{"id":25004,"date":"2026-01-06T14:28:54","date_gmt":"2026-01-06T17:28:54","guid":{"rendered":"https:\/\/sobelconsult.com\/our-solutions-brazil\/regulatory-training-brazil\/"},"modified":"2026-02-23T08:41:49","modified_gmt":"2026-02-23T11:41:49","slug":"regulatory-training-brazil","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/de\/our-solutions-brazil\/regulatory-training-brazil\/","title":{"rendered":"MEDIZINISCHES BH-TRAINING"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"25004\" class=\"elementor elementor-25004 elementor-25002\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-56bdb0c e-flex e-con-boxed e-con e-parent\" data-id=\"56bdb0c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1b36b88 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"1b36b88\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">ISO 13485 Medizinprodukte und regulatorische Schulungen<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a2e089d elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"a2e089d\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&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\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Regulatory compliance is one of the greatest challenges for medical device manufacturers and importers. From ISO 13485 and MDSAP to Anvisa\u2019s RDCs, let Sobel train your team to meet every compliance requirement.\"}]\" data-inline-monday=\"true\">Die Einhaltung gesetzlicher Vorschriften ist eine der gr\u00f6\u00dften Herausforderungen f\u00fcr Hersteller und Importeure von Medizinprodukten. Von ISO 13485 und MDSAP bis hin zu den RDCs von Anvisa - lassen Sie Ihr Team von Sobel schulen, damit es alle Compliance-Anforderungen erf\u00fcllt. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8c7ade6 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"8c7ade6\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\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=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0MywidG9nZ2xlIjpmYWxzZX0%3D\">\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\">Holen Sie sich Expertenunterst\u00fctzung<\/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\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-042b021 e-flex e-con-boxed e-con e-parent\" data-id=\"042b021\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-3f18e97 e-con-full e-flex e-con e-child\" data-id=\"3f18e97\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-428564f e-con-full e-transform e-flex e-con e-child\" data-id=\"428564f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation_mobile&quot;:&quot;fadeIn&quot;,&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:96,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-109,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e7250b3 elementor-widget elementor-widget-heading\" data-id=\"e7250b3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">F\u00fcr wen?<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4d4dbdd elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"4d4dbdd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\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-ac439c0 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"ac439c0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Hersteller von Medizinprodukten, die sich auf die Registrierung in Brasilien oder auf internationalen M\u00e4rkten vorbereiten.<\/span>\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\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Importeure und H\u00e4ndler, die die gesetzlichen Anforderungen erf\u00fcllen m\u00fcssen.<\/span>\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\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Teams in den Bereichen Regulatory Affairs, F&amp;E und Qualit\u00e4t, die technische Schulungen ben\u00f6tigen.<\/span>\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\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Fachleute, die sich auf Audits und Inspektionen vorbereiten.<\/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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-374281a e-con-full e-flex e-con e-child\" data-id=\"374281a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation_mobile&quot;:&quot;fadeIn&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a897246 elementor-widget elementor-widget-image\" data-id=\"a897246\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"755\" height=\"1024\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png\" class=\"attachment-large size-large wp-image-18565\" alt=\"A portable vital signs monitor sits on a table. Office supplies are also on the table. It looks like a doctor&#039;s office.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png 755w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-221x300.png 221w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-768x1041.