{"id":8119,"date":"2025-07-18T09:46:25","date_gmt":"2025-07-18T01:46:25","guid":{"rendered":"https:\/\/www.thy-precision.com\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8oem%e3%83%91%e3%83%bc%e3%83%88%e3%83%8a%e3%83%bc%e3%81%ae%e8%a6%8b%e6%a5%b5%e3%82%81%e6%96%b9%ef%bc%9a%e5%93%81%e8%b3%aa%e3%83%bb%e8%a6%8f%e5%88%b6%e5%af%be\/"},"modified":"2026-04-02T15:31:16","modified_gmt":"2026-04-02T07:31:16","slug":"how-to-select-medical-device-oem-partner","status":"publish","type":"post","link":"https:\/\/www.thy-precision.com\/ja\/how-to-select-medical-device-oem-partner\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668OEM\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u898b\u6975\u3081\u65b9\uff1a\u54c1\u8cea\u30fb\u898f\u5236\u5bfe\u5fdc\u30fb\u751f\u7523\u4f53\u5236\u306e\u30c1\u30a7\u30c3\u30af\u9805\u76ee"},"content":{"rendered":"\n<p>\u533b\u7642\u6a5f\u5668\u696d\u754c\u3067\u306f\u3001\u9ad8\u3044\u7cbe\u5ea6\u3001\u5b89\u5168\u6027\u3001\u305d\u3057\u3066\u53b3\u683c\u306a\u898f\u5236\u9075\u5b88\u304c\u6c42\u3081\u3089\u308c\u308b\u305f\u3081\u3001\u533b\u7642\u6a5f\u5668OEM\uff08Original Equipment Manufacturer\uff1a\u76f8\u624b\u5148\u30d6\u30e9\u30f3\u30c9\u88fd\u9020\u696d\u8005\uff09\u3068\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7\u306f\u533b\u7642\u95a2\u9023\u4f01\u696d\u306b\u3068\u3063\u3066\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\u3002<br><br>\u5c02\u9580OEM\u3078\u88fd\u9020\u3092\u59d4\u8a17\u3059\u308b\u3053\u3068\u3067\u3001\u4f01\u696d\u306f\u9ad8\u54c1\u8cea\u304b\u3064\u898f\u5236\u306b\u9069\u5408\u3057\u305f\u533b\u7642\u6a5f\u5668\u3092\u78ba\u4fdd\u3057\u306a\u304c\u3089\u3001\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3084\u60a3\u8005\u30b1\u30a2\u306b\u96c6\u4e2d\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002\u9069\u5207\u306aOEM\u3092\u9078\u5b9a\u3059\u308b\u3053\u3068\u306f\u3001\u30b3\u30b9\u30c8\u52b9\u7387\u3001\u5e02\u5834\u6295\u5165\u30b9\u30d4\u30fc\u30c9\u3001\u305d\u3057\u3066\u5b89\u5b9a\u3057\u305f\u54c1\u8cea\u3092\u5b9f\u73fe\u3059\u308b\u3046\u3048\u3067\u4e0d\u53ef\u6b20\u3067\u3059\u3002 <\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 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\/how-to-select-medical-device-oem-partner\/#%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8OEM%E3%81%A8%E3%81%AF%EF%BC%9F\" >\u533b\u7642\u6a5f\u5668OEM\u3068\u306f\uff1f<\/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\/how-to-select-medical-device-oem-partner\/#%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8OEM%E3%81%AE7%E3%81%A4%E3%81%AE%E4%B8%BB%E8%A6%81%E3%83%A1%E3%83%AA%E3%83%83%E3%83%88\" >\u533b\u7642\u6a5f\u5668OEM\u306e7\u3064\u306e\u4e3b\u8981\u30e1\u30ea\u30c3\u30c8<\/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\/how-to-select-medical-device-oem-partner\/#1%E9%AB%98%E7%B2%BE%E5%BA%A6%E3%81%8B%E3%81%A4%E5%9D%87%E4%B8%80%E3%81%AA%E5%93%81%E8%B3%AA\" >1.\u9ad8\u7cbe\u5ea6\u304b\u3064\u5747\u4e00\u306a\u54c1\u8cea<\/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\/how-to-select-medical-device-oem-partner\/#2%E3%82%B3%E3%82%B9%E3%83%88%E5%8A%B9%E7%8E%87%E3%81%AE%E6%9C%80%E5%A4%A7%E5%8C%96\" >2.\u30b3\u30b9\u30c8\u52b9\u7387\u306e\u6700\u5927\u5316<\/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\/how-to-select-medical-device-oem-partner\/#3%E8%A3%BD%E9%80%A0%E6%9C%9F%E9%96%93%E3%81%AE%E7%9F%AD%E7%B8%AE\" >3.\u88fd\u9020\u671f\u9593\u306e\u77ed\u7e2e<\/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\/how-to-select-medical-device-oem-partner\/#4%E3%82%AB%E3%82%B9%E3%82%BF%E3%83%9E%E3%82%A4%E3%82%BA%E5%AF%BE%E5%BF%9C%E5%8A%9B\" >4.\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u5bfe\u5fdc\u529b<\/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\/how-to-select-medical-device-oem-partner\/#5%E8%B1%8A%E5%AF%8C%E3%81%AA%E6%9D%90%E6%96%99%E9%81%B8%E6%8A%9E%E8%82%A2\" >5.\u8c4a\u5bcc\u306a\u6750\u6599\u9078\u629e\u80a2<\/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\/how-to-select-medical-device-oem-partner\/#6%E5%8E%B3%E6%A0%BC%E3%81%AA%E5%93%81%E8%B3%AA%E7%AE%A1%E7%90%86%E4%BD%93%E5%88%B6\" >6.\u53b3\u683c\u306a\u54c1\u8cea\u7ba1\u7406\u4f53\u5236<\/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\/how-to-select-medical-device-oem-partner\/#7%E6%8B%A1%E5%BC%B5%E5%8F%AF%E8%83%BD%E3%81%AA%E7%94%9F%E7%94%A3%E4%BD%93%E5%88%B6\" >7.\u62e1\u5f35\u53ef\u80fd\u306a\u751f\u7523\u4f53\u5236<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.thy-precision.com\/ja\/how-to-select-medical-device-oem-partner\/#%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8OEM%EF%BC%9A%E3%81%AA%E3%81%9C%E3%82%A2%E3%82%A6%E3%83%88%E3%82%BD%E3%83%BC%E3%82%B7%E3%83%B3%E3%82%B0%E3%81%8C%E4%BC%81%E6%A5%AD%E6%B4%BB%E5%8B%95%E3%81%AB%E3%83%A1%E3%83%AA%E3%83%83%E3%83%88%E3%82%92%E3%82%82%E3%81%9F%E3%82%89%E3%81%99%E3%81%AE%E3%81%8B%EF%BC%9F\" >\u533b\u7642\u6a5f\u5668OEM\uff1a\u306a\u305c\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u304c\u4f01\u696d\u6d3b\u52d5\u306b\u30e1\u30ea\u30c3\u30c8\u3092\u3082\u305f\u3089\u3059\u306e\u304b\uff1f<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.thy-precision.com\/ja\/how-to-select-medical-device-oem-partner\/#1%E3%82%B3%E3%82%A2%E6%A5%AD%E5%8B%99%E3%81%B8%E3%81%AE%E9%9B%86%E4%B8%AD\" >1.