{"id":4773,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/toxikologische-risikobewertung-europa\/"},"modified":"2026-02-18T11:33:13","modified_gmt":"2026-02-18T14:33:13","slug":"toxicological-risk-assessment-tra","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/toxicological-risk-assessment-tra\/","title":{"rendered":"Toxikologische Risikobewertung - Europa"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"4773\" class=\"elementor elementor-4773 elementor-1717\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-710dd80 e-flex e-con-boxed e-con e-parent\" data-id=\"710dd80\" 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-493e861 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"493e861\" 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\">Toxikologische Risikobewertung (TRA) 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-3ba25a0 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"3ba25a0\" 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\":\"Chemical safety must be supported by robust evidence to place medical devices on the European market. Sobel\u2019s Human Safety team develops Toxicological Risk Assessments (TRA) aligned with EU MDR and ISO 10993 expectations.\"}]\" data-inline-monday=\"true\">Um Medizinprodukte auf den europ\u00e4ischen Markt zu bringen, muss die chemische Sicherheit durch solide Beweise gest\u00fctzt werden. Das Sobel-Team f\u00fcr menschliche Sicherheit entwickelt toxikologische Risikobewertungen (TRA), die den Erwartungen der EU MDR und der ISO 10993 entsprechen. <\/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-df80535 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"df80535\" 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-affa2cd e-flex e-con-boxed e-con e-parent\" data-id=\"affa2cd\" 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-60db83a e-con-full e-flex e-con e-child\" data-id=\"60db83a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-374eedf e-con-full e-transform e-flex e-con e-child\" data-id=\"374eedf\" 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-52b22e0 elementor-widget elementor-widget-heading\" data-id=\"52b22e0\" 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-48263e5 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"48263e5\" 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-2f33bc6 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"2f33bc6\" 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 Produkte auf den europ\u00e4ischen Markt bringen<\/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 biologische Bewertungen im Rahmen der EU-MDR vorbereiten oder aktualisieren<\/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\">Regulierungs- und F&amp;E-Teams, die sich mit den Anforderungen an chemische Sicherheit und Biokompatibilit\u00e4t befassen<\/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\">Organisationen, die auf Fragen der benannten Stelle zu toxikologischen Risiken antworten<\/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-502a446 e-con-full e-flex e-con e-child\" data-id=\"502a446\" 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-12bd3cd elementor-widget elementor-widget-image\" data-id=\"12bd3cd\" 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-06a398d e-flex e-con-boxed e-con e-parent\" data-id=\"06a398d\" 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-3887ac8 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"3887ac8\" 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 delivers a toxicological risk assessment TRA aligned with ISO 10993-1, ISO 10993-17, and ISO 10993-18, integrating scientific evidence with regulatory expectations.\"}]\" data-inline-monday=\"true\">Sobel liefert eine toxikologische Risikobewertung TRA, die mit ISO 10993-1, ISO 10993-17 und ISO 10993-18 \u00fcbereinstimmt und wissenschaftliche Erkenntnisse mit regulatorischen Erwartungen verbindet.<\/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-791c168 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"791c168\" 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-4bb5c83 e-flex e-con-boxed e-con e-parent\" data-id=\"4bb5c83\" 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-1b553ef elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"1b553ef\" 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-3e54a4d elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"3e54a4d\" 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-9e51dd7 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"9e51dd7\" 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-b077de2 e-con-full e-flex e-con e-child\" data-id=\"b077de2\" 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-eb06578 elementor-widget elementor-widget-text-editor\" data-id=\"eb06578\" 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\":\"Under the EU MDR, manufacturers must demonstrate that no unacceptable chemical risks exist as part of the biological evaluation.\"}]\" data-inline-monday=\"true\">Gem\u00e4\u00df der EU-MDR m\u00fcssen die Hersteller im Rahmen der biologischen Bewertung nachweisen, dass keine unannehmbaren chemischen Risiken bestehen.