{"id":570,"date":"2026-02-10T15:37:14","date_gmt":"2026-02-10T12:37:14","guid":{"rendered":"https:\/\/www.bplussolutions.com\/?page_id=570"},"modified":"2026-02-11T10:58:18","modified_gmt":"2026-02-11T07:58:18","slug":"industry-knowledge-base","status":"publish","type":"page","link":"https:\/\/www.bplussolutions.com\/tr\/industry-knowledge-base\/","title":{"rendered":"Sekt\u00f6r Bilgi Bankas\u0131"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"570\" class=\"elementor elementor-570\" 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<div class=\"elementor-element elementor-element-6f9c2d65 e-flex e-con-boxed e-con e-parent\" data-id=\"6f9c2d65\" 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<div class=\"elementor-element elementor-element-f8024e4 e-con-full e-flex e-con e-child\" data-id=\"f8024e4\" data-element_type=\"container\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b1d6623 elementor-widget elementor-widget-heading\" data-id=\"b1d6623\" 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\">Sekt\u00f6r Bilgi Bankas\u0131<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c1b895b elementor-icon-list--layout-inline elementor-mobile-align-center elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"c1b895b\" 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\">Sekt\u00f6r Bilgi Bankas\u0131<\/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<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4bd51812 elementor-widget elementor-widget-text-editor\" data-id=\"4bd51812\" 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=\"205\" data-end=\"508\">The medical device industry operates within a complex and continuously evolving regulatory environment. This knowledge base brings together key global resources, regulatory authorities, standards organizations, and databases that support compliance, quality management, and product lifecycle activities.<\/p>\r\n<p data-start=\"510\" data-end=\"669\">These references are widely used by manufacturers, regulatory professionals, quality managers, and clinical specialists working with medical devices worldwide.<\/p>\r\n\r\n<h3 data-start=\"676\" data-end=\"713\">Regulatory Authorities &amp; Guidance<\/h3>\r\n<p data-start=\"715\" data-end=\"805\"><strong data-start=\"715\" data-end=\"756\">European Commission \u2014 Medical Devices<\/strong><br data-start=\"756\" data-end=\"759\" \/><a class=\"decorated-link cursor-pointer\" target=\"_new\" rel=\"noopener\" data-start=\"759\" data-end=\"805\">https:\/\/health.ec.europa.eu\/medical-devices_en<\/a><\/p>\r\n<p data-start=\"807\" data-end=\"892\"><strong data-start=\"807\" data-end=\"844\">EU MDR (Regulation (EU) 2017\/745)<\/strong><br data-start=\"844\" data-end=\"847\" \/><a class=\"decorated-link\" href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\" target=\"_new\" rel=\"noopener\" data-start=\"847\" data-end=\"892\">https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj<\/a><\/p>\r\n<p data-start=\"894\" data-end=\"1045\"><strong data-start=\"894\" data-end=\"921\">MDCG Guidance Documents<\/strong><br data-start=\"921\" data-end=\"924\" \/><a class=\"decorated-link\" href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en\" target=\"_new\" rel=\"noopener\" data-start=\"924\" data-end=\"1045\">https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en<\/a><\/p>\r\n<p data-start=\"1047\" data-end=\"1144\"><strong data-start=\"1047\" data-end=\"1106\">FDA \u2014 Center for Devices and Radiological Health (CDRH)<\/strong><br data-start=\"1106\" data-end=\"1109\" \/><a class=\"decorated-link\" href=\"https:\/\/www.fda.gov\/medical-devices\" target=\"_new\" rel=\"noopener\" data-start=\"1109\" data-end=\"1144\">https:\/\/www.fda.gov\/medical-devices<\/a><\/p>\r\n<p data-start=\"1146\" data-end=\"1227\"><strong data-start=\"1146\" data-end=\"1203\">IMDRF (International Medical Device Regulators Forum)<\/strong><br data-start=\"1203\" data-end=\"1206\" \/><a class=\"decorated-link\" href=\"https:\/\/www.imdrf.org\/\" target=\"_new\" rel=\"noopener\" data-start=\"1206\" data-end=\"1227\">https:\/\/www.imdrf.org<\/a><\/p>\r\n\r\n<h3 data-start=\"1234\" data-end=\"1268\">Standards &amp; Quality Management<\/h3>\r\n<p data-start=\"1270\" data-end=\"1374\"><strong data-start=\"1270\" data-end=\"1332\">ISO 13485 \u2014 Quality Management Systems for Medical Devices<\/strong><br data-start=\"1332\" data-end=\"1335\" \/><a class=\"decorated-link\" href=\"https:\/\/www.iso.org\/standard\/59752.html\" target=\"_new\" rel=\"noopener\" data-start=\"1335\" data-end=\"1374\">https:\/\/www.iso.org\/standard\/59752.html<\/a><\/p>\r\n<p data-start=\"1376\" data-end=\"1469\"><strong data-start=\"1376\" data-end=\"1427\">ISO 14971 \u2014 Risk Management for Medical Devices<\/strong><br