{"id":26016,"date":"2026-01-09T16:39:43","date_gmt":"2026-01-09T19:39:43","guid":{"rendered":"https:\/\/sobelconsult.com\/our-solutions-canada\/regulatory-representative-for-health-canada\/"},"modified":"2026-02-18T11:33:23","modified_gmt":"2026-02-18T14:33:23","slug":"tra-toxicological-risk-assessment","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/","title":{"rendered":"MED CAN Evaluaci\u00f3n de riesgos toxicol\u00f3gicos (por sustancia) (TRA)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"26016\" class=\"elementor elementor-26016 elementor-25973\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5731aeb e-flex e-con-boxed e-con e-parent\" data-id=\"5731aeb\" 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-544e873 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"544e873\" 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\">TRA - Evaluaci\u00f3n del riesgo toxicol\u00f3gico de los productos sanitarios en Canad\u00e1<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c5e4998 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"c5e4998\" 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\":\"A TRA Toxicological Risk Assessment is a key element to demonstrate the chemical safety of medical devices submitted to Health Canada. Sobel supports manufacturers by preparing a structured TRA Toxicological Risk Assessment aligned with ISO 10993-18 and Canadian regulatory expectations.\"}]\" data-inline-monday=\"true\">Una Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos TRA es un elemento clave para demostrar la seguridad qu\u00edmica de los productos sanitarios presentados a Health Canada. Sobel ayuda a los fabricantes a preparar una Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos TRA estructurada, de acuerdo con la norma ISO 10993-18 y las expectativas de la normativa canadiense. <\/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-bf58285 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"bf58285\" 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-41fa7f5 e-flex e-con-boxed e-con e-parent\" data-id=\"41fa7f5\" 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-77acf8c e-con-full e-flex e-con e-child\" data-id=\"77acf8c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-e57185a e-con-full e-transform e-flex e-con e-child\" data-id=\"e57185a\" 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-66ea73e elementor-widget elementor-widget-heading\" data-id=\"66ea73e\" 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-55f8c1a elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"55f8c1a\" 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-23d2b42 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"23d2b42\" 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 buscan la autorizaci\u00f3n de comercializaci\u00f3n de Health Canada<\/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 con sede local o internacional que se preparan para registrar productos sanitarios para el mercado canadiense<\/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\">Fabricantes que necesitan una Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos TRA basada en los resultados de la caracterizaci\u00f3n qu\u00edmica<\/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 que requieren una justificaci\u00f3n toxicol\u00f3gica independiente utilizando los datos existentes<\/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 pretenden confirmar la aceptabilidad de sustancias identificadas en las condiciones de uso previstas<\/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-891c55f e-con-full e-flex e-con e-child\" data-id=\"891c55f\" 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-ad879c0 elementor-widget elementor-widget-image\" data-id=\"ad879c0\" 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-2383672 e-flex e-con-boxed e-con e-parent\" data-id=\"2383672\" 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-4859fce elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"4859fce\" 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 provides independent toxicological expertise focused on chemical risk evaluation grounded in existing evidence.\"}]\" data-inline-monday=\"true\">Sobel proporciona conocimientos toxicol\u00f3gicos independientes centrados en la evaluaci\u00f3n del riesgo qu\u00edmico basada en las pruebas existentes.<\/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-d6f97b7 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"d6f97b7\" 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-da8d4f8 e-flex e-con-boxed e-con e-parent\" data-id=\"da8d4f8\" 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-b8e02b5 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"b8e02b5\" 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-abdd779 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"abdd779\" 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-044e5c2 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"044e5c2\" 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-754181b e-con-full e-flex e-con e-child\" data-id=\"754181b\" 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-9af521d elementor-widget elementor-widget-text-editor\" data-id=\"9af521d\" 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 TRA Toxicological Risk Assessment provides structured justification of chemical safety, supporting Health Canada expectations for material-related risk evaluation.\"}]\" data-inline-monday=\"true\">Una Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos TRA proporciona una justificaci\u00f3n estructurada de la seguridad qu\u00edmica, apoyando las expectativas de Health Canada para la evaluaci\u00f3n de riesgos relacionados con los materiales.