<\/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-07cc50b e-con-full e-flex e-con e-child\" data-id=\"07cc50b\" 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-0bd019c elementor-widget elementor-widget-text-editor\" data-id=\"0bd019c\" 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 toxicological risk assessment evaluates identified substances, defines exposure limits, and assesses whether associated risks are acceptable for the intended use of the device.\"}]\" data-inline-monday=\"true\">Bei einer toxikologischen Risikobewertung werden die identifizierten Stoffe bewertet, Expositionsgrenzen festgelegt und beurteilt, ob die damit verbundenen Risiken f\u00fcr die beabsichtigte Verwendung des Produkts akzeptabel sind.<\/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-5aa58ea e-con-full e-flex e-con e-child\" data-id=\"5aa58ea\" 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-1d95149 elementor-widget elementor-widget-text-editor\" data-id=\"1d95149\" 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 robust TRA strengthens your biological evaluation, supports smoother Notified Body review, and reduces the likelihood of objections, requests for additional data, or delays in CE marking.\"}]\" data-inline-monday=\"true\">Eine robuste TRA st\u00e4rkt Ihre biologische Bewertung, unterst\u00fctzt eine reibungslosere \u00dcberpr\u00fcfung durch die benannte Stelle und verringert die Wahrscheinlichkeit von Einw\u00e4nden, Anfragen nach zus\u00e4tzlichen Daten oder Verz\u00f6gerungen bei der CE-Kennzeichnung.<\/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-1f4ebbd e-flex e-con-boxed e-con e-parent\" data-id=\"1f4ebbd\" 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-5d0e2b5 e-con-full e-flex e-con e-child\" data-id=\"5d0e2b5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a517e7c elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"a517e7c\" 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\">Chemische Daten in vertretbare Sicherheitsaussagen umwandeln<\/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-2ec245a e-con-full e-flex e-con e-child\" data-id=\"2ec245a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ec2c6cc elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"ec2c6cc\" 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\":\"Our approach focuses on relevance, traceability, and transparency \u2014 ensuring that toxicological conclusions are clearly linked to chemical characterization data, clinical context, and intended use.\"}]\" data-inline-monday=\"true\">Gem\u00e4\u00df der EU-MDR m\u00fcssen die Hersteller chemische Substanzen, die von Medizinprodukten freigesetzt werden, bewerten und nachweisen, dass die Expositionswerte keine inakzeptablen Risiken f\u00fcr Patienten oder Anwender darstellen.  <strong>Die toxikologische Risikobewertung f\u00fcr Medizinprodukte integriert Daten zur chemischen Charakterisierung, toxikologische Referenzwerte und Methoden zur Expositionsbewertung, um die biologische Bewertung und die Einhaltung der CE-Kennzeichnung zu unterst\u00fctzen.<\/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-b0706f4 e-flex e-con-boxed e-con e-parent\" data-id=\"b0706f4\" 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-ec710d4 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"ec710d4\" 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\">Stoffsicherheitsbeurteilung, die das Vertrauen der Beh\u00f6rden st\u00e4rkt.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-29666ce elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"29666ce\" 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_29666ce *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_29666ce{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_29666ce .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_29666ce .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_29666ce  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_29666ce  .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_29666ce .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_29666ce .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-item-bullet i, #uc_horizontal_timeline_elementor_29666ce .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_29666ce .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_29666ce .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_29666ce .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_29666ce\">\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_29666ce\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-17ded05\">\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=\"#\" >\u00dcberpr\u00fcfung der chemischen Charakterisierung<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Bewertung der identifizierten und quantifizierten Produktbestandteile auf der Grundlage einer chemischen Charakterisierung gem\u00e4\u00df ISO 10993-18.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-7eccb7c\">\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=\"#\" >Bewertung der toxikologischen Daten<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Sammlung und Bewertung vorhandener toxikologischer Daten f\u00fcr Stoffe und Materialien, einschlie\u00dflich \u00f6ffentlich zug\u00e4nglicher Literatur und relevanter eigener Quellen.