\u30b3\u30a2\u696d\u52d9\u3078\u306e\u96c6\u4e2d<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.thy-precision.com\/ja\/how-to-select-medical-device-oem-partner\/#2%E3%83%AA%E3%82%B9%E3%82%AF%E3%81%AE%E8%BB%BD%E6%B8%9B\" >2.\u30ea\u30b9\u30af\u306e\u8efd\u6e1b<\/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\/how-to-select-medical-device-oem-partner\/#3%E8%BF%85%E9%80%9F%E3%81%AA%E5%B8%82%E5%A0%B4%E6%8A%95%E5%85%A5%E6%88%A6%E7%95%A5\" >3.\u8fc5\u901f\u306a\u5e02\u5834\u6295\u5165\u6226\u7565<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.thy-precision.com\/ja\/how-to-select-medical-device-oem-partner\/#%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8OEM%E3%82%92%E9%81%B8%E5%AE%9A%E3%81%99%E3%82%8B%E9%9A%9B%E3%81%AE%E9%87%8D%E8%A6%81%E3%81%AA%E3%83%9D%E3%82%A4%E3%83%B3%E3%83%88\" 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class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/www.thy-precision.com\/ja\/how-to-select-medical-device-oem-partner\/#4%E3%82%B3%E3%82%B9%E3%83%88%E3%81%8A%E3%82%88%E3%81%B3%E3%82%B5%E3%83%9D%E3%83%BC%E3%83%88%E4%BD%93%E5%88%B6\" >4.\u30b3\u30b9\u30c8\u304a\u3088\u3073\u30b5\u30dd\u30fc\u30c8\u4f53\u5236<\/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\/how-to-select-medical-device-oem-partner\/#%E8%A3%BD%E9%80%A0%E5%B7%A5%E7%A8%8B%E3%81%AB%E3%81%8A%E3%81%91%E3%82%8B%E3%83%88%E3%83%AC%E3%83%BC%E3%82%B5%E3%83%93%E3%83%AA%E3%83%86%E3%82%A3\" >\u88fd\u9020\u5de5\u7a0b\u306b\u304a\u3051\u308b\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/www.thy-precision.com\/ja\/how-to-select-medical-device-oem-partner\/#%E6%9C%80%E9%81%A9%E3%81%AA%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8OEM%E3%83%91%E3%83%BC%E3%83%88%E3%83%8A%E3%83%BC%E3%82%92%E8%A6%8B%E3%81%A4%E3%81%91%E3%82%8B%EF%BC%9ATHY%E7%B2%BE%E5%AF%86%E5%B7%A5%E6%A5%AD\" >\u6700\u9069\u306a\u533b\u7642\u6a5f\u5668OEM\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u898b\u3064\u3051\u308b\uff1aTHY\u7cbe\u5bc6\u5de5\u696d<\/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%A8OEM%E3%81%A8%E3%81%AF%EF%BC%9F\"><\/span><strong>\u533b\u7642\u6a5f\u5668OEM\u3068\u306f\uff1f<\/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\/2025\/07\/\u533b\u7642\u6a5f\u5668OEM\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u898b\u6975\u3081\u65b9\uff1a\u54c1\u8cea\u30fb\u898f\u5236\u5bfe\u5fdc\u30fb\u751f\u7523\u4f53\u5236\u306e\u30c1\u30a7\u30c3\u30af\u9805\u76ee-02.webp\" alt=\"\" class=\"wp-image-8123\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/07\/\u533b\u7642\u6a5f\u5668OEM\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u898b\u6975\u3081\u65b9\uff1a\u54c1\u8cea\u30fb\u898f\u5236\u5bfe\u5fdc\u30fb\u751f\u7523\u4f53\u5236\u306e\u30c1\u30a7\u30c3\u30af\u9805\u76ee-02.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/07\/\u533b\u7642\u6a5f\u5668OEM\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u898b\u6975\u3081\u65b9\uff1a\u54c1\u8cea\u30fb\u898f\u5236\u5bfe\u5fdc\u30fb\u751f\u7523\u4f53\u5236\u306e\u30c1\u30a7\u30c3\u30af\u9805\u76ee-02-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u88fd\u9020\u5206\u91ce\u306b\u304a\u3044\u3066\u3001OEM\uff08Original Equipment Manufacturer\uff09\u306f\u3001\u4ed6\u793e\u30d6\u30e9\u30f3\u30c9\u3068\u3057\u3066\u8ca9\u58f2\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u30fb\u88fd\u9020\u3092\u62c5\u3046\u91cd\u8981\u306a\u5b58\u5728\u3067\u3059\u3002<br><br>\u9867\u5ba2\u306e\u8a2d\u8a08\u56f3\u306b\u57fa\u3065\u3044\u3066\u88fd\u9020\u306e\u307f\u3092\u884c\u3046\u53d7\u8a17\u30e1\u30fc\u30ab\u30fc\u3068\u306f\u7570\u306a\u308a\u3001OEM\u306f\u81ea\u793e\u306e\u6280\u8853\u529b\u3001\u72ec\u81ea\u6280\u8853\u3001\u898f\u5236\u5bfe\u5fdc\u30ce\u30a6\u30cf\u30a6\u3092\u6d3b\u7528\u3057\u3066\u9769\u65b0\u7684\u306a\u533b\u7642\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u306e\u958b\u767a\u306b\u8ca2\u732e\u3059\u308b\u3053\u3068\u304c\u591a\u3044\u306e\u304c\u7279\u5fb4\u3067\u3059\u3002<br><\/p>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668OEM\u306f\u3001\u767d\u8840\u7403\u9664\u53bb\u30d5\u30a3\u30eb\u30bf\u30fc\u3001\u7d30\u80de\u5206\u96e2\u88c5\u7f6e\u3001\u5916\u79d1\u7528\u5668\u5177\u3001\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u7528\u90e8\u54c1\u306a\u3069\u3001\u5e45\u5e83\u3044\u88fd\u54c1\u306e\u88fd\u9020\u3092\u62c5\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u88fd\u54c1\u306f\u53b3\u3057\u304f\u898f\u5236\u3055\u308c\u3066\u304a\u308a\u3001\u5b89\u5168\u6027\u30fb\u4fe1\u983c\u6027\u30fb\u6709\u52b9\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001ISO 