{"id":9995,"date":"2026-04-10T15:47:37","date_gmt":"2026-04-10T14:47:37","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/servicios-de-consultoria-para-la-industria-farmaceutica\/servicios-regulatorios-y-gestion-de-calidad\/regulacao-e-controle-de-qualidade-de-dispositivos-medicos\/"},"modified":"2026-04-16T01:16:35","modified_gmt":"2026-04-16T00:16:35","slug":"regulacion-y-control-de-calidad-de-los-dispositivos-medicos","status":"publish","type":"page","link":"https:\/\/els-solutions.com\/es\/servicios-de-consultoria-para-la-industria-farmaceutica\/servicios-regulatorios-y-gestion-de-calidad\/regulacion-y-control-de-calidad-de-los-dispositivos-medicos\/","title":{"rendered":"Regula\u00e7\u00e3o e Controle de Qualidade de Dispositivos M\u00e9dicos"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"9995\" class=\"elementor elementor-9995\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-18db4f30 e-flex e-con-boxed e-con e-parent\" data-id=\"18db4f30\" 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-6ab10a66 e-con-full e-flex e-con e-child\" data-id=\"6ab10a66\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-400912b9 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"400912b9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Servicios de control de calidad y regulaci\u00f3n de dispositivos m\u00e9dicos<\/h1>\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-2be63c6c e-flex e-con-boxed e-con e-parent\" data-id=\"2be63c6c\" 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-4a249514 e-con-full e-flex e-con e-child\" data-id=\"4a249514\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-583553e0 elementor-widget elementor-widget-image\" data-id=\"583553e0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"591\" height=\"434\" src=\"https:\/\/els-solutions.com\/cms\/wp-content\/uploads\/2026\/04\/regulacao-controle-de-qualidade-dispostivos-medicos.jpg\" class=\"attachment-large size-large wp-image-9021\" alt=\"\" srcset=\"https:\/\/els-solutions.com\/cms\/wp-content\/uploads\/2026\/04\/regulacao-controle-de-qualidade-dispostivos-medicos.jpg 591w, https:\/\/els-solutions.com\/cms\/wp-content\/uploads\/2026\/04\/regulacao-controle-de-qualidade-dispostivos-medicos-300x220.jpg 300w\" sizes=\"(max-width: 591px) 100vw, 591px\" \/>\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<div class=\"elementor-element elementor-element-41f702a2 e-con-full e-flex e-con e-child\" data-id=\"41f702a2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4bc3b530 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"4bc3b530\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>La regulaci\u00f3n y el control de calidad de los dispositivos m\u00e9dicos son fundamentales para garantizar la seguridad, el rendimiento, la trazabilidad y la continuidad operativa en mercados altamente regulados.<\/p><p>A diferencia de otros productos, los dispositivos m\u00e9dicos est\u00e1n sujetos a rigurosos requisitos t\u00e9cnicos, un seguimiento continuo y responsabilidades claras a lo largo de su ciclo de vida.<\/p><p>ELS Group act\u00faa como socio t\u00e9cnico estrat\u00e9gico en servicios de gesti\u00f3n regulatoria y de calidad para dispositivos m\u00e9dicos, brindando apoyo a fabricantes, distribuidores y titulares de autorizaciones de comercializaci\u00f3n desde la fase de desarrollo hasta la poscomercializaci\u00f3n, con operaciones integradas en Europa y Latinoam\u00e9rica.<\/p><p>Con presencia en 11 pa\u00edses, equipos locales especializados y experiencia directa con autoridades reguladoras y organismos notificados, ELS Group estructura soluciones regulatorias y de calidad que permiten una operaci\u00f3n predecible, una reducci\u00f3n de riesgos y la sostenibilidad de las operaciones internacionales.<\/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-5ca9cff3 e-flex e-con-boxed e-con e-parent\" data-id=\"5ca9cff3\" 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-dea76f elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-widget elementor-widget-heading\" data-id=\"dea76f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">El Grupo ELS ofrece un alcance integral en materia de regulaci\u00f3n y control de calidad de dispositivos m\u00e9dicos.