b\u3057\u306b\u304f\u3055\u3084\u8996\u899a\u4e0a\u306e\u5236\u7d04\u306a\u3069\u304c\u3042\u308b\u30e6\u30fc\u30b6\u30fc\u3067\u3082\u64cd\u4f5c\u3057\u3084\u3059\u3044\u8a2d\u8a08<br><\/li>\n\n\n\n<li>\u591a\u69d8\u306a\u30e6\u30fc\u30b6\u30fc\u3078\u306e\u5bfe\u5fdc\uff1a <br>\u5e74\u9f62\u3001\u4f53\u683c\u3001\u8eab\u4f53\u80fd\u529b\u306a\u3069\u306e\u9055\u3044\u3092\u8003\u616e\u3057\u305f\u8a2d\u8a08<br><\/li>\n\n\n\n<li>\u30d2\u30e5\u30fc\u30de\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\uff08HFE\uff09\uff1a <br>\u30e6\u30fc\u30b6\u30d3\u30ea\u30c6\u30a3\u8a55\u4fa1\u3084\u5b9f\u969b\u306e\u4f7f\u7528\u74b0\u5883\u3092\u60f3\u5b9a\u3057\u305f\u691c\u8a3c\u306b\u3088\u308b\u4f7f\u7528\u30a8\u30e9\u30fc\u306e\u4f4e\u6e1b<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AE%E8%A3%BD%E9%80%A0%E3%83%91%E3%83%BC%E3%83%88%E3%83%8A%E3%83%BC%E3%82%92%E9%81%B8%E3%81%B6%E9%9A%9B%E3%81%AE%E3%83%9D%E3%82%A4%E3%83%B3%E3%83%88\"><\/span><strong>\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u9078\u3076\u969b\u306e\u30dd\u30a4\u30f3\u30c8<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2026\/02\/\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u3068\u306f\uff1f\u88fd\u54c1\u4f01\u753b\u304b\u3089\u8a66\u4f5c\u30fb\u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c\u3092\u89e3\u8aac04.jpg\" alt=\"\" class=\"wp-image-8835\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2026\/02\/\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u3068\u306f\uff1f\u88fd\u54c1\u4f01\u753b\u304b\u3089\u8a66\u4f5c\u30fb\u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c\u3092\u89e3\u8aac04.jpg 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2026\/02\/\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u3068\u306f\uff1f\u88fd\u54c1\u4f01\u753b\u304b\u3089\u8a66\u4f5c\u30fb\u91cf\u7523\u30fb\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6d41\u308c\u3092\u89e3\u8aac04-768x422.jpg 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306e\u88fd\u54c1\u5316\u3092\u6210\u529f\u3055\u305b\u308b\u305f\u3081\u306b\u306f\u3001\u9069\u5207\u306a\u88fd\u9020\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u9078\u3076\u3053\u3068\u3082\u91cd\u8981\u3067\u3059\u3002<br>\u88fd\u9020\u4f1a\u793e\u3092\u9078\u5b9a\u3059\u308b\u969b\u306b\u306f\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306e\u7d4c\u9a13\u3001\u5bfe\u5fdc\u53ef\u80fd\u306a\u5de5\u7a0b\u3001<a href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/\">\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0<\/a>\u306a\u3069\u306e\u88fd\u9020\u74b0\u5883\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"1_ISO_13485%E8%AA%8D%E8%A8%BC%E3%82%92%E5%8F%96%E5%BE%97%E3%81%97%E3%81%A6%E3%81%84%E3%82%8B%E3%81%8B\"><\/span><strong>1. ISO 13485\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u308b\u304b<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.thy-precision.com\/ja\/iso-standards-for-medical-devices-the-meaning-of-iso-13485\/\">ISO 13485<\/a>\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u3059\u308b\u56fd\u969b\u898f\u683c\u3067\u3059\u3002<br>ISO 