{"id":1051,"date":"2026-08-27T10:00:00","date_gmt":"2026-08-27T01:00:00","guid":{"rendered":"https:\/\/www.sdicompany.com\/column\/?p=1051"},"modified":"2026-07-27T11:36:34","modified_gmt":"2026-07-27T02:36:34","slug":"medical-device-validation","status":"publish","type":"post","link":"https:\/\/www.sdicompany.com\/column\/medical-device-validation\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306b\u304a\u3051\u308b\u300c\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u300d\u3068\u30c7\u30a3\u30c3\u30d7\u30b3\u30fc\u30bf\u30fc\uff5cIQ\/OQ\u5bfe\u5fdc\u3068\u30c7\u30fc\u30bf\u7ba1\u7406"},"content":{"rendered":"\n<p>\u533b\u7642\u7528\u30ab\u30c6\u30fc\u30c6\u30eb\u3084\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u5de5\u7a0b\u306b\u304a\u3044\u3066\u3001\u5b9f\u9a13\u5ba4\u3067\u306e\u8a66\u4f5c\u6210\u529f\u306f\u30b4\u30fc\u30eb\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u60a3\u8005\u306e\u547d\u306b\u95a2\u308f\u308b\u533b\u7642\u6a5f\u5668\u306e\u91cf\u7523\u306b\u306f\u3001FDA\u3084ISO 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class=\"wp-block-heading\"><strong>2. \u8a2d\u5099\u5c0e\u5165\u6642\u306b\u6c42\u3081\u3089\u308c\u308bIQ\uff08\u636e\u4ed8\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff09\u3068OQ\uff08\u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff09<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u6b63\u78ba\u306b\u52d5\u3044\u3066\u3044\u308b\u8a3c\u62e0\u306e\u63d0\u793a<\/strong><\/h3>\n\n\n\n<p>\u65b0\u3057\u3044\u30c7\u30a3\u30c3\u30d7\u30b3\u30fc\u30bf\u30fc\u3092\u5de5\u5834\u306b\u5c0e\u5165\u3059\u308b\u969b\u3001\u5fc5\u305a\u8981\u6c42\u3055\u308c\u308b\u306e\u304c\u300cIQ\u300d\u3068\u300cOQ\u300d\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3067\u3059\u3002<\/p>\n\n\n\n<p>IQ\uff08Installation 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