{"id":8016,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/evaluacion-de-riesgos-toxicologicos-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\/es\/our-solutions-europe\/toxicological-risk-assessment-tra\/","title":{"rendered":"Evaluaci\u00f3n de riesgos toxicol\u00f3gicos - Europa"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"8016\" class=\"elementor elementor-8016 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\">Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos (ERT) para Productos Sanitarios<\/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\">La seguridad qu\u00edmica debe estar respaldada por pruebas s\u00f3lidas para comercializar productos sanitarios en el mercado europeo. El equipo de Seguridad Humana de Sobel desarrolla Evaluaciones de Riesgos Toxicol\u00f3gicos (TRA) en consonancia con las expectativas del MDR de la UE y la ISO 10993. <\/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%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%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\">Consigue ayuda de expertos<\/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\">\u00bfPara qui\u00e9n?<\/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\">Fabricantes de productos sanitarios que comercializan productos en el mercado europeo<\/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\">Empresas que preparan o actualizan evaluaciones biol\u00f3gicas conforme al MDR de la UE<\/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\">Equipos reguladores y de I+D que abordan los requisitos de seguridad qu\u00edmica y biocompatibilidad<\/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\">Organizaciones que responden a las preguntas del Organismo Notificado relacionadas con los riesgos toxicol\u00f3gicos<\/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-18567\" 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 ofrece una evaluaci\u00f3n de riesgos toxicol\u00f3gicos TRA alineada con las normas ISO 10993-1, ISO 10993-17 e ISO 10993-18, que integra las pruebas cient\u00edficas con las expectativas normativas.<\/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%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%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\">\u00a1Consigue apoyo!<\/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-18573\" 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\">\u00bfPor qu\u00e9 necesitas este servicio?<\/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\">Seg\u00fan el MDR de la UE, los fabricantes deben demostrar que no existen riesgos qu\u00edmicos inaceptables como parte de la evaluaci\u00f3n biol\u00f3gica.<\/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\">Una evaluaci\u00f3n del riesgo toxicol\u00f3gico eval\u00faa las sustancias identificadas, define los l\u00edmites de exposici\u00f3n y valora si los riesgos asociados son aceptables para el uso previsto del producto.<\/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\">Un TRA s\u00f3lido refuerza tu evaluaci\u00f3n biol\u00f3gica, facilita la revisi\u00f3n del Organismo Notificado y reduce la probabilidad de objeciones, solicitudes de datos adicionales o retrasos en el marcado CE.<\/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\">Convertir los datos qu\u00edmicos en conclusiones de seguridad defendibles<\/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\">Seg\u00fan el MDR de la UE, los fabricantes deben evaluar las sustancias qu\u00edmicas liberadas por los productos sanitarios y demostrar que los niveles de exposici\u00f3n no presentan riesgos inaceptables para los pacientes o usuarios.  <strong>La evaluaci\u00f3n del riesgo toxicol\u00f3gico de los productos sanitarios integra datos de caracterizaci\u00f3n qu\u00edmica, valores de referencia toxicol\u00f3gicos y metodolog\u00edas de evaluaci\u00f3n de la exposici\u00f3n para apoyar la evaluaci\u00f3n biol\u00f3gica y el cumplimiento del marcado CE.<\/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\">Evaluaci\u00f3n de la seguridad qu\u00edmica que respalda la confianza normativa.<\/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=\"#\" >Revisi\u00f3n de la caracterizaci\u00f3n qu\u00edmica<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Evaluaci\u00f3n de los constituyentes identificados y cuantificados del dispositivo basada en la caracterizaci\u00f3n qu\u00edmica realizada de acuerdo con la norma 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=\"#\" >Evaluaci\u00f3n de los datos toxicol\u00f3gicos<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Recopilaci\u00f3n y evaluaci\u00f3n de los datos toxicol\u00f3gicos existentes sobre sustancias y materiales, incluida la bibliograf\u00eda disponible p\u00fablicamente y las fuentes patentadas pertinentes.<\/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=\"#\" >Definici\u00f3n de exposici\u00f3n y l\u00edmite<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Definici\u00f3n de valores de ingesta tolerables, l\u00edmites de exposici\u00f3n y m\u00e1rgenes de seguridad basados en el uso previsto, la duraci\u00f3n de la exposici\u00f3n y la poblaci\u00f3n de pacientes, de acuerdo con la norma 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=\"#\" >Evaluaci\u00f3n del riesgo y aceptabilidad<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Evaluaci\u00f3n de los riesgos identificados frente a los criterios establecidos para determinar la aceptabilidad e identificar la necesidad de pruebas adicionales o medidas de control de riesgos.