{"id":26045,"date":"2026-01-09T16:54:30","date_gmt":"2026-01-09T19:54:30","guid":{"rendered":"https:\/\/sobelconsult.com\/our-solutions-canada\/material-characterization-canada\/"},"modified":"2026-01-09T17:03:15","modified_gmt":"2026-01-09T20:03:15","slug":"material-characterization-canada","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/de\/our-solutions-canada\/material-characterization-canada\/","title":{"rendered":"MED CAN MAT C"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"26045\" class=\"elementor elementor-26045\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-277a599 e-flex e-con-boxed e-con e-parent\" data-id=\"277a599\" 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-fff8f62 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"fff8f62\" 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\">Materialcharakterisierung (MAT C) f\u00fcr Medizinprodukte<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1bda098 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"1bda098\" 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\":\"For medical devices commercialized in Canada, material-related risks must be identified, understood, and justified. A structured Material Characterization (MAT C) supports this requirement by documenting device materials, processes, and relevant physical characteristics in line with ISO 10993-1.\"}]\" data-inline-monday=\"true\">F\u00fcr Medizinprodukte, die in Kanada vermarktet werden, m\u00fcssen materialbezogene Risiken identifiziert, verstanden und begr\u00fcndet werden. Eine strukturierte Materialcharakterisierung (MAT C) unterst\u00fctzt diese Anforderung durch die Dokumentation von Produktmaterialien, Prozessen und relevanten physikalischen Eigenschaften in \u00dcbereinstimmung mit ISO 10993-1. <\/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-ccd9625 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"ccd9625\" 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-889851d e-flex e-con-boxed e-con e-parent\" data-id=\"889851d\" 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-612ae68 e-con-full e-flex e-con e-child\" data-id=\"612ae68\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-6f085f0 e-con-full e-transform e-flex e-con e-child\" data-id=\"6f085f0\" 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-8338bf1 elementor-widget elementor-widget-heading\" data-id=\"8338bf1\" 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-7102573 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"7102573\" 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-78ff131 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"78ff131\" 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 der Klassen I, II, III und IV<\/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\">Unternehmen, die materialbezogene Unterlagen zur Unterst\u00fctzung der biologischen Bewertung erstellen<\/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\">Regulatorische und technische Teams, die eine strukturierte Dokumentation der Materialcharakterisierung 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\">Hersteller mit Produkten, die komplexe Materialien, Prozesse oder Sterilisationsschritte beinhalten<\/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\">Unternehmen, die Dokumentationen f\u00fcr regulierte M\u00e4rkte erstellen, die die ISO 10993-Normen anerkennen<\/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-2180525 e-con-full e-flex e-con e-child\" data-id=\"2180525\" 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-84764bb elementor-widget elementor-widget-image\" data-id=\"84764bb\" 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-99f7e3d e-flex e-con-boxed e-con e-parent\" data-id=\"99f7e3d\" 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-4129d65 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"4129d65\" 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\":\"Sobel supports manufacturers by preparing structured Material Characterization (MAT C) Reports aligned with ISO 10993-1, supporting biological safety evaluation and downstream risk assessments.\"}]\" data-inline-monday=\"true\">Sobel unterst\u00fctzt Hersteller durch die Erstellung von strukturierten Materialcharakterisierungsberichten (MAT C), die sich an der ISO 10993-1 orientieren und die biologische Sicherheitsbewertung und nachgelagerte Risikobewertungen unterst\u00fctzen.<\/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-63304d7 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"63304d7\" 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-99708fc e-flex e-con-boxed e-con e-parent\" data-id=\"99708fc\" 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-f14dc2e elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"f14dc2e\" 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.webp\" class=\"attachment-full size-full wp-image-18571\" alt=\"Vector rectangle blue\" \/>\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-4a74f24 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"4a74f24\" 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-147f5f5 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"147f5f5\" 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-63c6567 e-con-full e-flex e-con e-child\" data-id=\"63c6567\" 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-43c4666 elementor-widget elementor-widget-text-editor\" data-id=\"43c4666\" 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\":\"Material characterization provides structured identification and documentation of device materials, manufacturing processes, and relevant physical characteristics.