13485\u3084FDA QSR\uff08\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u898f\u5247\uff09\u306a\u3069\u306e\u696d\u754c\u57fa\u6e96\u3078\u306e\u53b3\u683c\u306a\u6e96\u62e0\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002 <br><br>OEM\u3068ODM\uff08Original Design Manufacturer\uff09\u306f\u6df7\u540c\u3055\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u77e5\u7684\u8ca1\u7523\u306e\u6240\u6709\u6a29\u3001\u8a2d\u8a08\u95a2\u4e0e\u5ea6\u3001\u88fd\u9020\u306e\u67d4\u8edf\u6027\u306b\u9055\u3044\u304c\u3042\u308a\u307e\u3059\u3002<br><br>OEM\uff1a\u9867\u5ba2\u306e\u72ec\u81ea\u8a2d\u8a08\u306b\u57fa\u3065\u304d\u88fd\u9020\u3057\u3001\u77e5\u7684\u8ca1\u7523\u6a29\u306f\u9867\u5ba2\u304c\u4fdd\u6301<br>ODM\uff1a\u3042\u3089\u304b\u3058\u3081\u8a2d\u8a08\u3055\u308c\u305f\u88fd\u54c1\u3092\u63d0\u4f9b\u3057\u3001\u9867\u5ba2\u306f\u4e00\u90e8\u6539\u826f\u30fb\u30d6\u30e9\u30f3\u30c9\u5316\u304c\u53ef\u80fd\uff08\u305f\u3060\u3057\u4e2d\u6838\u6280\u8853\u306fODM\u5074\u306b\u5e30\u5c5e\u3059\u308b\u3053\u3068\u304c\u591a\u3044\uff09  <\/p>\n\n\n\n<p>\u3053\u306e\u9055\u3044\u306f\u3001\u7af6\u4e89\u306e\u6fc0\u3057\u3044\u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u304a\u3044\u3066\u3001\u72ec\u81ea\u6027\u3084\u898f\u5236\u5bfe\u5fdc\u3001\u5dee\u5225\u5316\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u6975\u3081\u3066\u91cd\u8981\u3067\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%A8OEM%E3%81%AE7%E3%81%A4%E3%81%AE%E4%B8%BB%E8%A6%81%E3%83%A1%E3%83%AA%E3%83%83%E3%83%88\"><\/span><strong>\u533b\u7642\u6a5f\u5668OEM\u306e7\u3064\u306e\u4e3b\u8981\u30e1\u30ea\u30c3\u30c8<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"1%E9%AB%98%E7%B2%BE%E5%BA%A6%E3%81%8B%E3%81%A4%E5%9D%87%E4%B8%80%E3%81%AA%E5%93%81%E8%B3%AA\"><\/span><strong>1.\u9ad8\u7cbe\u5ea6\u304b\u3064\u5747\u4e00\u306a\u54c1\u8cea<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u88fd\u9020\u3067\u306f\u30df\u30af\u30ed\u30f3\u5358\u4f4d\u306e\u7cbe\u5ea6\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002OEM\u306f\u9ad8\u7cbe\u5ea6<a href=\"https:\/\/www.thy-precision.com\/ja\/injection-moulding-a-step-by-step-process-breakdown-jp\/\">\u5c04\u51fa\u6210\u5f62<\/a>\u3001CNC\u52a0\u5de5\u3001\u30ed\u30dc\u30c3\u30c8\u81ea\u52d5\u5316\u3092\u6d3b\u7528\u3057\u3001\u53b3\u5bc6\u306a\u516c\u5dee\u3067\u88fd\u54c1\u3092\u88fd\u9020\u3057\u307e\u3059\u3002 <\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"2%E3%82%B3%E3%82%B9%E3%83%88%E5%8A%B9%E7%8E%87%E3%81%AE%E6%9C%80%E5%A4%A7%E5%8C%96\"><\/span><strong>2.\u30b3\u30b9\u30c8\u52b9\u7387\u306e\u6700\u5927\u5316<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>OEM\u3068\u63d0\u643a\u3059\u308b\u3053\u3068\u3067\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u81ea\u793e\u3067\u306e\u88fd\u9020\u8a2d\u5099\u306e\u8a2d\u7f6e\u3001\u4eba\u6750\u6559\u80b2\u3001\u898f\u5236\u5bfe\u5fdc\u30a4\u30f3\u30d5\u30e9\u306e\u6574\u5099\u3068\u3044\u3063\u305f\u8ca0\u62c5\u3092\u4e0d\u8981\u306b\u3067\u304d\u308b\u305f\u3081\u3001\u904b\u55b6\u30b3\u30b9\u30c8\u3092\u5927\u5e45\u306b\u524a\u6e1b\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002<br><br>OEM\u306f\u30b9\u30b1\u30fc\u30eb\u30e1\u30ea\u30c3\u30c8\u306e\u6069\u6075\u3092\u53d7\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u3001\u539f\u6750\u6599\u3092\u3088\u308a\u4f4e\u4fa1\u683c\u3067\u8abf\u9054\u3057\u306a\u304c\u3089\u88fd\u9020\u52b9\u7387\u3092\u6700\u9069\u5316\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u3067\u3059\u3002<br>\u3055\u3089\u306b\u3001\u81ea\u52d5\u5316\u3055\u308c\u305f\u751f\u7523\u30e9\u30a4\u30f3\u3084\u30ea\u30fc\u30f3\u751f\u7523\u65b9\u5f0f\u3092\u5c0e\u5165\u3059\u308b\u3053\u3068\u3067\u3001\u6750\u6599\u30ed\u30b9\u3092\u524a\u6e1b\u3057\u3001\u751f\u7523\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u30b3\u30b9\u30c8\u524a\u6e1b\u3092\u5b9f\u73fe\u3057\u3066\u3044\u307e\u3059\u3002 <\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"3%E8%A3%BD%E9%80%A0%E6%9C%9F%E9%96%93%E3%81%AE%E7%9F%AD%E7%B8%AE\"><\/span><strong>3.