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-23bf6c35 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"23bf6c35\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>La experiencia de ELS Group en regulaci\u00f3n y control de calidad de dispositivos m\u00e9dicos abarca todo el ciclo de vida del producto, desde el cumplimiento normativo inicial hasta la fase posterior a la comercializaci\u00f3n, incluyendo certificaciones, auditor\u00edas y vigilancia continua.<\/p><p>Nuestro trabajo incluye los siguientes servicios integrados y personalizados:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-42a35303 e-con-full e-flex e-con e-child\" data-id=\"42a35303\" 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-10cf372b elementor-widget elementor-widget-n-accordion\" data-id=\"10cf372b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&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\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-2820\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2820\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Estrategia regulatoria, clasificaci\u00f3n y viabilidad <\/h3><\/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-angle-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M177 159.7l136 136c9.4 9.4 9.4 24.6 0 33.9l-22.6 22.6c-9.4 9.4-24.6 9.4-33.9 0L160 255.9l-96.4 96.4c-9.4 9.4-24.6 9.4-33.9 0L7 329.7c-9.4-9.4-9.4-24.6 0-33.9l136-136c9.4-9.5 24.6-9.5 34-.1z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M143 352.3L7 216.3c-9.4-9.4-9.4-24.6 0-33.9l22.6-22.6c9.4-9.4 24.6-9.4 33.9 0l96.4 96.4 96.4-96.4c9.4-9.4 24.6-9.4 33.9 0l22.6 22.6c9.4 9.4 9.4 24.6 0 33.9l-136 136c-9.2 9.4-24.4 9.4-33.8 0z\"><\/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-2820\" class=\"elementor-element elementor-element-18382f41 e-con-full e-flex e-con e-child\" data-id=\"18382f41\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-52d9f69a elementor-align-start elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"52d9f69a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">An\u00e1lisis de clasificaci\u00f3n de riesgos de dispositivos m\u00e9dicos seg\u00fan el organismo regulador local.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Elaboraci\u00f3n de informes de viabilidad regulatoria para el registro de dispositivos m\u00e9dicos.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Evaluaci\u00f3n de la conformidad y verificaci\u00f3n del cumplimiento de los requisitos reglamentarios.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">An\u00e1lisis de deficiencias de la documentaci\u00f3n t\u00e9cnica<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Apoyo regulatorio estrat\u00e9gico<\/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\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2821\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2821\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Ciclo de vida de registro, notificaci\u00f3n y regulaci\u00f3n <\/h3><\/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-angle-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M177 159.7l136 136c9.4 9.4 9.4 24.6 0 33.9l-22.6 22.6c-9.4 9.4-24.6 9.4-33.9 0L160 255.9l-96.4 96.4c-9.4 9.4-24.6 9.4-33.9 0L7 329.7c-9.4-9.4-9.4-24.6 0-33.9l136-136c9.4-9.5 24.6-9.5 34-.1z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M143 352.3L7 216.3c-9.4-9.4-9.4-24.6 0-33.9l22.6-22.6c9.4-9.4 24.6-9.4 33.9 0l96.4 96.4 96.4-96.4c9.4-9.4 24.6-9.4 33.9 0l22.6 22.6c9.4 9.4 9.4 24.6 0 33.9l-136 136c-9.2 9.4-24.4 9.4-33.8 0z\"><\/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-2821\" class=\"elementor-element elementor-element-3935f711 e-con-full e-flex e-con e-child\" data-id=\"3935f711\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1f998476 elementor-align-start elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"1f998476\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Registro de dispositivos m\u00e9dicos, incluyendo la preparaci\u00f3n, revisi\u00f3n y presentaci\u00f3n del expediente t\u00e9cnico.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Notificaci\u00f3n de dispositivos m\u00e9dicos, incluyendo la preparaci\u00f3n y presentaci\u00f3n del expediente t\u00e9cnico.