\"}]\" data-inline-monday=\"true\">Die Materialcharakterisierung bietet eine strukturierte Identifizierung und Dokumentation von Ger\u00e4tematerialien, Herstellungsprozessen und relevanten physikalischen Eigenschaften.<\/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-63a16c8 e-con-full e-flex e-con e-child\" data-id=\"63a16c8\" 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-37fd5e2 elementor-widget elementor-widget-text-editor\" data-id=\"37fd5e2\" 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\":\"It supports risk analysis by linking materials, processing steps, and potential chemical exposure scenarios.\"}]\" data-inline-monday=\"true\">Es unterst\u00fctzt die Risikoanalyse durch die Verkn\u00fcpfung von Materialien, Verarbeitungsschritten und m\u00f6glichen chemischen Expositionsszenarien.<\/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-b45a59c e-con-full e-flex e-con e-child\" data-id=\"b45a59c\" 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-f6e1cce elementor-widget elementor-widget-text-editor\" data-id=\"f6e1cce\" 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\":\"A clear MAT C report forms the basis for biological evaluation and toxicological risk assessment when required.\"}]\" data-inline-monday=\"true\">Ein klarer MAT C-Bericht bildet die Grundlage f\u00fcr die biologische Bewertung und die toxikologische Risikobewertung, falls erforderlich.<\/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-48c6a52 e-flex e-con-boxed e-con e-parent\" data-id=\"48c6a52\" 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-4470ae4 e-con-full e-flex e-con e-child\" data-id=\"4470ae4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-49ddae8 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"49ddae8\" 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\">Sicherheit beginnt auf der Ebene der Materialien<\/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-3d2cbe6 e-con-full e-flex e-con e-child\" data-id=\"3d2cbe6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b923019 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"b923019\" 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 class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"ISO 10993-1 requires manufacturers to understand and document the materials used in a medical device, how they are processed, and how they may contribute to patient or user exposure. Sobel delivers structured material characterization services based on device classification and regulatory expectations.\"}]\" data-inline-monday=\"true\">Die ISO 10993-1 verlangt von den Herstellern, die in einem Medizinprodukt verwendeten Materialien zu verstehen und zu dokumentieren, wie sie verarbeitet werden und wie sie zur Exposition von Patienten oder Anwendern beitragen k\u00f6nnen. Sobel bietet strukturierte Dienstleistungen zur Materialcharakterisierung auf der Grundlage der Ger\u00e4teklassifizierung und der regulatorischen Erwartungen. <\/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-00cc883 e-flex e-con-boxed e-con e-parent\" data-id=\"00cc883\" 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-e00efa8 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"e00efa8\" 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\">Eine strukturierte Materialcharakterisierung unterst\u00fctzt vertretbare Sicherheitsentscheidungen.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b70b00a elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"b70b00a\" 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_b70b00a *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_b70b00a .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_b70b00a .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_b70b00a  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_b70b00a  .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_b70b00a .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_b70b00a .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-bullet i, #uc_horizontal_timeline_elementor_b70b00a .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_b70b00a .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_b70b00a .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_b70b00a\">\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_b70b00a\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-ae303a4\">\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 den Umfang<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Auf der Grundlage Ihrer Ger\u00e4teklasse (I-IV), der verf\u00fcgbaren Dokumentation und der Projektziele stimmen wir den am besten geeigneten Umfang der Materialcharakterisierung gem\u00e4\u00df ISO 10993-1 ab.