\u88fd\u9020\u671f\u9593\u306e\u77ed\u7e2e<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u304a\u3044\u3066\u3001\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u30b9\u30d4\u30fc\u30c9\u306f\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\u3002\u7279\u306b\u3001\u8f38\u6db2\u30bb\u30c3\u30c8\u3001\u30b5\u30fc\u30b8\u30ab\u30eb\u30de\u30b9\u30af\u3001\u8a3a\u65ad\u7528\u691c\u67fb\u30ad\u30c3\u30c8\u306a\u3069\u9700\u8981\u306e\u9ad8\u3044\u6d88\u8017\u54c1\u306b\u304a\u3044\u3066\u306f\u3001\u305d\u306e\u91cd\u8981\u6027\u304c\u4e00\u5c64\u9ad8\u307e\u308a\u307e\u3059\u3002OEM\u306f\u3001\u4e8b\u524d\u306b\u691c\u8a3c\u6e08\u307f\u306e\u91d1\u578b\u3001\u81ea\u52d5\u5316\u3055\u308c\u305f\u7d44\u7acb\u30e9\u30a4\u30f3\u3001\u8fc5\u901f\u306a\u8a66\u4f5c\u6280\u8853\u3092\u6d3b\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u751f\u7523\u30d7\u30ed\u30bb\u30b9\u3092\u52b9\u7387\u5316\u3057\u307e\u3059\u3002 <br><br>\u78ba\u7acb\u3055\u308c\u305f\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306b\u3088\u308a\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u53b3\u3057\u3044\u7d0d\u671f\u306b\u3082\u5bfe\u5fdc\u3057\u306a\u304c\u3089\u3001\u54c1\u8cea\u4fdd\u8a3c\u304a\u3088\u3073\u5404\u7a2e\u898f\u5236\u3078\u306e\u9069\u5408\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"4%E3%82%AB%E3%82%B9%E3%82%BF%E3%83%9E%E3%82%A4%E3%82%BA%E5%AF%BE%E5%BF%9C%E5%8A%9B\"><\/span><strong>4.\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u5bfe\u5fdc\u529b<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u4fe1\u983c\u3067\u304d\u308b\u533b\u7642\u6a5f\u5668OEM\u306f\u3001\u9867\u5ba2\u306e\u8981\u4ef6\u306b\u5408\u308f\u305b\u305f\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u751f\u7523\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<a href=\"https:\/\/www.thy-precision.com\/ja\/medical-device-implants-what-you-should-know\/\">\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8<\/a>\u5411\u3051\u306e\u751f\u4f53\u9069\u5408\u6750\u6599\u306e\u958b\u767a\u3084\u3001\u4eba\u9593\u5de5\u5b66\u306b\u57fa\u3065\u3044\u305f\u5916\u79d1\u7528\u5668\u5177\u306e\u8a2d\u8a08\u306a\u3069\u3001OEM\u306f\u9ad8\u3044\u30ec\u30d9\u30eb\u306e\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u5bfe\u5fdc\u3092\u5b9f\u73fe\u3057\u307e\u3059\u3002 <br><br>\u307e\u305f\u3001\u591a\u304f\u306e\u30e1\u30fc\u30ab\u30fc\u306f\u5171\u540c\u8a2d\u8a08\uff08\u30b3\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\uff09\u30b5\u30fc\u30d3\u30b9\u3082\u63d0\u4f9b\u3057\u3066\u304a\u308a\u3001\u9867\u5ba2\u3068\u5354\u529b\u3057\u306a\u304c\u3089\u3001\u6027\u80fd\u5411\u4e0a\u3001\u30b3\u30b9\u30c8\u524a\u6e1b\u3001\u91cf\u7523\u9069\u5408\u6027\u306e\u6700\u9069\u5316\u3092\u56f3\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"5%E8%B1%8A%E5%AF%8C%E3%81%AA%E6%9D%90%E6%96%99%E9%81%B8%E6%8A%9E%E8%82%A2\"><\/span><strong>5.\u8c4a\u5bcc\u306a\u6750\u6599\u9078\u629e\u80a2<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668OEM\u306f\u3001\u751f\u4f53\u9069\u5408\u6027\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u3001\u533b\u7642\u7528\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u3001\u5148\u9032\u30dd\u30ea\u30de\u30fc\u306a\u3069\u3001FDA\u627f\u8a8d\u304a\u3088\u3073ISO\u6e96\u62e0\u306e\u591a\u69d8\u306a\u6750\u6599\u3092\u5229\u7528\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u6750\u6599\u306f\u3001\u7121\u83cc\u6027\u3001\u8010\u4e45\u6027\u3001\u305d\u3057\u3066\u60a3\u8005\u5b89\u5168\u6027\u306e\u78ba\u4fdd\u306b\u304a\u3044\u3066\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\u3002 <br><br>\u3055\u3089\u306b\u3001\u8907\u5408\u6750\u6599\u6210\u5f62\u3084\u30cf\u30a4\u30d6\u30ea\u30c3\u30c9\u6750\u6599\u7d71\u5408\u306e\u5c02\u9580\u77e5\u8b58\u3092\u6301\u3064OEM\u306f\u3001\u67d4\u8edf\u6027\u3001\u5f37\u5ea6\u3001\u6297\u83cc\u6027\u3092\u5358\u4e00\u90e8\u54c1\u5185\u3067\u7d44\u307f\u5408\u308f\u305b\u305f\u30c7\u30d0\u30a4\u30b9\u306e\u958b\u767a\u3082\u53ef\u80fd\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"6%E5%8E%B3%E6%A0%BC%E3%81%AA%E5%93%81%E8%B3%AA%E7%AE%A1%E7%90%86%E4%BD%93%E5%88%B6\"><\/span><strong>6.\u53b3\u683c\u306a\u54c1\u8cea\u7ba1\u7406\u4f53\u5236<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668OEM\u306f\u3001FDA\u3001ISO 13485\u3001GMP\uff08\u9069\u6b63\u88fd\u9020\u898f\u7bc4\uff09\u306a\u3069\u306e\u53b3\u683c\u306a\u898f\u5236\u57fa\u6e96\u306b\u5f93\u3044\u3001\u5f37\u56fa\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4f53\u5236\u306e\u3082\u3068\u3067\u904b\u55b6\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"7%E6%8B%A1%E5%BC%B5%E5%8F%AF%E8%83%BD%E3%81%AA%E7%94%9F%E7%94%A3%E4%BD%93%E5%88%B6\"><\/span><strong>7.