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-792b003\">\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=\"#\" >Definition von Exposition und Grenzwerten<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Definition von tolerierbaren Aufnahmewerten, Expositionsgrenzen und Sicherheitsmargen auf der Grundlage des Verwendungszwecks, der Expositionsdauer und der Patientenpopulation, in \u00dcbereinstimmung mit ISO 10993-17.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-ed2a6fe\">\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=\"#\" >Risikobewertung und Akzeptanz<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Bewertung der identifizierten Risiken anhand festgelegter Kriterien, um die Akzeptanz zu bestimmen und die Notwendigkeit zus\u00e4tzlicher Tests oder Risikokontrollma\u00dfnahmen zu ermitteln.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-acb052e\">\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=\"#\" >Klinische Anwendung und Expositionskontext<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Analyse der Daten zur klinischen Vorgeschichte der Verwendung des Produkts, der Referenzprodukte und der Exposition des Menschen gegen\u00fcber relevanten Substanzen.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-8d4e956\">\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=\"#\" >TRA-Berichterstattung<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Erstellung eines strukturierten Berichts zur toxikologischen Risikobewertung, der sich zur Aufnahme in die technische Dokumentation und die biologischen Bewertungsakten eignet.<\/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-a0e1d0c elementor-align-center elementor-widget elementor-widget-button\" data-id=\"a0e1d0c\" 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-73781af e-flex e-con-boxed e-con e-parent\" data-id=\"73781af\" 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-cb893f8 e-con-full e-flex e-con e-child\" data-id=\"cb893f8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8f983e6 elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"8f983e6\" 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-c0a0cf0 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"c0a0cf0\" 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-6946564 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"6946564\" 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\":\"A toxicological risk assessment (TRA) is not a standalone exercise. Under the European regulatory framework, chemical safety must be supported by complementary evaluations and documentation, which Sobel also supports through integrated regulatory and scientific services, such as:\"}]\" data-inline-monday=\"true\">Eine toxikologische Risikobewertung (TRA) ist keine eigenst\u00e4ndige Aufgabe. Nach dem europ\u00e4ischen Rechtsrahmen muss die Chemikaliensicherheit durch erg\u00e4nzende Bewertungen und Dokumentationen unterst\u00fctzt werden, die Sobel auch durch <a href=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/\" target=\"_blank\" rel=\"noopener\">EU MDR Regulatory Compliance Solutions<\/a> unterst\u00fctzt: <\/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-ae01c00 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"ae01c00\" 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-d91a723 e-con-full e-flex e-con e-child\" data-id=\"d91a723\" 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-a408afa elementor-widget elementor-widget-heading\" data-id=\"a408afa\" 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\"><a href=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/medical-device-internal-audits\/\" target=\"_blank\">Interne Audits<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ab4899a elementor-widget elementor-widget-text-editor\" data-id=\"ab4899a\" 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\":\"Internal audits supporting ISO 13485 compliance and notified body readiness in Europe.\"}]\" data-inline-monday=\"true\">Interne Audits zur Unterst\u00fctzung der Einhaltung von ISO 13485 und der Bereitschaft der benannten Stelle in Europa.<\/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-02e91e1 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"02e91e1\" 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=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/medical-device-internal-audits\/\" 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\">Mehr sehen<\/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-8bcdbc4 e-con-full e-flex e-con e-child\" data-id=\"8bcdbc4\" 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-878cea1 elementor-widget elementor-widget-heading\" data-id=\"878cea1\" 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\"><a href=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/ce-mark-medical-devices-support\/\" target=\"_blank\">Unterst\u00fctzung bei der CE-Kennzeichnung<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-711438f elementor-widget elementor-widget-text-editor\" data-id=\"711438f\" 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\":\"Gap analysis, technical documentation, and ongoing regulatory \"},{\"attributes\":{\"sanitizedSize\":\"16px\"},\"insert\":\"for CE Mark for Medical Devices\"},{\"insert\":\".\"}]\" data-inline-monday=\"true\">L\u00fcckenanalyse, technische Dokumentation und laufende Regulierung f\u00fcr die CE-Kennzeichnung von Medizinprodukten.