{"id":1654,"date":"2021-03-11T18:18:30","date_gmt":"2021-03-11T18:18:30","guid":{"rendered":"http:\/\/www.validant.com\/eu-mdr-ivdr%e3%81%ae%e9%81%b5%e5%ae%88\/"},"modified":"2021-04-14T20:47:39","modified_gmt":"2021-04-14T20:47:39","slug":"eu-mdr-ivdr%e3%81%ae%e9%81%b5%e5%ae%88","status":"publish","type":"page","link":"https:\/\/www.validant.com\/ja\/eu-mdr-ivdr%e3%81%ae%e9%81%b5%e5%ae%88\/","title":{"rendered":"EU MDR\/IVDR\u306e\u9075\u5b88"},"content":{"rendered":"\n<section class=\"wp-block-mkl-section-block\"><div class=\"section-bg bg__stretched\" style=\"background-image:url(https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/eu-mdr-compliance.jpg);opacity:1\"><\/div>\n<div class=\"wp-block-mkl-section-block container pt-xl\">\n<p><\/p>\n<\/div>\n<\/section>\n\n<section class=\"wp-block-mkl-section-block transparent\">\n<div class=\"wp-block-mkl-section-block has-white-background-color container panel pb-xs ot-l bb\">\n<h1 class=\"has-text-align-center pt-xxs wp-block-heading\"><strong><span class=\"has-inline-color has-green-color\">EU MDR\/IVDR\u306e\u9075\u5b88<\/span><\/strong>\u306b\u5411\u3051\u305f\u6e96\u5099<\/h1>\n\n\n\n<p class=\"has-text-align-center maxc1000 pt-xxs\">\u6307\u4ee4\u3067\u306f\u306a\u304f\u306a\u308a\u307e\u3057\u305f\u304c\u3001\u7f70\u5247\u3092\u4f34\u3046\u6cd5\u5f8b\u3067\u3042\u308b\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u898f\u5247(EU MDR)\u304a\u3088\u3073\u6b27\u5dde\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\u898f\u5247 (EU IVDR)\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u7bc4\u56f2\u3068\u53b3\u683c\u6027\u304c\u5287\u7684\u306b\u62e1\u5927\u3055\u308c\u307e\u3059\u3002\u898f\u5247\u3078\u306e\u62b5\u89e6\u3092\u56de\u907f\u3059\u308b\u306b\u306f\u3001\u9075\u5b88\u306b\u5411\u3051\u3066\u5805\u5b9f\u306a\u6e96\u5099\u304c\u3067\u304d\u308b\u512a\u308c\u305f\u30d1\u30fc\u30c8\u30ca\u30fc\u304c\u5fc5\u8981\u3067\u3059\u3002<strong>Validant\u304c\u9078\u3070\u308c\u308b\u7406\u7531\u306f\uff1f<\/strong><\/p>\n\n\n\n<p><\/p>\n<\/div>\n<\/section>\n\n<section class=\"wp-block-mkl-section-block\">\n<div class=\"wp-block-mkl-section-block container pt-z pb-z\">\n<div class=\"wp-block-columns mt-s is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column page-content is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:65%\">\n<div class=\"wp-block-group relative pt-s\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<figure class=\"wp-block-image size-large pin-left\"><img loading=\"lazy\" decoding=\"async\" width=\"470\" height=\"433\" src=\"http:\/\/www.validant.com\/wp-content\/uploads\/2020\/11\/eu-mdr-compliance-readiness.jpg\" alt=\"EU MDR&#x306E;&#x9075;&#x5B88;&#x306B;&#x5411;&#x3051;&#x305F;&#x6E96;&#x5099;\" class=\"wp-image-1468\" srcset=\"https:\/\/www.validant.com\/wp-content\/uploads\/2020\/11\/eu-mdr-compliance-readiness.jpg 470w, https:\/\/www.validant.com\/wp-content\/uploads\/2020\/11\/eu-mdr-compliance-readiness-300x276.jpg 300w\" sizes=\"auto, (max-width: 470px) 100vw, 470px\" \/><\/figure>\n\n\n<div class=\"wp-block-mkl-section-block