\u62e1\u5f35\u53ef\u80fd\u306a\u751f\u7523\u4f53\u5236<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u9700\u8981\u306e\u5909\u52d5\u306b\u5fdc\u3058\u3066\u3001OEM\u306f\u67d4\u8edf\u306b\u62e1\u5f35\u53ef\u80fd\u306a\u751f\u7523\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u3057\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u751f\u7523\u91cf\u3092\u52b9\u7387\u7684\u306b\u5897\u6e1b\u3067\u304d\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059\u3002\u5148\u9032\u7684\u306aOEM\u306f\u30e2\u30b8\u30e5\u30fc\u30eb\u5316\u3055\u308c\u305f\u88fd\u9020\u30b7\u30b9\u30c6\u30e0\u3078\u6295\u8cc7\u3057\u3066\u304a\u308a\u3001\u88fd\u54c1\u54c1\u8cea\u3084\u30ea\u30fc\u30c9\u30bf\u30a4\u30e0\u3092\u640d\u306a\u3046\u3053\u3068\u306a\u304f\u751f\u7523\u898f\u6a21\u3092\u62e1\u5927\u30fb\u7e2e\u5c0f\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u3067\u3059\u3002\u3053\u306e\u67d4\u8edf\u6027\u306f\u3001\u65b0\u88fd\u54c1\u3092\u5e02\u5834\u6295\u5165\u3059\u308b\u4f01\u696d\u3084\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u3078\u5c55\u958b\u3059\u308b\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u5927\u304d\u306a\u30e1\u30ea\u30c3\u30c8\u3068\u306a\u308a\u307e\u3059\u3002  <\/p>\n\n\n\n<p>\u5f93\u6765\u306e\u88fd\u9020\u4e0a\u306e\u30e1\u30ea\u30c3\u30c8\u306b\u52a0\u3048\u3001\u4e00\u90e8\u306e\u533b\u7642\u6a5f\u5668OEM\u306f\u3001\u72ec\u81ea\u958b\u767a\u306e\u6750\u6599\u914d\u5408\u6280\u8853\u3092\u88fd\u9020\u5de5\u7a0b\u306b\u7d44\u307f\u8fbc\u3093\u3067\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u7279\u8a31\u6280\u8853\u306b\u3088\u308a\u3001\u533b\u7642\u6a5f\u5668\u306e\u6297\u83cc\u6027\u3001\u6297\u51dd\u56fa\u6027\u3001\u751f\u4f53\u9069\u5408\u6027\u304c\u5411\u4e0a\u3057\u3001\u81e8\u5e8a\u73fe\u5834\u304a\u3088\u3073\u60a3\u8005\u30b1\u30a2\u306b\u304a\u3044\u3066\u3001\u3088\u308a\u5b89\u5168\u304b\u3064\u9ad8\u3044\u6709\u52b9\u6027\u3092\u5b9f\u73fe\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3053\u3046\u3057\u305f\u6750\u6599\u9769\u65b0\u306f\u3001\u611f\u67d3\u5bfe\u7b56\u306e\u5f37\u5316\u3001\u88fd\u54c1\u5bff\u547d\u306e\u5ef6\u9577\u3001\u7121\u83cc\u74b0\u5883\u4e0b\u3067\u306e\u6027\u80fd\u5411\u4e0a\u306b\u5bc4\u4e0e\u3057\u307e\u3059\u3002\u4fe1\u983c\u3067\u304d\u308bOEM\u30d1\u30fc\u30c8\u30ca\u30fc\u3068\u5354\u696d\u3059\u308b\u3053\u3068\u3067\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3068\u5e02\u5834\u5c55\u958b\u306b\u5c02\u5ff5\u3057\u3064\u3064\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u3068\u898f\u683c\u9069\u5408\u6027\u3092\u9ad8\u3044\u6c34\u6e96\u3067\u7dad\u6301\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u306b\u306a\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%A8OEM%EF%BC%9A%E3%81%AA%E3%81%9C%E3%82%A2%E3%82%A6%E3%83%88%E3%82%BD%E3%83%BC%E3%82%B7%E3%83%B3%E3%82%B0%E3%81%8C%E4%BC%81%E6%A5%AD%E6%B4%BB%E5%8B%95%E3%81%AB%E3%83%A1%E3%83%AA%E3%83%83%E3%83%88%E3%82%92%E3%82%82%E3%81%9F%E3%82%89%E3%81%99%E3%81%AE%E3%81%8B%EF%BC%9F\"><\/span><strong>\u533b\u7642\u6a5f\u5668OEM\uff1a\u306a\u305c\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u304c\u4f01\u696d\u6d3b\u52d5\u306b\u30e1\u30ea\u30c3\u30c8\u3092\u3082\u305f\u3089\u3059\u306e\u304b\uff1f<\/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\/2025\/07\/\u533b\u7642\u6a5f\u5668OEM\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u898b\u6975\u3081\u65b9\uff1a\u54c1\u8cea\u30fb\u898f\u5236\u5bfe\u5fdc\u30fb\u751f\u7523\u4f53\u5236\u306e\u30c1\u30a7\u30c3\u30af\u9805\u76ee-03.webp\" alt=\"\" class=\"wp-image-8126\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/07\/\u533b\u7642\u6a5f\u5668OEM\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u898b\u6975\u3081\u65b9\uff1a\u54c1\u8cea\u30fb\u898f\u5236\u5bfe\u5fdc\u30fb\u751f\u7523\u4f53\u5236\u306e\u30c1\u30a7\u30c3\u30af\u9805\u76ee-03.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/07\/\u533b\u7642\u6a5f\u5668OEM\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u898b\u6975\u3081\u65b9\uff1a\u54c1\u8cea\u30fb\u898f\u5236\u5bfe\u5fdc\u30fb\u751f\u7523\u4f53\u5236\u306e\u30c1\u30a7\u30c3\u30af\u9805\u76ee-03-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p>\u4e16\u754c\u306e\u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u304a\u3044\u3066\u3001Original Equipment Manufacturer\uff08OEM\uff09\u3078\u306e\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u306f\u3001\u696d\u52d9\u52b9\u7387\u3068\u7af6\u4e89\u529b\u3092\u9ad8\u3081\u308b\u305f\u3081\u306e\u91cd\u8981\u306a\u6226\u7565\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002OEM\u3068\u63d0\u643a\u3059\u308b\u3053\u3068\u3067\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u88fd\u9020\u696d\u52d9\u3092\u5c02\u9580\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u59d4\u8a17\u3067\u304d\u3001\u30b3\u30a2\u4e8b\u696d\u306b\u96c6\u4e2d\u3057\u3064\u3064\u3001\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3057\u3001\u88fd\u54c1\u306e\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u6642\u9593\u3092\u77ed\u7e2e\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002 <\/p>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u88fd\u9020\u3092OEM\u306b\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u3059\u308b\u4e3b\u306a3\u3064\u306e\u30e1\u30ea\u30c3\u30c8\u3092\u3054\u7d39\u4ecb\u3057\u307e\u3059\uff1a<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"1%E3%82%B3%E3%82%A2%E6%A5%AD%E5%8B%99%E3%81%B8%E3%81%AE%E9%9B%86%E4%B8%AD\"><\/span><strong>1.