{"id":29,"date":"2024-10-30T14:42:57","date_gmt":"2024-10-30T11:42:57","guid":{"rendered":"https:\/\/www.bplussolutions.com\/?page_id=29"},"modified":"2026-03-29T16:31:16","modified_gmt":"2026-03-29T13:31:16","slug":"solutions","status":"publish","type":"page","link":"https:\/\/www.bplussolutions.com\/tr\/solutions\/","title":{"rendered":"\u00c7\u00f6z\u00fcmler"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"29\" class=\"elementor elementor-29\" data-elementor-settings=\"{&quot;element_pack_global_tooltip_width&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_width_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_width_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_padding&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_padding_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_padding_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true}}\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3ab25dfa elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3ab25dfa\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-d7f8903\" data-id=\"d7f8903\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2b5259ae elementor-widget elementor-widget-heading\" data-id=\"2b5259ae\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">EU MDR Reg\u00fclasyon \u0130nceleme Paketleri\n<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-389bb08f elementor-icon-list--layout-inline elementor-mobile-align-center elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"389bb08f\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<ul class=\"elementor-icon-list-items elementor-inline-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-inline-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.bplussolutions.com\/tr\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"icon icon-home\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Ana Sayfa<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-inline-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"icon icon-chevron-right\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">\u00c7\u00f6z\u00fcmler<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-6c16da\" data-id=\"6c16da\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t<div class=\"elementor-element elementor-element-c85c1b0 e-flex e-con-boxed e-con e-parent\" data-id=\"c85c1b0\" data-element_type=\"container\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ad3e578 elementor-widget elementor-widget-text-editor\" data-id=\"ad3e578\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Onaylanm\u0131\u015f Kurulu\u015f ba\u015fvurusundan \u00f6nce uyum bo\u015fluklar\u0131n\u0131 belirlemek i\u00e7in tasarlanm\u0131\u015f, sistematik ve belirli kapsaml\u0131 reg\u00fclasyon dok\u00fcmantasyonu incelemeleri.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e34162b e-flex e-con-boxed e-con e-parent\" data-id=\"e34162b\" data-element_type=\"container\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-34e1eaa elementor-widget elementor-widget-text-editor\" data-id=\"34e1eaa\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"352\" data-end=\"421\">T\u00fcm inceleme talepleri gizlilik ve ba\u011f\u0131ms\u0131zl\u0131k ilkeleriyle ele al\u0131nmaktad\u0131r.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-db59e27 e-flex e-con-boxed e-con e-parent\" data-id=\"db59e27\" data-element_type=\"container\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e917c27 elementor-widget elementor-widget-heading\" data-id=\"e917c27\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><br>Literat\u00fcr Tarama Stratejisi Tasar\u0131m\u0131\n<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2fbd3c7 elementor-widget elementor-widget-text-editor\" data-id=\"2fbd3c7\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"417\" data-end=\"473\"><strong data-start=\"417\" data-end=\"473\">MDR-uyumlu literat\u00fcr tarama protokol\u00fc olu\u015fturma<\/strong><\/p><p data-start=\"475\" data-end=\"573\"><strong data-start=\"475\" data-end=\"485\">Scope:<\/strong> Arama stratejisi, PICO \u00e7er\u00e7evesi, anahtar kelime tan\u0131m\u0131<br data-start=\"537\" data-end=\"540\" \/><strong data-start=\"540\" data-end=\"553\">Delivery:<\/strong> 3-5 i\u015f g\u00fcn\u00fc<\/p><p data-start=\"575\" data-end=\"597\">Hizmet kapsam\u0131nda alacaklar\u0131n\u0131z:<\/p><ul data-start=\"598\" data-end=\"791\"><li data-section-id=\"189ynuu\" data-start=\"598\" data-end=\"653\"><strong>Sistematik literat\u00fcr tarama protokol\u00fc (CEP ile uyumlu)<\/strong><\/li><li data-section-id=\"1mwb30r\" data-start=\"654\" data-end=\"717\"><strong>Veri-taban\u0131 odakl\u0131 anahtar kelime stratejisi (PubMed, Cochrane, ect.)