<\/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-77bde70 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"77bde70\" 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=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/ce-mark-medical-devices-support\/\" 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\">Mehr sehen<\/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-19b42a3 e-con-full e-flex e-con e-child\" data-id=\"19b42a3\" 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-138bc8f elementor-widget elementor-widget-heading\" data-id=\"138bc8f\" 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\"><a href=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/biological-evaluation-europe\/\" target=\"_blank\">Biologische Bewertung (BEP, BER)<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8a55ad0 elementor-widget elementor-widget-text-editor\" data-id=\"8a55ad0\" 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\":\"MAT C reports, updates, and expert reviews aligned with ISO 10993-1.\"}]\" data-inline-monday=\"true\">Dienstleistungen zur biologischen Bewertung durch Experten. BEP, BER, Gap-Analyse und regulatorische Unterst\u00fctzung. <\/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-1554691 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"1554691\" 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=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/biological-evaluation-europe\/\" 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\">Mehr sehen<\/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-7672763 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"7672763\" 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-8e56da7 e-con-full e-flex e-con e-child\" data-id=\"8e56da7\" 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-b08e589 e-con-full e-flex e-con e-child\" data-id=\"b08e589\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b110cf1 elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"b110cf1\" 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 Bewertungen, die eine sichere CE-Kennzeichnung unterst\u00fctzen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d7fc8fa elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d7fc8fa\" 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\tEine gut durchgef\u00fchrte toxikologische Risikobewertung TRA ist unerl\u00e4sslich, um die Sicherheit von Chemikalien nachzuweisen und die Einhaltung der EU-MDR zu unterst\u00fctzen.\n\n<strong>Sobel kombiniert toxikologisches Fachwissen mit dem Verst\u00e4ndnis f\u00fcr gesetzliche Vorschriften, um Bewertungen zu liefern, die wissenschaftlich fundiert und klar dokumentiert sind und den Erwartungen der benannten Stelle entsprechen.<\/strong>\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-4e1f545 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"4e1f545\" 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\">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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fcef03c e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"fcef03c\" 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-daefa26 elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"daefa26\" 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-2291\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2291\" 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-2291\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2291\"><p><b>1. Was ist eine Toxikologische Risikobewertung (TRA)?<\/b><\/p>\n<p>Eine toxikologische Risikobewertung (TRA) ist eine strukturierte wissenschaftliche Bewertung, mit der beurteilt wird, ob chemische Substanzen, die von einem Medizinprodukt freigesetzt werden, ein inakzeptables Risiko f\u00fcr Patienten oder Anwender darstellen. Im europ\u00e4ischen Kontext unterst\u00fctzt die TRA die biologische Bewertung, die gem\u00e4\u00df der Verordnung (EU) 2017\/745 (EU MDR) erforderlich ist, und orientiert sich an der ISO 10993-Reihe. <\/p>\n<p><b>2. Wann ist eine toxikologische Risikobewertung gem\u00e4\u00df der EU-MDR erforderlich?<\/b><\/p>\n<p>Eine TRA ist erforderlich, wenn bei der chemischen Charakterisierung Stoffe identifiziert werden, die aus einem Medizinprodukt freigesetzt werden k\u00f6nnen und eine toxikologische Bewertung erfordern. Sie ist Teil der biologischen Bewertung, um nachzuweisen, dass f\u00fcr die vorgesehene Verwendung des Produkts keine unannehmbaren chemischen Risiken bestehen. <\/p>\n<p><b>3. Welche Standards gelten f\u00fcr die toxikologische Risikobewertung in Europa?<\/b><\/p>\n<p>TRA-Aktivit\u00e4ten orientieren sich in erster Linie an ISO 10993-1, ISO 10993-17 und ISO 10993-18. Diese Normen legen fest, wie Daten zur chemischen Charakterisierung erzeugt werden, wie Expositionsgrenzen festgelegt werden und wie toxikologische Risiken bewertet und dokumentiert werden. <\/p>\n<p><b>4. Ist eine TRA f\u00fcr alle Medizinprodukte erforderlich?<\/b><\/p>\n<p>Nicht unbedingt. Die Notwendigkeit einer TRA h\u00e4ngt von Faktoren wie den Materialien des Produkts, der Art und Dauer des K\u00f6rperkontakts, den Ergebnissen der chemischen Charakterisierung und dem Verwendungszweck ab. Wenn Substanzen identifiziert werden, die eine toxikologische Bewertung erfordern, wird eine TRA notwendig.  <\/p>\n<p><b>5. Wie unterscheidet sich eine TRA von einer chemischen Charakterisierung?