{"id":7977,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/apoyo-en-asuntos-reglamentarios-europa\/"},"modified":"2026-02-02T15:22:06","modified_gmt":"2026-02-02T18:22:06","slug":"ce-mark-medical-devices-support","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/","title":{"rendered":"Apoyo en Asuntos Reglamentarios - Europa"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7977\" class=\"elementor elementor-7977 elementor-1721\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6308376 e-flex e-con-boxed e-con e-parent\" data-id=\"6308376\" 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-38fa5d9 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"38fa5d9\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Apoyo normativo: Marcado CE para productos sanitarios<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-217dfef elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"217dfef\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Para entrar en el mercado europeo, los productos sanitarios deben cumplir los requisitos del marcado CE. Sobel apoya a fabricantes e importadores con servicios normativos estructurados para ayudarles a definir la v\u00eda, abordar las lagunas de cumplimiento y avanzar con confianza.<\/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-48394ca elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"48394ca\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Consigue ayuda de expertos<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d46791e e-flex e-con-boxed e-con e-parent\" data-id=\"d46791e\" 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-6cb329a e-con-full e-flex e-con e-child\" data-id=\"6cb329a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-b7be641 e-con-full e-transform e-flex e-con e-child\" data-id=\"b7be641\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation_mobile&quot;:&quot;fadeIn&quot;,&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:96,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-109,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-257443f elementor-widget elementor-widget-heading\" data-id=\"257443f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">\u00bfPara qui\u00e9n?<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c5e1e6a elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"c5e1e6a\" 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-dd3e887 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"dd3e887\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Empresas que preparan, actualizan o revisan presentaciones de productos sanitarios con marcado CE conforme a los requisitos de la UE<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Fabricantes e importadores que buscan la conformidad con el Marcado CE para el mercado europeo<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Equipos de AR\/QA que necesitan un apoyo normativo estructurado y alineado con la legislaci\u00f3n de la UE<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Organizaciones que necesitan asesoramiento experto para el Marcado CE de Productos Sanitarios<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-df41c58 e-con-full e-flex e-con e-child\" data-id=\"df41c58\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation_mobile&quot;:&quot;fadeIn&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8f6cf11 elementor-widget elementor-widget-image\" data-id=\"8f6cf11\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"755\" height=\"1024\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png\" class=\"attachment-large size-large wp-image-18567\" alt=\"A portable vital signs monitor sits on a table. Office supplies are also on the table. It looks like a doctor&#039;s office.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png 755w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-221x300.png 221w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-768x1041.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services.png 1011w\" sizes=\"(max-width: 755px) 100vw, 755px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-373723a e-flex e-con-boxed e-con e-parent\" data-id=\"373723a\" 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-b2e3b3d elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"b2e3b3d\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"From early planning to ongoing compliance, our experts help transform CE Mark Medical Devices regulatory requirements into a manageable, business-oriented pathway.\"}]\" data-inline-monday=\"true\">Desde la planificaci\u00f3n inicial hasta el cumplimiento continuo, nuestros expertos ayudan a transformar los requisitos reglamentarios del Marcado CE de Productos Sanitarios en una v\u00eda manejable y orientada a la empresa.<\/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-2085954 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"2085954\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">\u00a1Consigue apoyo!