<\/strong><\/li><li data-section-id=\"150xboq\" data-start=\"718\" data-end=\"754\"><strong>Dahil etme ve hari\u00e7 tutma kriterleri<\/strong><\/li><li data-section-id=\"1uebj21\" data-start=\"755\" data-end=\"791\"><strong>Arama metodolojisi dok\u00fcmantasyonu<\/strong><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6ea73ab elementor-align-center elementor-widget elementor-widget-button\" data-id=\"6ea73ab\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.bplussolutions.com\/tr\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request Confidential Call<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c718e97 elementor-widget elementor-widget-heading\" data-id=\"c718e97\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><br>Systematic Literature Search &amp; Screening\n<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-acc5716 elementor-widget elementor-widget-text-editor\" data-id=\"acc5716\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"846\" data-end=\"903\"><strong data-start=\"846\" data-end=\"903\">Comprehensive literature identification and selection<\/strong><\/p><p data-start=\"905\" data-end=\"999\"><strong data-start=\"905\" data-end=\"915\">Scope:<\/strong> Scientific databases and vigilance data sources<br data-start=\"963\" data-end=\"966\" \/><strong data-start=\"966\" data-end=\"979\">Delivery:<\/strong> 5\u20137 business days<\/p><p data-start=\"1001\" data-end=\"1023\">Hizmet kapsam\u0131nda alacaklar\u0131n\u0131z:<\/p><ul data-start=\"1024\" data-end=\"1184\"><li data-section-id=\"6lrdyc\" data-start=\"1024\" data-end=\"1078\"><strong>Literature search results (PubMed, Cochrane, etc.)<\/strong><\/li><li data-section-id=\"1aumiq\" data-start=\"1079\" data-end=\"1109\"><strong>Title &amp; abstract screening<\/strong><\/li><li data-section-id=\"7q42xb\" data-start=\"1110\" data-end=\"1141\"><strong>Full-text article selection<\/strong><\/li><li data-section-id=\"1kk8ci2\" data-start=\"1142\" data-end=\"1184\"><strong>Structured article list (Excel format)<\/strong><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3777480 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"3777480\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.bplussolutions.com\/tr\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request Confidential Call<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6160dc3 elementor-widget elementor-widget-heading\" data-id=\"6160dc3\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><br>State of the Art (SoTA) Analysis\n<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b77f438 elementor-widget elementor-widget-text-editor\" data-id=\"b77f438\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"1615\" data-end=\"1685\"><strong data-start=\"1615\" data-end=\"1685\">Definition of current clinical practice and benchmark technologies<\/strong><\/p><p data-start=\"1687\" data-end=\"1797\"><strong data-start=\"1687\" data-end=\"1697\">Scope:<\/strong> Clinical guidelines, alternative treatments, comparable devices<br data-start=\"1761\" data-end=\"1764\" \/><strong data-start=\"1764\" data-end=\"1777\">Delivery:<\/strong> 5\u20137 business days<\/p><p data-start=\"1799\" data-end=\"1821\">Hizmet kapsam\u0131nda alacaklar\u0131n\u0131z:<\/p><ul data-start=\"1822\" data-end=\"1986\"><li data-section-id=\"1c9hyt6\" data-start=\"1822\" data-end=\"1851\"><strong>State of the art analysis<\/strong><\/li><li data-section-id=\"qf7yhc\" data-start=\"1852\" data-end=\"1903\"><strong>Identification of alternative treatment options<\/strong><\/li><li data-section-id=\"ven6k7\" data-start=\"1904\" data-end=\"1955\"><strong>Benchmark comparison with existing technologies<\/strong><\/li><li data-section-id=\"4wbqan\" data-start=\"1956\" data-end=\"1986\"><strong>Clinical practice overview<\/strong><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c89297 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"1c89297\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.bplussolutions.com\/tr\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request Confidential Call<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ed78f47 elementor-widget elementor-widget-heading\" data-id=\"ed78f47\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><br>NB-Ready CER Express Review<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cadf952 elementor-widget elementor-widget-text-editor\" data-id=\"cadf952\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong><span style=\"caret-color: #000000; color: #000000; text-align: var(--text-align); font-size: 1rem;\">Independent MDR Annex XIV Clinical Evaluation Review<\/span><\/strong><\/p><p><strong>Scope:<\/strong> Clinical Evaluation Report (CER)<br data-start=\"851\" data-end=\"854\" \/><strong>Delivery:<\/strong> 5 business days<\/p><p>Hizmet kapsam\u0131nda alacaklar\u0131n\u0131z:<\/p><p><strong>\u2022 MDR Annex XIV alignment review<\/strong><br data-start=\"935\" data-end=\"938\" \/><strong>\u2022 Structured deficiency list<\/strong><br data-start=\"966\" data-end=\"969\" \/><strong>\u2022 Risk flag summary<\/strong><br data-start=\"988\" data-end=\"991\" \/><strong>\u2022 Submission-readiness commentary<\/strong><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e7f7cfd e-flex e-con-boxed e-con e-parent\" data-id=\"e7f7cfd\" data-element_type=\"container\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-71891d2 