<\/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-661b2d1 e-con-full e-flex e-con e-child\" data-id=\"661b2d1\" 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-178bc3d elementor-widget elementor-widget-text-editor\" data-id=\"178bc3d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"It allows manufacturers to define tolerable limits and safety margins based on intended use, exposure scenarios, and existing toxicological evidence.\"}]\" data-inline-monday=\"true\">Permite a los fabricantes definir l\u00edmites tolerables y m\u00e1rgenes de seguridad basados en el uso previsto, los escenarios de exposici\u00f3n y las pruebas toxicol\u00f3gicas existentes.<\/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-b3dd678 e-con-full e-flex e-con e-child\" data-id=\"b3dd678\" 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-35534f2 elementor-widget elementor-widget-text-editor\" data-id=\"35534f2\" 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 well-documented TRA helps identify unacceptable risks early and supports informed decisions on additional testing or risk control measures.\"}]\" data-inline-monday=\"true\">Un TRA bien documentado ayuda a identificar pronto los riesgos inaceptables y respalda las decisiones informadas sobre pruebas adicionales o medidas de control de riesgos.<\/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-95ed058 e-flex e-con-boxed e-con e-parent\" data-id=\"95ed058\" 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-6ebb293 e-con-full e-flex e-con e-child\" data-id=\"6ebb293\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3b63838 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"3b63838\" 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\">Requisitos de la evaluaci\u00f3n del riesgo toxicol\u00f3gico para las presentaciones del Ministerio de Sanidad de Canad\u00e1<\/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-5b13501 e-con-full e-flex e-con e-child\" data-id=\"5b13501\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b70ea7a elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"b70ea7a\" 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 well-prepared TRA Toxicological Risk Assessment provides evidence-based justification for material safety and supports confident regulatory decision-making.\"}]\" data-inline-monday=\"true\">Para muchas presentaciones de productos sanitarios en Canad\u00e1, los fabricantes deben demostrar que los componentes qu\u00edmicos no presentan riesgos inaceptables para los pacientes o usuarios.  <strong>La evaluaci\u00f3n del riesgo toxicol\u00f3gico (TRA) integra los datos de caracterizaci\u00f3n qu\u00edmica, la evaluaci\u00f3n de la exposici\u00f3n y los valores toxicol\u00f3gicos de referencia para apoyar la evaluaci\u00f3n de la seguridad biol\u00f3gica y la revisi\u00f3n reglamentaria del Ministerio de Sanidad de Canad\u00e1.<\/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-2feeebc e-flex e-con-boxed e-con e-parent\" data-id=\"2feeebc\" 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-6011026 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"6011026\" 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\">La confianza reglamentaria comienza con la justificaci\u00f3n toxicol\u00f3gica.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a4ad15d elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"a4ad15d\" 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_a4ad15d *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_a4ad15d .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_a4ad15d  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_a4ad15d  .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_a4ad15d .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-item-bullet i, #uc_horizontal_timeline_elementor_a4ad15d .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_a4ad15d .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_a4ad15d .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_a4ad15d\">\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_a4ad15d\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-e43fc00\">\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=\"#\" >Alcance y revisi\u00f3n de datos<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">T\u00fa proporcionas los resultados de la caracterizaci\u00f3n qu\u00edmica, y nosotros confirmamos qu\u00e9 componentes son aptos para la evaluaci\u00f3n toxicol\u00f3gica.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-01a41b7\">\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=\"#\" >Recopilaci\u00f3n de datos toxicol\u00f3gicos<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Recopilamos y evaluamos la informaci\u00f3n existente sobre la toxicidad de las sustancias o materiales identificados.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-d8bcc70\">\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=\"#\" >L\u00edmites tolerables y m\u00e1rgenes de seguridad<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Definimos los l\u00edmites tolerables y los m\u00e1rgenes de seguridad bas\u00e1ndonos en el uso previsto, los supuestos de exposici\u00f3n y las pruebas disponibles.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-f12c4ad\">\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 la aceptabilidad del riesgo<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Evaluamos los riesgos identificados en funci\u00f3n de criterios establecidos para determinar su aceptabilidad.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-ae303a4\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Conclusiones y recomendaciones<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Identificamos la necesidad de pruebas o medidas de control de riesgos adicionales e incluimos el an\u00e1lisis pertinente del historial de uso cl\u00ednico o los datos de exposici\u00f3n humana, cuando proceda.