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-f327a09\">\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=\"#\" >Informationen teilen<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Sie stellen die verf\u00fcgbare Dokumentation zu Ger\u00e4tematerialien, Herstellungsverfahren, Verpackung\/Sterilisation (falls zutreffend) und Produktkonfiguration zur Verf\u00fcgung.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-a145d0a\">\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=\"#\" >Technische Bewertung<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Unsere Experten f\u00fchren den vereinbarten Umfang durch und liefern einen strukturierten Materialcharakterisierungsbericht (MAT C), der den Anforderungen der ISO 10993-1 und dem Kontext Ihres Ger\u00e4ts entspricht.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-f2b4d0e\">\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=\"#\" >Bericht<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Die daraus resultierende Dokumentation unterst\u00fctzt die biologischen Bewertungsaktivit\u00e4ten, die materialbezogene Risikoanalyse und die risikobasierte Entscheidungsfindung \u00fcber Ihren gesamten Regulierungspfad hinweg.<\/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-d6828b0 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"d6828b0\" 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-762ac84 animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"762ac84\" 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-2046434 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"2046434\" 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\">Welcher Service gilt f\u00fcr Ihr Medizinprodukt?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5ee72a1 elementor-widget elementor-widget-text-editor\" data-id=\"5ee72a1\" 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\":\"When preparing material-related documentation for medical devices, manufacturers can follow two distinct material characterization pathways, depending on device classification and regulatory expectations. Both approaches are aligned with ISO 10993-1 and designed to support biological safety evaluation:\"}]\" data-inline-monday=\"true\">Bei der Erstellung der materialbezogenen Dokumentation f\u00fcr Medizinprodukte k\u00f6nnen die Hersteller je nach Produktklassifizierung und regulatorischen Erwartungen zwei unterschiedliche Wege der Materialcharakterisierung beschreiten. Beide Ans\u00e4tze orientieren sich an der ISO 10993-1 und sind darauf ausgelegt, die biologische Sicherheitsbewertung zu unterst\u00fctzen: <\/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-1fab86c e-flex e-con-boxed e-con e-child\" data-id=\"1fab86c\" 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-3ede3af e-con-full e-flex e-con e-child\" data-id=\"3ede3af\" 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-ed3d6f9 elementor-widget elementor-widget-heading\" data-id=\"ed3d6f9\" 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\">Materialcharakterisierung (MAT C) - Klasse I und II<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1ec1cf9 elementor-widget elementor-widget-text-editor\" data-id=\"1ec1cf9\" 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\":\"For Class I and II medical devices, material characterization focuses on documenting device materials, manufacturing processes, and relevant physical characteristics to support material-related risk identification. The assessment is structured to reflect the device context, intended use, and exposure considerations, providing a clear technical foundation to support biological evaluation and downstream safety decisions.\"}]\" data-inline-monday=\"true\">Bei Medizinprodukten der Klassen I und II konzentriert sich die Materialcharakterisierung auf die Dokumentation von Produktmaterialien, Herstellungsprozessen und relevanten physikalischen Eigenschaften, um die Identifizierung materialbezogener Risiken zu unterst\u00fctzen. Die Bewertung ist so strukturiert, dass sie den Produktkontext, die beabsichtigte Verwendung und die Expositionserw\u00e4gungen widerspiegelt und eine klare technische Grundlage f\u00fcr die biologische Bewertung und nachgelagerte Sicherheitsentscheidungen bietet. <\/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-85316ee e-con-full e-flex e-con e-child\" data-id=\"85316ee\" 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-ee126ee elementor-widget elementor-widget-heading\" data-id=\"ee126ee\" 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\">Materialcharakterisierung (MAT C) - Klasse III und IV<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7262a63 elementor-widget elementor-widget-text-editor\" data-id=\"7262a63\" 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\":\"For Class III and IV medical devices, material characterization follows the same ISO 10993-1 framework while addressing the higher level of scrutiny typically associated with increased risk classification. The documentation provides structured visibility into materials, processes, and relevant chemical and physical characteristics, supporting a more robust risk analysis and biological safety strategy.