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"71891d2\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.bplussolutions.com\/tr\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request Confidential Review<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e539bc8 e-flex e-con-boxed e-con e-parent\" data-id=\"e539bc8\" data-element_type=\"container\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-36479f7 elementor-widget elementor-widget-heading\" data-id=\"36479f7\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><br>Technical Documentation Compliance Review\n<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6ec522d elementor-widget elementor-widget-text-editor\" data-id=\"6ec522d\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"902\" data-end=\"958\"><strong>Independent Annex II &amp; III Technical File Assessment<\/strong><\/p><p data-start=\"960\" data-end=\"1041\"><strong data-start=\"960\" data-end=\"970\">Scope:<\/strong><br data-start=\"970\" data-end=\"973\" \/>Full technical documentation review according to MDR Annex II &amp; III.<\/p><p>Hizmet kapsam\u0131nda alacaklar\u0131n\u0131z:<\/p><ul><li data-start=\"1072\" data-end=\"1152\"><strong>Structured compliance gap analysis\u00a0<\/strong><\/li><li data-start=\"1155\" data-end=\"1220\"><strong>Risk management documentation assessment (EN ISO 14971 alignment)<\/strong><\/li><li data-start=\"1223\" data-end=\"1256\"><strong>GSPR consistency review (Annex I)<\/strong><\/li><li data-start=\"1259\" data-end=\"1306\"><strong>Classification &amp; rule verification (Annex VIII)<\/strong><\/li><li data-start=\"1309\" data-end=\"1365\"><strong>Structured deficiency list ready for internal correction<\/strong><\/li><li data-start=\"1368\" data-end=\"1396\"><strong>Executive compliance summary<\/strong><\/li><\/ul><p>\u00a0<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ab9e05b e-flex e-con-boxed e-con e-parent\" data-id=\"ab9e05b\" data-element_type=\"container\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2de2ee0 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"2de2ee0\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.bplussolutions.com\/tr\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request Technical File Review<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>EU MDR Regulatory Review Packages Home Structured, fixed-scope regulatory document reviews designed to identify compliance gaps before notified body submission. All review requests are handled confidentially and independently. Literature Search Strategy Design MDR-compliant literature search protocol development Scope: Search strategy, PICO framework, keyword definitionDelivery: 3\u20135 business days What you will receive: Structured literature search protocol [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-29","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU MDR CER Review Services | B Plus Solutions<\/title>\n<meta name=\"description\" content=\"Independent EU MDR Clinical Evaluation Report (CER) review services designed to identify compliance gaps before notified body submission.\" \/>\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.bplussolutions.com\/tr\/solutions\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU MDR CER Review Services | B Plus Solutions\" \/>\n<meta property=\"og:description\" content=\"Independent EU MDR Clinical Evaluation Report (CER) review services designed to identify compliance gaps before notified body submission.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.bplussolutions.com\/tr\/solutions\/\" \/>\n<meta property=\"og:site_name\" content=\"B+ SOLUTIONS\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-29T13:31:16+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Tahmini okuma s\u00fcresi\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 dakika\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.bplussolutions.com\/solutions\/\",\"url\":\"https:\/\/www.bplussolutions.com\/solutions\/\",\"name\":\"EU MDR CER Review Services | B Plus Solutions\",\"isPartOf\":{\"@id\":\"https:\/\/www.bplussolutions.com\/#website\"},\"datePublished\":\"2024-10-30T11:42:57+00:00\",\"dateModified\":\"2026-03-29T13:31:16+00:00\",\"description\":\"Independent EU MDR Clinical Evaluation Report (CER) review services designed to identify compliance gaps before notified body submission.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.bplussolutions.com\/solutions\/#breadcrumb\"},\"inLanguage\":\"tr\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.bplussolutions.com\/solutions\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.bplussolutions.com\/solutions\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.bplussolutions.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Solutions\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.bplussolutions.com\/#website\",\"url\":\"https:\/\/www.bplussolutions.com\/\",\"name\":\"B+ SOLUTIONS\",\"description\":\"Smart Medical Device Solutions - 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