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1cb974b e-flex e-con-boxed e-con e-parent\" data-id=\"1cb974b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ef8a1f2 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"ef8a1f2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1259\" height=\"275\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.png\" class=\"attachment-full size-full wp-image-18573\" alt=\"Vector rectangle blue\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.png 1259w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-300x66.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-1024x224.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-768x168.png 768w\" sizes=\"(max-width: 1259px) 100vw, 1259px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a2680aa elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"a2680aa\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u00bfPor qu\u00e9 necesitas este servicio?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bccb97e e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"bccb97e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-a9e3136 e-con-full e-flex e-con e-child\" data-id=\"a9e3136\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9590850 elementor-widget elementor-widget-text-editor\" data-id=\"9590850\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"CE Mark compliance is a legal requirement for medical devices in Europe; without it, market access is impossible.\"}]\" data-inline-monday=\"true\">El cumplimiento del marcado CE es un requisito legal para los productos sanitarios en Europa; sin \u00e9l, el acceso al mercado es imposible.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0e6c8e6 e-con-full e-flex e-con e-child\" data-id=\"0e6c8e6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bd737c4 elementor-widget elementor-widget-text-editor\" data-id=\"bd737c4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"CE Mark is required for all medical device classes in Europe, ensuring compliance across the entire product range, from low to high risk.\"}]\" data-inline-monday=\"true\">El marcado CE es obligatorio para todas las clases de productos sanitarios en Europa, lo que garantiza el cumplimiento en toda la gama de productos, desde los de bajo riesgo hasta los de alto riesgo.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e7751aa e-con-full e-flex e-con e-child\" data-id=\"e7751aa\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-032f14b elementor-widget elementor-widget-text-editor\" data-id=\"032f14b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"With expert guidance, you minimize risks of non-compliance and reduce the need for rework or redesign.\"}]\" data-inline-monday=\"true\">Con la orientaci\u00f3n de expertos, minimizas los riesgos de incumplimiento y reduces la necesidad de reelaboraci\u00f3n o redise\u00f1o.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5d2f0c4 e-flex e-con-boxed e-con e-parent\" data-id=\"5d2f0c4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-be78b73 e-con-full e-flex e-con e-child\" data-id=\"be78b73\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-77802f2 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"77802f2\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">El cumplimiento normativo del MDR 2017 requiere una estrategia clara<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1d2237a e-con-full e-flex e-con e-child\" data-id=\"1d2237a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-773cf03 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"773cf03\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"With MDR 2017 fully in force, CE Mark Medical Devices are subject to stricter documentation, traceability, and lifecycle requirements. \"}]\" data-inline-monday=\"true\">Con el MDR 2017 plenamente en vigor, los productos sanitarios con marcado CE est\u00e1n sujetos a requisitos m\u00e1s estrictos de documentaci\u00f3n, trazabilidad y ciclo de vida.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c5c43f8 e-flex e-con-boxed e-con e-parent\" data-id=\"c5c43f8\" 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-6eff25b elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"6eff25b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Sobel apoya a los fabricantes de productos sanitarios con marcado CE con un enfoque normativo estructurado y basado en el riesgo.  <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f0938ab elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"f0938ab\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ucaddon_horizontal_timeline.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n<!-- start Horizontal Timeline -->\n\t\t<link id='font-awesome-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-all.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='font-awesome-4-shim-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-v4-shims.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='owl-carousel-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/owl-carousel-new\/assets\/owl.carousel.css' type='text\/css' rel='stylesheet' >\n\n<style>\/* widget: Horizontal Timeline *\/\n\n#uc_horizontal_timeline_elementor_f0938ab *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_f0938ab .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_f0938ab .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_f0938ab  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_f0938ab  .carousel-nav button i{\n  position: absolute;\n     top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%);\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_f0938ab .