{"id":5472,"date":"2024-05-28T10:02:12","date_gmt":"2024-05-28T02:02:12","guid":{"rendered":"https:\/\/www.thy-precision.com\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ae%e5%8f%97%e8%a8%97%e8%a3%bd%e9%80%a0%e6%a5%ad%e8%80%85%e3%82%92%e6%8e%a2%e3%81%99%e9%9a%9b%e3%81%ab%e7%9f%a5%e3%81%a3%e3%81%a6%e3%81%8a%e3%81%8f%e3%81%b9\/"},"modified":"2025-06-19T01:07:37","modified_gmt":"2025-06-18T17:07:37","slug":"contract-medical-device-manufacturer-what-you-need-to-know","status":"publish","type":"post","link":"https:\/\/www.thy-precision.com\/ja\/contract-medical-device-manufacturer-what-you-need-to-know\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u53d7\u8a17\u88fd\u9020\u696d\u8005\u3092\u63a2\u3059\u969b\u306b\u77e5\u3063\u3066\u304a\u304f\u3079\u304d\u4e8b\u9805"},"content":{"rendered":"\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\/contract-medical-device-manufacturer-what-you-need-to-know\/#%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%AE%E5%8F%97%E8%A8%97%E8%A3%BD%E9%80%A0OEM%E3%81%A8%E3%81%AF%EF%BC%9F\" >\u533b\u7642\u6a5f\u5668\u306e\u53d7\u8a17\u88fd\u9020(OEM)\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\/contract-medical-device-manufacturer-what-you-need-to-know\/#%E5%8F%97%E8%A8%97%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E8%A3%BD%E9%80%A0%E6%A5%AD%E8%80%85%E3%81%AE%E5%BD%B9%E5%89%B2%E3%81%A8%E3%81%AF%EF%BC%9F\" >\u53d7\u8a17\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u306e\u5f79\u5272\u3068\u306f\uff1f<\/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\/contract-medical-device-manufacturer-what-you-need-to-know\/#%E5%93%81%E8%B3%AA%E3%82%B3%E3%83%B3%E3%83%97%E3%83%A9%E3%82%A4%E3%82%A2%E3%83%B3%E3%82%B9%E3%81%AE%E7%A2%BA%E4%BF%9D\" >\u54c1\u8cea\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u78ba\u4fdd<\/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\/contract-medical-device-manufacturer-what-you-need-to-know\/#%E7%94%9F%E7%94%A3%E3%81%AE%E5%8A%B9%E7%8E%87%E5%8C%96%E3%81%A8%E3%82%B3%E3%82%B9%E3%83%88%E5%89%8A%E6%B8%9B\" >\u751f\u7523\u306e\u52b9\u7387\u5316\u3068\u30b3\u30b9\u30c8\u524a\u6e1b<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.thy-precision.com\/ja\/contract-medical-device-manufacturer-what-you-need-to-know\/#%E5%8F%97%E8%A8%97%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E8%A3%BD%E9%80%A0%E6%A5%AD%E8%80%85%E3%82%92%E9%81%B8%E3%81%B6%E3%82%B3%E3%83%84\" >\u53d7\u8a17\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u3092\u9078\u3076\u30b3\u30c4<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.thy-precision.com\/ja\/contract-medical-device-manufacturer-what-you-need-to-know\/#%E9%AB%98%E5%93%81%E8%B3%AA%E3%81%AA%E8%A3%BD%E9%80%A0%E3%81%A8ISO13485%E8%AA%8D%E8%A8%BC\" >\u9ad8\u54c1\u8cea\u306a\u88fd\u9020\u3068ISO13485\u8a8d\u8a3c<\/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\/contract-medical-device-manufacturer-what-you-need-to-know\/#%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