<\/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-c572d80 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"c572d80\" 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-37f1a4d e-flex e-con-boxed e-con e-parent\" data-id=\"37f1a4d\" 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-ed8dc67 e-con-full e-flex e-con e-child\" data-id=\"ed8dc67\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-079845b elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"079845b\" 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-06a527d elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"06a527d\" 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-367b626 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"367b626\" 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 supports your Canadian pathway by delivering a consistent, structured TRA Toxicological Risk Assessment aligned with internationally recognized standards accepted by Health Canada. Depending on your submission strategy, you may also need:\"}]\" data-inline-monday=\"true\">Nuestro enfoque apoya tu v\u00eda canadiense proporcionando una Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos TRA coherente y estructurada, alineada con las normas reconocidas internacionalmente y aceptadas por el Ministerio de Sanidad de Canad\u00e1. Dependiendo de tu estrategia de presentaci\u00f3n, tambi\u00e9n puedes necesitar: <\/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-9133154 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"9133154\" 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-062ce54 e-con-full e-flex e-con e-child\" data-id=\"062ce54\" 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-508f0d8 elementor-widget elementor-widget-heading\" data-id=\"508f0d8\" 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-canada\/medical-device-biological-evaluation-plan-report\/\" target=\"_blank\">Evaluaci\u00f3n biol\u00f3gica<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b8cb37d elementor-widget elementor-widget-text-editor\" data-id=\"b8cb37d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Expert ISO 10993 biological evaluations for biocompatibility, safety, and regulatory success.\"}]\" data-inline-monday=\"true\">Evaluaciones biol\u00f3gicas expertas ISO 10993 para la biocompatibilidad, la seguridad y el \u00e9xito 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-6c98fd0 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"6c98fd0\" 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-canada\/medical-device-biological-evaluation-plan-report\/\" 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-15a8d68 e-con-full e-flex e-con e-child\" data-id=\"15a8d68\" 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-ceccc87 elementor-widget elementor-widget-heading\" data-id=\"ceccc87\" 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-canada\/medical-device-technical-documentation\/\" target=\"_blank\">Elaboraci\u00f3n del Expediente T\u00e9cnico<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-daed920 elementor-widget elementor-widget-text-editor\" data-id=\"daed920\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Guidance to structure technical documentation for regulatory submissions.\"}]\" data-inline-monday=\"true\">Orientaciones para estructurar la documentaci\u00f3n t\u00e9cnica de las presentaciones reglamentarias.<\/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-dc801d9 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"dc801d9\" 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-canada\/medical-device-technical-documentation\/\" 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-3d7f71e e-con-full e-flex e-con e-child\" data-id=\"3d7f71e\" 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-5bae243 elementor-widget elementor-widget-heading\" data-id=\"5bae243\" 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-canada\/regulatory-submission-readiness\/\" target=\"_blank\">An\u00e1lisis de brechas<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6cc7a01 elementor-widget elementor-widget-text-editor\" data-id=\"6cc7a01\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"TRA aligned with ISO 10993-18 and Health Canada expectations.\"}]\" data-inline-monday=\"true\">Revisi\u00f3n de la preparaci\u00f3n para la presentaci\u00f3n y revisi\u00f3n de la etiqueta 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-55efa2c elementor-align-center elementor-widget elementor-widget-button\" data-id=\"55efa2c\" 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-canada\/regulatory-submission-readiness\/\" 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-2d2b0a9 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"2d2b0a9\" 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-8e1b455 e-con-full e-flex e-con e-child\" data-id=\"8e1b455\" 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-cb8088d e-con-full e-flex e-con e-child\" data-id=\"cb8088d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2a6ca0d elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"2a6ca0d\" 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\">Justificaci\u00f3n de seguridad qu\u00edmica alineada con las expectativas de Health Canada<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57c3696 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"57c3696\" 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\":\"Health Canada expects manufacturers to show that identified chemical constituents do not pose unacceptable risks to patients or users. Talk to Sobel and get expert support to build a structured, evidence-based TRA Toxicological Risk Assessment for your medical device!\"}]\" data-inline-monday=\"true\">Health Canada espera que los fabricantes demuestren que los componentes qu\u00edmicos identificados no suponen riesgos inaceptables para los pacientes o usuarios. Habla con Sobel y obt\u00e9n apoyo experto para elaborar una Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos TRA estructurada y basada en pruebas para tu producto sanitario. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7d76380 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"7d76380\" 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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-79e045f e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"79e045f\" 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-b488530 elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"b488530\" 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-1891\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1891\" 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-1891\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1891\"><p><b>1. \u00bfEs obligatoria una Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos TRA para las presentaciones de Health Canada?<\/b><\/p>\n<p>Se espera que los fabricantes demuestren que las sustancias qu\u00edmicas presentes en un producto sanitario no plantean riesgos inaceptables. Un TRA estructurado es una forma ampliamente aceptada de respaldar esta expectativa cuando la exposici\u00f3n qu\u00edmica es relevante. <\/p>\n<p><b>2. \u00bfQu\u00e9 presentaciones de Health Canada suelen requerir un TRA?<\/b><\/p>\n<p>Normalmente se requiere un TRA para los productos sanitarios en los que la caracterizaci\u00f3n qu\u00edmica identifica sustancias que pueden provocar la exposici\u00f3n del paciente o del usuario. Esto se aplica a distintas clases de productos, en funci\u00f3n de los materiales, el tipo de contacto y la duraci\u00f3n de la exposici\u00f3n. <\/p>\n<p><b>3. \u00bfEst\u00e1 la TRA alineada con las normas ISO aceptadas por Health Canada?<\/b><\/p>\n<p>S\u00ed. El TRA se desarrolla en consonancia con la serie ISO 10993, en particular la ISO 10993-18, reconocida internacionalmente y com\u00fanmente aceptada por Health Canada como parte de la evaluaci\u00f3n de la seguridad biol\u00f3gica. <\/p>\n<p><b>4. \u00bfSe puede actualizar un TRA existente para presentarlo a Health Canada?<\/b><\/p>\n<p>S\u00ed. Las evaluaciones toxicol\u00f3gicas existentes pueden revisarse y actualizarse para reflejar las normas ISO actuales, los escenarios de exposici\u00f3n o las expectativas de Health Canada, siempre que se disponga de los datos subyacentes. <\/p>\n<p><strong>5. \u00bfC\u00f3mo apoya una evaluaci\u00f3n toxicol\u00f3gica del riesgo las aprobaciones del Ministerio de Sanidad de Canad\u00e1?<\/strong><\/p>\n<p>Una evaluaci\u00f3n del riesgo toxicol\u00f3gico apoya las presentaciones del Ministerio de Sanidad de Canad\u00e1 demostrando que las sustancias qu\u00edmicas liberadas por el producto sanitario no plantean riesgos inaceptables. La TRA proporciona c\u00e1lculos de exposici\u00f3n, justificaci\u00f3n toxicol\u00f3gica y m\u00e1rgenes de seguridad que refuerzan la documentaci\u00f3n de la evaluaci\u00f3n de la seguridad biol\u00f3gica. <\/p>\n<p><strong>6. \u00bfD\u00f3nde puedo encontrar apoyo normativo completo para la presentaci\u00f3n de productos sanitarios al mercado?  <\/strong><\/p>\n<p>La Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos es s\u00f3lo un componente de la documentaci\u00f3n reglamentaria m\u00e1s amplia necesaria para la aprobaci\u00f3n de productos sanitarios. Las empresas que busquen asistencia reglamentaria integral pueden explorar nuestras <a href=\"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/\" target=\"_blank\" rel=\"noopener\">Soluciones de Cumplimiento Normativo de Productos San<\/a>itarios, que abarcan la evaluaci\u00f3n biol\u00f3gica, la documentaci\u00f3n t\u00e9cnica, la evaluaci\u00f3n cl\u00ednica y el apoyo a la presentaci\u00f3n al mercado mundial. <\/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 de riesgos toxicol\u00f3gicos (TRA) para productos sanitarios en Canad\u00e1. Apoya las presentaciones de Health Canada con evaluaciones alineadas con la norma ISO 10993. <\/p>\n","protected":false},"author":15,"featured_media":26813,"parent":8423,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-26016","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>TRA Evaluaci\u00f3n del riesgo toxicol\u00f3gico de los productos sanitarios | Canad\u00e1<\/title>\n<meta name=\"description\" content=\"Construye una justificaci\u00f3n defendible de la seguridad qu\u00edmica con los servicios de Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos de TRA. Apoyo normativo Health Canada.\" \/>\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-canada\/tra-toxicological-risk-assessment\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MED CAN Evaluaci\u00f3n de riesgos toxicol\u00f3gicos (por sustancia) (TRA)\" \/>\n<meta property=\"og:description\" content=\"Construye una justificaci\u00f3n defendible de la seguridad qu\u00edmica con los servicios de Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos de TRA. Apoyo normativo Health Canada.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-18T14:33:23+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/hero-sec-canada-dekstop-1.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1079\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\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=\"5 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-canada\/tra-toxicological-risk-assessment\/\",\"url\":\"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/\",\"name\":\"TRA Evaluaci\u00f3n del riesgo toxicol\u00f3gico de los productos sanitarios | Canad\u00e1\",\"isPartOf\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/hero-sec-canada-dekstop-1.png\",\"datePublished\":\"2026-01-09T19:39:43+00:00\",\"dateModified\":\"2026-02-18T14:33:23+00:00\",\"description\":\"Construye una justificaci\u00f3n defendible de la seguridad qu\u00edmica con los servicios de Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos de TRA. Apoyo normativo Health Canada.