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services.png 1011w\" sizes=\"(max-width: 755px) 100vw, 755px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\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-a3ff97e e-flex e-con-boxed e-con e-parent\" data-id=\"a3ff97e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-80a501b elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"80a501b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&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\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Learn from experts in ISO 13485, MDSAP, RDCs and biological evaluation to achieve compliance and efficiency.\"}]\" data-inline-monday=\"true\">Lernen Sie von Experten in den Bereichen ISO 13485, MDSAP, RDCs und biologische Bewertung, um Konformit\u00e4t und Effizienz zu erreichen.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4d8b30d elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"4d8b30d\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\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=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0MywidG9nZ2xlIjpmYWxzZX0%3D\">\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\">Holen Sie sich Unterst\u00fctzung!<\/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\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-4378ffe e-flex e-con-boxed e-con e-parent\" data-id=\"4378ffe\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dd6448c elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"dd6448c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1259\" height=\"275\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.png\" class=\"attachment-full size-full wp-image-18571\" alt=\"Vector rectangle blue\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.png 1259w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-300x66.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-1024x224.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-768x168.png 768w\" sizes=\"(max-width: 1259px) 100vw, 1259px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a211487 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"a211487\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Warum brauchen Sie diesen Service?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ef306b2 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"ef306b2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-4e95500 e-con-full e-flex e-con e-child\" data-id=\"4e95500\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7563b9a elementor-widget elementor-widget-text-editor\" data-id=\"7563b9a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"The regulatory landscape for medical devices changes rapidly, with new RDCs, ISO revisions, and international requirements that directly impact compliance strategies.\"}]\" data-inline-monday=\"true\">Die regulatorische Landschaft f\u00fcr Medizinprodukte \u00e4ndert sich schnell, mit neuen RDCs, ISO-Revisionen und internationalen Anforderungen, die sich direkt auf die Compliance-Strategien auswirken.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-401116f e-con-full e-flex e-con e-child\" data-id=\"401116f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3a205a1 elementor-widget elementor-widget-text-editor\" data-id=\"3a205a1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Without proper training, companies face delays, rework, and even product rejections that can increase costs and damage credibility.\"}]\" data-inline-monday=\"true\">Ohne eine angemessene Schulung m\u00fcssen Unternehmen mit Verz\u00f6gerungen, Nacharbeiten und sogar Produktablehnungen rechnen, die die Kosten in die H\u00f6he treiben und der Glaubw\u00fcrdigkeit schaden k\u00f6nnen.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6470883 e-con-full e-flex e-con e-child\" data-id=\"6470883\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-299a7ee elementor-widget elementor-widget-text-editor\" data-id=\"299a7ee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Expert-led training equips your team with the knowledge to anticipate changes, streamline submissions, and stay ahead of competitors.\"}]\" data-inline-monday=\"true\">Eine von Experten geleitete Schulung vermittelt Ihrem Team das Wissen, um \u00c4nderungen zu antizipieren, Einreichungen zu rationalisieren und der Konkurrenz voraus zu sein.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\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-3537aa6 e-flex e-con-boxed e-con e-parent\" data-id=\"3537aa6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-538d849 e-con-full e-flex e-con e-child\" data-id=\"538d849\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-59f2367 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"59f2367\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Wissen, das zu Ergebnissen f\u00fchrt<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-75c326f e-con-full e-flex e-con e-child\" data-id=\"75c326f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f83479a elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"f83479a\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&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\t\t<p>Wenn Sie Ihr Team schulen, verringern Sie die Risiken bei der Einhaltung von Vorschriften, beschleunigen die Einreichung von Antr\u00e4gen und gew\u00e4hrleisten die Sicherheit von Patienten und Anwendern.