\u30b3\u30a2\u696d\u52d9\u3078\u306e\u96c6\u4e2d<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u306f\u3001\u8a2d\u8a08\u3001\u8a66\u9a13\u3001\u898f\u5236\u627f\u8a8d\u53d6\u5f97\u3001\u5927\u91cf\u751f\u7523\u7ba1\u7406\u306a\u3069\u3092\u542b\u3080\u3001\u975e\u5e38\u306b\u591a\u304f\u306e\u30ea\u30bd\u30fc\u30b9\u3092\u5fc5\u8981\u3068\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002\u81ea\u793e\u3067\u88fd\u9020\u8a2d\u5099\u3092\u69cb\u7bc9\u3059\u308b\u306b\u306f\u3001\u591a\u984d\u306e\u521d\u671f\u6295\u8cc7\u304c\u5fc5\u8981\u3068\u306a\u308a\u3001\u3055\u3089\u306b\u898f\u5236\u9075\u5b88\u3084\u54c1\u8cea\u57fa\u6e96\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306e\u7d99\u7d9a\u7684\u306a\u53d6\u308a\u7d44\u307f\u3082\u6c42\u3081\u3089\u308c\u307e\u3059\u3002 <br><br>OEM\u3078\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u3059\u308b\u3053\u3068\u3067\u3001\u4f01\u696d\u306fISO 13485\u304a\u3088\u3073FDA\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u305f\u30e1\u30fc\u30ab\u30fc\u306e\u88fd\u9020\u4f53\u5236\u3092\u6d3b\u7528\u3057\u306a\u304c\u3089\u3001\u81ea\u793e\u306f\u6280\u8853\u9769\u65b0\u3001\u88fd\u54c1\u958b\u767a\u3001\u30d6\u30e9\u30f3\u30c9\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u3001\u5e02\u5834\u62e1\u5927\u3068\u3044\u3063\u305f\u6226\u7565\u7684\u6d3b\u52d5\u306b\u6ce8\u529b\u3067\u304d\u307e\u3059\u3002<br><br>\u3055\u3089\u306b\u3001\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u306b\u3088\u308a\u3001\u81ea\u52d5\u7d44\u7acb\u30e9\u30a4\u30f3\u3001\u30ed\u30dc\u30c3\u30c8\u64cd\u4f5c\u3001\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u76e3\u8996\u30b7\u30b9\u30c6\u30e0\u306a\u3069\u3001OEM\u306e\u9ad8\u5ea6\u306a\u6280\u8853\u3084\u751f\u7523\u8a2d\u5099\u3092\u6d3b\u7528\u3067\u304d\u3001\u88fd\u9020\u5de5\u7a0b\u306e\u5404\u6bb5\u968e\u304c\u6700\u9ad8\u6c34\u6e96\u306e\u54c1\u8cea\u57fa\u6e96\u3092\u6e80\u305f\u3059\u3053\u3068\u3092\u78ba\u5b9f\u306b\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"2%E3%83%AA%E3%82%B9%E3%82%AF%E3%81%AE%E8%BB%BD%E6%B8%9B\"><\/span><strong>2.\u30ea\u30b9\u30af\u306e\u8efd\u6e1b<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u696d\u754c\u306f\u3001FDA\uff08\u7c73\u56fd\uff09\u3001MDR\uff08EU\uff09\u3001ISO 13485\u3001GMP\uff08\u9069\u6b63\u88fd\u9020\u898f\u7bc4\uff09\u306a\u3069\u306e\u898f\u5236\u5f53\u5c40\u306b\u3088\u3063\u3066\u53b3\u3057\u304f\u7ba1\u7406\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3068\u898f\u5236\u9069\u5408\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u5305\u62ec\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u7ba1\u7406\u304a\u3088\u3073\u54c1\u8cea\u4fdd\u8a3c\u4f53\u5236\u306e\u69cb\u7bc9\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002 <br><br>\u81ea\u793e\u751f\u7523\u3092\u9078\u629e\u3057\u305f\u5834\u5408\u3001\u4f01\u696d\u306f\u54c1\u8cea\u691c\u67fb\u3001\u8a8d\u8a3c\u8a66\u9a13\u3001\u898f\u5236\u5bfe\u5fdc\u7ba1\u7406\u306b\u591a\u984d\u306e\u6295\u8cc7\u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306b\u8c4a\u5bcc\u306a\u7d4c\u9a13\u3092\u6301\u3064OEM\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u3059\u3067\u306b\u78ba\u7acb\u3055\u308c\u305f\u898f\u5236\u9075\u5b88\u4f53\u5236\u3068\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\uff08\u8ffd\u8de1\u53ef\u80fd\u6027\uff09\u30b7\u30b9\u30c6\u30e0\u3092\u5099\u3048\u3066\u304a\u308a\u3001\u5e02\u5834\u30ea\u30b9\u30af\u3001\u898f\u5236\u7f70\u5247\u3001\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u306e\u30ea\u30b9\u30af\u3092\u52b9\u679c\u7684\u306b\u4f4e\u6e1b\u3057\u307e\u3059\u3002 <br><br>\u3055\u3089\u306b\u3001OEM\u30e1\u30fc\u30ab\u30fc\u306f\u9ad8\u7cbe\u5ea6\u5149\u5b66\u691c\u67fb\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>\u751f\u7523\u3001\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u76e3\u8996\u6280\u8853\u306a\u3069\u3001\u591a\u5c64\u7684\u306a\u54c1\u8cea\u691c\u67fb\u30d7\u30ed\u30bb\u30b9\u3092\u5c0e\u5165\u3057\u3066\u304a\u308a\u3001\u3059\u3079\u3066\u306e\u88fd\u54c1\u30ed\u30c3\u30c8\u304c\u81e8\u5e8a\u4f7f\u7528\u57fa\u6e96\u3092\u6e80\u305f\u3059\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u3001\u88fd\u54c1\u30ea\u30b9\u30af\u3092\u5927\u5e45\u306b\u4f4e\u6e1b\u3057\u307e\u3059\u3002<br><br>\u4f8b\u3048\u3070\u3001\u8840\u6db2\u5206\u96e2\u88c5\u7f6e\u3092\u958b\u767a\u3059\u308b\u4f01\u696d\u306f\u3001\u81ea\u793e\u3067\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3084\u691c\u67fb\u30e9\u30dc\u3092\u69cb\u7bc9\u3059\u308b\u5834\u5408\u3001\u591a\u5927\u306a\u30b3\u30b9\u30c8\u8ca0\u62c5\u304c\u767a\u751f\u3057\u307e\u3059\u3002\u3057\u304b\u3057\u3001ISO 13485\u6e96\u62e0\u306e\u751f\u7523\u74b0\u5883\u3092\u6301\u3064OEM\u3068\u63d0\u643a\u3059\u308b\u3053\u3068\u3067\u3001\u898f\u5236\u9069\u5408\u3092\u78ba\u4fdd\u3057\u306a\u304c\u3089\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ea\u30b9\u30af\u3068\u8ca1\u52d9\u8ca0\u62c5\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\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=\"3%E8%BF%85%E9%80%9F%E3%81%AA%E5%B8%82%E5%A0%B4%E6%8A%95%E5%85%A5%E6%88%A6%E7%95%A5\"><\/span><strong>3.