E3%81%A7%E3%81%AE%E8%A3%BD%E9%80%A0%E8%83%BD%E5%8A%9B\" >\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3067\u306e\u88fd\u9020\u80fd\u529b<\/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\/contract-medical-device-manufacturer-what-you-need-to-know\/#%E9%81%A9%E5%88%87%E3%81%AA%E6%A9%9F%E6%A2%B0%E3%81%A8%E8%A8%AD%E5%82%99\" >\u9069\u5207\u306a\u6a5f\u68b0\u3068\u8a2d\u5099<\/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\/contract-medical-device-manufacturer-what-you-need-to-know\/#%E8%A3%BD%E9%80%A0%E5%8A%B9%E7%8E%87\" >\u88fd\u9020\u52b9\u7387<\/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\/contract-medical-device-manufacturer-what-you-need-to-know\/#%E3%81%BE%E3%81%A8%E3%82%81\" >\u307e\u3068\u3081<\/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%E5%8F%97%E8%A8%97%E8%A3%BD%E9%80%A0OEM%E3%81%A8%E3%81%AF%EF%BC%9F\"><\/span><strong>\u533b\u7642\u6a5f\u5668\u306e\u53d7\u8a17\u88fd\u9020(OEM)\u3068\u306f\uff1f<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/06\/JP_contract_medical_device-072-jpg.webp\" alt=\"\u533b\u7642\u6a5f\u5668\u306e\u53d7\u8a17\u88fd\u9020(OEM)\u3068\u306f\uff1f\" class=\"wp-image-5427\"\/><\/figure>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u306e\u53d7\u8a17\u88fd\u9020(OEM)\u306f\u3001\u533b\u7642\u7523\u696d\u306e\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u304a\u3044\u3066\u4e0d\u53ef\u6b20\u306a\u90e8\u5206\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002 \u3053\u308c\u3089\u306e\u5c02\u9580\u4f01\u696d\u306f\u3001\u5c02\u9580\u77e5\u8b58\u3068\u751f\u7523\u80fd\u529b\u3092\u6d3b\u7528\u3057\u3001\u958b\u767a\u5143\u306e\u30e1\u30fc\u30ab\u30fc\u306e\u4ee3\u308f\u308a\u306b\u533b\u7642\u6a5f\u5668\u3084\u90e8\u54c1\u3092\u88fd\u9020\u3057\u307e\u3059\u3002 \u30c7\u30d0\u30a4\u30b9\u306e\u751f\u7523\u306e\u5168\u3066\u306e\u5de5\u7a0b\u3092\u793e\u5185\u3067\u884c\u3046\u306e\u3067\u306f\u306a\u304f\u3001\u53d7\u8a17\u30d1\u30fc\u30c8\u30ca\u30fc\u306b\u88fd\u9020\u3092\u5916\u6ce8\u3059\u308b\u3053\u3068\u304c\u591a\u3044\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u53d7\u8a17\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u306e\u5f79\u5272\u306f\u3001\u304a\u5ba2\u69d8\u306e\u88fd\u54c1\u8a2d\u8a08\u3068\u4ed5\u69d8\u3092\u5143\u306b\u3001\u9ad8\u54c1\u8cea\u3067\u9069\u5207\u306a\u90e8\u54c1\u306b\u5909\u63db\u3059\u308b\u3053\u3068\u3067\u3059\u3002 \u307e\u305f\u3001\u30af\u30e9\u30b9I\u3001II\u3001III\u306e\u533b\u7642\u6a5f\u5668\u3092\u88fd\u9020\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u8a2d\u5099\u3001\u8a8d\u8a3c\u3001\u304a\u3088\u3073\u898f\u5236\u95a2\u9023\u306e\u77e5\u8b58\u3092\u6301\u3063\u3066\u3044\u307e\u3059\u3002 \u88fd\u9020\u3060\u3051\u3067\u306a\u304f\u3001\u5305\u88c5\u3001\u30e9\u30d9\u30ea\u30f3\u30b0\u3001\u6ec5\u83cc\u306a\u3069\u306e\u8ffd\u52a0\u30b5\u30fc\u30d3\u30b9\u3082\u63d0\u4f9b\u3057\u3001\u30bf\u30fc\u30f3\u30ad\u30fc\u65b9\u5f0f\u3067\u306e\u88fd\u9020\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%8F%97%E8%A8%97%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E8%A3%BD%E9%80%A0%E6%A5%AD%E8%80%85%E3%81%AE%E5%BD%B9%E5%89%B2%E3%81%A8%E3%81%AF%EF%BC%9F\"><\/span><strong>\u53d7\u8a17\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u306e\u5f79\u5272\u3068\u306f\uff1f<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/06\/JP_contract_medical_device-08-1-jpg.webp\" alt=\"\u53d7\u8a17\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u306e\u5f79\u5272\u3068\u306f\uff1f\" class=\"wp-image-5430\"\/><\/figure>\n\n\n\n<p>\u53d7\u8a17\u88fd\u9020\u696d\u8005\u3068\u9023\u643a\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u3044\u304f\u3064\u304b\u306e\u6226\u7565\u7684\u5229\u70b9\u304c\u3042\u308a\u307e\u3059\u3002 \u88fd\u54c1\u306e\u7814\u7a76\u958b\u767a\u306b\u96c6\u4e2d\u3057\u3001\u4f9b\u7d66\u9023\u9396\u3092\u52b9\u7387\u5316\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 <\/p>\n\n\n\n<p>\u53d7\u8a17\u88fd\u9020\u696d\u8005\u306f\u307e\u305f\u3001\u53b3\u3057\u3044\u7d0d\u671f\u3092\u5b88\u308a\u3001\u751f\u7523\u30b3\u30b9\u30c8\u3092\u6291\u5236\u3057\u3001\u88fd\u54c1\u304c\u3059\u3079\u3066\u306e\u95a2\u9023\u696d\u754c\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002 \u3053\u306e\u76f8\u4e92\u5354\u529b\u7684\u306a\u5354\u529b\u95a2\u4fc2\u306b\u3088\u308a\u3001OEM\u306f\u3088\u308a\u5b89\u5168\u3067\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u533b\u7642\u6280\u8853\u3092\u3088\u308a\u52b9\u7387\u7684\u306b\u5e02\u5834\u306b\u63d0\u4f9b\u3059\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=\"%E5%93%81%E8%B3%AA%E3%82%B3%E3%83%B3%E3%83%97%E3%83%A9%E3%82%A4%E3%82%A2%E3%83%B3%E3%82%B9%E3%81%AE%E7%A2%BA%E4%BF%9D\"><\/span><strong>\u54c1\u8cea\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u78ba\u4fdd<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u54c1\u8cea\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u78ba\u4fdd\u306f\u3001\u533b\u7642\u6a5f\u5668\u53d7\u8a17\u88fd\u9020\u696d\u8005\u306b\u3068\u3063\u3066\u6700\u512a\u5148\u4e8b\u9805\u3067\u3059\u3002 \u88fd\u54c1\u306b\u3088\u3063\u3066\u306f\u4eba\u547d\u304c\u95a2\u308f\u308b\u305f\u3081\u3001\u54c1\u8cea\u306b\u3088\u308b\u554f\u984c\u3092\u672a\u7136\u306b\u9632\u3050\u3053\u3068\u306f\u91cd\u8981\u306a\u8cac\u4efb\u3067\u3059\u3002 \u3053\u308c\u3089\u306e\u5c02\u9580\u4f01\u696d\u306f\u3001\u751f\u7523\u30d7\u30ed\u30bb\u30b9\u3092\u901a\u3058\u3066\u3059\u3079\u3066\u306e\u30a2\u30a4\u30c6\u30e0\u3092\u5fb9\u5e95\u7684\u306b\u691c\u67fb\u30fb\u8a55\u4fa1\u3057\u3001\u9ad8\u5ea6\u306a\u6e2c\u5b9a\u6a5f\u5668\u3092\u4f7f\u7528\u3057\u3066\u8fc5\u901f\u306b\u6b20\u9665\u3092\u7279\u5b9a\u3057\u5bfe\u51e6\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u500b\u3005\u306e\u88fd\u54c1\u306e\u54c1\u8cea\u7ba1\u7406\u3060\u3051\u3067\u306a\u304f\u3001\u53d7\u8a17\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u306f\u3001\u751f\u7523\u30d7\u30ed\u30bb\u30b9\u306e\u7d99\u7d9a\u7684\u306a\u6539\u5584\u3082\u4efb\u3055\u308c\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.thy-precision.com\/ja\/iso-standards-for-medical-devices-the-meaning-of-iso-13485\/\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 