has-white-background-color panel square ml-l z1 w80\">\n<h3 class=\"wp-block-heading\" id=\"scope\"><strong><span class=\"has-inline-color has-green-color\">\u9075\u5b88\u306b\u5411\u3051\u305f\u6e96\u5099\u3092\u52a0\u901f\u3055\u305b\u308b<\/span><\/strong>\u7dcf\u5408\u30b5\u30dd\u30fc\u30c8<\/h3>\n\n\n\n<p>COVID-19\u5371\u6a5f\u306b\u3088\u308a\u6b27\u5dde\u59d4\u54e1\u4f1a\u306f<a aria-label=\"undefined (opens in a new tab)\" rel=\"noreferrer noopener\" href=\"https:\/\/www.medicaldesignandoutsourcing.com\/breaking-eu-mdr-is-postponed-by-one-year-due-to-coronavirus-pandemic\/\" target=\"_blank\">MDR\u306e\u767a\u52b9\u65e5<\/a>\u30921\u5e74\u5ef6\u671f\u3057\u307e\u3057\u305f\u304c\u3001\u81e8\u5e8a\u8a55\u4fa1\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u3001\u4e00\u822c\u7684\u306a\u5b89\u5168\u6027\u3068\u6027\u80fd\u306e\u8981\u4ef6(GSPR)\u3001\u7d0d\u5165\u696d\u8005\/\u4e8b\u696d\u8005\u306e\u7ba1\u7406\u3001\u30e9\u30d9\u30eb\u8868\u793a\u3001\u4e0a\u5e02\u5f8c\u8abf\u67fb\u3001\u30d3\u30b8\u30e9\u30f3\u30b9(\u6ce8\u610f\u7fa9\u52d9)\u3001\u305d\u306e\u4ed6\u306e\u95a2\u9023\u30d7\u30ed\u30bb\u30b9\u304c\u5927\u5e45\u306b\u5909\u66f4\u3055\u308c\u307e\u3057\u305f\u3002\u88fd\u9020\u696d\u8005\u306f\u3053\u306e\u5ef6\u671f\u3055\u308c\u305f\u671f\u9650\u306b\u9593\u306b\u5408\u3046\u3088\u3046\u306b\u3001\u3053\u308c\u3089\u306e\u9805\u76ee\u306b\u3064\u3044\u3066\u305f\u3060\u3061\u306b\u5bfe\u51e6\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>Validant\u3067\u306f\u3001\u8fc5\u901f\u306a\u5b9f\u65bd\u3001\u304a\u3088\u3073\u9075\u5b88\u30d7\u30ed\u30bb\u30b9\u3092\u6301\u7d9a\u53ef\u80fd\u306b\u3059\u308b\u793e\u5185\u54c1\u8cea\u90e8\u9580\u3068\u85ac\u4e8b\u90e8\u9580\u306e\u5f37\u5316\u306e\u4e21\u65b9\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u305f\u3001\u5b9f\u7e3e\u306e\u3042\u308b\u65b9\u6cd5\u3092\u63a1\u7528\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u6b21\u306e\u30b5\u30fc\u30d3\u30b9\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"mb-z wp-block-list\"><li><strong>\u30ae\u30e3\u30c3\u30d7\u8a55\u4fa1:<\/strong> QMS (\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0)\u6587\u66f8\u3068\u6280\u8853\u6587\u66f8\u3082\u691c\u67fb<\/li><li><strong>\u516c\u8a8d\u6a5f\u95a2\u3078\u306e\u7533\u8acb\u304a\u3088\u3073\u5bfe\u5fdc:<\/strong> CE\u30de\u30fc\u30af\u304a\u3088\u3073ISO 13845\u8a8d\u8a3c\u306e\u53d6\u5f97<\/li><li><strong>\u9075\u5b88\u8a08\u753b\u306e\u5b9f\u65bd:<\/strong> \u6bb5\u968e\u7684\u306a\u5b9f\u65bd\u624b\u6cd5\u3068\u3001\u5f53\u793e\u306e\u73fe\u5834\u6d3e\u9063\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u3092\u4f7f\u7528<\/li><li><strong>\u7814\u4fee\u304a\u3088\u3073\u77e5\u8b58\u4f1d\u9054:<\/strong> \u78ba\u5b9f\u306b\u9075\u5b88\u72b6\u614b\u3092\u6301\u7d9a<\/li><li><strong>\u7d99\u7d9a\u7684\u306a\u30d5\u30a1\u30a4\u30eb\u306e\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9:<\/strong> \u8907\u96d1\u306a\u65b0\u3057\u3044\u8a18\u9332\u65b9\u6cd5\u3078\u306e\u5bfe\u5fdc\u3092\u652f\u63f4<\/li><\/ul><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-group