\u8fc5\u901f\u306a\u5e02\u5834\u6295\u5165\u6226\u7565<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u304a\u3044\u3066\u3001\u5e02\u5834\u6295\u5165\u307e\u3067\u306e\u30b9\u30d4\u30fc\u30c9\u306f\u6210\u529f\u3092\u5de6\u53f3\u3059\u308b\u91cd\u8981\u306a\u8981\u7d20\u3067\u3059\u3002OEM\u3078\u306e\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u306b\u3088\u308a\u3001\u751f\u7523\u30b5\u30a4\u30af\u30eb\u3092\u77ed\u7e2e\u3057\u3001\u8fc5\u901f\u306a\u91cf\u7523\u4f53\u5236\u306e\u69cb\u7bc9\u304c\u53ef\u80fd\u3068\u306a\u308a\u3001\u88fd\u54c1\u3092\u7d20\u65e9\u304f\u5e02\u5834\u3078\u6295\u5165\u3057\u3066\u7dca\u6025\u306e\u533b\u7642\u30cb\u30fc\u30ba\u306b\u5bfe\u5fdc\u3067\u304d\u307e\u3059\u3002 <br><br>OEM\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u5305\u62ec\u7684\u306a\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u7ba1\u7406\u3001\u9ad8\u5ea6\u306a\u91d1\u578b\u8a2d\u8a08\u3001\u88fd\u9020\u6280\u8853\u3092\u5099\u3048\u3066\u304a\u308a\u3001\u88fd\u54c1\u8a2d\u8a08\u3092\u52b9\u7387\u7684\u306b\u91cf\u7523\u54c1\u3078\u3068\u8ee2\u63db\u3057\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u81e8\u5e8a\u8a66\u9a13\u304a\u3088\u3073\u5e02\u5834\u5c55\u958b\u304c\u52a0\u901f\u3055\u308c\u308b\u3068\u540c\u6642\u306b\u3001\u5927\u91cf\u306e\u539f\u6750\u6599\u3092\u4e00\u62ec\u8abf\u9054\u3067\u304d\u308bOEM\u306e\u5f37\u307f\u3092\u6d3b\u304b\u3057\u3066\u3001\u539f\u6750\u6599\u30b3\u30b9\u30c8\u3092\u5927\u5e45\u306b\u524a\u6e1b\u3057\u3001\u4fa1\u683c\u7af6\u4e89\u529b\u3092\u78ba\u4fdd\u3067\u304d\u307e\u3059\u3002 <br><br>\u4f8b\u3048\u3070\u3001COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u671f\u9593\u4e2d\u3001\u4eba\u5de5\u547c\u5438\u5668\u3084\u8a3a\u65ad\u30ad\u30c3\u30c8\u306a\u3069\u306e\u533b\u7642\u7528\u4fdd\u8b77\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u4e16\u754c\u7684\u306a\u9700\u8981\u304c\u6025\u5897\u3057\u307e\u3057\u305f\u3002\u591a\u304f\u306e\u533b\u7642\u6a5f\u5668OEM\u306f\u8fc5\u901f\u306b\u751f\u7523\u30e9\u30a4\u30f3\u3092\u9069\u5fdc\u3055\u305b\u3001\u4f01\u696d\u304c\u6570\u9031\u9593\u4ee5\u5185\u306b\u88fd\u54c1\u8a8d\u8a3c\u304a\u3088\u3073\u91cf\u7523\u3092\u5b8c\u4e86\u3067\u304d\u308b\u4f53\u5236\u3092\u6574\u3048\u3001\u5e02\u5834\u3078\u306e\u8fc5\u901f\u306a\u4f9b\u7d66\u3092\u5b9f\u73fe\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u306f\u3001OEM\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u304c\u7af6\u4e89\u512a\u4f4d\u6027\u3092\u3082\u305f\u3089\u3059\u660e\u78ba\u306a\u4e8b\u4f8b\u3068\u3044\u3048\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%A8OEM%E3%82%92%E9%81%B8%E5%AE%9A%E3%81%99%E3%82%8B%E9%9A%9B%E3%81%AE%E9%87%8D%E8%A6%81%E3%81%AA%E3%83%9D%E3%82%A4%E3%83%B3%E3%83%88\"><\/span><strong>\u533b\u7642\u6a5f\u5668OEM\u3092\u9078\u5b9a\u3059\u308b\u969b\u306e\u91cd\u8981\u306a\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\/2025\/07\/\u533b\u7642\u6a5f\u5668OEM\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u898b\u6975\u3081\u65b9\uff1a\u54c1\u8cea\u30fb\u898f\u5236\u5bfe\u5fdc\u30fb\u751f\u7523\u4f53\u5236\u306e\u30c1\u30a7\u30c3\u30af\u9805\u76ee-04.webp\" alt=\"\" class=\"wp-image-8129\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/07\/\u533b\u7642\u6a5f\u5668OEM\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u898b\u6975\u3081\u65b9\uff1a\u54c1\u8cea\u30fb\u898f\u5236\u5bfe\u5fdc\u30fb\u751f\u7523\u4f53\u5236\u306e\u30c1\u30a7\u30c3\u30af\u9805\u76ee-04.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/07\/\u533b\u7642\u6a5f\u5668OEM\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u898b\u6975\u3081\u65b9\uff1a\u54c1\u8cea\u30fb\u898f\u5236\u5bfe\u5fdc\u30fb\u751f\u7523\u4f53\u5236\u306e\u30c1\u30a7\u30c3\u30af\u9805\u76ee-04-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p>\u9069\u5207\u306a\u533b\u7642\u6a5f\u5668Original Equipment Manufacturer\uff08OEM\uff09\u3092\u9078\u5b9a\u3059\u308b\u3053\u3068\u306f\u3001\u88fd\u54c1\u54c1\u8cea\u3001\u898f\u5236\u9075\u5b88\u3001\u305d\u3057\u3066\u4f01\u696d\u5168\u4f53\u306e\u6210\u529f\u306b\u76f4\u63a5\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u6975\u3081\u3066\u91cd\u8981\u306a\u610f\u601d\u6c7a\u5b9a\u3067\u3059\u3002\u4ee5\u4e0b\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668OEM\u3092\u9078\u3076\u969b\u306b\u691c\u8a0e\u3059\u3079\u304d5\u3064\u306e\u91cd\u8981\u306a\u8981\u7d20\u3092\u89e3\u8aac\u3057\u307e\u3059\uff1a <\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"1%E7%B5%8C%E9%A8%93%E3%81%A8%E5%B0%82%E9%96%80%E6%80%A7\"><\/span><strong>1.