<\/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=\"#\" >Uso cl\u00ednico y contexto de exposici\u00f3n<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">An\u00e1lisis de datos relacionados con el historial cl\u00ednico de uso del dispositivo, los dispositivos de referencia y la exposici\u00f3n humana a sustancias relevantes.<\/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=\"#\" >Informes TRA<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Elaboraci\u00f3n de un informe estructurado de Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos adecuado para su inclusi\u00f3n en la documentaci\u00f3n t\u00e9cnica y en los expedientes de evaluaci\u00f3n biol\u00f3gica.<\/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%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%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\">\u00a1Empieza ya!<\/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\">Servicios relacionados <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\">Una evaluaci\u00f3n de riesgos toxicol\u00f3gicos (ERT) no es un ejercicio independiente. Seg\u00fan el marco normativo europeo, la seguridad qu\u00edmica debe apoyarse en evaluaciones y documentaci\u00f3n complementarias, que Sobel tambi\u00e9n respalda a trav\u00e9s de <a href=\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/\" target=\"_blank\" rel=\"noopener\">las Soluciones de Cumplimiento Normativo EU MDR<\/a>: <\/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\/es\/our-solutions-europe\/medical-device-internal-audits\/\" target=\"_blank\">Auditor\u00edas internas<\/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\">Auditor\u00edas internas de apoyo al cumplimiento de la norma ISO 13485 y preparaci\u00f3n para organismos notificados en 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\/es\/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\">Ver m\u00e1s<\/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\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/\" target=\"_blank\">Asistencia reglamentaria para el marcado CE<\/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\">An\u00e1lisis de deficiencias, documentaci\u00f3n t\u00e9cnica y normativa en curso para el marcado CE de productos sanitarios.<\/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\/es\/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\">Ver m\u00e1s<\/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\/es\/our-solutions-europe\/biological-evaluation-europe\/\" target=\"_blank\">Evaluaci\u00f3n biol\u00f3gica (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\">Servicios expertos de evaluaci\u00f3n biol\u00f3gica. BEP, BER, an\u00e1lisis de carencias y apoyo normativo. <\/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\/es\/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\">Ver m\u00e1s<\/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\">Evaluaciones toxicol\u00f3gicas que respaldan un marcado CE seguro<\/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\tUna evaluaci\u00f3n toxicol\u00f3gica del riesgo TRA bien ejecutada es esencial para demostrar la seguridad qu\u00edmica y apoyar el cumplimiento de las MDR de la UE.\n\n<strong>Sobel combina la experiencia toxicol\u00f3gica y la comprensi\u00f3n de la normativa para ofrecer evaluaciones cient\u00edficamente s\u00f3lidas, claramente documentadas y en consonancia con las expectativas de los Organismos Notificados.<\/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%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%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\">Consigue ayuda de expertos<\/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\">\u00bfA\u00fan tienes preguntas? Consulta nuestras 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. \u00bfQu\u00e9 es una Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos (ERT)?<\/b><\/p>\n<p>Una Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos (TRA) es una evaluaci\u00f3n cient\u00edfica estructurada que valora si las sustancias qu\u00edmicas liberadas por un producto sanitario plantean riesgos inaceptables para los pacientes o los usuarios. En el contexto europeo, la TRA apoya la evaluaci\u00f3n biol\u00f3gica exigida por el Reglamento (UE) 2017\/745 (MDR de la UE) y se rige por la serie ISO 10993. <\/p>\n<p><b>2. \u00bfCu\u00e1ndo se requiere una Evaluaci\u00f3n Toxicol\u00f3gica de Riesgos seg\u00fan el MDR de la UE?<\/b><\/p>\n<p>Se requiere una TRA cuando la caracterizaci\u00f3n qu\u00edmica identifica sustancias que pueden liberarse de un producto sanitario y requieren una evaluaci\u00f3n toxicol\u00f3gica. Forma parte de la evaluaci\u00f3n biol\u00f3gica para demostrar que no existen riesgos qu\u00edmicos inaceptables para el uso previsto del producto. <\/p>\n<p><b>3. \u00bfQu\u00e9 normas se aplican a la Evaluaci\u00f3n Toxicol\u00f3gica de Riesgos en Europa?