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Renovaci\u00f3n del registro de dispositivos m\u00e9dicos<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Cambios posteriores al registro<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Cancelaci\u00f3n del registro de dispositivos m\u00e9dicos<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Transferencia de la titularidad del registro de dispositivos m\u00e9dicos<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Redacci\u00f3n de respuestas a notificaciones e infracciones en materia de salud y seguridad.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Recurso administrativo de primera instancia para la regularizaci\u00f3n de dispositivos m\u00e9dicos.<\/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\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2822\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2822\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Uni\u00f3n Europea, Reino Unido y mercados internacionales <\/h3><\/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-angle-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M177 159.7l136 136c9.4 9.4 9.4 24.6 0 33.9l-22.6 22.6c-9.4 9.4-24.6 9.4-33.9 0L160 255.9l-96.4 96.4c-9.4 9.4-24.6 9.4-33.9 0L7 329.7c-9.4-9.4-9.4-24.6 0-33.9l136-136c9.4-9.5 24.6-9.5 34-.1z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M143 352.3L7 216.3c-9.4-9.4-9.4-24.6 0-33.9l22.6-22.6c9.4-9.4 24.6-9.4 33.9 0l96.4 96.4 96.4-96.4c9.4-9.4 24.6-9.4 33.9 0l22.6 22.6c9.4 9.4 9.4 24.6 0 33.9l-136 136c-9.2 9.4-24.4 9.4-33.8 0z\"><\/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-2822\" class=\"elementor-element elementor-element-1f28e4d7 e-con-full e-flex e-con e-child\" data-id=\"1f28e4d7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7ec9b35 elementor-align-start elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"7ec9b35\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Preparaci\u00f3n del expediente MDR para dispositivos m\u00e9dicos.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Actualizaci\u00f3n de los expedientes de la Directiva de Dispositivos M\u00e9dicos (MDD) al Reglamento de Dispositivos M\u00e9dicos (MDR) en la Uni\u00f3n Europea.<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Registro EUDAMED<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Representante Europeo Autorizado (EUAR \/ EUREP)<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Persona responsable del cumplimiento normativo (PRRC)<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Persona responsable en el Reino Unido (Representante en el Reino Unido)<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Persona responsable de Suiza (CH REP)<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Certificaci\u00f3n de Evaluaci\u00f3n de Conformidad del Reino Unido (UKCA)<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Apoyo regulatorio en la MHRA<\/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\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<div class=\"elementor-element elementor-element-4624845f e-con-full e-flex e-con e-child\" data-id=\"4624845f\" 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-62e25699 elementor-widget elementor-widget-n-accordion\" data-id=\"62e25699\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&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\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-1650\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1650\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Calidad, certificaciones y auditor\u00edas <\/h3><\/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-angle-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M177 159.7l136 136c9.4 9.4 9.4 24.6 0 33.9l-22.6 22.6c-9.4 9.4-24.6 9.4-33.9 0L160 255.9l-96.4 96.4c-9.4 9.4-24.6 9.4-33.9 0L7 329.7c-9.4-9.4-9.4-24.6 0-33.9l136-136c9.4-9.5 24.6-9.5 34-.1z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M143 352.3L7 216.3c-9.4-9.4-9.4-24.6 0-33.9l22.6-22.6c9.4-9.4 24.6-9.4 33.9 0l96.4 96.4 96.4-96.4c9.4-9.4 24.6-9.4 33.9 0l22.6 22.6c9.4 9.4 9.4 24.6 0 33.9l-136 136c-9.2 9.4-24.4 9.4-33.8 0z\"><\/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-1650\" class=\"elementor-element elementor-element-566fd8d5 e-con-full e-flex e-con e-child\" data-id=\"566fd8d5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3d75895 elementor-align-start elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"3d75895\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Certificaci\u00f3n ISO 