13485\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/a>\u306b\u5f93\u3044\u3001\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u52b9\u679c\u3092\u691c\u8a3c\u3057\u3001\u88fd\u9020\u3055\u308c\u305f\u90e8\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3053\u306e\u3088\u3046\u306b\u53b3\u683c\u306a\u54c1\u8cea\u57fa\u6e96\u3092\u5b88\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u533b\u7642\u6a5f\u5668\u53d7\u8a17\u88fd\u9020\u696d\u8005\u306f\u3001\u88fd\u9020\u3057\u305f\u30c7\u30d0\u30a4\u30b9\u304c\u3059\u3079\u3066\u306e\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u521d\u3081\u3066\u3001\u81e8\u5e8a\u73fe\u5834\u3067\u4fe1\u983c\u6027\u3092\u6301\u3063\u3066\u6a5f\u80fd\u3059\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E7%94%9F%E7%94%A3%E3%81%AE%E5%8A%B9%E7%8E%87%E5%8C%96%E3%81%A8%E3%82%B3%E3%82%B9%E3%83%88%E5%89%8A%E6%B8%9B\"><\/span><strong>\u751f\u7523\u306e\u52b9\u7387\u5316\u3068\u30b3\u30b9\u30c8\u524a\u6e1b<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u53d7\u8a17\u88fd\u9020\u696d\u8005\u306fOEM\u306b\u30bf\u30fc\u30f3\u30ad\u30fc\u306e\u751f\u7523\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002 \u65bd\u8a2d\u3084\u8a2d\u5099\u304b\u3089\u4eba\u54e1\u3084\u7269\u6d41\u307e\u3067\u3001\u88fd\u9020\u8cac\u4efb\u306e\u5168\u7bc4\u56f2\u3092\u7db2\u7f85\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 \u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u88fd\u4f5c\u304b\u3089\u5927\u898f\u6a21\u306a\u88fd\u54c1\u30ea\u30ea\u30fc\u30b9\u307e\u3067\u3001\u53d7\u8a17\u88fd\u9020\u696d\u8005\u306f\u3053\u308c\u3089\u306e\u521d\u671f\u8ca0\u62c5\u3092\u5f15\u304d\u53d7\u3051\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u88fd\u9020\u3060\u3051\u3067\u306a\u304f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5546\u54c1\u5316\u306b\u5fc5\u8981\u306a\u4ed8\u968f\u30b5\u30fc\u30d3\u30b9\uff08\u5305\u88c5\u3001\u6eb6\u63a5\u3001\u88c5\u98fe\u3001\u6ec5\u83cc\u306a\u3069\uff09\u3092\u7ba1\u7406\u3057\u307e\u3059\u3002 \u3053\u306e\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u30d7\u30ed\u30bb\u30b9\u3092\u53d6\u308a\u6271\u3046\u3053\u3068\u306b\u3088\u308a\u3001\u958b\u767a\u5143\u306e\u4f01\u696d\u306f\u88fd\u54c1\u306e\u9769\u65b0\u3068\u60a3\u8005\u30b1\u30a2\u306e\u5411\u4e0a\u306b\u96c6\u4e2d\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u751f\u7523\u3092\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001OEM\u306f\u8cc7\u672c\u96c6\u7d04\u7684\u306a\u6295\u8cc7\u3084\u904b\u7528\u306e\u8907\u96d1\u3055\u3092\u907f\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 \u3053\u308c\u306b\u3088\u308a\u3001\u5e02\u5834\u306b\u5b89\u5168\u3067\u52b9\u679c\u7684\u306a\u533b\u7642\u6280\u8853\u3092\u3082\u305f\u3089\u3059\u969b\u306e\u8fc5\u901f\u6027\u3001\u53cd\u5fdc\u6027\u3001\u30b3\u30b9\u30c8\u52b9\u7387\u304c\u5411\u4e0a\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%8F%97%E8%A8%97%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E8%A3%BD%E9%80%A0%E6%A5%AD%E8%80%85%E3%82%92%E9%81%B8%E3%81%B6%E3%82%B3%E3%83%84\"><\/span><strong>\u53d7\u8a17\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u3092\u9078\u3076\u30b3\u30c4<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/06\/JP_contract_medical_device-10-2-jpg.webp\" alt=\"\u9069\u5207\u306a\u53d7\u8a17\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u3092\u9078\u3073\u3076\u306b\u306f\uff1f\" class=\"wp-image-5433\"\/><\/figure>\n\n\n\n<p>\u9069\u5207\u306a\u53d7\u8a17\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u3092\u9078\u3076\u3053\u3068\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u306f\u8907\u96d1\u306a\u6c7a\u5b9a\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002 \u53d7\u8a17\u88fd\u9020\u696d\u8005\u306f\u3001\u91d1\u578b\u306e\u5236\u4f5c\u3084\u6210\u5f62\u304b\u3089R&amp;D\u8a2d\u8a08\u3001\u30ab\u30b9\u30bf\u30e0\u30d1\u30c3\u30b1\u30fc\u30b8\u30f3\u30b0\u307e\u3067\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306e\u3055\u307e\u3056\u307e\u306a\u30b5\u30fc\u30d3\u30b9\u3092\u62c5\u5f53\u3057\u3066\u304a\u308a\u3001 \u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30e1\u30fc\u30ab\u30fc\u306e\u9577\u671f\u7684\u306a\u6210\u529f\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u91cd\u8981\u306a\u8981\u7d20\u306b\u306a\u3063\u3066\u304a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E9%AB%98%E5%93%81%E8%B3%AA%E3%81%AA%E8%A3%BD%E9%80%A0%E3%81%A8ISO13485%E8%AA%8D%E8%A8%BC\"><\/span><strong>\u9ad8\u54c1\u8cea\u306a\u88fd\u9020\u3068ISO13485\u8a8d\u8a3c<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u9ad8\u54c1\u8cea\u306a\u30b7\u30b9\u30c6\u30e0\u3068<a href=\"https:\/\/www.thy-precision.com\/ja\/iso-standards-for-medical-devices-the-meaning-of-iso-13485\/\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 13485\u8a8d\u8a3c<\/a>\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30e1\u30fc\u30ab\u30fc\u3068\u5354\u529b\u3059\u308b\u533b\u7642\u53d7\u8a17\u88fd\u9020\u696d\u8005\u306b\u3068\u3063\u3066\u975e\u5e38\u306b\u4fa1\u5024\u304c\u3042\u308a\u307e\u3059\u3002 \u56fd\u969b\u7684\u306b\u8a8d\u3081\u3089\u308c\u305f\u57fa\u6e96\u3092\u30af\u30ea\u30a2\u3059\u308b\u305f\u3081\u306b\u3001\u53d7\u8a17\u88fd\u9020\u696d\u8005\u306b\u306f\u53b3\u3057\u3044\u8981\u4ef6\u3092\u8ab2\u3055\u308c\u3001\u4e00\u8cab\u3057\u305f\u898f\u5236\u57fa\u6e96\u3092\u6e80\u305f\u3059\u3053\u3068\u3067\u3001\u304a\u5ba2\u69d8\u306e\u30cb\u30fc\u30ba\u306b\u5fdc\u3048\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002 ISO 