13485\u306b\u57fa\u3065\u3044\u305f\u54c1\u8cea\u7ba1\u7406\u4f53\u5236\u3092\u69cb\u7bc9\u3057\u3066\u3044\u308b\u30e1\u30fc\u30ab\u30fc\u3092\u9078\u3076\u3053\u3068\u3067\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306b\u5fc5\u8981\u3068\u306a\u308b\u5de5\u7a0b\u7ba1\u7406\u3001\u6587\u66f8\u7ba1\u7406\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306a\u3069\u3078\u306e\u5bfe\u5fdc\u3092\u9032\u3081\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002  <\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"2_%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E8%A6%8F%E5%88%B6%E8%A6%81%E6%B1%82%E3%82%92%E7%90%86%E8%A7%A3%E3%81%97%E3%81%A6%E3%81%84%E3%82%8B%E3%81%8B\"><\/span><strong>2. \u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u898f\u5236\u8981\u6c42\u3092\u7406\u89e3\u3057\u3066\u3044\u308b\u304b<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30fb\u88fd\u9020\u3067\u306f\u3001\u8ca9\u58f2\u5e02\u5834\u3084\u88fd\u54c1\u5206\u985e\u306b\u5fdc\u3058\u305f\u3055\u307e\u3056\u307e\u306a\u898f\u5236\u8981\u6c42\u3078\u306e\u5bfe\u5fdc\u304c\u5fc5\u8981\u3067\u3059\u3002<br>\u533b\u7642\u6a5f\u5668\u5206\u91ce\u3067\u306e\u88fd\u9020\u7d4c\u9a13\u3092\u6301\u3061\u3001ISO 13485\u306a\u3069\u306e\u54c1\u8cea\u8981\u6c42\u3092\u7406\u89e3\u3057\u305f\u88fd\u9020\u30d1\u30fc\u30c8\u30ca\u30fc\u3068\u958b\u767a\u521d\u671f\u304b\u3089\u9023\u643a\u3059\u308b\u3053\u3068\u3067\u3001\u91cf\u7523\u6bb5\u968e\u3067\u767a\u751f\u3059\u308b\u554f\u984c\u3084\u8a2d\u8a08\u5909\u66f4\u306e\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3067\u304d\u307e\u3059\u3002 <\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"3_%E9%96%8B%E7%99%BA%E3%81%8B%E3%82%89%E9%87%8F%E7%94%A3%E3%81%BE%E3%81%A7%E4%B8%80%E8%B2%AB%E3%81%97%E3%81%A6%E5%AF%BE%E5%BF%9C%E3%81%A7%E3%81%8D%E3%82%8B%E3%81%8B\"><\/span><strong>3. \u958b\u767a\u304b\u3089\u91cf\u7523\u307e\u3067\u4e00\u8cab\u3057\u3066\u5bfe\u5fdc\u3067\u304d\u308b\u304b<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u8907\u6570\u306e\u5de5\u7a0b\u3092\u4e00\u793e\u3067\u5bfe\u5fdc\u3067\u304d\u308b\u88fd\u9020\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u9078\u629e\u3059\u308b\u3053\u3068\u3067\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u9593\u306e\u8abf\u6574\u8ca0\u62c5\u3092\u8efd\u6e1b\u3057\u3001\u88fd\u54c1\u958b\u767a\u3092\u52b9\u7387\u5316\u3067\u304d\u307e\u3059\u3002<br>\u4f8b\u3048\u3070\u3001DFM\uff08\u88fd\u9020\u6027\u3092\u8003\u616e\u3057\u305f\u8a2d\u8a08\uff09\u3001\u8a66\u4f5c\u3001\u6750\u6599\u9078\u5b9a\u3001\u91d1\u578b\u88fd\u4f5c\u3001\u5c04\u51fa\u6210\u5f62\u3001\u7d44\u7acb\u3001\u691c\u67fb\u3001\u5305\u88c5\u306a\u3069\u3092\u4e00\u8cab\u3057\u3066\u5bfe\u5fdc\u3067\u304d\u308c\u3070\u3001\u8a66\u4f5c\u6bb5\u968e\u3067\u5f97\u3089\u308c\u305f\u77e5\u898b\u3092\u91cf\u7523\u5de5\u7a0b\u3078\u53cd\u6620\u3057\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002 <\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"4_%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E8%A3%BD%E9%80%A0%E3%81%AB%E5%AF%BE%E5%BF%9C%E3%81%97%E3%81%A6%E3%81%84%E3%82%8B%E3%81%8B\"><\/span><strong>4. \u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u308b\u304b<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u7642\u6a5f\u5668\u3084\u533b\u7642\u7528\u90e8\u54c1\u3067\u306f\u3001\u88fd\u54c1\u7528\u9014\u306b\u5fdc\u3058\u3066\u7570\u7269\u3084\u5fae\u7c92\u5b50\u306a\u3069\u306e\u6c5a\u67d3\u30ea\u30b9\u30af\u3092\u7ba1\u7406\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<br>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3067\u306e\u88fd\u9020\u304c\u5fc5\u8981\u3068\u306a\u308b\u88fd\u54c1\u3067\u306f\u3001ISO 