13485<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Certificaci\u00f3n ISO 14971<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Certificaci\u00f3n de Buenas Pr\u00e1cticas de Fabricaci\u00f3n para Dispositivos M\u00e9dicos<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Certificaci\u00f3n de Buenas Pr\u00e1cticas de Distribuci\u00f3n para Dispositivos M\u00e9dicos<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Certificaci\u00f3n CE para dispositivos m\u00e9dicos<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Certificaci\u00f3n MDSAP y auditor\u00edas MDSAP<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Preparaci\u00f3n para las auditor\u00edas por parte de los organismos notificados<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Auditor\u00edas de cumplimiento<\/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\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1651\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1651\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Certificaciones t\u00e9cnicas y requisitos espec\u00edficos <\/h3><\/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-angle-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M177 159.7l136 136c9.4 9.4 9.4 24.6 0 33.9l-22.6 22.6c-9.4 9.4-24.6 9.4-33.9 0L160 255.9l-96.4 96.4c-9.4 9.4-24.6 9.4-33.9 0L7 329.7c-9.4-9.4-9.4-24.6 0-33.9l136-136c9.4-9.5 24.6-9.5 34-.1z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M143 352.3L7 216.3c-9.4-9.4-9.4-24.6 0-33.9l22.6-22.6c9.4-9.4 24.6-9.4 33.9 0l96.4 96.4 96.4-96.4c9.4-9.4 24.6-9.4 33.9 0l22.6 22.6c9.4 9.4 9.4 24.6 0 33.9l-136 136c-9.2 9.4-24.4 9.4-33.8 0z\"><\/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-1651\" class=\"elementor-element elementor-element-3a99ded8 e-con-full e-flex e-con e-child\" data-id=\"3a99ded8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6caede7c elementor-align-start elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"6caede7c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Certificaci\u00f3n INMETRO (IEC 60601)<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Certificaci\u00f3n ANATEL<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Asignaci\u00f3n del C\u00f3digo de Dispositivo M\u00e9dico (CDM)<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Identificaci\u00f3n \u00danica de Dispositivo (UDI)<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Verificaci\u00f3n de los requisitos de etiquetado<\/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\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1652\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1652\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Vigilancia, poscomercializaci\u00f3n y seguridad <\/h3><\/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-angle-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M177 159.7l136 136c9.4 9.4 9.4 24.6 0 33.9l-22.6 22.6c-9.4 9.4-24.6 9.4-33.9 0L160 255.9l-96.4 96.4c-9.4 9.4-24.6 9.4-33.9 0L7 329.7c-9.4-9.4-9.4-24.6 0-33.9l136-136c9.4-9.5 24.6-9.5 34-.1z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M143 352.3L7 216.3c-9.4-9.4-9.4-24.6 0-33.9l22.6-22.6c9.4-9.4 24.6-9.4 33.9 0l96.4 96.4 96.4-96.4c9.4-9.4 24.6-9.4 33.9 0l22.6 22.6c9.4 9.4 9.4 24.6 0 33.9l-136 136c-9.2 9.4-24.4 9.4-33.8 0z\"><\/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-1652\" class=\"elementor-element elementor-element-4e8b0a3e e-con-full e-flex e-con e-child\" data-id=\"4e8b0a3e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-86f44f elementor-align-start elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"86f44f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Vigilancia posterior a la comercializaci\u00f3n<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Seguimiento posterior a la comercializaci\u00f3n<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Estudios posteriores a la comercializaci\u00f3n<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Seguimiento del desempe\u00f1o posterior a la comercializaci\u00f3n (PCPM)<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Seguimiento cl\u00ednico posterior a la comercializaci\u00f3n (PCCF)<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Informe de evaluaci\u00f3n cl\u00ednica (CER)<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Informe de evaluaci\u00f3n cl\u00ednica de dispositivos