\"}]\" data-inline-monday=\"true\">F\u00fcr Medizinprodukte der Klassen III und IV folgt die Materialcharakterisierung demselben Rahmenwerk wie ISO 10993-1, ber\u00fccksichtigt jedoch das h\u00f6here Ma\u00df an Kontrolle, das typischerweise mit einer h\u00f6heren Risikoklassifizierung einhergeht. Die Dokumentation bietet einen strukturierten Einblick in Materialien, Prozesse und relevante chemische und physikalische Eigenschaften und unterst\u00fctzt so eine robustere Risikoanalyse und biologische Sicherheitsstrategie. <\/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-dfd9bc8 elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile e-con-full e-flex e-con e-child\" data-id=\"dfd9bc8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-482ac5c e-con-full e-flex e-con e-child\" data-id=\"482ac5c\" 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-93d6300 elementor-widget elementor-widget-heading\" data-id=\"93d6300\" 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-7007d35 elementor-widget elementor-widget-text-editor\" data-id=\"7007d35\" 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-c95cea7 e-con-full e-flex e-con e-child\" data-id=\"c95cea7\" 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-fc99b20 elementor-widget elementor-widget-heading\" data-id=\"fc99b20\" 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-393d581 elementor-widget elementor-widget-text-editor\" data-id=\"393d581\" 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-cd5f9a1 e-con-full e-flex e-con e-child\" data-id=\"cd5f9a1\" 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-257cc1a elementor-widget elementor-widget-heading\" data-id=\"257cc1a\" 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-fc47362 elementor-widget elementor-widget-text-editor\" data-id=\"fc47362\" 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<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f4dd7c elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-heading\" data-id=\"3f4dd7c\" 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\">Sie wissen nicht, wie Sie Ihr Medizinprodukt bei Anvisa registrieren?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ede5b45 elementor-widget elementor-widget-text-editor\" data-id=\"ede5b45\" 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=\"[{\"attributes\":{\"bold\":true},\"insert\":\"If you are unsure which material characterization pathway best fits your device, Sobel can help you identify the most appropriate scenario based on your device classification, available documentation, and regulatory objectives.\"}]\" data-inline-monday=\"true\">Wenn Sie sich nicht sicher sind, welcher Materialcharakterisierungspfad am besten zu Ihrem Ger\u00e4t passt, kann Sobel Ihnen helfen, das am besten geeignete Szenario auf der Grundlage Ihrer Ger\u00e4teklassifizierung, der verf\u00fcgbaren Dokumentation und der regulatorischen Ziele zu ermitteln.<\/p>\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-b229f62 e-flex e-con-boxed e-con e-parent\" data-id=\"b229f62\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6cb7972 e-con-full e-flex e-con e-child\" data-id=\"6cb7972\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-00a725b elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"00a725b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" 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-2d5bca8 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"2d5bca8\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Verwandte Dienstleistungen <br><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e316979 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"e316979\" 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 class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Material characterization is a fundamental step in demonstrating the chemical safety of medical devices. Depending on your device and regulatory strategy, you may also require:\"}]\" data-inline-monday=\"true\">Die Materialcharakterisierung ist ein grundlegender Schritt beim Nachweis der chemischen Sicherheit von Medizinprodukten. Abh\u00e4ngig von Ihrem Produkt und Ihrer regulatorischen Strategie ben\u00f6tigen Sie m\u00f6glicherweise auch: <\/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-b0cd08f e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"b0cd08f\" 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-fe00e35 e-con-full e-flex e-con e-child\" data-id=\"fe00e35\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7dc7886 elementor-widget elementor-widget-heading\" data-id=\"7dc7886\" 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\">Biologische Bewertung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fc763af elementor-widget elementor-widget-text-editor\" data-id=\"fc763af\" 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 ISO 10993 biological evaluations for biocompatibility, safety, and regulatory success.