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-item-bullet i, #uc_horizontal_timeline_elementor_f0938ab .ue-item-bullet svg{\n  position: absolute;\n  top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%); \n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_f0938ab .ue-carousel-item-holder{\n  display: flex;\n  flex-direction: column;\n  align-items: stretch;\n  height:100%;\n}\n\n<\/style>\n\n<div class=\"ue-horizontal-timeline\" id=\"uc_horizontal_timeline_elementor_f0938ab\">\n     <div class=\"carousel-nav\">\n            <button class=\"carousel-prev\" aria-label=\"Previous\">\n                <i class=' ti-arrow-circle-left'><\/i>\n            <\/button>\n            <button class=\"carousel-next\" aria-label=\"Next\">\n                <i class=' ti-arrow-circle-right'><\/i>\n            <\/button>\n        <\/div>\n    <div class=\"owl-carousel owl-theme uc-items-wrapper item-horizontal-timeline  \" id=\"uc_horizontal_timeline_elementor_f0938ab\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-d826337\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Define tu camino hacia el Marcado CE<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">En funci\u00f3n de tu tipo de dispositivo, clase de riesgo y estado actual de la documentaci\u00f3n, te ayudamos a definir qu\u00e9 servicio de Marcado CE -o combinaci\u00f3n de servicios- se ajusta mejor a tus necesidades normativas.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-9bf08e7\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Compartir la documentaci\u00f3n existente<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Proporcionas la documentaci\u00f3n disponible, y Sobel revisa los materiales necesarios para realizar el servicio de marcado CE seleccionado seg\u00fan las expectativas normativas de la UE.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-31a8586\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Recibir salidas reguladoras<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Nuestro equipo entrega el alcance acordado -como las conclusiones del an\u00e1lisis de deficiencias, la recopilaci\u00f3n de documentaci\u00f3n t\u00e9cnica o la orientaci\u00f3n normativa escrita- con unos pasos siguientes y un contexto normativo claros.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-a99586b\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Avanza con confianza<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Una vez aclarada la normativa, tu equipo puede proceder a la correcci\u00f3n, las presentaciones o las actividades de cumplimiento en curso, con el apoyo de la experiencia de Sobel.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n\n  <\/div>\n<\/div>\n<!-- end Horizontal Timeline -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b5c68c5 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"b5c68c5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">\u00a1Empieza ya!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-238f082 animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"238f082\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2f3dbfb elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"2f3dbfb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u00bfQu\u00e9 servicio se aplica a tu producto sanitario?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0e892e0 elementor-widget elementor-widget-text-editor\" data-id=\"0e892e0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"MDR 2017 establishes different regulatory expectations depending on risk class, device type, and lifecycle stage. For CE Mark Medical Devices, Sobel offers the following regulatory support options:\"}]\" data-inline-monday=\"true\">El MDR 2017 establece diferentes expectativas normativas en funci\u00f3n de la clase de riesgo, el tipo de dispositivo y la fase del ciclo de vida. Para los productos sanitarios con marcado CE, Sobel ofrece las siguientes opciones de apoyo normativo: <\/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-a33d4f0 e-con-full e-flex e-con e-child\" data-id=\"a33d4f0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-0737f35 e-con-full e-flex e-con e-child\" data-id=\"0737f35\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4b6e4fd elementor-widget elementor-widget-heading\" data-id=\"4b6e4fd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">An\u00e1lisis de carencias (Clase I y IIa)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c6315b1 elementor-widget elementor-widget-text-editor\" data-id=\"c6315b1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Recommended for manufacturers preparing for MDR alignment or reviewing their current regulatory readiness. This service assesses whether your existing documentation, evaluations, and post-market information are aligned with applicable CE Mark requirements, helping identify regulatory gaps and priorities before moving forward.