{"id":26007,"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\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/","title":{"rendered":"MED CAN \u00c9valuation du risque toxicologique (par substance) (TRA)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"26007\" class=\"elementor elementor-26007 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 - \u00c9valuation du risque toxicologique pour les dispositifs m\u00e9dicaux au Canada<\/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\">L&rsquo;\u00e9valuation du risque toxicologique TRA est un \u00e9l\u00e9ment cl\u00e9 pour d\u00e9montrer la s\u00e9curit\u00e9 chimique des dispositifs m\u00e9dicaux soumis \u00e0 Sant\u00e9 Canada. Sobel soutient les fabricants en pr\u00e9parant une \u00e9valuation structur\u00e9e du risque toxicologique TRA conforme \u00e0 la norme ISO 10993-18 et aux attentes r\u00e9glementaires canadiennes. <\/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%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%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\">Obtenez l'aide d'un expert<\/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\">Pour qui ?<\/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\">Fabricants de dispositifs m\u00e9dicaux cherchant \u00e0 obtenir l'autorisation de mise sur le march\u00e9 de Sant\u00e9 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\">Entreprises locales ou internationales qui se pr\u00e9parent \u00e0 enregistrer des dispositifs m\u00e9dicaux pour le march\u00e9 canadien<\/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\">Les fabricants qui ont besoin d'une \u00e9valuation du risque toxicologique de l'EMR bas\u00e9e sur les r\u00e9sultats de la caract\u00e9risation chimique<\/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\">Les \u00e9quipes charg\u00e9es de la r\u00e9glementation qui exigent une justification toxicologique ind\u00e9pendante \u00e0 l'aide des donn\u00e9es existantes<\/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\">Entreprises visant \u00e0 confirmer l'acceptabilit\u00e9 des substances identifi\u00e9es dans les conditions d'utilisation pr\u00e9vues<\/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-18564\" 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 fournit une expertise toxicologique ind\u00e9pendante ax\u00e9e sur l&rsquo;\u00e9valuation des risques chimiques fond\u00e9e sur les preuves existantes.<\/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%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%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\">Obtenez de l'aide !<\/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-18570\" 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\">Pourquoi avez-vous besoin de ce service ?<\/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\">Une \u00e9valuation des risques toxicologiques TRA fournit une justification structur\u00e9e de la s\u00e9curit\u00e9 des produits chimiques et r\u00e9pond aux attentes de Sant\u00e9 Canada en mati\u00e8re d&rsquo;\u00e9valuation des risques li\u00e9s aux mat\u00e9riaux.<\/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\">Il permet aux fabricants de d\u00e9finir des limites tol\u00e9rables et des marges de s\u00e9curit\u00e9 en fonction de l&rsquo;utilisation pr\u00e9vue, des sc\u00e9narios d&rsquo;exposition et des preuves toxicologiques existantes.<\/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\">Une EMR bien document\u00e9e permet d&rsquo;identifier rapidement les risques inacceptables et de prendre des d\u00e9cisions \u00e9clair\u00e9es sur les essais suppl\u00e9mentaires ou les mesures de contr\u00f4le des risques.<\/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\">Exigences en mati\u00e8re d'\u00e9valuation des risques toxicologiques pour les demandes pr\u00e9sent\u00e9es \u00e0 Sant\u00e9 Canada<\/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\">Pour de nombreuses demandes d&rsquo;homologation de dispositifs m\u00e9dicaux au Canada, les fabricants doivent d\u00e9montrer que les composants chimiques ne pr\u00e9sentent pas de risques inacceptables pour les patients ou les utilisateurs.  <strong>L&rsquo;\u00e9valuation des risques toxicologiques (TRA) int\u00e8gre les donn\u00e9es de caract\u00e9risation chimique, l&rsquo;\u00e9valuation de l&rsquo;exposition et les valeurs toxicologiques de r\u00e9f\u00e9rence pour soutenir l&rsquo;\u00e9valuation de la s\u00e9curit\u00e9 biologique et l&rsquo;examen r\u00e9glementaire de Sant\u00e9 Canada.<\/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 confiance r\u00e9glementaire commence par une justification toxicologique.<\/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=\"#\" >Champ d'application et examen des donn\u00e9es<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Vous fournissez les r\u00e9sultats de la caract\u00e9risation chimique et nous confirmons quels constituants peuvent faire l'objet d'une \u00e9valuation toxicologique.