<\/p><p><strong>Unsere Spezialisten bei Sobel bieten Ihnen aktuelle Schulungsprogramme, die auf Ihr Unternehmen zugeschnitten sind.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\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-99bebbd e-flex e-con-boxed e-con e-parent\" data-id=\"99bebbd\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-04da3a2 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"04da3a2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Bereiten Sie Ihr Team auf alle Compliance-Anforderungen vor, in Brasilien und weltweit.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6f9329e elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"6f9329e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ucaddon_horizontal_timeline.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n<!-- start Horizontal Timeline -->\n\t\t<link id='font-awesome-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-all.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='font-awesome-4-shim-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-v4-shims.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='owl-carousel-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/owl-carousel-new\/assets\/owl.carousel.css' type='text\/css' rel='stylesheet' >\n\n<style>\/* widget: Horizontal Timeline *\/\n\n#uc_horizontal_timeline_elementor_6f9329e *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_6f9329e .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_6f9329e .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_6f9329e  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_6f9329e  .carousel-nav button i{\n  position: absolute;\n     top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%);\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_6f9329e .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-item-bullet i, #uc_horizontal_timeline_elementor_6f9329e .ue-item-bullet svg{\n  position: absolute;\n  top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%); \n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_6f9329e .ue-carousel-item-holder{\n  display: flex;\n  flex-direction: column;\n  align-items: stretch;\n  height:100%;\n}\n\n<\/style>\n\n<div class=\"ue-horizontal-timeline\" id=\"uc_horizontal_timeline_elementor_6f9329e\">\n     <div class=\"carousel-nav\">\n            <button class=\"carousel-prev\" aria-label=\"Previous\">\n                <i class=' ti-arrow-circle-left'><\/i>\n            <\/button>\n            <button class=\"carousel-next\" aria-label=\"Next\">\n                <i class=' ti-arrow-circle-right'><\/i>\n            <\/button>\n        <\/div>\n    <div class=\"owl-carousel owl-theme uc-items-wrapper item-horizontal-timeline  \" id=\"uc_horizontal_timeline_elementor_6f9329e\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-4a90fc4\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >W\u00e4hlen Sie Ihr Training<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">W\u00e4hlen Sie aus Modulen zu ISO-Normen, Anvisa-Vorschriften oder internationalen Rahmenwerken.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-5c02afd\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Definieren Sie das Format<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">W\u00e4hlen Sie zwischen Fernschulung \u00fcber MS Teams oder Vor-Ort-Schulung in Ihren R\u00e4umlichkeiten.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-ed34ef6\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Angewandte Kenntnisse<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Lernen Sie direkt von Fachleuten mit praktischer Erfahrung in der Regulierung von Medizinprodukten.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-a6513ad\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Zertifizierte Fertigstellung<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Jeder Teilnehmer erh\u00e4lt ein offizielles Schulungszertifikat.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n\n  <\/div>\n<\/div>\n<!-- end Horizontal Timeline -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-15292cf elementor-align-center elementor-widget elementor-widget-button\" data-id=\"15292cf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\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=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0MywidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Beginnen Sie jetzt!<\/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\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-4e2a8cd animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"4e2a8cd\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-70ccb56 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"70ccb56\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Unsere Trainingsprogramme<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2417a03 elementor-widget elementor-widget-text-editor\" data-id=\"2417a03\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"From ISO 13485 medical devices to Biological Evaluation training, Sobel provides your team with up-to-date, practical knowledge. Each course combines comprehensive content, flexible format (online or on-site), and official certification of participation.