relative pt-s mt-s\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<figure class=\"wp-block-image size-large pin-right\"><img loading=\"lazy\" decoding=\"async\" width=\"433\" height=\"470\" src=\"http:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/proven-experts-inset-img.jpg\" alt=\"&#x5B9F;&#x7E3E;&#x306E;&#x3042;&#x308B;&#x30A8;&#x30AD;&#x30B9;&#x30D1;&#x30FC;&#x30C8;&#x306E;&#x306F;&#x3081;&#x8FBC;&#x307F;&#x753B;&#x50CF;\" class=\"wp-image-1470\" srcset=\"https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/proven-experts-inset-img.jpg 433w, https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/proven-experts-inset-img-276x300.jpg 276w\" sizes=\"auto, (max-width: 433px) 100vw, 433px\" \/><\/figure>\n\n\n<div class=\"wp-block-mkl-section-block has-white-background-color panel square w80 z1 pl-z pb-xxs\">\n<h3 class=\"max600 wp-block-heading\" id=\"specialty\">EU MDR\/IVDR\u306e\u9075\u5b88\u306e<strong><span class=\"has-inline-color has-green-color\">\u5b9f\u7e3e\u3092\u6301\u3064\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u3068\u306e\u5354\u529b<\/span><\/strong><\/h3>\n\n\n\n<p>Validant\u306e\u30c1\u30fc\u30e0\u306f\u3001\u30d9\u30f3\u30c1\u30e3\u30fc\u4f01\u696d\u304b\u3089\u4e0a\u4f4d30\u793e\u306b\u5165\u308b\u4e00\u6d41\u4f01\u696d\u307e\u3067\u3001\u533b\u7642\u6a5f\u5668\u3092\u6271\u3046\u9867\u5ba2\u4f01\u696d\u304cEU MDR\u304a\u3088\u3073IVDR\u3092\u9075\u5b88\u3059\u308b\u6301\u7d9a\u7684\u306a\u624b\u6cd5\u3092\u5b9f\u65bd\u3067\u304d\u308b\u3088\u3046\u306b\u30b5\u30dd\u30fc\u30c8\u3057\u3066\u304d\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p>\u304a\u5ba2\u69d8\u306e\u30cb\u30fc\u30ba\u304c\u3001\u82e6\u60c5\u306b\u95a2\u3059\u308b\u5305\u62ec\u7684\u306a\u898f\u5236\u6226\u7565\u306e\u958b\u767a\u3068\u5b9f\u884c\u3092<br\/>\u884c\u3046\u4e00\u62ec\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3001\u5b9a\u671f\u7684\u5b89\u5168\u6027\u6700\u65b0\u5831\u544a(PSUR)\u3084<br\/>\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a(CER)\u306a\u3069\u7279\u5b9a\u306e\u8907\u96d1\u306a\u4e8b\u9805\u306b\u53d6\u308a\u7d44\u3080\u305f\u3081\u306e<br\/>\u8ffd\u52a0\u306e\u5c02\u9580\u77e5\u8b58\u306e\u3044\u305a\u308c\u3067\u3082\u3001<br\/>\u304a\u5ba2\u69d8\u304c\u5fc5\u8981\u3068\u3059\u308b\u3068\u304d\u3068\u5834\u6240\u306b\u3001<br\/>\u975e\u5e38\u306b\u512a\u308c\u305f\u30ea\u30bd\u30fc\u30b9\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n<\/div>\n<\/div><\/div>\n\n\n\n<p><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column pl-s page-sidebar is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:35%\">\n<div class=\"wp-block-mkl-section-block has-grey-background-color panel-small sidebar-menu mb-xs\">\n<p class=\"mb-z\"><strong><span class=\"has-inline-color has-olive-color\">\u4e8b\u4f8b<\/span><\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong><strong>EU