{"id":4377,"date":"2025-10-03T11:28:48","date_gmt":"2025-10-03T16:28:48","guid":{"rendered":"https:\/\/www.accademia.com\/?page_id=4377"},"modified":"2026-02-23T16:49:46","modified_gmt":"2026-02-23T21:49:46","slug":"iso-13485","status":"publish","type":"page","link":"https:\/\/www.accademia.com\/en\/iso-13485\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"4377\" class=\"elementor elementor-4377\" data-elementor-settings=\"{&quot;ha_cmc_init_switcher&quot;:&quot;no&quot;}\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-49c1c3e e-ecs-flex e-flex e-con-boxed e-con e-parent\" data-id=\"49c1c3e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-01e6a3b elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-spacer\" data-id=\"01e6a3b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\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-8ccb69a elementor-hidden-desktop elementor-widget elementor-widget-spacer\" data-id=\"8ccb69a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\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-7db521e elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"7db521e\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&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\">La gestion de la qualit\u00e9 pour <br>les appareils m\u00e9dicaux <\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7af5a1a elementor-hidden-desktop elementor-widget elementor-widget-spacer\" data-id=\"7af5a1a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\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-096573d elementor-hidden-tablet elementor-hidden-mobile elementor-widget elementor-widget-spacer\" data-id=\"096573d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\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<div class=\"elementor-element elementor-element-aff50d2 e-ecs-flex e-flex e-con-boxed e-con e-parent\" data-id=\"aff50d2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-eb8a5e6 elementor-widget elementor-widget-button\" data-id=\"eb8a5e6\" 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:\/\/www.accademia.com\/en\/services\/\">\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\">&lt; Back to previous page<\/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 class=\"elementor-element elementor-element-ff23714 elementor-widget elementor-widget-spacer\" data-id=\"ff23714\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\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-e970670 elementor-widget elementor-widget-heading\" data-id=\"e970670\" 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<h3 class=\"elementor-heading-title elementor-size-default\">A framework for medical excellence: ISO 13485<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b29ce34 elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"b29ce34\" 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-8b907e4 elementor-widget elementor-widget-text-editor\" data-id=\"8b907e4\" 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 style=\"font-weight: 400;\">The safety of medical devices is a fundamental priority for Canadians, as it ensures the protection of patients and users while strengthening confidence in the healthcare system. That is why ISO 13485 plays such an important role. This international standard sets strict requirements for medical device quality management systems to ensure safe design, manufacturing, and use. It provides an essential framework for companies seeking to meet high standards of quality and regulatory compliance, while contributing to the continuous improvement of healthcare practices.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9eca428 e-ecs-flex e-flex e-con-boxed e-con e-parent\" data-id=\"9eca428\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-92c0adf elementor-widget elementor-widget-spacer\" data-id=\"92c0adf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\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-f65849f elementor-widget elementor-widget-heading\" data-id=\"f65849f\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Our various training courses offered on the subject<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0b2f14d elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"0b2f14d\" 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-20a9788 elementor-widget elementor-widget-n-accordion\" data-id=\"20a9788\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-3420\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-3420\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Understanding 13485 : 2016 \u2013 7 hours  <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-3420\" class=\"elementor-element elementor-element-63f872a e-con-full e-ecs-flex e-flex e-con e-child\" data-id=\"63f872a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9e7153d elementor-widget elementor-widget-text-editor\" data-id=\"9e7153d\" 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<h6><strong>Course Objective<\/strong><\/h6><p>This course aims to help participants develop a solid understanding of each of the clauses in ISO 13485:2016, how they are interrelated to create a dynamic quality management system that contributes to the achievement of the organization's quality objectives in line with its strategic objectives.<\/p><h6><strong>Target audience<\/strong><\/h6><p style=\"font-weight: 400;\">This course is primarily intended for management personnel and, more generally, any staff who want to learn about and understand the standard, or staff who, although already somewhat familiar with the standard, want to refresh their understanding of its requirements.<\/p><h6><strong>Content Elements<\/strong><\/h6><p style=\"font-weight: 400;\">The course covers the following topics:<\/p><ul><li>Concepts and definitions<\/li><li>Management commitment<\/li><li>Resource management<\/li><li>Product realization<\/li><li><span style=\"font-weight: 400;\">Measurement, analysis, and improvement<\/span><\/li><\/ul><h6><strong>Notes<\/strong><\/h6><p>There are no prerequisites for participating in this course. However, some knowledge of medical devices will help maximize the benefits of the training.<\/p><p>\u00a0<\/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-c3abfa7 elementor-align-left elementor-widget elementor-widget-button\" data-id=\"c3abfa7\" 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=\"http:\/\/www.accademia.com\/wp-content\/uploads\/2026\/02\/COM-13485-PLAN.pdf\">\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\">Downloadable Lesson Plan<\/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<\/details>\n\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<div class=\"elementor-element elementor-element-43b6577 elementor-widget elementor-widget-spacer\" data-id=\"43b6577\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\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<div class=\"elementor-element elementor-element-dd17e5c e-ecs-flex e-flex e-con-boxed e-con e-parent\" data-id=\"dd17e5c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-313c43c e-con-full e-ecs-flex e-flex e-con e-child\" data-id=\"313c43c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t<div class=\"elementor-element elementor-element-163c5a5 e-con-full e-ecs-flex e-flex e-con e-child\" data-id=\"163c5a5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-320a8c2 e-con-full e-ecs-flex e-flex elementor-invisible e-con e-child\" data-id=\"320a8c2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;slideInRight&quot;,&quot;animation_mobile&quot;:&quot;none&quot;,&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-317e6c8 elementor-widget elementor-widget-heading\" data-id=\"317e6c8\" 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<h3 class=\"elementor-heading-title elementor-size-default\">What if it wasn't exactly training you needed?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-50417e4 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"50417e4\" 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-a03e2d8 elementor-widget elementor-widget-text-editor\" data-id=\"a03e2d8\" 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>Beyond knowledge development, we also offer personalized support: assistance in obtaining your certification, maintenance of your management system with an experienced part-time resource, or strategic support to improve your processes.<\/p><p>Whatever your situation, we are here to help you move forward effectively.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-56d9496 e-con-full e-ecs-flex e-flex e-con e-child\" data-id=\"56d9496\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t<div class=\"elementor-element elementor-element-5244a1b e-con-full e-ecs-flex e-flex e-con e-child\" data-id=\"5244a1b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;ecs_container_type&quot;:&quot;flex&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-30f3c82 elementor-mobile-align-center elementor-align-center elementor-widget elementor-widget-button\" data-id=\"30f3c82\" 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=\"\/en\/CONTACT\/\">\n\t\t\t\t\t\t<span 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