\"}]\" data-inline-monday=\"true\">Fachkundige biologische Bewertungen nach ISO 10993 f\u00fcr Biokompatibilit\u00e4t, Sicherheit und regulatorischen Erfolg.<\/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-90bdbe2 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"90bdbe2\" 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=\"#footer-cta\" target=\"_blank\">\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\">Kontaktieren Sie uns<\/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<div class=\"elementor-element elementor-element-60687e1 e-con-full e-flex e-con e-child\" data-id=\"60687e1\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6a0ae53 elementor-widget elementor-widget-heading\" data-id=\"6a0ae53\" 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\">Toxikologische Risikobewertung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-40c6529 elementor-widget elementor-widget-text-editor\" data-id=\"40c6529\" 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<div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"TRA aligned with ISO 10993-18 and Health Canada expectations.\"}]\" data-inline-monday=\"true\">TRA entspricht der ISO 10993-18 und den Erwartungen von Health Canada.<\/p><\/div><\/div><\/div><\/div>\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-4d050cc elementor-align-center elementor-widget elementor-widget-button\" data-id=\"4d050cc\" 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=\"#footer-cta\" target=\"_blank\">\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\">Kontaktieren Sie uns<\/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<div class=\"elementor-element elementor-element-d66731b e-con-full e-flex e-con e-child\" data-id=\"d66731b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f251aed elementor-widget elementor-widget-heading\" data-id=\"f251aed\" 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\">Technische Ausarbeitung der Datei<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af6bdf1 elementor-widget elementor-widget-text-editor\" data-id=\"af6bdf1\" 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\":\"Guidance to structure technical documentation for regulatory submissions.\"}]\" data-inline-monday=\"true\">Leitfaden zur Strukturierung der technischen Dokumentation f\u00fcr Zulassungsantr\u00e4ge.<\/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-6d62746 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"6d62746\" 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=\"#footer-cta\" target=\"_blank\">\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\">Kontaktieren Sie uns<\/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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-62e60c9 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"62e60c9\" 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-fcabdd7 e-con-full e-flex e-con e-child\" data-id=\"fcabdd7\" 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-a6a9c47 e-con-full e-flex e-con e-child\" data-id=\"a6a9c47\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-399ea4c elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"399ea4c\" 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\">Von der Materialcharakterisierung bis zur Rechtfertigung der chemischen Sicherheit<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-130a391 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"130a391\" 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\":\"A structured material characterization is essential to understand your device materials, support risk analysis, and enable downstream biological and toxicological assessments. Talk to Sobel and ensure your MAT C documentation is clear, traceable, and aligned with ISO 10993-1 expectations.\"}]\" data-inline-monday=\"true\">Eine strukturierte Materialcharakterisierung ist unerl\u00e4sslich, um Ihre Ger\u00e4tematerialien zu verstehen, Risikoanalysen zu unterst\u00fctzen und nachgelagerte biologische und toxikologische Bewertungen zu erm\u00f6glichen. Sprechen Sie mit Sobel und stellen Sie sicher, dass Ihre MAT C-Dokumentation klar, r\u00fcckverfolgbar und auf die Erwartungen der ISO 10993-1 abgestimmt ist. <\/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-a0aead1 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"a0aead1\" 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-0be8334 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"0be8334\" 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-01cb405 elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"01cb405\" 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-1881\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1881\" 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-1881\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1881\"><p><b>1. Ist die Materialcharakterisierung f\u00fcr Medizinprodukte in Kanada obligatorisch?