{"id":1403,"date":"2021-03-10T22:11:23","date_gmt":"2021-03-10T22:11:23","guid":{"rendered":"http:\/\/www.validant.com\/eu-mdr-ivdr-%e5%90%88%e8%a7%84\/"},"modified":"2021-03-26T14:11:05","modified_gmt":"2021-03-26T14:11:05","slug":"eu-mdr-ivdr-%e5%90%88%e8%a7%84","status":"publish","type":"page","link":"https:\/\/www.validant.com\/zh-hans\/eu-mdr-ivdr-%e5%90%88%e8%a7%84\/","title":{"rendered":"EU MDR\/IVDR \u5408\u89c4"},"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\">\u4e3a <strong><span class=\"has-inline-color has-green-color\">EU MDR\/IVDR \u5408\u89c4<\/span><\/strong>\u505a\u597d\u51c6\u5907<\/h1>\n\n\n\n<p class=\"has-text-align-center maxc1000 pt-xxs\">\u8fd9\u4e9b\u4e0d\u518d\u662f\u6307\u4ee4\uff0c\u800c\u662f\u4f1a\u5b9e\u65bd\u5904\u7f5a\u7684\u6cd5\u5f8b\uff0c\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4 (EU MDR) \u548c\u4f53\u5916\u8bca\u65ad\u6cd5\u89c4 (EU IVDR) \u5c06\u5927\u5e45\u63d0\u9ad8\u5408\u89c4\u8303\u56f4\u548c\u4e25\u683c\u7a0b\u5ea6\u3002\u4e3a\u6700\u5927\u9650\u5ea6\u51cf\u5c11\u98ce\u9669\uff0c\u60a8\u9700\u8981\u4e00\u4e2a\u4e13\u5bb6\u5408\u4f5c\u4f19\u4f34\u6765\u786e\u4fdd\u60a8\u4e3a\u5408\u89c4\u505a\u597d\u51c6\u5907\u3002<strong>\u4e3a\u4ec0\u4e48\u9009\u62e9 Validant\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 &#x5408;&#x89C4;&#x51C6;&#x5907;\" class=\"wp-image-1404\" 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\">\u5168\u65b9\u4f4d\u652f\u6301\uff0c<strong><span class=\"has-inline-color has-green-color\">\u52a0\u901f\u5408\u89c4\u51c6\u5907<\/span><\/strong><\/h3>\n\n\n\n<p>\u5c3d\u7ba1\u65b0\u51a0\u75c5\u6bd2\u5371\u673a\u5bfc\u81f4\u6b27\u76df\u59d4\u5458\u4f1a<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\">\u5c06 MDR \u7684\u751f\u6548\u65e5\u671f\u63a8\u8fdf\u4e86\u4e00\u5e74<\/a>\uff0c\u4f46\u5728\u4e34\u5e8a\u8bc4\u4f30\u3001\u98ce\u9669\u7ba1\u7406\u3001\u901a\u7528\u5b89\u5168\u548c\u6027\u80fd\u8981\u6c42 (GSPR)\u3001\u4f9b\u5e94\u5546\/\u7ecf\u6d4e\u8fd0\u8425\u5546\u63a7\u5236\u3001\u6807\u7b7e\u3001\u4e0a\u5e02\u540e\u76d1\u6d4b\u3001\u8b66\u6212\u548c\u5236\u9020\u5546\u5fc5\u987b\u7acb\u5373\u89e3\u51b3\u7684\u5176\u4ed6\u76f8\u5173\u6d41\u7a0b\u65b9\u9762\uff0c\u751a\u81f3\u5728\u8fd9\u4e00\u5ef6\u957f\u7684\u622a\u6b62\u65e5\u671f\u4e4b\u524d\uff0c\u90fd\u53ef\u80fd\u53d1\u751f\u91cd\u5927\u53d8\u5316\u3002<\/p>\n\n\n\n<p>Validant \u91c7\u7528\u884c\u4e4b\u6709\u6548\u7684\u65b9\u6cd5\uff0c\u6ce8\u91cd\u5feb\u901f\u6267\u884c\u5e76\u4f7f\u60a8\u7684\u5185\u90e8\u8d28\u91cf\u548c\u76d1\u7ba1\u90e8\u95e8\u6709\u80fd\u529b\u7ef4\u6301\u5408\u89c4\u6d41\u7a0b\u3002\u670d\u52a1\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul class=\"mb-z wp-block-list\"><li><strong>\u6f0f\u6d1e\u8bc4\u4f30\uff1a<\/strong>\u5ba1\u67e5\u60a8\u7684 QMS \u548c\u6280\u672f\u6587\u6863<\/li><li><strong>\u516c\u544a\u673a\u6784\u63d0\u4ea4\u548c\u56de\u590d\uff1a<\/strong>\u83b7\u5f97 CE \u6807\u5fd7\u53ca ISO 13845 \u8bc1\u4e66<\/li><li><strong>\u5408\u89c4\u8ba1\u5212\u6267\u884c\uff1a<\/strong>\u91c7\u7528\u5206\u9636\u6bb5\u5b9e\u65bd\u529e\u6cd5\u53ca\u6211\u4eec\u7684\u73b0\u573a\u4e13\u5bb6<\/li><li><strong>\u57f9\u8bad\u53ca\u77e5\u8bc6\u8f6c\u79fb\uff1a<\/strong>\u786e\u4fdd\u6301\u7eed\u5408\u89c4<\/li><li><strong>\u6301\u7eed\u6587\u4ef6\u7ef4\u62a4\uff1a<\/strong>\u5e2e\u52a9\u7ba1\u7406\u65b0\u7684\u6587\u4ef6\u5f52\u6863\u590d\u6742\u6027<\/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=\"&#x516C;&#x8BA4;&#x7684;&#x4E13;&#x5BB6;-&#x63D2;&#x5165;&#x56FE;&#x7247;\" class=\"wp-image-1408\" 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\">\u4e0e\u5728 EU MDR\/IVDR \u5408\u89c4\u65b9\u9762<strong><span class=\"has-inline-color has-green-color\">\u516c\u8ba4\u7684\u4e13\u5bb6\u5408\u4f5c<\/span><\/strong><\/h3>\n\n\n\n<p>\u4ece\u521d\u521b\u4f01\u4e1a\u5230\u524d 30 \u5f3a\u9886\u5148\u4f01\u4e1a\uff0cValidant \u56e2\u961f\u5df2\u5e2e\u52a9\u591a\u5bb6\u533b\u7597\u8bbe\u5907\u5ba2\u6237\u5b9e\u65bd\u9075\u5b88 EU MDR \u548c IVDR \u5408\u89c4\u6027\u7684\u53ef\u6301\u7eed\u65b9\u6cd5\u3002<\/p>\n\n\n\n<p>\u65e0\u8bba\u60a8\u9700\u8981\u7edf\u5305\u89e3\u51b3\u65b9\u6848\u6765\u5f00\u53d1\u548c\u6267\u884c\u5b8c\u6574\u3001<br\/>\u5408\u89c4\u7684\u76d1\u7ba1\u6218\u7565\uff0c\u8fd8\u662f\u9700\u8981\u989d\u5916\u7684\u4e13\u4e1a\u77e5\u8bc6<br\/>\u6765\u89e3\u51b3\u7279\u5b9a\u7684\u590d\u6742\u95ee\u9898\uff0c\u5982\u5b9a\u671f\u5b89\u5168\u6027\u66f4\u65b0\u62a5\u544a (PSUR) <br\/>\u6216\u4e34\u5e8a\u8bc4\u4f30\u62a5\u544a (CER)\uff0c<br\/>Validant \u90fd\u5c06\u5728\u60a8\u9700\u8981\u7684\u65f6\u95f4\u548c\u5730\u70b9<br\/>\u63d0\u4f9b\u60a8\u9700\u8981\u7684\u4e13\u5bb6\u8d44\u6e90\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\">\u6848\u4f8b\u7814\u7a76<\/span><\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u5e2e\u52a9\u5404\u79cd\u89c4\u6a21\u7684\u5ba2\u6237<strong>\u4e3a <strong>EU MDR\/IVDR <br\/>\u5408\u89c4<\/strong>\u505a\u597d\u51c6\u5907<\/strong><\/h3>\n\n\n\n<p>\u5404\u51c6\u5907\u9636\u6bb5\u7684\u5236\u9020\u5546\u90fd\u501f\u52a9\u6211\u4eec\u884c\u4e4b\u6709\u6548\u7684\u65b9\u6cd5\u5b9e\u73b0\u4e86\u5408\u89c4\u3002<\/p>\n\n\n\n<p