<\/b><\/p>\n<p>Die chemische Charakterisierung identifiziert und quantifiziert Substanzen, die von einem Ger\u00e4t freigesetzt werden, in der Regel gem\u00e4\u00df ISO 10993-18. Eine TRA bewertet die toxikologische Relevanz dieser Stoffe, definiert Expositionsgrenzen und bewertet, ob die damit verbundenen Risiken akzeptabel sind. <\/p>\n<p><b>6. K\u00f6nnen vorhandene toxikologische Daten in einer TRA verwendet werden?<\/b><\/p>\n<p>Ja. Eine TRA st\u00fctzt sich in hohem Ma\u00dfe auf vorhandene toxikologische Daten aus der wissenschaftlichen Literatur, aus Datenbanken und aus einschl\u00e4gigen eigenen Quellen. Neue Tests werden nur dann in Betracht gezogen, wenn die vorhandenen Daten nicht ausreichen, um eine solide Risikobewertung durchzuf\u00fchren.  <\/p>\n<p><b>7. Ersetzt eine TRA den Biologischen Bewertungsbericht (BER)?<\/b><\/p>\n<p>Nein. Eine TRA ersetzt nicht den <a href=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/biological-evaluation-europe\/\">Bericht zur biologischen Bewertung<\/a>. Er unterst\u00fctzt die biologische Bewertung, indem er toxikologische Schlussfolgerungen in Bezug auf die chemische Sicherheit liefert, die dann in den BER integriert werden.  <\/p>\n<p><strong>8. Wie unterst\u00fctzt eine toxikologische Risikobewertung die CE-Kennzeichnung?<\/strong><\/p>\n<p>Eine toxikologische Risikobewertung <a href=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/ce-mark-medical-devices-support\/\" target=\"_blank\" rel=\"noopener\">unterst\u00fctzt die CE-Kennzeichnung<\/a>, indem sie nachweist, dass von dem Medizinprodukt freigesetzte chemische Substanzen keine unannehmbaren Gesundheitsrisiken darstellen. Die TRA liefert wissenschaftlich begr\u00fcndete Expositionsgrenzwerte und toxikologische Schlussfolgerungen, die in die Dokumentation der biologischen Bewertung einflie\u00dfen, die w\u00e4hrend der Konformit\u00e4tsbewertung gepr\u00fcft wird. <\/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>Toxikologische Risikobewertung f\u00fcr Medizinprodukte im Einklang mit EU MDR und ISO 10993. Chemische Sicherheitsbewertung und biologische Beurteilung. <\/p>\n","protected":false},"author":11,"featured_media":7259,"parent":7806,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-4773","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>Toxikologische Risikobewertung (TRA) f\u00fcr Medizinprodukte<\/title>\n<meta name=\"description\" content=\"Toxikologische Risikobewertung durch Experten (TRA) in \u00dcbereinstimmung mit der EU MDR und ISO 10993 zur Unterst\u00fctzung der Beweise f\u00fcr die chemische Sicherheit.\" \/>\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-europe\/toxicological-risk-assessment-tra\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Toxikologische Risikobewertung - Europa\" \/>\n<meta property=\"og:description\" content=\"Toxikologische Risikobewertung durch Experten (TRA) in \u00dcbereinstimmung mit der EU MDR und ISO 10993 zur Unterst\u00fctzung der Beweise f\u00fcr die chemische Sicherheit.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/toxicological-risk-assessment-tra\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-18T14:33:13+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Risk-Management-1.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"657\" \/>\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=\"5\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-europe\/toxicological-risk-assessment-tra\/\",\"url\":\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/toxicological-risk-assessment-tra\/\",\"name\":\"Toxikologische Risikobewertung (TRA) f\u00fcr Medizinprodukte\",\"isPartOf\":{\"@id\":\"https:\/\/sobelconsult.com\/de\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/toxicological-risk-assessment-tra\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/toxicological-risk-assessment-tra\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Risk-Management-1.webp\",\"datePublished\":\"2025-06-01T13:00:00+00:00\",\"dateModified\":\"2026-02-18T14:33:13+00:00\",\"description\":\"Toxikologische Risikobewertung durch Experten (TRA) in \u00dcbereinstimmung mit der EU MDR und ISO 10993 zur Unterst\u00fctzung der Beweise f\u00fcr die chemische Sicherheit.\",\"breadcrumb\":{\"@id\":\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/toxicological-risk-assessment-tra\/#breadcrumb\"},\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/toxicological-risk-assessment-tra\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/toxicological-risk-assessment-tra\/#primaryimage\",\"url\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Risk-Management-1.webp\",\"contentUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Risk-Management-1.webp\",\"width\":1000,\"height\":657,\"caption\":\"Top view of young successful businessman in white shirt working on wooden table\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/toxicological-risk-assessment-tra\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\/\/sobelconsult.com\/de\/home\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Unsere L\u00f6sungen f\u00fcr Europa\",\"item\":\"https:\/\/sobelconsult.com\/de\/our-solutions-europe\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Toxikologische Risikobewertung &#8211; 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