MDR\/IVDR<br\/>\u306e\u9075\u5b88<\/strong>\u306b\u5411\u3051\u3066<\/strong>\u3042\u3089\u3086\u308b\u898f\u6a21\u306e\u9867\u5ba2\u3092\u30b5\u30dd\u30fc\u30c8<\/h3>\n\n\n\n<p>\u3059\u3079\u3066\u306e\u6e96\u5099\u6bb5\u968e\u306b\u3042\u308b\u88fd\u9020\u4f1a\u793e\u306f\u3001\u5b9f\u7e3e\u306e\u3042\u308b\u5f53\u793e\u306e\u65b9\u6cd5\u3092\u6d3b\u7528\u3057\u3066\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u9054\u6210\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"more\"><a href=\"http:\/\/www.validant.com\/ja\/%e4%ba%8b%e4%be%8b-eu-mdr-ivdr%e3%81%ae%e9%81%b5%e5%ae%88%e3%81%ab%e5%90%91%e3%81%91%e3%81%9f%e6%ba%96%e5%82%99\/\">\u4e8b\u4f8b\u3092\u898b\u308b<\/a><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-mkl-section-block has-grey-background-color panel-small mb-xs\">\n<figure class=\"wp-block-image size-large banner\"><img loading=\"lazy\" decoding=\"async\" width=\"426\" height=\"216\" src=\"http:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/eu-mdr-thumbnail.jpg\" alt=\"EU MDR&#x306E;&#x30B5;&#x30E0;&#x30CD;&#x30A4;&#x30EB;\" class=\"wp-image-1180\" srcset=\"https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/eu-mdr-thumbnail.jpg 426w, https:\/\/www.validant.com\/wp-content\/uploads\/2020\/07\/eu-mdr-thumbnail-300x152.jpg 300w\" sizes=\"auto, (max-width: 426px) 100vw, 426px\" \/><\/figure>\n\n\n<p class=\"mb-z\"><strong><span class=\"has-inline-color has-olive-color\">\u30d1\u30f3\u30d5\u30ec\u30c3\u30c8<\/span><\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">EU MDR\/IVDR\u306e\u9075\u5b88\u306b\u5411\u3051\u305f\u6e96\u5099<\/h3>\n\n\n\n<p class=\"more\"><a href=\"\/wp-content\/uploads\/2020\/07\/Validant-EU-MDR-120519.pdf\" target=\"_blank\" aria-label=\"undefined (opens in a new tab)\" rel=\"noreferrer noopener\">\u4eca\u3059\u3050\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9<\/a><\/p>\n<\/div>\n\n\n\n<h4 class=\"has-green-color has-text-color mb-xxs wp-block-heading\"><strong>\u30d0\u30f3\u30c6\u30fc\u30b8\u30dd\u30a4\u30f3\u30c8\u306e\u8a18\u4e8b<\/strong><\/h4>\n\n\n\t\n<\/div>\n<\/div>\n\n\n\n<p><\/p>\n<\/div>\n<\/section>\n\n<section class=\"wp-block-mkl-section-block cta-panel mt-m mb-m\">\n<div class=\"wp-block-mkl-section-block container panel bg-greengrad\">\n<div class=\"wp-block-mkl-section-block has-green-background-color bg-greengrad panel\">\n<p><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-columns relative is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<h2 class=\"has-white-color has-text-color wp-block-heading\">\u3069\u306e\u3088\u3046\u306a<strong><span class=\"has-inline-color has-lightblue-color\">\u5f53\u793e\u306e\u30b5\u30fc\u30d3\u30b9<br\/><\/span><\/strong>\u304c\u3054\u5e0c\u671b\u3067\u3059\u304b\uff1f<\/h2>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p class=\"has-text-color has-white-color large\">\u5b9f\u73fe\u3055\u305b\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u304a\u77e5\u3089\u305b\u304f\u3060\u3055\u3044\u3002<br\/><strong>\u5f53\u793e\u306e\u7d4c\u9a13\u3092\u6ce8\u304e\u8fbc\u3093\u3067\u3001\u304a\u5ba2\u69d8\u306e\u5177\u4f53\u7684\u306a\u554f\u984c\u306b\u53d6\u308a\u7d44\u307f\u307e\u3059\u3002<\/strong><\/p>\n\n\n\n<p class=\"btn white\"><a 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