<\/b><\/p>\n<p>Von den Herstellern wird erwartet, dass sie im Rahmen der biologischen Bewertung ein klares Verst\u00e4ndnis der Produktmaterialien und ihrer m\u00f6glichen Auswirkungen auf die Patientensicherheit nachweisen. Die Materialcharakterisierung ist eine allgemein anerkannte Methode, um diese Erwartung zu erf\u00fcllen. <\/p>\n<p><b>2. Welche Ger\u00e4teklassen erfordern typischerweise eine Materialcharakterisierung?<\/b><\/p>\n<p>Die Materialcharakterisierung kann auf Medizinprodukte aller Klassen (I-IV) anwendbar sein, je nach Materialzusammensetzung, K\u00f6rperkontakt und Dauer der Exposition. Die Tiefe der Dokumentation nimmt in der Regel mit der Risikoklasse des Produkts zu. <\/p>\n<p><b>3. Entspricht MAT C den von Health Canada akzeptierten ISO-Normen?<\/b><\/p>\n<p>Ja. MAT C wurde in Anlehnung an die ISO 10993-1 entwickelt, die international anerkannt ist und von Health Canada f\u00fcr die Bewertung der biologischen Sicherheit allgemein akzeptiert wird. <\/p>\n<p><b>4. Umfasst die Materialcharakterisierung eine toxikologische Risikobewertung?<\/b><\/p>\n<p>Nein. Die toxikologische Risikobewertung (TRA) ist nicht Teil des MAT C Service. Sie k\u00f6nnen sich jedoch darauf verlassen, dass Sobel auch diesen Schritt unterst\u00fctzt, indem die TRA von erfahrenen Experten durchgef\u00fchrt wird.  <\/p>\n<p><b>5. Ist dieser Service f\u00fcr Unternehmen mit Sitz au\u00dferhalb Kanadas geeignet?<\/b><\/p>\n<p>Ja. Sobel unterst\u00fctzt sowohl kanadische als auch internationale Hersteller, die medizinische Ger\u00e4te f\u00fcr den kanadischen Markt vorbereiten. <\/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>Materialcharakterisierung (MAT C) f\u00fcr Medizinprodukte F\u00fcr Medizinprodukte, die in Kanada vermarktet werden, m\u00fcssen materialbezogene Risiken identifiziert, verstanden und begr\u00fcndet werden. Eine strukturierte Materialcharakterisierung (MAT C) unterst\u00fctzt diese Anforderung durch die Dokumentation von Produktmaterialien, Prozessen und relevanten physikalischen Eigenschaften in \u00dcbereinstimmung mit ISO 10993-1. Holen Sie sich Expertenunterst\u00fctzung F\u00fcr wen? Hersteller von Medizinprodukten der Klassen I, [&hellip;]<\/p>\n","protected":false},"author":16,"featured_media":0,"parent":8391,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-26045","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Materialcharakterisierung (MAT C) f\u00fcr Medizinprodukte | Kanada<\/title>\n<meta name=\"description\" content=\"Materialcharakterisierung (MAT C) f\u00fcr Medizinprodukte, die f\u00fcr den kanadischen Markt bestimmt sind, angelehnt an ISO 10993-1.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-canada\/material-characterization-canada\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MED CAN MAT C\" \/>\n<meta property=\"og:description\" content=\"Materialcharakterisierung (MAT C) f\u00fcr Medizinprodukte, die f\u00fcr den kanadischen Markt bestimmt sind, angelehnt an ISO 10993-1.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/de\/our-solutions-canada\/material-characterization-canada\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-09T20:03:15+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1011\" \/>\n\t<meta property=\"og:image:height\" content=\"1371\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data1\" content=\"6\u00a0Minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/our-solutions-canada\\\/material-characterization-canada\\\/\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/our-solutions-canada\\\/material-characterization-canada\\\/\",\"name\":\"Materialcharakterisierung (MAT C) f\u00fcr Medizinprodukte | Kanada\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/our-solutions-canada\\\/material-characterization-canada\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/our-solutions-canada\\\/material-characterization-canada\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/image-medcialdevices-services-755x1024.png\",\"datePublished\":\"2026-01-09T19:54:30+00:00\",\"dateModified\":\"2026-01-09T20:03:15+00:00\",\"description\":\"Materialcharakterisierung (MAT C) f\u00fcr Medizinprodukte, die f\u00fcr den kanadischen Markt bestimmt sind, angelehnt an ISO 10993-1.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/our-solutions-canada\\\/material-characterization-canada\\\/#breadcrumb\"},\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/sobelconsult.com\\\/de\\\/our-solutions-canada\\\/material-characterization-canada\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/our-solutions-canada\\\/material-characterization-canada\\\/#primaryimage\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/image-medcialdevices-services-755x1024.png\",\"contentUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/image-medcialdevices-services-755x1024.png\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/our-solutions-canada\\\/material-characterization-canada\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/home\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Unsere L\u00f6sungen Kanada\",\"item\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/our-solutions-canada\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"MED