\"}]\" data-inline-monday=\"true\">Von ISO 13485 Medizinprodukten bis hin zu Schulungen zur biologischen Bewertung - Sobel versorgt Ihr Team mit aktuellem, praktischem Wissen. Jeder Kurs kombiniert umfassende Inhalte, ein flexibles Format (online oder vor Ort) und eine offizielle Teilnahmebescheinigung. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-421b9c2 e-flex e-con-boxed e-con e-child\" data-id=\"421b9c2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-06d21ac e-con-full e-flex e-con e-child\" data-id=\"06d21ac\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ea51f35 elementor-widget elementor-widget-heading\" data-id=\"ea51f35\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 13485:2016 Schulung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ddc05a6 elementor-widget elementor-widget-text-editor\" data-id=\"ddc05a6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"The ISO 13485 standard defines the requirements for a quality management system specific to the medical device industry. This training helps your team understand how to implement and maintain compliance with ISO 13485:2016, ensuring consistent product quality and facilitating regulatory submissions in Brazil and abroad.\"}]\" data-inline-monday=\"true\">Die Norm ISO 13485 definiert die Anforderungen an ein Qualit\u00e4tsmanagementsystem speziell f\u00fcr die Medizinprodukteindustrie. Diese Schulung hilft Ihrem Team zu verstehen, wie man die ISO 13485:2016 einf\u00fchrt und einh\u00e4lt, um eine gleichbleibende Produktqualit\u00e4t zu gew\u00e4hrleisten und die Einreichung von Zulassungsantr\u00e4gen in Brasilien und im Ausland zu erleichtern. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-dae15bd e-con-full e-flex e-con e-child\" data-id=\"dae15bd\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3197026 elementor-widget elementor-widget-heading\" data-id=\"3197026\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">MDSAP-Schulung (Einzelauditprogramm f\u00fcr Medizinprodukte)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-66fbe51 elementor-widget elementor-widget-text-editor\" data-id=\"66fbe51\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"The MDSAP allows a single regulatory audit to cover multiple jurisdictions (including the U.S., Canada, Brazil, Japan, and Australia). This training provides a complete overview of the MDSAP requirements, audit structure, and best practices to prepare your company for successful certification.\"}]\" data-inline-monday=\"true\">Der MDSAP erm\u00f6glicht es, dass ein einziges regulatorisches Audit mehrere Gerichtsbarkeiten abdeckt (einschlie\u00dflich der USA, Kanada, Brasilien, Japan und Australien). Diese Schulung bietet einen vollst\u00e4ndigen \u00dcberblick \u00fcber die MDSAP-Anforderungen, die Auditstruktur und die besten Praktiken, um Ihr Unternehmen auf eine erfolgreiche Zertifizierung vorzubereiten. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-eb814f7 e-con-full e-flex e-con e-child\" data-id=\"eb814f7\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ff5276e elementor-widget elementor-widget-heading\" data-id=\"ff5276e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">RDC 665\/2022 Schulung (b-GMP)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3725164 elementor-widget elementor-widget-text-editor\" data-id=\"3725164\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"RDC 665\/2022 establishes Good Manufacturing Practices (GMP) requirements for medical devices in Brazil. This training explains the regulation in detail and guides participants on how to apply GMP principles in daily operations to avoid non-compliance findings during Anvisa inspections.\"}]\" data-inline-monday=\"true\">Die RDC 665\/2022 legt die Anforderungen an die Gute Herstellungspraxis (GMP) f\u00fcr Medizinprodukte in Brasilien fest. Diese Schulung erl\u00e4utert die Verordnung im Detail und zeigt den Teilnehmern, wie sie die GMP-Grunds\u00e4tze im t\u00e4glichen Betrieb anwenden k\u00f6nnen, um Verst\u00f6\u00dfe bei Anvisa-Inspektionen zu vermeiden. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-02e5605 e-con-full e-flex e-con e-child\" data-id=\"02e5605\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-03946b9 elementor-widget elementor-widget-heading\" data-id=\"03946b9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">RDC 751\/2022 Schulung (Registrierung und Benachrichtigung)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c297a18 elementor-widget elementor-widget-text-editor\" data-id=\"c297a18\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"RDC 751\/2022 defines the classification rules, notification, and registration requirements for medical devices in Brazil. This training prepares participants to correctly classify their devices, understand submission requirements, and comply with labeling and instructions for use standards.