m\u00e9dicos<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Informe peri\u00f3dico de seguridad (PSR)<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Gesti\u00f3n de quejas y retiradas de productos<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Garant\u00eda de seguridad y rendimiento para dispositivos m\u00e9dicos de diagn\u00f3stico in vitro (GSPR)<\/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\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<div class=\"elementor-element elementor-element-5ad1be5f e-con-full e-flex e-con e-child\" data-id=\"5ad1be5f\" 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-62d0553d elementor-widget elementor-widget-n-accordion\" data-id=\"62d0553d\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&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\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-1650\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1650\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Pruebas, validaciones y representaci\u00f3n <\/h3><\/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-angle-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M177 159.7l136 136c9.4 9.4 9.4 24.6 0 33.9l-22.6 22.6c-9.4 9.4-24.6 9.4-33.9 0L160 255.9l-96.4 96.4c-9.4 9.4-24.6 9.4-33.9 0L7 329.7c-9.4-9.4-9.4-24.6 0-33.9l136-136c9.4-9.5 24.6-9.5 34-.1z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M143 352.3L7 216.3c-9.4-9.4-9.4-24.6 0-33.9l22.6-22.6c9.4-9.4 24.6-9.4 33.9 0l96.4 96.4 96.4-96.4c9.4-9.4 24.6-9.4 33.9 0l22.6 22.6c9.4 9.4 9.4 24.6 0 33.9l-136 136c-9.2 9.4-24.4 9.4-33.8 0z\"><\/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-1650\" class=\"elementor-element elementor-element-7a07ccc9 e-con-full e-flex e-con e-child\" data-id=\"7a07ccc9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3523a258 elementor-align-start elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"3523a258\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Verificaci\u00f3n y validaci\u00f3n de dispositivos m\u00e9dicos<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Estudios precl\u00ednicos y estudios cl\u00ednicos<\/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\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1651\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1651\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Servicios de alojamiento y representaci\u00f3n local, que incluyen: <\/h3><\/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-angle-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M177 159.7l136 136c9.4 9.4 9.4 24.6 0 33.9l-22.6 22.6c-9.4 9.4-24.6 9.4-33.9 0L160 255.9l-96.4 96.4c-9.4 9.4-24.6 9.4-33.9 0L7 329.7c-9.4-9.4-9.4-24.6 0-33.9l136-136c9.4-9.5 24.6-9.5 34-.1z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M143 352.3L7 216.3c-9.4-9.4-9.4-24.6 0-33.9l22.6-22.6c9.4-9.4 24.6-9.4 33.9 0l96.4 96.4 96.4-96.4c9.4-9.4 24.6-9.4 33.9 0l22.6 22.6c9.4 9.4 9.4 24.6 0 33.9l-136 136c-9.2 9.4-24.4 9.4-33.8 0z\"><\/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-1651\" class=\"elementor-element elementor-element-497264a0 e-con-full e-flex e-con e-child\" data-id=\"497264a0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-29ea83b3 elementor-align-start elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"29ea83b3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Representante legal<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Representaci\u00f3n t\u00e9cnica<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Vigilancia posterior al registro<\/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\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1652\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1652\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Importaci\u00f3n, exportaci\u00f3n y comercio internacional <\/h3><\/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-angle-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M177 159.7l136 136c9.4 9.4 9.4 24.6 0 33.9l-22.6 22.6c-9.4 9.4-24.6 9.4-33.9 0L160 255.9l-96.4 96.4c-9.4 9.4-24.6 9.4-33.9 0L7 329.7c-9.4-9.4-9.4-24.6 0-33.9l136-136c9.4-9.5 24.6-9.5 34-.1z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M143 352.3L7 216.3c-9.4-9.4-9.4-24.6 0-33.9l22.6-22.6c9.4-9.4 24.6-9.4 33.9 0l96.4 96.4 96.4-96.4c9.4-9.4 24.6-9.4 33.9 0l22.6 22.6c9.4 9.4 9.4 24.6 0 33.9l-136 