<\/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=\"#\" >Compilation des donn\u00e9es toxicologiques<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Nous rassemblons et \u00e9valuons les informations existantes sur la toxicit\u00e9 des substances ou mat\u00e9riaux identifi\u00e9s.<\/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=\"#\" >Limites tol\u00e9rables et marges de s\u00e9curit\u00e9<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Nous d\u00e9finissons les limites tol\u00e9rables et les marges de s\u00e9curit\u00e9 sur la base de l'utilisation pr\u00e9vue, des hypoth\u00e8ses d'exposition et des preuves 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=\"#\" >\u00c9valuation de l'acceptabilit\u00e9 des risques<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Nous \u00e9valuons les risques identifi\u00e9s par rapport \u00e0 des crit\u00e8res \u00e9tablis afin de d\u00e9terminer leur acceptabilit\u00e9.<\/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=\"#\" >Conclusions et recommandations<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Nous identifions la n\u00e9cessit\u00e9 de tests suppl\u00e9mentaires ou de mesures de contr\u00f4le des risques et incluons une analyse pertinente de l'historique de l'utilisation clinique ou des donn\u00e9es relatives \u00e0 l'exposition humaine, le cas \u00e9ch\u00e9ant.<\/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%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%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\">Commencez d\u00e8s maintenant !<\/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\">Services connexes <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\">Notre approche soutient votre fili\u00e8re canadienne en fournissant une \u00e9valuation des risques toxicologiques coh\u00e9rente et structur\u00e9e, align\u00e9e sur les normes internationales reconnues et accept\u00e9es par Sant\u00e9 Canada. En fonction de votre strat\u00e9gie de soumission, vous pourriez \u00e9galement avoir besoin de.. : <\/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\/fr\/our-solutions-canada\/medical-device-biological-evaluation-plan-report\/\" target=\"_blank\">\u00c9valuation biologique<\/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\">\u00c9valuations biologiques ISO 10993 par des experts pour la biocompatibilit\u00e9, la s\u00e9curit\u00e9 et le respect des r\u00e9glementations.<\/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\/fr\/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\">Voir plus<\/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\/fr\/our-solutions-canada\/medical-device-technical-documentation\/\" target=\"_blank\">\u00c9laboration du dossier technique<\/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\">Conseils pour structurer la documentation technique en vue des soumissions r\u00e9glementaires.<\/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\/fr\/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\">Voir plus<\/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\/fr\/our-solutions-canada\/regulatory-submission-readiness\/\" target=\"_blank\">Analyse des lacunes<\/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\">Examen de l&rsquo;\u00e9tat de pr\u00e9paration de la soumission et examen de l&rsquo;\u00e9tiquetage pour les dispositifs m\u00e9dicaux.  <\/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\/fr\/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\">Voir plus<\/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\">Justification de la s\u00e9curit\u00e9 chimique align\u00e9e sur les attentes de Sant\u00e9 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\">Sant\u00e9 Canada attend des fabricants qu&rsquo;ils d\u00e9montrent que les composants chimiques identifi\u00e9s ne pr\u00e9sentent pas de risques inacceptables pour les patients ou les utilisateurs. Parlez \u00e0 Sobel et obtenez le soutien d&rsquo;experts pour \u00e9laborer une \u00e9valuation structur\u00e9e et factuelle des risques toxicologiques pour votre dispositif m\u00e9dical ! <\/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%3DeyJpZCI6ODQyOCwidG9nZ2xlIjpmYWxzZX0%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\">Commencez d\u00e8s maintenant !<\/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\">Vous avez encore des questions ? Consultez notre 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. Une \u00e9valuation des risques toxicologiques de l&rsquo;EMR est-elle obligatoire pour les soumissions \u00e0 Sant\u00e9 Canada ?