\"}]\" data-inline-monday=\"true\">Recomendado para fabricantes que se preparan para la alineaci\u00f3n MDR o que revisan su actual preparaci\u00f3n reglamentaria. Este servicio eval\u00faa si tu documentaci\u00f3n, evaluaciones e informaci\u00f3n poscomercializaci\u00f3n actuales est\u00e1n alineadas con los requisitos aplicables del marcado CE, ayudando a identificar las lagunas y prioridades normativas antes de seguir adelante. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-840c0c1 e-con-full e-flex e-con e-child\" data-id=\"840c0c1\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-55dde62 elementor-widget elementor-widget-heading\" data-id=\"55dde62\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">An\u00e1lisis de carencias (Clase IIb y III)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e13f406 elementor-widget elementor-widget-text-editor\" data-id=\"e13f406\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Designed for higher-risk medical devices subject to increased regulatory scrutiny. This gap analysis focuses on the alignment of technical documentation, clinical and biological evaluations, risk management, and post-market considerations with MDR 2017\/745 and applicable guidance, supporting informed regulatory decisions for complex devices.\"}]\" data-inline-monday=\"true\">Dise\u00f1ado para productos sanitarios de alto riesgo sujetos a un mayor escrutinio normativo. Este an\u00e1lisis de deficiencias se centra en la alineaci\u00f3n de la documentaci\u00f3n t\u00e9cnica, las evaluaciones cl\u00ednicas y biol\u00f3gicas, la gesti\u00f3n de riesgos y las consideraciones posteriores a la comercializaci\u00f3n con el MDR 2017\/745 y las directrices aplicables, apoyando la toma de decisiones normativas informadas para dispositivos complejos. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0f46477 e-con-full e-flex e-con e-child\" data-id=\"0f46477\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5ae98b6 elementor-widget elementor-widget-heading\" data-id=\"5ae98b6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Documentaci\u00f3n t\u00e9cnica (Clase I)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-70c0e04 elementor-widget elementor-widget-text-editor\" data-id=\"70c0e04\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Intended for manufacturers that need to compile CE Mark\u2013compliant documentation for lower-risk devices. Sobel structures the technical documentation in line with MDR 2017\/745 requirements, using the information and evidence provided by your team to build a coherent and submission-ready file.\"}]\" data-inline-monday=\"true\">Dirigido a fabricantes que necesitan compilar documentaci\u00f3n conforme al Marcado CE para dispositivos de bajo riesgo. Sobel estructura la documentaci\u00f3n t\u00e9cnica de acuerdo con los requisitos del MDR 2017\/745, utilizando la informaci\u00f3n y las pruebas aportadas por tu equipo para construir un expediente coherente y listo para su presentaci\u00f3n. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bfb7952 e-con-full e-flex e-con e-child\" data-id=\"bfb7952\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-75a0c61 e-con-full e-flex e-con e-child\" data-id=\"75a0c61\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3f9ce43 elementor-widget elementor-widget-heading\" data-id=\"3f9ce43\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Documentaci\u00f3n T\u00e9cnica (Clase Ir, Im, Is)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1d7d44a elementor-widget elementor-widget-text-editor\" data-id=\"1d7d44a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Suitable for specific Class I device categories that require additional regulatory controls. This service supports the structured compilation of technical documentation under MDR 2017\/745, ensuring consistency and traceability across the materials provided.\"}]\" data-inline-monday=\"true\">Adecuado para categor\u00edas espec\u00edficas de dispositivos de Clase I que requieren controles reglamentarios adicionales. Este servicio apoya la compilaci\u00f3n estructurada de documentaci\u00f3n t\u00e9cnica conforme al MDR 2017\/745, garantizando la coherencia y la trazabilidad de los materiales proporcionados. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b778df2 e-con-full e-flex e-con e-child\" data-id=\"b778df2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f60092b elementor-widget elementor-widget-heading\" data-id=\"f60092b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Documentaci\u00f3n t\u00e9cnica (Clase IIa, IIb, III)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-da93493 elementor-widget elementor-widget-text-editor\" data-id=\"da93493\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Developed for manufacturers of higher-risk medical devices requiring robust, MDR-aligned technical documentation. Sobel supports the compilation and structuring of documentation according to Annex II requirements, helping ensure regulatory consistency across complex device portfolios.\"}]\" data-inline-monday=\"true\">Desarrollado para fabricantes de productos sanitarios de alto riesgo que requieren una documentaci\u00f3n t\u00e9cnica s\u00f3lida y alineada con el MDR. Sobel ayuda a recopilar y estructurar la documentaci\u00f3n de acuerdo con los requisitos del Anexo II, contribuyendo a garantizar la coherencia reglamentaria en carteras de dispositivos complejas. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4f9720c e-con-full e-flex e-con e-child\" data-id=\"4f9720c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a5ebd66 elementor-widget elementor-widget-heading\" data-id=\"a5ebd66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Ayuda reglamentaria mensual (inicial)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5205cd7 elementor-widget elementor-widget-text-editor\" data-id=\"5205cd7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Ideal for companies that need ongoing regulatory guidance rather than a one-time service. This support model helps clarify regulatory pathways, confirm device classification, review documentation, and manage regulatory activities over time, adapting to evolving CE Mark requirements.\"}]\" data-inline-monday=\"true\">Ideal para empresas que necesitan orientaci\u00f3n normativa continua en lugar de un servicio puntual. Este modelo de asistencia ayuda a aclarar las v\u00edas reglamentarias, confirmar la clasificaci\u00f3n de los dispositivos, revisar la documentaci\u00f3n y gestionar las actividades reglamentarias a lo largo del tiempo, adapt\u00e1ndose a la evoluci\u00f3n de los requisitos del marcado CE. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d7167e1 e-con-full e-flex e-con e-child\" data-id=\"d7167e1\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8d38c68 elementor-widget elementor-widget-heading\" data-id=\"8d38c68\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Consultor\u00eda Mensual - Apoyo en Asuntos Reglamentarios<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3d7a46c elementor-widget elementor-widget-text-editor\" data-id=\"3d7a46c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Best suited for targeted regulatory questions related to CE Mark and EU compliance. This service provides written expert guidance through a structured project platform, helping teams resolve regulatory doubts without committing to a broader project scope.\"}]\" data-inline-monday=\"true\">El m\u00e1s adecuado para cuestiones normativas espec\u00edficas relacionadas con el marcado CE y el cumplimiento de la UE. Este servicio proporciona orientaci\u00f3n experta por escrito a trav\u00e9s de una plataforma de proyecto estructurada, ayudando a los equipos a resolver dudas normativas sin comprometerse con un proyecto de mayor alcance. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dde35ac elementor-widget elementor-widget-text-editor\" data-id=\"dde35ac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"attributes\":{\"bold\":true},\"insert\":\"You may rely on one or multiple services, depending on your device classification, maturity level, and regulatory strategy.\"}]\" data-inline-monday=\"true\"><strong>Puedes confiar en uno o varios servicios, dependiendo de tu clasificaci\u00f3n de dispositivos, nivel de madurez y estrategia normativa.<\/strong><\/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-b2a488b e-flex e-con-boxed e-con e-parent\" data-id=\"b2a488b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-718159e e-con-full e-flex e-con e-child\" data-id=\"718159e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ae451ad elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"ae451ad\" 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-bb2b80c elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"bb2b80c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Servicios relacionados <br><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1714840 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"1714840\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Sobel also supports CE Mark Medical Devices manufacturers with complementary regulatory services, including:\"}]\" data-inline-monday=\"true\">Sobel tambi\u00e9n presta apoyo a los fabricantes de productos sanitarios con marcado CE con servicios reglamentarios complementarios, entre los que se incluyen:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-36628f3 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"36628f3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-7cc4a2b e-con-full e-flex e-con e-child\" data-id=\"7cc4a2b\" 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-12b408b elementor-widget elementor-widget-heading\" data-id=\"12b408b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Representante autorizado<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2dc6e88 elementor-widget elementor-widget-text-editor\" data-id=\"2dc6e88\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Our team handles regulatory communication, technical documentation, and compliance.\"}]\" data-inline-monday=\"true\">Nuestro equipo se encarga de la comunicaci\u00f3n normativa, la documentaci\u00f3n t\u00e9cnica y el cumplimiento.<\/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-3cf5f60 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"3cf5f60\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/european-authorized-representative-europe\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Ver m\u00e1s<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b9fb115 e-con-full e-flex e-con e-child\" data-id=\"b9fb115\" 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-fb0c76f elementor-widget elementor-widget-heading\" data-id=\"fb0c76f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Evaluaci\u00f3n biol\u00f3gica<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-658c664 elementor-widget elementor-widget-text-editor\" data-id=\"658c664\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Experience in robust biological evaluation for medical devices, in line with the ISO 10993-1.