<\/b><\/p>\n<p>Las actividades de TRA se gu\u00edan principalmente por las normas ISO 10993-1, ISO 10993-17 e ISO 10993-18. Estas normas definen c\u00f3mo se generan los datos de caracterizaci\u00f3n qu\u00edmica, c\u00f3mo se establecen los l\u00edmites de exposici\u00f3n y c\u00f3mo se eval\u00faan y documentan los riesgos toxicol\u00f3gicos. <\/p>\n<p><b>4. \u00bfEs necesario un TRA para todos los productos sanitarios?<\/b><\/p>\n<p>No necesariamente. La necesidad de una TRA depende de factores como los materiales del dispositivo, la naturaleza y duraci\u00f3n del contacto con el cuerpo, los resultados de la caracterizaci\u00f3n qu\u00edmica y el uso previsto. Cuando se identifican sustancias que requieren una evaluaci\u00f3n toxicol\u00f3gica, se hace necesaria una TRA.  <\/p>\n<p><b>5. \u00bfEn qu\u00e9 se diferencia una TRA de una caracterizaci\u00f3n qu\u00edmica?<\/b><\/p>\n<p>La caracterizaci\u00f3n qu\u00edmica identifica y cuantifica las sustancias liberadas por un dispositivo, normalmente de acuerdo con la norma ISO 10993-18. Un TRA eval\u00faa la relevancia toxicol\u00f3gica de esas sustancias, define los l\u00edmites de exposici\u00f3n y valora si los riesgos asociados son aceptables. <\/p>\n<p><b>6. \u00bfPueden utilizarse los datos toxicol\u00f3gicos existentes en una TRA?<\/b><\/p>\n<p>S\u00ed. Una TRA se basa en gran medida en los datos toxicol\u00f3gicos existentes procedentes de la literatura cient\u00edfica, las bases de datos y las fuentes propias pertinentes. S\u00f3lo se consideran nuevas pruebas cuando los datos existentes son insuficientes para apoyar una evaluaci\u00f3n de riesgos s\u00f3lida.  <\/p>\n<p><b>7. \u00bfEl TRA sustituye al Informe de Evaluaci\u00f3n Biol\u00f3gica (IEB)?<\/b><\/p>\n<p>No. Un TRA no sustituye al <a href=\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/biological-evaluation-europe\/\">Informe de Evaluaci\u00f3n Biol\u00f3gica<\/a>. Apoya la evaluaci\u00f3n biol\u00f3gica aportando conclusiones toxicol\u00f3gicas relacionadas con la seguridad qu\u00edmica, que luego se integran en el REC.  <\/p>\n<p><strong>8. \u00bfC\u00f3mo apoya una evaluaci\u00f3n toxicol\u00f3gica del riesgo el marcado CE?<\/strong><\/p>\n<p>Una evaluaci\u00f3n del riesgo toxicol\u00f3gico <a href=\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/\" target=\"_blank\" rel=\"noopener\">respalda el marcado CE<\/a> al demostrar que las sustancias qu\u00edmicas liberadas por el producto sanitario no presentan riesgos inaceptables para la salud. La TRA proporciona l\u00edmites de exposici\u00f3n cient\u00edficamente justificados y conclusiones toxicol\u00f3gicas que se incorporan a la documentaci\u00f3n de evaluaci\u00f3n biol\u00f3gica revisada durante la evaluaci\u00f3n de la conformidad. <\/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>Evaluaci\u00f3n del riesgo toxicol\u00f3gico de los productos sanitarios conforme al MDR de la UE y a la norma ISO 10993. Evaluaci\u00f3n de la seguridad qu\u00edmica y evaluaci\u00f3n biol\u00f3gica. <\/p>\n","protected":false},"author":11,"featured_media":7261,"parent":7793,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-8016","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>Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos (ERT) para Productos Sanitarios<\/title>\n<meta name=\"description\" content=\"Evaluaci\u00f3n experta del riesgo toxicol\u00f3gico (TRA) en l\u00ednea con el MDR de la UE y la ISO 10993, que respalda las pruebas de seguridad qu\u00edmica.\" \/>\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\/es\/our-solutions-europe\/toxicological-risk-assessment-tra\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Evaluaci\u00f3n de riesgos toxicol\u00f3gicos - Europa\" \/>\n<meta property=\"og:description\" content=\"Evaluaci\u00f3n experta del riesgo toxicol\u00f3gico (TRA) en l\u00ednea con el MDR de la UE y la ISO 10993, que respalda las pruebas de seguridad qu\u00edmica.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/es\/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=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data1\" content=\"6 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/toxicological-risk-assessment-tra\/\",\"url\":\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/toxicological-risk-assessment-tra\/\",\"name\":\"Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos (ERT) para Productos Sanitarios\",\"isPartOf\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/toxicological-risk-assessment-tra\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/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\":\"Evaluaci\u00f3n experta del riesgo toxicol\u00f3gico (TRA) en l\u00ednea con el MDR de la UE y la ISO 10993, que respalda las pruebas de seguridad qu\u00edmica.\",\"breadcrumb\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/toxicological-risk-assessment-tra\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/toxicological-risk-assessment-tra\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/sobelconsult.com\/es\/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\/es\/our-solutions-europe\/toxicological-risk-assessment-tra\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Inicio\",\"item\":\"https:\/\/sobelconsult.com\/es\/home\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Consultor\u00eda regulatoria en Europa\",\"item\":\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Evaluaci\u00f3n de riesgos toxicol\u00f3gicos &#8211; 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