\"}]\" data-inline-monday=\"true\">Die RDC 751\/2022 definiert die Klassifizierungsregeln, Melde- und Registrierungsanforderungen f\u00fcr Medizinprodukte in Brasilien. Diese Schulung bereitet die Teilnehmer darauf vor, ihre Produkte korrekt zu klassifizieren, die Einreichungsanforderungen zu verstehen und die Standards f\u00fcr die Kennzeichnung und Gebrauchsanweisung einzuhalten. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\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-91bfe71 e-flex e-con-boxed e-con e-child\" data-id=\"91bfe71\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-2ce756c e-con-full e-flex e-con e-child\" data-id=\"2ce756c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7f86858 elementor-widget elementor-widget-heading\" data-id=\"7f86858\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">RDC 848\/2024 Ausbildung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8caaebb elementor-widget elementor-widget-text-editor\" data-id=\"8caaebb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"RDC 848\/2024 replaces RDC 546\/2021 and introduces updated safety and performance requirements for medical devices, IVDs, and software. This training explains the regulation\u2019s impact on manufacturers and importers, covering the fundamental requirements that must be met for market access in Brazil.\"}]\" data-inline-monday=\"true\">Die RDC 848\/2024 ersetzt die RDC 546\/2021 und f\u00fchrt aktualisierte Sicherheits- und Leistungsanforderungen f\u00fcr Medizinprodukte, IVDs und Software ein. Diese Schulung erl\u00e4utert die Auswirkungen der Verordnung auf Hersteller und Importeure und behandelt die grundlegenden Anforderungen, die f\u00fcr den Marktzugang in Brasilien erf\u00fcllt werden m\u00fcssen. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bd21d29 e-con-full e-flex e-con e-child\" data-id=\"bd21d29\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f3c6bd8 elementor-widget elementor-widget-heading\" data-id=\"f3c6bd8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">MDR 2017\/745 Ausbildung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e88d934 elementor-widget elementor-widget-text-editor\" data-id=\"e88d934\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"The European Medical Device Regulation (MDR 2017\/745) represents one of the most comprehensive and complex frameworks worldwide. This training provides an overview of the MDR requirements, including classification, conformity assessment routes, technical documentation, and post-market surveillance obligations, helping companies prepare for EU compliance.\"}]\" data-inline-monday=\"true\">Die Europ\u00e4ische Verordnung \u00fcber Medizinprodukte (MDR 2017\/745) stellt eines der umfassendsten und komplexesten Regelwerke weltweit dar. Diese Schulung bietet einen \u00dcberblick \u00fcber die Anforderungen der MDR, einschlie\u00dflich Klassifizierung, Konformit\u00e4tsbewertungswege, technische Dokumentation und Verpflichtungen zur \u00dcberwachung nach dem Inverkehrbringen, und hilft Unternehmen bei der Vorbereitung auf die Einhaltung der EU-Vorschriften. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d097039 e-con-full e-flex e-con e-child\" data-id=\"d097039\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc0cafc elementor-widget elementor-widget-heading\" data-id=\"dc0cafc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 10993 Schulung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bfccb56 elementor-widget elementor-widget-text-editor\" data-id=\"bfccb56\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"ISO 10993 is the international standard for biological evaluation, establishing how to assess biocompatibility and safety of medical devices. This training ensures that your team understands the latest updates to the standard, how to design biological evaluation plans, and how to avoid costly delays in regulatory submissions.\"}]\" data-inline-monday=\"true\">ISO 10993 ist die internationale Norm f\u00fcr die biologische Bewertung, die festlegt, wie die Biokompatibilit\u00e4t und Sicherheit von Medizinprodukten zu bewerten ist. Diese Schulung stellt sicher, dass Ihr Team die neuesten Aktualisierungen der Norm kennt, wei\u00df, wie biologische Bewertungspl\u00e4ne erstellt werden und wie kostspielige Verz\u00f6gerungen bei der Einreichung von Zulassungsantr\u00e4gen vermieden werden k\u00f6nnen. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7759964 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"7759964\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-ed18f66 e-con-full e-flex e-con e-child\" data-id=\"ed18f66\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-5ec8c18 e-con-full e-flex e-con e-child\" data-id=\"5ec8c18\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9253e04 elementor-widget elementor-widget-heading\" data-id=\"9253e04\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Bef\u00e4higen Sie Ihr Team zum Erfolg bei der Regulierung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f91718 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"0f91718\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Schulungen sind eine strategische Investition, um die Einhaltung von Vorschriften und die Marktbereitschaft zu verbessern.