class=\"more\"><a href=\"http:\/\/www.validant.com\/zh-hans\/%e6%a1%88%e4%be%8b%e7%a0%94%e7%a9%b6%ef%bc%9a%e4%b8%ba-eu-mdr-ivdr-%e5%90%88%e8%a7%84%e5%81%9a%e5%87%86%e5%a4%87\/\">\u67e5\u770b\u6848\u4f8b\u7814\u7a76<\/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 &#x7F29;&#x7565;&#x56FE;\" class=\"wp-image-1028\" 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\">\u624b\u518c<\/span><\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u4e3a EU MDR\/IVDR \u5408\u89c4\u505a\u597d\u51c6\u5907<\/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\">\u7acb\u5373\u4e0b\u8f7d<\/a><\/p>\n<\/div>\n\n\n\n<h4 class=\"has-green-color has-text-color mb-xxs wp-block-heading\"><strong>\u6765\u81ea The Vantage Point<\/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\">\u9700\u8981\u6211\u4eec<strong><span class=\"has-inline-color has-lightblue-color\"><br\/>\u6548\u52b3\u5417\uff1f<\/span><\/strong><\/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\">\u544a\u8bc9\u6211\u4eec\u60a8\u7684\u76ee\u6807\u3002<br\/><strong>\u6211\u4eec\u5c06\u7aed\u5c3d\u6240\u80fd\u6765\u89e3\u51b3\u60a8\u7684\u5177\u4f53\u95ee\u9898\u3002<\/strong><\/p>\n\n\n\n<p class=\"btn white\"><a href=\"http:\/\/www.validant.com\/zh-hans\/%e8%af%b7%e6%b1%82%e5%92%a8%e8%af%a2\/\">\u6b64\u5904\u5f00\u59cb<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-1403","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EU MDR \/ IVDR \u5408\u89c4\u51c6\u5907 | \u4e3a\u65b0\u7684\u6b27\u76df\u6cd5\u89c4\u505a\u597d\u51c6\u5907<\/title>\n<meta name=\"description\" content=\"\u4ece\u521d\u521b\u4f01\u4e1a\u5230\u524d 30 \u5f3a\u9886\u5148\u4f01\u4e1a\uff0cValidant \u5df2\u5e2e\u52a9\u591a\u5bb6\u533b\u7597\u8bbe\u5907\u5ba2\u6237\u5b9e\u65bd\u9075\u5b88 EU MDR \u548c IVDR \u5408\u89c4\u6027\u7684\u53ef\u6301\u7eed\u65b9\u6cd5\u3002\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.validant.com\/zh-hans\/eu-mdr-ivdr-%e5%90%88%e8%a7%84\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU MDR \/ IVDR \u5408\u89c4\u51c6\u5907 | \u4e3a\u65b0\u7684\u6b27\u76df\u6cd5\u89c4\u505a\u597d\u51c6\u5907\" \/>\n<meta property=\"og:description\" content=\"\u4ece\u521d\u521b\u4f01\u4e1a\u5230\u524d 30 \u5f3a\u9886\u5148\u4f01\u4e1a\uff0cValidant \u5df2\u5e2e\u52a9\u591a\u5bb6\u533b\u7597\u8bbe\u5907\u5ba2\u6237\u5b9e\u65bd\u9075\u5b88 EU MDR \u548c 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