{"id":7576,"date":"2020-05-14T12:26:45","date_gmt":"2020-05-14T12:26:45","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7576"},"modified":"2022-11-14T07:19:18","modified_gmt":"2022-11-14T07:19:18","slug":"medical-device-clinical-evaluation-report-sample-free","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-clinical-evaluation-report-sample-free\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u30b5\u30f3\u30d7\u30eb\uff08\u7121\u6599"},"content":{"rendered":"<p><em>\u30ae\u30ea\u30c3\u30b7\u30e5\u30fb\u30d2\u30eb\u30d1\u30e9 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing\">\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u306eKolabtree\u3067\u306f\u3001MDR\u6e96\u62e0\u306e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3068\u3057\u3066\u4f7f\u7528\u3067\u304d\u308b\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u30b5\u30f3\u30d7\u30eb\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002 <\/em><\/p>\n<p>\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER\uff09\u306f\u3001EU\u5e02\u5834\u306b\u6295\u5165\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u306e\u5fc5\u9808\u6587\u66f8\u3067\u3059\u3002CER\u306f\u3001EU\u306eMDR\u8981\u4ef6\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u3001\u30c6\u30af\u30cb\u30ab\u30eb\u30d5\u30a1\u30a4\u30eb\u3068\u3068\u3082\u306b\u63d0\u51fa\u3055\u308c\u307e\u3059\u3002\u9069\u5408\u3057\u3066\u3044\u308c\u3070\u3001\u305d\u306e\u6a5f\u5668\u304cEU\u3067\u5b89\u5168\u306b\u8ca9\u58f2\u3067\u304d\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u300cCE\u30de\u30fc\u30af\u300d\u304c\u4ed8\u4e0e\u3055\u308c\u307e\u3059\u3002<\/p>\n<p>\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306e\u30b5\u30f3\u30d7\u30eb\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3057\u3066\u884c\u308f\u308c\u305f\u81e8\u5e8a\u8a55\u4fa1\u306e\u7d50\u679c\u3092\u6587\u66f8\u5316\u3057\u305f\u3082\u306e\u3067\u3059\u3002\u30c7\u30d0\u30a4\u30b9\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u60c5\u5831\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30fc\u30bf\u3001\u30c6\u30af\u30cb\u30ab\u30eb\u30c7\u30b6\u30a4\u30f3\u306e\u8aac\u660e\u3001\u6587\u732e\u691c\u7d22\u306a\u3069\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002CER\u306f1\u3064\u306e\u30c7\u30d0\u30a4\u30b9\u306b\u7279\u5316\u3057\u3066\u304a\u308a\u3001\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3057\u3066\u7d99\u7d9a\u7684\u306b\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u305f\u3081\u3001\u5e38\u306b\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<p>\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304cCER\u306e\u5168\u4f53\u7684\u306a\u6d41\u308c\u3084\u5185\u5bb9\u3092\u7406\u89e3\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3001\u7121\u6599\u306e\u30b5\u30f3\u30d7\u30eb\u307e\u305f\u306fCER\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u3067\u304d\u307e\u3059\u3002\u3053\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u53c2\u8003\/\u30ac\u30a4\u30c0\u30f3\u30b9\u3068\u3057\u3066\u306e\u307f\u4f7f\u7528\u3055\u308c\u308b\u3053\u3068\u3092\u610f\u56f3\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<div class='mailmunch-forms-short-code mailmunch-forms-widget-888372' style='display: none !important;'><\/div>\n<p>Girish Hirpara is a medical writer with 13 years of clinical <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30ea\u30b5\u30fc\u30c1<\/a> experience. His expertise spans all aspects of regulatory compliance including ICH-GCP, MEDDEV 2.7.1\/Rev 4, EU MDR 2017\/745, EU IVDR 2017\/746, ISO- 14155, SOPs, and others. <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/girish-hirpara\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERSample\">Girish\u3078\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u304a\u554f\u3044\u5408\u308f\u305b\u306f\u3053\u3061\u3089<\/a>.<\/p>\n<p>Kolabtree\u3067\u306f\u3001\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306eCER\u30e9\u30a4\u30bf\u30fc\u3084\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u306b\u30aa\u30f3\u30c7\u30de\u30f3\u30c9\u3067\u30b3\u30f3\u30bf\u30af\u30c8\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u3092\u6d3b\u7528\u3057\u3001Abbott\u3001J&amp;J\u3001Medtronic\u3001Thermo Fisher Scientific\u306a\u3069\u306e\u30c8\u30c3\u30d7\u4f01\u696d\u3067\u6d3b\u8e8d\u3057\u305f\u7d4c\u9a13\u8c4a\u5bcc\u306a\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30da\u30b7\u30e3\u30ea\u30b9\u30c8\u3092\u63a1\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u307e\u305f\u3001\u81e8\u5e8a\u8a66\u9a13\u3001\u6587\u732e\u691c\u7d22\u3001\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0\u306a\u3069\u3067\u7406\u89e3\u3092\u6df1\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u7814\u7a76\u8005\u3068\u4e00\u7dd2\u306b\u4ed5\u4e8b\u3092\u3059\u308b\u3053\u3068\u3082\u3067\u304d\u307e\u3059\u3002<br \/>\n\u30d3\u30e5\u30fc <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-reports-cer\">\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u306e\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u30e9\u30a4\u30bf\u30fc<\/a>. <strong><a href=\"https:\/\/www.kolabtree.com\/create-project\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERSample\">\u4eca\u3059\u3050\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6295\u7a3f\u3059\u308b<\/a><\/strong><\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Girish Hirpara, regulatory consultant on Kolabtree, provides a clinical evaluation report sample for medical devices to use as a template for MDR compliance. The clinical evaluation report (CER) is a mandatory document for medical devices that are to be placed in the EU market. The CER is submitted along with the technical file to meet EU MDR requirements. If compliant, the device is awarded a &#8216;CE Mark&#8217; which certifies that the device can safely be marketed\/sold in the EU. The clinical evaluation report sample documents the results of the clinical evaluation done for a medical device. It includes information on the safety and effectiveness of a device, data from clinical<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-clinical-evaluation-report-sample-free\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":7585,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"image","meta":[],"categories":[540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Device Clinical Evaluation Report Sample (Free)<\/title>\n<meta name=\"description\" content=\"An expert-sourced clinical evaluation report sample for medical device companies preparing for MDR compliance. Use this referenence template for free.\" \/>\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.kolabtree.com\/blog\/ja\/medical-device-clinical-evaluation-report-sample-free\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Clinical Evaluation Report Sample (Free)\" \/>\n<meta property=\"og:description\" content=\"An expert-sourced clinical evaluation report sample for medical device companies preparing for MDR compliance. Use this referenence template for free.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/medical-device-clinical-evaluation-report-sample-free\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2020-05-14T12:26:45+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-11-14T07:19:18+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/medical-device-CER-sample.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"628\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"2\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Medical Device Clinical Evaluation Report Sample (Free)","description":"An expert-sourced clinical evaluation report sample for medical device companies preparing for MDR compliance. 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She has over a decade of experience in publishing, advertising and digital content creation.","url":"https:\/\/www.kolabtree.com\/blog\/ja\/author\/ramyas\/"}]}},"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/7576"}],"collection":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/comments?post=7576"}],"version-history":[{"count":11,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/7576\/revisions"}],"predecessor-version":[{"id":10381,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/7576\/revisions\/10381"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/media\/7585"}],"wp:attachment":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/media?parent=7576"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/categories?post=7576"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/tags?post=7576"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}