data-start=\"1427\" data-end=\"1430\" \/><a class=\"decorated-link\" href=\"https:\/\/www.iso.org\/standard\/72704.html\" target=\"_new\" rel=\"noopener\" data-start=\"1430\" data-end=\"1469\">https:\/\/www.iso.org\/standard\/72704.html<\/a><\/p>\r\n<p data-start=\"1471\" data-end=\"1568\"><strong data-start=\"1471\" data-end=\"1508\">IEC 62366 \u2014 Usability Engineering<\/strong><br data-start=\"1508\" data-end=\"1511\" \/><a class=\"decorated-link cursor-pointer\" target=\"_new\" rel=\"noopener\" data-start=\"1511\" data-end=\"1568\">https:\/\/www.iec.ch\/dyn\/www\/f?p=103:85:0::::FSP_LANG_ID:25<\/a><\/p>\r\n\r\n<h3 data-start=\"1575\" data-end=\"1607\">Databases &amp; Regulatory Tools<\/h3>\r\n<p data-start=\"1609\" data-end=\"1695\"><strong data-start=\"1609\" data-end=\"1638\">EUDAMED Information Pages<\/strong><br data-start=\"1638\" data-end=\"1641\" \/><a class=\"decorated-link cursor-pointer\" target=\"_new\" rel=\"noopener\" data-start=\"1641\" data-end=\"1695\">https:\/\/health.ec.europa.eu\/medical-devices\/eudamed_en<\/a><\/p>\r\n<p data-start=\"1697\" data-end=\"1787\"><strong data-start=\"1697\" data-end=\"1753\">GUDID (Global Unique Device Identification Database)<\/strong><br data-start=\"1753\" data-end=\"1756\" \/><a class=\"decorated-link\" href=\"https:\/\/accessgudid.nlm.nih.gov\/\" target=\"_new\" rel=\"noopener\" data-start=\"1756\" data-end=\"1787\">https:\/\/accessgudid.nlm.nih.gov<\/a><\/p>\r\n<p data-start=\"1789\" data-end=\"1926\"><strong data-start=\"1789\" data-end=\"1813\">Devices@FDA Database<\/strong><br data-start=\"1813\" data-end=\"1816\" \/><a class=\"decorated-link\" href=\"https:\/\/www.fda.gov\/medical-devices\/device-advice-comprehensive-regulatory-assistance\/medical-device-databases\" target=\"_new\" rel=\"noopener\" data-start=\"1816\" data-end=\"1926\">https:\/\/www.fda.gov\/medical-devices\/device-advice-comprehensive-regulatory-assistance\/medical-device-databases<\/a><\/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\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Industry Knowledge Base Home The medical device industry operates within a complex and continuously evolving regulatory environment. This knowledge base brings together key global resources, regulatory authorities, standards organizations, and databases that support compliance, quality management, and product lifecycle activities. These references are widely used by manufacturers, regulatory professionals, quality managers, and clinical specialists working [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-570","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>Industry Knowledge Base | Medical Device Regulatory Resources<\/title>\n<meta name=\"description\" content=\"Explore key regulatory authorities, standards, and databases used in the medical device industry, including MDR, ISO standards, and global regulatory resources.\" \/>\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\/industry-knowledge-base\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Industry Knowledge Base | Medical Device Regulatory Resources\" \/>\n<meta property=\"og:description\" content=\"Explore key regulatory authorities, standards, and databases used in the medical device industry, including MDR, ISO standards, and global regulatory resources.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.bplussolutions.com\/tr\/industry-knowledge-base\/\" \/>\n<meta property=\"og:site_name\" content=\"B+ SOLUTIONS\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-11T07:58:18+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=\"1 dakika\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.bplussolutions.com\/industry-knowledge-base\/\",\"url\":\"https:\/\/www.bplussolutions.com\/industry-knowledge-base\/\",\"name\":\"Industry Knowledge Base | Medical Device Regulatory Resources\",\"isPartOf\":{\"@id\":\"https:\/\/www.bplussolutions.com\/#website\"},\"datePublished\":\"2026-02-10T12:37:14+00:00\",\"dateModified\":\"2026-02-11T07:58:18+00:00\",\"description\":\"Explore key regulatory authorities, standards, and databases used in the medical device industry, including MDR, ISO standards, and global regulatory resources.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.bplussolutions.com\/industry-knowledge-base\/#breadcrumb\"},\"inLanguage\":\"tr\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.bplussolutions.com\/industry-knowledge-base\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.bplussolutions.com\/industry-knowledge-base\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.bplussolutions.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Industry Knowledge Base\"}]},{\"@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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