136c-9.2 9.4-24.4 9.4-33.8 0z\"><\/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-1652\" class=\"elementor-element elementor-element-71d708fb e-con-full e-flex e-con e-child\" data-id=\"71d708fb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a7603fb elementor-align-start elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"a7603fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Importaci\u00f3n y exportaci\u00f3n de dispositivos m\u00e9dicos<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-dot-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 56c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m0-48C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 168c-44.183 0-80 35.817-80 80s35.817 80 80 80 80-35.817 80-80-35.817-80-80-80z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Certificado de venta gratuita<\/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\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7ecfe13 e-flex e-con-boxed e-con e-parent\" data-id=\"7ecfe13\" 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-3a28e659 e-con-full e-flex e-con e-child\" data-id=\"3a28e659\" 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-79bb14d3 elementor-widget__width-inherit elementor-widget-tablet__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"79bb14d3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Al integrar la regulaci\u00f3n y el control de calidad de los dispositivos m\u00e9dicos en una \u00fanica estrategia, el Grupo ELS permite a las empresas operar con mayor previsibilidad regulatoria, seguridad t\u00e9cnica y cumplimiento continuo en m\u00faltiples mercados.<\/p><p>M\u00e1s all\u00e1 de la mera ejecuci\u00f3n de procesos, el grupo act\u00faa como socio estrat\u00e9gico, brindando apoyo en decisiones cruciales que impactan la seguridad del paciente, el rendimiento del producto y la sostenibilidad de las operaciones regulatorias a lo largo del tiempo.<\/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-23f5defc elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-widget elementor-widget-heading\" data-id=\"23f5defc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Consultor\u00eda estrat\u00e9gica para la industria farmac\u00e9utica y regulatoria<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af4d609 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"af4d609\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Expertos en consultor\u00eda farmac\u00e9utica, estrategia regulatoria y acceso al mercado para apoyar a su empresa en materia de seguridad, cumplimiento normativo y eficiencia. Hable con un consultor.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7757001c elementor-align-center elementor-widget__width-inherit elementor-widget elementor-widget-button\" data-id=\"7757001c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"tel:+351214525038\" target=\"_blank\">\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\">Quiero hablar con un especialista<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\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-53394f6c e-flex e-con-boxed e-con e-parent\" data-id=\"53394f6c\" 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-5f0f523e elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-widget elementor-widget-heading\" data-id=\"5f0f523e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Preguntas frecuentes sobre la regulaci\u00f3n y el control de calidad de los dispositivos m\u00e9dicos.<\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-708f0854 e-con-full e-flex e-con e-child\" data-id=\"708f0854\" 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-3b69a572 elementor-widget elementor-widget-n-accordion\" data-id=\"3b69a572\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&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\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-9960\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9960\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> \u00bfQu\u00e9 son la regulaci\u00f3n y el control de calidad de los dispositivos m\u00e9dicos? <\/h3><\/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-angle-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M177 159.7l136 136c9.4 9.4 9.4 24.6 0 33.9l-22.6 22.6c-9.4 9.4-24.6 9.4-33.9 0L160 255.9l-96.4 96.4c-9.4 9.4-24.6 