<\/b><\/p>\n<p>Les fabricants sont cens\u00e9s d\u00e9montrer que les substances chimiques pr\u00e9sentes dans un dispositif m\u00e9dical ne pr\u00e9sentent pas de risques inacceptables. Une EMR structur\u00e9e est un moyen largement accept\u00e9 de r\u00e9pondre \u00e0 cette attente lorsque l&rsquo;exposition \u00e0 des substances chimiques est pertinente. <\/p>\n<p><b>2. Quelles sont les demandes de Sant\u00e9 Canada qui n\u00e9cessitent g\u00e9n\u00e9ralement une EMR ?<\/b><\/p>\n<p>Une EMR est g\u00e9n\u00e9ralement requise pour les dispositifs m\u00e9dicaux lorsque la caract\u00e9risation chimique identifie des substances susceptibles d&rsquo;entra\u00eener une exposition du patient ou de l&rsquo;utilisateur. Cela s&rsquo;applique \u00e0 diff\u00e9rentes classes de dispositifs, en fonction des mat\u00e9riaux, du type de contact et de la dur\u00e9e de l&rsquo;exposition. <\/p>\n<p><b>3. L&rsquo;EMR est-elle conforme aux normes ISO accept\u00e9es par Sant\u00e9 Canada ?<\/b><\/p>\n<p>Oui. L&rsquo;EMR est \u00e9labor\u00e9e conform\u00e9ment \u00e0 la s\u00e9rie ISO 10993, en particulier ISO 10993-18, qui est reconnue au niveau international et commun\u00e9ment accept\u00e9e par Sant\u00e9 Canada dans le cadre de l&rsquo;\u00e9valuation de la s\u00e9curit\u00e9 biologique. <\/p>\n<p><b>4. Une EMR existante peut-elle \u00eatre mise \u00e0 jour pour une demande d&rsquo;autorisation aupr\u00e8s de Sant\u00e9 Canada ?<\/b><\/p>\n<p>Oui. Les \u00e9valuations toxicologiques existantes peuvent \u00eatre revues et mises \u00e0 jour pour refl\u00e9ter les normes ISO actuelles, les sc\u00e9narios d&rsquo;exposition ou les attentes de Sant\u00e9 Canada, \u00e0 condition que les donn\u00e9es sous-jacentes soient disponibles. <\/p>\n<p><strong>5. Comment l&rsquo;\u00e9valuation des risques toxicologiques contribue-t-elle \u00e0 l&rsquo;obtention des autorisations de Sant\u00e9 Canada ?<\/strong><\/p>\n<p>Une \u00e9valuation des risques toxicologiques soutient les demandes de Sant\u00e9 Canada en d\u00e9montrant que les substances chimiques lib\u00e9r\u00e9es par le dispositif m\u00e9dical ne pr\u00e9sentent pas de risques inacceptables. L&rsquo;EMR fournit des calculs d&rsquo;exposition, des justifications toxicologiques et des marges de s\u00e9curit\u00e9 qui renforcent la documentation de l&rsquo;\u00e9valuation de la s\u00e9curit\u00e9 biologique. <\/p>\n<p><strong>6. O\u00f9 puis-je trouver une assistance r\u00e9glementaire compl\u00e8te pour les demandes de mise sur le march\u00e9 de dispositifs m\u00e9dicaux ?  <\/strong><\/p>\n<p>L&rsquo;\u00e9valuation des risques toxicologiques n&rsquo;est qu&rsquo;une composante de la documentation r\u00e9glementaire plus large requise pour l&rsquo;approbation des dispositifs m\u00e9dicaux. Les entreprises \u00e0 la recherche d&rsquo;une assistance r\u00e9glementaire de bout en bout peuvent explorer nos <a href=\"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/\" target=\"_blank\" rel=\"noopener\">solutions de conformit\u00e9 r\u00e9glementaire pour les dispositifs m\u00e9dicaux<\/a>, qui couvrent l&rsquo;\u00e9valuation biologique, la documentation technique, l&rsquo;\u00e9valuation clinique et l&rsquo;aide \u00e0 la soumission sur le march\u00e9 mondial. <\/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>\u00c9valuation du risque toxicologique (TRA) pour les dispositifs m\u00e9dicaux au Canada. Soutenez les soumissions de Sant\u00e9 Canada avec des \u00e9valuations align\u00e9es sur la norme ISO 10993. <\/p>\n","protected":false},"author":15,"featured_media":26810,"parent":8454,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-26007","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 \u00c9valuation du risque toxicologique pour les dispositifs m\u00e9dicaux - Canada<\/title>\n<meta name=\"description\" content=\"Les services d&#039;\u00e9valuation des risques toxicologiques de TRA vous permettent d&#039;\u00e9laborer un raisonnement d\u00e9fendable en mati\u00e8re de s\u00e9curit\u00e9 chimique. Soutien r\u00e9glementaire Sant\u00e9 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\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MED CAN \u00c9valuation du risque toxicologique (par substance) (TRA)\" \/>\n<meta property=\"og:description\" content=\"Les services d&#039;\u00e9valuation des risques toxicologiques de TRA vous permettent d&#039;\u00e9laborer un raisonnement d\u00e9fendable en mati\u00e8re de s\u00e9curit\u00e9 chimique. Soutien r\u00e9glementaire Sant\u00e9 Canada.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/fr\/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=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data1\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/\",\"url\":\"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/\",\"name\":\"TRA \u00c9valuation du risque toxicologique pour les dispositifs m\u00e9dicaux - Canada\",\"isPartOf\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/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\":\"Les services d'\u00e9valuation des risques toxicologiques de TRA vous permettent d'\u00e9laborer un raisonnement d\u00e9fendable en mati\u00e8re de s\u00e9curit\u00e9 chimique. Soutien r\u00e9glementaire Sant\u00e9 Canada.