\",\"breadcrumb\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/#primaryimage\",\"url\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/hero-sec-canada-dekstop-1.png\",\"contentUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/hero-sec-canada-dekstop-1.png\",\"width\":1920,\"height\":1079,\"caption\":\"Composition featuring the Canadian flag on one side, a light blue gradient, and medical equipment on the other.\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Inicio\",\"item\":\"https:\/\/sobelconsult.com\/es\/home\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Nuestras soluciones Canad\u00e1\",\"item\":\"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"MED CAN Evaluaci\u00f3n de riesgos toxicol\u00f3gicos (por sustancia) (TRA)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/sobelconsult.com\/es\/#website\",\"url\":\"https:\/\/sobelconsult.com\/es\/\",\"name\":\"Sobel\",\"description\":\"Regulatory Consultancy\",\"publisher\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/sobelconsult.com\/es\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/sobelconsult.com\/es\/#organization\",\"name\":\"Sobel\",\"url\":\"https:\/\/sobelconsult.com\/es\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/sobelconsult.com\/es\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png\",\"contentUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png\",\"width\":741,\"height\":290,\"caption\":\"Sobel\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"TRA Evaluaci\u00f3n del riesgo toxicol\u00f3gico de los productos sanitarios | Canad\u00e1","description":"Construye una justificaci\u00f3n defendible de la seguridad qu\u00edmica con los servicios de Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos de TRA. Apoyo normativo Health Canada.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/","og_locale":"es_ES","og_type":"article","og_title":"MED CAN Evaluaci\u00f3n de riesgos toxicol\u00f3gicos (por sustancia) (TRA)","og_description":"Construye una justificaci\u00f3n defendible de la seguridad qu\u00edmica con los servicios de Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos de TRA. Apoyo normativo Health Canada.","og_url":"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/","og_site_name":"Sobel","article_modified_time":"2026-02-18T14:33:23+00:00","og_image":[{"width":1920,"height":1079,"url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/hero-sec-canada-dekstop-1.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Tiempo de lectura":"5 minuto"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/","url":"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/","name":"TRA Evaluaci\u00f3n del riesgo toxicol\u00f3gico de los productos sanitarios | Canad\u00e1","isPartOf":{"@id":"https:\/\/sobelconsult.com\/es\/#website"},"primaryImageOfPage":{"@id":"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/#primaryimage"},"image":{"@id":"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/#primaryimage"},"thumbnailUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/hero-sec-canada-dekstop-1.png","datePublished":"2026-01-09T19:39:43+00:00","dateModified":"2026-02-18T14:33:23+00:00","description":"Construye una justificaci\u00f3n defendible de la seguridad qu\u00edmica con los servicios de Evaluaci\u00f3n de Riesgos Toxicol\u00f3gicos de TRA. Apoyo normativo Health Canada.","breadcrumb":{"@id":"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/#primaryimage","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/hero-sec-canada-dekstop-1.png","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/hero-sec-canada-dekstop-1.png","width":1920,"height":1079,"caption":"Composition featuring the Canadian flag on one side, a light blue gradient, and medical equipment on the other."},{"@type":"BreadcrumbList","@id":"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/tra-toxicological-risk-assessment\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Inicio","item":"https:\/\/sobelconsult.com\/es\/home\/"},{"@type":"ListItem","position":2,"name":"Nuestras soluciones Canad\u00e1","item":"https:\/\/sobelconsult.com\/es\/our-solutions-canada\/"},{"@type":"ListItem","position":3,"name":"MED CAN Evaluaci\u00f3n de riesgos toxicol\u00f3gicos (por sustancia) (TRA)"}]},{"@type":"WebSite","@id":"https:\/\/sobelconsult.com\/es\/#website","url":"https:\/\/sobelconsult.com\/es\/","name":"Sobel","description":"Regulatory Consultancy","publisher":{"@id":"https:\/\/sobelconsult.com\/es\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/sobelconsult.com\/es\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/sobelconsult.com\/es\/#organization","name":"Sobel","url":"https:\/\/sobelconsult.com\/es\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/sobelconsult.com\/es\/#\/schema\/logo\/image\/","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png","width":741,"height":290,"caption":"Sobel"},"image":{"@id":"https:\/\/sobelconsult.com\/es\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages\/26016","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/users\/15"}],"replies":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/comments?post=26016"}],"version-history":[{"count":9,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages\/26016\/revisions"}],"predecessor-version":[{"id":31906,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages\/26016\/revisions\/31906"}],"up":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages\/8423"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/media\/26813"}],"wp:attachment":[{"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/media?parent=26016"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}