\u7d4c\u9a13\u3068\u5c02\u9580\u6027<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668OEM\u306f\u3001\u7cbe\u5bc6\u88fd\u9020\u306e\u5b9f\u7e3e\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u306e\u5c02\u9580\u77e5\u8b58\u3001\u305d\u3057\u3066\u9ad8\u5ea6\u306a\u751f\u7523\u80fd\u529b\u3092\u5099\u3048\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u8907\u96d1\u306a\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3001\u8a66\u4f5c\u3001\u91cf\u7523\u306b\u304a\u3044\u3066\u9577\u5e74\u306e\u7d4c\u9a13\u3092\u6301\u3064\u4f01\u696d\u306f\u3001\u3088\u308a\u9ad8\u3044\u4fe1\u983c\u6027\u3068\u9769\u65b0\u6027\u3092\u63d0\u4f9b\u3067\u304d\u307e\u3059\u3002 <br><br>\u307e\u305f\u3001\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u6750\u6599\u3084\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u306b\u7279\u5316\u3057\u305fOEM\u306f\u3001\u767d\u8840\u7403\u9664\u53bb\u30d5\u30a3\u30eb\u30bf\u30fc\u3001\u7d30\u80de\u5206\u96e2\u88c5\u7f6e\u3001\u57cb\u3081\u8fbc\u307f\u578b\u533b\u7642\u6a5f\u5668\u306a\u3069\u306e\u9ad8\u611f\u5ea6\u306a\u533b\u7642\u7528\u9014\u306b\u304a\u3044\u3066\u3001\u512a\u308c\u305f\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"2%E8%A6%8F%E5%88%B6%E9%81%B5%E5%AE%88\"><\/span><strong>2.\u898f\u5236\u9075\u5b88<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u533b\u7642\u696d\u754c\u306f\u6700\u3082\u53b3\u3057\u304f\u898f\u5236\u3055\u308c\u3066\u3044\u308b\u5206\u91ce\u306e\u4e00\u3064\u3067\u3042\u308a\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u56fd\u969b\u57fa\u6e96\u3078\u306e\u9069\u5408\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\uff1a<\/li>\n<\/ol>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.thy-precision.com\/ja\/iso-standards-for-medical-devices-the-meaning-of-iso-13485\/\">ISO 13485<\/a> \u2013 \u533b\u7642\u6a5f\u5668\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u3059\u308b\u56fd\u969b\u6a19\u6e96<br><\/li>\n\n\n\n<li>FDA\uff0821 CFR Part 820\uff09 \u2013 \u7c73\u56fd\u306e\u533b\u7642\u6a5f\u5668\u898f\u5236\u8981\u4ef6\u3078\u306e\u9069\u5408\u3092\u4fdd\u8a3c<br><\/li>\n\n\n\n<li>MDR\uff08EU\u533b\u7642\u6a5f\u5668\u898f\u5247\uff09 \u2013 \u6b27\u5dde\u5e02\u5834\u306b\u304a\u3051\u308b\u9069\u5408\u8981\u4ef6<br><\/li>\n\n\n\n<li>GMP\uff08\u9069\u6b63\u88fd\u9020\u898f\u7bc4\uff09 \u2013 \u88fd\u9020\u306e\u4e00\u8cab\u6027\u3068\u54c1\u8cea\u3092\u4fdd\u8a3c<br><\/li>\n<\/ul>\n\n\n\n<p>\u9069\u683c\u306a\u533b\u7642OEM\u306f\u3001\u8a8d\u8a3c\u53d6\u5f97\u6e08\u307f\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u8a2d\u5099\u3001\u88fd\u9020\u5de5\u7a0b\u306e\u5b8c\u5168\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u53b3\u683c\u306a\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u78ba\u7acb\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u305d\u306e\u6587\u66f8\u7ba1\u7406\u304a\u3088\u3073\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u624b\u9806\u306f\u3001\u56fd\u969b\u7684\u306a\u898f\u5236\u8981\u4ef6\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3079\u304d\u3067\u3059\u3002 <br><\/p>\n\n\n\n<p>\u4f8b\u3048\u3070\u3001\u7c73\u56fd\u307e\u305f\u306f\u6b27\u5dde\u5e02\u5834\u3078\u306e\u53c2\u5165\u3092\u76ee\u6307\u3059\u4f01\u696d\u306b\u3068\u3063\u3066\u3001FDA\u767b\u9332\u304a\u3088\u3073CE\u8a8d\u8a3c\u3092\u6709\u3059\u308bOEM\u306e\u9078\u5b9a\u306f\u3001\u898f\u5236\u627f\u8a8d\u53d6\u5f97\u306b\u304a\u3044\u3066\u4e0d\u53ef\u6b20\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"3%E8%A3%BD%E9%80%A0%E5%8A%B9%E7%8E%87\"><\/span>3.\u88fd\u9020\u52b9\u7387<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u88fd\u9020\u52b9\u7387\u306f\u3001\u30b3\u30b9\u30c8\u7ba1\u7406\u3001\u751f\u7523\u30b9\u30d4\u30fc\u30c9\u3001\u5ec3\u68c4\u7269\u524a\u6e1b\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u307e\u3059\u3002OEM\u3092\u8a55\u4fa1\u3059\u308b\u969b\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u70b9\u3092\u691c\u8a0e\u3057\u3066\u304f\u3060\u3055\u3044\u3002 <br><\/li>\n<\/ol>\n\n\n\n<ul 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href=\"https:\/\/www.thy-precision.com\/ja\/contact\/\">THY\u7cbe\u5bc6\u5de5\u696d<\/a>\u307e\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002\u304a\u5ba2\u69d8\u306e\u4ed5\u69d8\u306b\u6700\u9069\u5316\u3055\u308c\u305f\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u3054\u63d0\u6848\u3044\u305f\u3057\u307e\u3059\u3002<br><br>\u95a2\u9023\u8a18\u4e8b\uff1a<br><a href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/\">\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u652f\u3048\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020<\/a><br><a 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