\",\"breadcrumb\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/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\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\/\/sobelconsult.com\/fr\/home\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Nos solutions Canada\",\"item\":\"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"MED CAN \u00c9valuation du risque toxicologique (par substance) (TRA)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/#website\",\"url\":\"https:\/\/sobelconsult.com\/fr\/\",\"name\":\"Sobel\",\"description\":\"Regulatory Consultancy\",\"publisher\":{\"@id\":\"https:\/\/sobelconsult.com\/fr\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/sobelconsult.com\/fr\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/#organization\",\"name\":\"Sobel\",\"url\":\"https:\/\/sobelconsult.com\/fr\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\/\/sobelconsult.com\/fr\/#\/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\/fr\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"TRA \u00c9valuation du risque toxicologique pour les dispositifs m\u00e9dicaux - Canada","description":"Les services d'\u00e9valuation des risques toxicologiques de TRA vous permettent d'\u00e9laborer un raisonnement d\u00e9fendable en mati\u00e8re de s\u00e9curit\u00e9 chimique. Soutien r\u00e9glementaire Sant\u00e9 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\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/","og_locale":"fr_FR","og_type":"article","og_title":"MED CAN \u00c9valuation du risque toxicologique (par substance) (TRA)","og_description":"Les services d'\u00e9valuation des risques toxicologiques de TRA vous permettent d'\u00e9laborer un raisonnement d\u00e9fendable en mati\u00e8re de s\u00e9curit\u00e9 chimique. Soutien r\u00e9glementaire Sant\u00e9 Canada.","og_url":"https:\/\/sobelconsult.com\/fr\/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":{"Dur\u00e9e de lecture estim\u00e9e":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/","url":"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/","name":"TRA \u00c9valuation du risque toxicologique pour les dispositifs m\u00e9dicaux - Canada","isPartOf":{"@id":"https:\/\/sobelconsult.com\/fr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/#primaryimage"},"image":{"@id":"https:\/\/sobelconsult.com\/fr\/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":"Les services d'\u00e9valuation des risques toxicologiques de TRA vous permettent d'\u00e9laborer un raisonnement d\u00e9fendable en mati\u00e8re de s\u00e9curit\u00e9 chimique. Soutien r\u00e9glementaire Sant\u00e9 Canada.","breadcrumb":{"@id":"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/#breadcrumb"},"inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/sobelconsult.com\/fr\/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\/fr\/our-solutions-canada\/tra-toxicological-risk-assessment\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/sobelconsult.com\/fr\/home\/"},{"@type":"ListItem","position":2,"name":"Nos solutions Canada","item":"https:\/\/sobelconsult.com\/fr\/our-solutions-canada\/"},{"@type":"ListItem","position":3,"name":"MED CAN \u00c9valuation du risque toxicologique (par substance) (TRA)"}]},{"@type":"WebSite","@id":"https:\/\/sobelconsult.com\/fr\/#website","url":"https:\/\/sobelconsult.com\/fr\/","name":"Sobel","description":"Regulatory Consultancy","publisher":{"@id":"https:\/\/sobelconsult.com\/fr\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/sobelconsult.com\/fr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/sobelconsult.com\/fr\/#organization","name":"Sobel","url":"https:\/\/sobelconsult.com\/fr\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/sobelconsult.com\/fr\/#\/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\/fr\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/pages\/26007","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/users\/15"}],"replies":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/comments?post=26007"}],"version-history":[{"count":9,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/pages\/26007\/revisions"}],"predecessor-version":[{"id":31910,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/pages\/26007\/revisions\/31910"}],"up":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/pages\/8454"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/media\/26810"}],"wp:attachment":[{"href":"https:\/\/sobelconsult.com\/fr\/wp-json\/wp\/v2\/media?parent=26007"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}