<\/p><p>Mit den Schulungsprogrammen von Sobel ist Ihr Unternehmen besser darauf vorbereitet, Inspektionen zu bew\u00e4ltigen, beh\u00f6rdliche Auflagen zu erf\u00fcllen und mit Zuversicht international zu expandieren.<\/p><p><strong>Sprechen Sie mit uns, ermitteln Sie den Schulungsbedarf Ihres Teams und lassen Sie Sobel sich um den Rest k\u00fcmmern.<\/strong><\/p>\t\t\t\t\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-da4e808 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"da4e808\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\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=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0MywidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Beginnen Sie jetzt!<\/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\t\t<\/div>\n\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-76a97ce e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"76a97ce\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-baf1a86 elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"baf1a86\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1961\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1961\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Haben Sie noch Fragen? Schauen Sie in unsere FAQ <\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1961\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1961\"><p><b>1. Wer kann an den ISO 13485-Schulungen f\u00fcr Medizinprodukte teilnehmen?<\/b><\/p>\n<p>Diese Schulungen sind ideal f\u00fcr Fachleute aus den Bereichen Regulatory Affairs, Qualit\u00e4tssicherung, F&amp;E und Produktion. Ganz gleich, ob Sie Ihre erste Einreichung bei Anvisa vorbereiten oder Ihr Unternehmen auf die Anforderungen der ISO 13485:2016 ausrichten, k\u00f6nnen sowohl Anf\u00e4nger als auch erfahrene Fachleute davon profitieren. <\/p>\n<p><b>2. Was deckt die MDSAP-Schulung ab?<\/b><\/p>\n<p>Unsere MDSAP-Schulung (Medical Device Single Audit Program) erkl\u00e4rt die vollst\u00e4ndige Struktur des Audits, die teilnehmenden L\u00e4nder und die besten Methoden zur Vorbereitung auf die Zertifizierung. Sie ist besonders n\u00fctzlich f\u00fcr Unternehmen, die mit einem einzigen Audit mehrere Aufsichtsbeh\u00f6rden treffen m\u00fcssen. <\/p>\n<p><b>3. Warum ist die RDC 665\/2022-Schulung wichtig?<\/b><\/p>\n<p>Die RDC 665\/2022-Schulung vermittelt ein klares Verst\u00e4ndnis der brasilianischen Good Manufacturing Practices (b-GMP) f\u00fcr Medizinprodukte. Dies ist wichtig f\u00fcr Unternehmen, die Nichtkonformit\u00e4ten bei Anvisa-Inspektionen vermeiden wollen. <\/p>\n<p><b>4. Wie kann die Schulung RDC 751\/2022 meinem Unternehmen helfen?<\/b><\/p>\n<p>Die RDC 751\/2022-Schulung bereitet Ihr Team darauf vor, Produkte korrekt zu klassifizieren und die Melde- und Registrierungswege zu verstehen. Au\u00dferdem werden die Anforderungen an die Kennzeichnung und die Gebrauchsanweisung erl\u00e4utert, um das Risiko einer Ablehnung durch die Beh\u00f6rden zu verringern. <\/p>\n<p><b>5. Bieten Sie auch Schulungen zur MDR 2017\/745 an?<\/b><\/p>\n<p>Ja. Die Schulung MDR 2017\/745 behandelt die europ\u00e4ische Medizinprodukteverordnung im Detail: Klassifizierung, Konformit\u00e4tsbewertung, technische Dokumentation und \u00dcberwachung nach dem Inverkehrbringen. Sie ist besonders relevant f\u00fcr brasilianische Unternehmen, die den Zugang zum EU-Markt planen.  <\/p>\n<p><b>6. Warum sollten Sie in eine Schulung zu ISO 10993 und biologischer Bewertung investieren?<\/b><\/p>\n<p>Die Schulung ISO 10993 \/ Biologische Bewertung vermittelt praktische Kenntnisse f\u00fcr die Erstellung und Ausf\u00fchrung von biologischen Bewertungspl\u00e4nen (BEP) und Berichten (BER). Dies gew\u00e4hrleistet die Einhaltung der internationalen Anforderungen und vermeidet kostspielige Verz\u00f6gerungen bei der Produktregistrierung. <\/p>\n<p><b>7. Kann ich verschiedene Schulungen in einem Programm kombinieren?<\/b><\/p>\n<p>Ja. Viele Kunden w\u00fcnschen ein ma\u00dfgeschneidertes Programm, das Themen wie ISO 13485:2016, RDC 751\/2022 und ISO 10993 kombiniert, je nach den Bed\u00fcrfnissen ihrer Teams f\u00fcr Regulatory Affairs und Qualit\u00e4t. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\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>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Sobel bietet Expertenschulungen zu ISO 13485 Medizinprodukten, MDSAP, ISO 10993 und den RDCs von Anvisa. Praktische Kurse, um Ihr Team auf die Einhaltung der Vorschriften in Brasilien vorzubereiten. <\/p>\n","protected":false},"author":15,"featured_media":25478,"parent":8431,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-25004","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Schulung zu den Vorschriften f\u00fcr Medizinprodukte | ISO 13485, RDC 665\/2022, MDR und mehr<\/title>\n<meta name=\"description\" content=\"Sobel bietet Expertenschulungen zu ISO 13485 Medizinprodukten, MDSAP, ISO 10993 und den RDCs von Anvisa. 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