14644\u30b7\u30ea\u30fc\u30ba\u306a\u3069\u306b\u57fa\u3065\u3044\u3066\u7ba1\u7406\u3055\u308c\u305f\u88fd\u9020\u74b0\u5883\u3092\u6301\u3064\u30e1\u30fc\u30ab\u30fc\u3092\u9078\u5b9a\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002 <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9069\u5207\u306a\u88fd\u9020\u30d1\u30fc\u30c8\u30ca\u30fc\u3068\u306e\u9023\u643a\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3084\u751f\u7523\u52b9\u7387\u3092\u9ad8\u3081\u3001\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u5186\u6ed1\u306b\u9032\u3081\u308b\u3046\u3048\u3067\u91cd\u8981\u306a\u8981\u7d20\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"THY%E7%B2%BE%E5%AF%86%E5%B7%A5%E6%A5%AD%E3%81%8C%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E8%A3%BD%E9%80%A0%E3%82%92%E3%82%B5%E3%83%9D%E3%83%BC%E3%83%88\"><\/span><strong>THY\u7cbe\u5bc6\u5de5\u696d\u304c\u533b\u7642\u6a5f\u5668\u88fd\u9020\u3092\u30b5\u30dd\u30fc\u30c8 <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.thy-precision.com\/ja\/\">THY\u7cbe\u5bc6\u5de5\u696d<\/a>\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u5411\u3051\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u90e8\u54c1\u306e\u958b\u767a\u30fb\u88fd\u9020\u3092\u652f\u63f4\u3057\u3066\u3044\u307e\u3059\u3002 <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">40\u5e74\u4ee5\u4e0a\u306b\u308f\u305f\u308a\u57f9\u3063\u3066\u304d\u305f\u7cbe\u5bc6\u91d1\u578b\u88fd\u4f5c\u30fb\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u5c04\u51fa\u6210\u5f62\u6280\u8853\u3092\u6d3b\u304b\u3057\u3001DFM\u3001\u8a66\u4f5c\u3001\u91d1\u578b\u88fd\u4f5c\u3001\u7cbe\u5bc6\u5c04\u51fa\u6210\u5f62\u304b\u3089\u7d44\u7acb\u30fb\u691c\u67fb\u30fb\u5305\u88c5\u307e\u3067\u3001\u88fd\u54c1\u958b\u767a\u304b\u3089\u91cf\u7523\u306b\u5411\u3051\u305f\u5e45\u5e83\u3044\u5de5\u7a0b\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u3059\u3002<br>\u307e\u305f\u3001ISO 13485\u306b\u57fa\u3065\u304f\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u4f53\u5236\u306e\u3082\u3068\u3001ISO 8\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3067\u306e\u5c04\u51fa\u6210\u5f62\u306b\u52a0\u3048\u3001\u88fd\u54c1\u4ed5\u69d8\u3084\u8981\u6c42\u3055\u308c\u308b\u6e05\u6d44\u5ea6\u306b\u5fdc\u3058\u305f\u30af\u30ea\u30fc\u30f3\u74b0\u5883\u3067\u306e\u7d44\u7acb\u30fb\u5305\u88c5\u306b\u3082\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u3059\u3002<br>\u5c0f\u30ed\u30c3\u30c8\u306e\u8a66\u4f5c\u304b\u3089\u91cf\u7523\u307e\u3067\u3001\u304a\u5ba2\u69d8\u306e\u88fd\u54c1\u4ed5\u69d8\u3084\u958b\u767a\u6bb5\u968e\u306b\u5408\u308f\u305b\u305f\u88fd\u9020\u65b9\u6cd5\u3092\u3054\u63d0\u6848\u3057\u307e\u3059\u3002<br>\u533b\u7642\u6a5f\u5668\u30fb\u533b\u7642\u7528\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u90e8\u54c1\u306e\u958b\u767a\u3084\u88fd\u9020\u59d4\u8a17\u3092\u3054\u691c\u8a0e\u306e\u5834\u5408\u306f\u3001THY\u7cbe\u5bc6\u5de5\u696d <a 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