13485\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u306f\u3001\u53d7\u8a17\u88fd\u9020\u696d\u8005\u304c\u696d\u754c\u306e\u57fa\u6e96\u306b\u7b49\u3057\u3044\u304b\u305d\u308c\u3092\u8d85\u3048\u308b\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3092\u78ba\u7acb\u3059\u308b\u305f\u3081\u306e\u6642\u9593\u3001\u52aa\u529b\u3001\u30ea\u30bd\u30fc\u30b9\u3092\u6295\u8cc7\u3057\u305f\u3053\u3068\u3092\u793a\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u751f\u7523\u54c1\u8cea\u306e\u4fdd\u8a3c\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u308f\u308b\u6c7a\u5b9a\u3067\u6700\u3082\u91cd\u8981\u306a\u8981\u7d20\u3067\u3059\u3002 ISO 13485\u8a8d\u8a3c\u3068\u54c1\u8cea\u7ba1\u7406\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u308b\u53d7\u8a17\u88fd\u9020\u696d\u8005\u3092\u9078\u3076\u3053\u3068\u306f\u3001 \u9577\u671f\u7684\u306b\u898b\u308b\u3068OEM\u3067\u4f7f\u308f\u308c\u308b\u6642\u9593\u3068\u91d1\u92ad\u306e\u7bc0\u7d04\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E3%81%A7%E3%81%AE%E8%A3%BD%E9%80%A0%E8%83%BD%E5%8A%9B\"><\/span><strong>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3067\u306e\u88fd\u9020\u80fd\u529b<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u65bd\u8a2d\u3092\u6301\u3064\u53d7\u8a17\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u3092\u9078\u3076\u3053\u3068\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u91cd\u8981\u306a\u5229\u70b9\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002 \u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u74b0\u5883\u3067\u88fd\u9020\u3055\u308c\u305f\u90e8\u54c1\u306f\u3001\u88fd\u54c1\u304c\u6ec5\u83cc\u51e6\u7406\u3055\u308c\u305f\u3088\u3046\u306a\u72b6\u614b\u3067\u5168\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u304c\u6271\u308f\u308c\u308b\u305f\u3081\u3001\u6c5a\u67d3\u306e\u30ea\u30b9\u30af\u304c\u4f4e\u304f\u306a\u308a\u307e\u3059\u3002 \u3053\u308c\u306b\u3088\u308a\u3001\u53b3\u683c\u306a\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u5c02\u9580\u6a5f\u5668\u304c\u88fd\u9020\u5168\u4f53\u306b\u304a\u3044\u3066\u9ad8\u3044\u30ec\u30d9\u30eb\u306e\u6e05\u6f54\u3055\u3068\u30b1\u30a2\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u3001\u3088\u308a\u826f\u3044\u54c1\u8cea\u306e\u30c7\u30d0\u30a4\u30b9\u304c\u5f97\u3089\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3055\u3089\u306b\u3001\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u65bd\u8a2d\u3092\u6301\u3064\u53d7\u8a17\u88fd\u9020\u696d\u8005\u306f\u3001\u30af\u30ea\u30fc\u30f3\u306a\u74b0\u5883\u3092\u7dad\u6301\u3057\u3001\u8a2d\u5099\u3092\u6700\u5927\u9650\u306e\u6ce8\u610f\u3092\u6255\u3063\u3066\u6271\u3046\u305f\u3081\u306b\u5fb9\u5e95\u7684\u306b\u8a13\u7df4\u3055\u308c\u305f\u9ad8\u5ea6\u306a\u6280\u8853\u8005\u304c\u5e38\u99d0\u3057\u3066\u3044\u307e\u3059\u3002 \u5c02\u9580\u7684\u306a\u77e5\u8b58\u3068\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u4e2d\u306e\u6ce8\u610f\u6df1\u3044\u53d6\u308a\u7d44\u307f\u306f\u3001OEM\u3067\u88fd\u9020\u3055\u308c\u308b\u88fd\u54c1\u54c1\u8cea\u3068\u4fe1\u983c\u6027\u306e\u4fdd\u8a3c\u3092\u5f37\u5316\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E9%81%A9%E5%88%87%E3%81%AA%E6%A9%9F%E6%A2%B0%E3%81%A8%E8%A8%AD%E5%82%99\"><\/span><strong>\u9069\u5207\u306a\u6a5f\u68b0\u3068\u8a2d\u5099<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<figure class=\"wp-block-image aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2024\/06\/JP_contract_medical_device-10-jpg.webp\" alt=\"\u9069\u5207\u306a\u6a5f\u68b0\u3068\u8a2d\u5099\" class=\"wp-image-5453\"\/><\/figure>\n\n\n\n<p>\u53d7\u8a17\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u3092\u9078\u3076\u969b\u306b\u306f\u3001\u88fd\u54c1\u3092\u52b9\u679c\u7684\u306b\u751f\u7523\u3059\u308b\u305f\u3081\u306e<a href=\"https:\/\/www.thy-precision.com\/ja\/facilities\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u9069\u5207\u306a\u6a5f\u68b0\u3068\u8a2d\u5099<\/a>\u3092\u6301\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002 \u88fd\u9020\u4f01\u696d\u306e\u6a5f\u68b0\u3068\u65bd\u8a2d\u306e\u80fd\u529b\u306f\u3001\u88fd\u9020\u8981\u4ef6\u3092\u6e80\u305f\u3059\u80fd\u529b\u306b\u76f4\u63a5\u5f71\u97ff\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u53d7\u8a17\u88fd\u9020\u696d\u8005\u306f\u3001\u5fc5\u8981\u306a\u6210\u5f62\u3001\u52a0\u5de5\u3001\u307e\u305f\u306f\u51e6\u7406\u8a2d\u5099\u3092\u6240\u6301\u3057\u3066\u3044\u308b\u304b\uff1f \u54c1\u8cea\u57fa\u6e96\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u751f\u7523\u80fd\u529b\u3068\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u65bd\u8a2d\u3092\u6240\u6709\u3057\u3066\u3044\u308b\u304b\uff1f \u3053\u308c\u3089\u306f\u91cd\u8981\u306a\u8003\u616e\u4e8b\u9805\u3067\u3042\u308a\u3001\u9069\u5207\u306a\u6a5f\u68b0\u3068\u30a4\u30f3\u30d5\u30e9\u306f\u5f7c\u3089\u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u306e\u57fa\u76e4\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u9069\u5207\u306a\u8a2d\u5099\u3092\u6301\u3064\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u9078\u3076\u3053\u3068\u3067\u3001\u88fd\u54c1\u8a2d\u8a08\u3092\u9ad8\u3044\u7cbe\u5ea6\u3068\u52b9\u7387\u3067\u5b9f\u884c\u3067\u304d\u3001\u54c1\u8cea\u554f\u984c\u3084\u9045\u5ef6\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 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noopener\">\u81ea\u52d5\u5316\u3055\u308c\u305f\u88fd\u9020<\/a>\u306e\u5c0e\u5165\u306f\u533b\u7642\u6a5f\u5668\u751f\u7523\u306b\u9769\u65b0\u3092\u3082\u305f\u3089\u3057\u3066\u3044\u307e\u3059\u3002 \u81ea\u52d5\u5316\u30d7\u30ed\u30bb\u30b9\u306f\u88fd\u9020\u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3092\u6700\u9069\u5316\u3057\u3001\u52b9\u7387\u3068\u54c1\u8cea\u3092\u5411\u4e0a\u3055\u305b\u3001\u4eba\u7684\u30df\u30b9\u3092\u6e1b\u3089\u3057\u307e\u3059\u3002 