9.4-33.9 0L7 329.7c-9.4-9.4-9.4-24.6 0-33.9l136-136c9.4-9.5 24.6-9.5 34-.1z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M143 352.3L7 216.3c-9.4-9.4-9.4-24.6 0-33.9l22.6-22.6c9.4-9.4 24.6-9.4 33.9 0l96.4 96.4 96.4-96.4c9.4-9.4 24.6-9.4 33.9 0l22.6 22.6c9.4 9.4 9.4 24.6 0 33.9l-136 136c-9.2 9.4-24.4 9.4-33.8 0z\"><\/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-9960\" class=\"elementor-element elementor-element-7e90d7c7 e-con-full e-flex e-con e-child\" data-id=\"7e90d7c7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-17d53549 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"17d53549\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Se trata del conjunto de actividades regulatorias, t\u00e9cnicas y de calidad que garantizan que los dispositivos m\u00e9dicos cumplan con los requisitos legales, de seguridad y de rendimiento exigidos por las autoridades sanitarias.<\/p><p>Esto incluye la clasificaci\u00f3n de riesgos, los registros, las certificaciones, la evaluaci\u00f3n cl\u00ednica, la farmacovigilancia posterior a la comercializaci\u00f3n y el mantenimiento del cumplimiento normativo durante todo el ciclo de vida del producto.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9961\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9961\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> \u00bfCu\u00e1ndo es necesario estructurar la regulaci\u00f3n y el control de calidad de los dispositivos m\u00e9dicos? <\/h3><\/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-angle-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M177 159.7l136 136c9.4 9.4 9.4 24.6 0 33.9l-22.6 22.6c-9.4 9.4-24.6 9.4-33.9 0L160 255.9l-96.4 96.4c-9.4 9.4-24.6 9.4-33.9 0L7 329.7c-9.4-9.4-9.4-24.6 0-33.9l136-136c9.4-9.5 24.6-9.5 34-.1z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M143 352.3L7 216.3c-9.4-9.4-9.4-24.6 0-33.9l22.6-22.6c9.4-9.4 24.6-9.4 33.9 0l96.4 96.4 96.4-96.4c9.4-9.4 24.6-9.4 33.9 0l22.6 22.6c9.4 9.4 9.4 24.6 0 33.9l-136 136c-9.2 9.4-24.4 9.4-33.8 0z\"><\/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-9961\" class=\"elementor-element elementor-element-68862271 e-con-full e-flex e-con e-child\" data-id=\"68862271\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-230693a7 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"230693a7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Desde las etapas iniciales del desarrollo del dispositivo, el marco regulatorio debe definirse antes del registro, pero sigue siendo necesario durante la comercializaci\u00f3n, las auditor\u00edas, los cambios posteriores al registro, la expansi\u00f3n a nuevos mercados y las actividades de vigilancia posterior a la comercializaci\u00f3n.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9962\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9962\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> \u00bfCu\u00e1l es la importancia de la clasificaci\u00f3n de riesgos para los dispositivos m\u00e9dicos? <\/h3><\/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-angle-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M177 159.7l136 136c9.4 9.4 9.4 24.6 0 33.9l-22.6 22.6c-9.4 9.4-24.6 9.4-33.9 0L160 255.9l-96.4 96.4c-9.4 9.4-24.6 9.4-33.9 0L7 329.7c-9.4-9.4-9.4-24.6 0-33.9l136-136c9.4-9.5 24.6-9.5 34-.1z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M143 352.3L7 216.3c-9.4-9.4-9.4-24.6 0-33.9l22.6-22.6c9.4-9.4 24.6-9.4 33.9 0l96.4 96.4 96.4-96.4c9.4-9.4 24.6-9.4 33.9 0l22.6 22.6c9.4 9.4 9.4 24.6 0 33.9l-136 136c-9.2 9.4-24.4 9.4-33.8 0z\"><\/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-9962\" class=\"elementor-element elementor-element-222f1ecd e-con-full e-flex e-con e-child\" data-id=\"222f1ecd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-648fdeb2 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"648fdeb2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>La clasificaci\u00f3n de riesgos determina el nivel de requisitos regulatorios aplicables al dispositivo. Una clasificaci\u00f3n incorrecta puede ocasionar retrabajos, retrasos, requisitos adicionales o incluso el rechazo del proceso regulatorio.<\/p><p>Por lo tanto, el an\u00e1lisis de la clasificaci\u00f3n de riesgos es un paso fundamental en la estrategia regulatoria.