CAN MAT C\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/#website\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/\",\"name\":\"Sobel\",\"description\":\"Regulatory Consultancy\",\"publisher\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"de\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/#organization\",\"name\":\"Sobel\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2024\\\/07\\\/Logo-Oficial-Website-White.webp\",\"contentUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2024\\\/07\\\/Logo-Oficial-Website-White.webp\",\"width\":741,\"height\":290,\"caption\":\"Sobel\"},\"image\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/de\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Materialcharakterisierung (MAT C) f\u00fcr Medizinprodukte | Kanada","description":"Materialcharakterisierung (MAT C) f\u00fcr Medizinprodukte, die f\u00fcr den kanadischen Markt bestimmt sind, angelehnt an ISO 10993-1.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/sobelconsult.com\/de\/our-solutions-canada\/material-characterization-canada\/","og_locale":"de_DE","og_type":"article","og_title":"MED CAN MAT C","og_description":"Materialcharakterisierung (MAT C) f\u00fcr Medizinprodukte, die f\u00fcr den kanadischen Markt bestimmt sind, angelehnt an ISO 10993-1.","og_url":"https:\/\/sobelconsult.com\/de\/our-solutions-canada\/material-characterization-canada\/","og_site_name":"Sobel","article_modified_time":"2026-01-09T20:03:15+00:00","og_image":[{"width":1011,"height":1371,"url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services.webp","type":"image\/webp"}],"twitter_card":"summary_large_image","twitter_misc":{"Gesch\u00e4tzte Lesezeit":"6\u00a0Minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/sobelconsult.com\/de\/our-solutions-canada\/material-characterization-canada\/","url":"https:\/\/sobelconsult.com\/de\/our-solutions-canada\/material-characterization-canada\/","name":"Materialcharakterisierung (MAT C) f\u00fcr Medizinprodukte | Kanada","isPartOf":{"@id":"https:\/\/sobelconsult.com\/de\/#website"},"primaryImageOfPage":{"@id":"https:\/\/sobelconsult.com\/de\/our-solutions-canada\/material-characterization-canada\/#primaryimage"},"image":{"@id":"https:\/\/sobelconsult.com\/de\/our-solutions-canada\/material-characterization-canada\/#primaryimage"},"thumbnailUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png","datePublished":"2026-01-09T19:54:30+00:00","dateModified":"2026-01-09T20:03:15+00:00","description":"Materialcharakterisierung (MAT C) f\u00fcr Medizinprodukte, die f\u00fcr den kanadischen Markt bestimmt sind, angelehnt an ISO 10993-1.","breadcrumb":{"@id":"https:\/\/sobelconsult.com\/de\/our-solutions-canada\/material-characterization-canada\/#breadcrumb"},"inLanguage":"de","potentialAction":[{"@type":"ReadAction","target":["https:\/\/sobelconsult.com\/de\/our-solutions-canada\/material-characterization-canada\/"]}]},{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/sobelconsult.com\/de\/our-solutions-canada\/material-characterization-canada\/#primaryimage","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png"},{"@type":"BreadcrumbList","@id":"https:\/\/sobelconsult.com\/de\/our-solutions-canada\/material-characterization-canada\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/sobelconsult.com\/de\/home\/"},{"@type":"ListItem","position":2,"name":"Unsere L\u00f6sungen Kanada","item":"https:\/\/sobelconsult.com\/de\/our-solutions-canada\/"},{"@type":"ListItem","position":3,"name":"MED CAN MAT C"}]},{"@type":"WebSite","@id":"https:\/\/sobelconsult.com\/de\/#website","url":"https:\/\/sobelconsult.com\/de\/","name":"Sobel","description":"Regulatory Consultancy","publisher":{"@id":"https:\/\/sobelconsult.com\/de\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/sobelconsult.com\/de\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"de"},{"@type":"Organization","@id":"https:\/\/sobelconsult.com\/de\/#organization","name":"Sobel","url":"https:\/\/sobelconsult.com\/de\/","logo":{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/sobelconsult.com\/de\/#\/schema\/logo\/image\/","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.webp","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.webp","width":741,"height":290,"caption":"Sobel"},"image":{"@id":"https:\/\/sobelconsult.com\/de\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/sobelconsult.com\/de\/wp-json\/wp\/v2\/pages\/26045","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sobelconsult.com\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sobelconsult.com\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/de\/wp-json\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/de\/wp-json\/wp\/v2\/comments?post=26045"}],"version-history":[{"count":0,"href":"https:\/\/sobelconsult.com\/de\/wp-json\/wp\/v2\/pages\/26045\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/de\/wp-json\/wp\/v2\/pages\/8391"}],"wp:attachment":[{"href":"https:\/\/sobelconsult.com\/de\/wp-json\/wp\/v2\/media?parent=26045"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}