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class=\"wp-image-5442\"\/><\/figure>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u306e\u53d7\u8a17\u88fd\u9020\u696d\u8005\u306f\u3001\u533b\u7642OEM\u306b\u3068\u3063\u3066\u6b20\u304b\u305b\u306a\u3044\u30d1\u30fc\u30c8\u30ca\u30fc\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002 \u3053\u308c\u3089\u306e\u5c02\u9580\u4f01\u696d\u306f\u3001\u88fd\u54c1\u8a2d\u8a08\u3092\u9ad8\u54c1\u8cea\u3067\u9069\u5408\u3059\u308b\u30c7\u30d0\u30a4\u30b9\u306b\u5909\u63db\u3059\u308b\u305f\u3081\u306e\u5c02\u9580\u77e5\u8b58\u3001\u8a2d\u5099\u3001\u304a\u3088\u3073\u898f\u5236\u95a2\u9023\u306e\u77e5\u8b58\u3092\u6301\u3063\u3066\u3044\u307e\u3059\u3002 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noopener\">\u533b\u7642\u6a5f\u5668\u53d7\u8a17\u88fd\u9020\u30b5\u30fc\u30d3\u30b9<\/a>\u306f\u3001\u304a\u5ba2\u69d8\u306e\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u3092\u3088\u308a\u52b9\u7387\u3088\u304f\u3001\u9ad8\u54c1\u8cea\u306a\u88fd\u54c1\u3092\u751f\u7523\u3059\u308b\u624b\u52a9\u3051\u304c\u3067\u304d\u308b\u3088\u3046\u3001\u30c1\u30fc\u30e0\u4e00\u540c\u5e38\u306b\u5fc3\u304c\u3051\u3066\u304a\u308a\u307e\u3059\u3002 \u533b\u7642\u95a2\u9023\u88fd\u54c1\u306eOEM\u3092\u304a\u8003\u3048\u306e\u5834\u5408\u306f\u3001\u662f\u975e\u304a\u6c17\u8efd\u306b<a href=\"https:\/\/www.thy-precision.com\/ja\/contact\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u304a\u554f\u3044\u5408\u308f<\/a>\u305b\u304f\u3060\u3055\u3044\u3002 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noopener\">\u7cbe\u5bc6\u5c04\u51fa\u6210\u5f62\u306e\u305f\u3081\u306e\u57fa\u672c\u7684\u306a\u8a2d\u8a08\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u533b\u7642\u6a5f\u5668\u306e\u53d7\u8a17\u88fd\u9020(OEM)\u3068\u306f\uff1f \u533b\u7642\u6a5f\u5668\u306e\u53d7\u8a17\u88fd\u9020(OEM)\u306f\u3001\u533b\u7642\u7523\u696d\u306e\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u304a\u3044\u3066\u4e0d\u53ef\u6b20\u306a\u90e8\u5206\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002 \u3053\u308c\u3089\u306e\u5c02\u9580\u4f01\u696d\u306f\u3001\u5c02\u9580\u77e5\u8b58\u3068\u751f\u7523\u80fd\u529b\u3092\u6d3b\u7528\u3057\u3001\u958b\u767a\u5143\u306e\u30e1\u30fc\u30ab\u30fc\u306e\u4ee3\u308f\u308a\u306b\u533b\u7642\u6a5f\u5668\u3084\u90e8\u54c1 [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":5451,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[35],"tags":[],"class_list":["post-5472","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u533b\u7642\u6a5f\u5668\u306e\u53d7\u8a17\u88fd\u9020\u696d\u8005\u3092\u63a2\u3059\u969b\u306b\u77e5\u3063\u3066\u304a\u304f\u3079\u304d\u4e8b\u9805<\/title>\n<meta name=\"description\" content=\"\u533b\u7642\u6a5f\u5668\u306e\u53d7\u8a17\u88fd\u9020\u696d\u8005(OEM)\u3092\u9078\u629e\u3059\u308b\u969b\u3001\u62bc\u3055\u3048\u3066\u304a\u304f\u3079\u304d\u4e8b\u9805\u3092\u3054\u7d39\u4ecb\u3044\u305f\u3057\u307e\u3059\u3002\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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