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9963\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9963\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> \u00bfCu\u00e1l es el papel de la norma ISO 13485 en la regulaci\u00f3n de los dispositivos m\u00e9dicos? <\/h3><\/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-angle-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M177 159.7l136 136c9.4 9.4 9.4 24.6 0 33.9l-22.6 22.6c-9.4 9.4-24.6 9.4-33.9 0L160 255.9l-96.4 96.4c-9.4 9.4-24.6 9.4-33.9 0L7 329.7c-9.4-9.4-9.4-24.6 0-33.9l136-136c9.4-9.5 24.6-9.5 34-.1z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M143 352.3L7 216.3c-9.4-9.4-9.4-24.6 0-33.9l22.6-22.6c9.4-9.4 24.6-9.4 33.9 0l96.4 96.4 96.4-96.4c9.4-9.4 24.6-9.4 33.9 0l22.6 22.6c9.4 9.4 9.4 24.6 0 33.9l-136 136c-9.2 9.4-24.4 9.4-33.8 0z\"><\/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-9963\" class=\"elementor-element elementor-element-2fec2401 e-con-full e-flex e-con e-child\" data-id=\"2fec2401\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ab238a6 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"ab238a6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>La norma ISO 13485 establece los requisitos para los sistemas de gesti\u00f3n de calidad aplicables a los dispositivos m\u00e9dicos.<\/p><p>Es un pilar fundamental para las certificaciones, auditor\u00edas y el cumplimiento normativo en diversos mercados, y el Grupo ELS la considera parte integral de su estrategia regulatoria, no solo un requisito documental.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9964\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9964\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> \u00bfEn qu\u00e9 pa\u00edses opera el Grupo ELS? <\/h3><\/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-angle-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M177 159.7l136 136c9.4 9.4 9.4 24.6 0 33.9l-22.6 22.6c-9.4 9.4-24.6 9.4-33.9 0L160 255.9l-96.4 96.4c-9.4 9.4-24.6 9.4-33.9 0L7 329.7c-9.4-9.4-9.4-24.6 0-33.9l136-136c9.4-9.5 24.6-9.5 34-.1z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M143 352.3L7 216.3c-9.4-9.4-9.4-24.6 0-33.9l22.6-22.6c9.4-9.4 24.6-9.4 33.9 0l96.4 96.4 96.4-96.4c9.4-9.4 24.6-9.4 33.9 0l22.6 22.6c9.4 9.4 9.4 24.6 0 33.9l-136 136c-9.2 9.4-24.4 9.4-33.8 0z\"><\/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-9964\" class=\"elementor-element elementor-element-1c94e1a0 e-con-full e-flex e-con e-child\" data-id=\"1c94e1a0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-74e0d378 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"74e0d378\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>ELS Group opera internacionalmente, con presencia en 11 pa\u00edses, ofreciendo apoyo regulatorio y de calidad en Europa y Latinoam\u00e9rica.<\/p><p>La compa\u00f1\u00eda cuenta con equipos locales especializados que trabajan de forma integrada con las principales autoridades reguladoras de cada regi\u00f3n, lo que le permite alinear las estrategias globales con los requisitos regulatorios espec\u00edficos de cada mercado.<\/p>\t\t\t\t\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Servicios de control de calidad y regulaci\u00f3n de dispositivos m\u00e9dicos La regulaci\u00f3n y el control de calidad de los dispositivos m\u00e9dicos son fundamentales para garantizar la seguridad, el rendimiento, la trazabilidad y la continuidad operativa en mercados altamente regulados. A diferencia de otros productos, los dispositivos m\u00e9dicos est\u00e1n sujetos a rigurosos requisitos t\u00e9cnicos, un seguimiento [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":0,"parent":9990,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-9995","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Regula\u00e7\u00e3o e Controle de Qualidade de Dispositivos M\u00e9dicos - ELS Group - Accelerating Innovation<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regula\u00e7\u00e3o e Controle de Qualidade de Dispositivos M\u00e9dicos - ELS Group - Accelerating Innovation\" \/>\n<meta property=\"og:description\" content=\"Servicios de control de calidad y regulaci\u00f3n de dispositivos m\u00e9dicos La regulaci\u00f3n y el control de calidad de los dispositivos m\u00e9dicos son fundamentales para garantizar la seguridad, el rendimiento, la trazabilidad y la continuidad operativa en mercados altamente regulados. 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