\"}]\" data-inline-monday=\"true\">Experiencia en evaluaci\u00f3n biol\u00f3gica robusta de productos sanitarios, conforme a la norma ISO 10993-1.<\/p><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aa8bda6 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"aa8bda6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/biological-evaluation-europe\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Ver m\u00e1s<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c94b260 e-con-full e-flex e-con e-child\" data-id=\"c94b260\" 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-0f47bcd elementor-widget elementor-widget-heading\" data-id=\"0f47bcd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Evaluaci\u00f3n cl\u00ednica<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-928336a elementor-widget elementor-widget-text-editor\" data-id=\"928336a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Clinical evaluation services. Compliance with MDR 2017\/745 in the preparation of the CER.\"}]\" data-inline-monday=\"true\">Servicios de evaluaci\u00f3n cl\u00ednica. Cumplimiento del MDR 2017\/745 en la elaboraci\u00f3n del CER. <\/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-7d0971c elementor-align-center elementor-widget elementor-widget-button\" data-id=\"7d0971c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/medical-device-clinical-evaluation\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Ver m\u00e1s<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6d10cec e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"6d10cec\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-047653e e-con-full e-flex e-con e-child\" data-id=\"047653e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-e3cb4b1 e-con-full e-flex e-con e-child\" data-id=\"e3cb4b1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-929210e elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"929210e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Apoyo normativo estrat\u00e9gico para productos sanitarios con marcado CE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-987c65d elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"987c65d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Managing CE Mark Medical Devices compliance under MDR 2017 requires clarity, structure, and expert guidance. Partner with Sobel Consultancy to strengthen your CE Mark Medical Devices regulatory pathway and build sustainable European market access.\"}]\" data-inline-monday=\"true\">Gestionar el cumplimiento del Marcado CE de Productos Sanitarios seg\u00fan el MDR 2017 requiere claridad, estructura y orientaci\u00f3n experta. As\u00f3ciate con Sobel Consultancy para reforzar tu v\u00eda reglamentaria del Marcado CE de Productos Sanitarios y crear un acceso sostenible al mercado europeo. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eaec5bc elementor-align-center elementor-widget elementor-widget-button\" data-id=\"eaec5bc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Consigue ayuda de expertos<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ff74c9a e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"ff74c9a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-907e074 elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"907e074\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1511\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1511\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">\u00bfA\u00fan tienes preguntas? Consulta nuestras FAQ <\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1511\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1511\"><p><b>1. \u00bfEs obligatorio el marcado CE para todos los productos sanitarios en Europa?<\/b><\/p>\n<p>S\u00ed. El Marcado CE de Productos Sanitarios es obligatorio para todas las clases de productos sanitarios destinados a comercializarse en el mercado europeo, desde los de bajo riesgo hasta los de alto riesgo. La v\u00eda de conformidad y los requisitos reglamentarios var\u00edan en funci\u00f3n de la clasificaci\u00f3n del producto, pero siempre se exige el Marcado CE.  <\/p>\n<p><b>2. \u00bfQu\u00e9 normativa regula el Marcado CE de los productos sanitarios?<\/b><\/p>\n<p>El marcado CE de productos sanitarios se rige por el Reglamento (UE) 2017\/745 (MDR 2017\/745). Este reglamento define las normas de clasificaci\u00f3n, las v\u00edas de evaluaci\u00f3n de la conformidad, los requisitos de la documentaci\u00f3n t\u00e9cnica y las obligaciones posteriores a la comercializaci\u00f3n. <\/p>\n<p><b>3. \u00bfQui\u00e9n es responsable de obtener el marcado CE?<\/b><\/p>\n<p>El fabricante es el principal responsable de garantizar el cumplimiento del Marcado CE. Sin embargo, los importadores y <a href=\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/european-authorized-representative-europe\/\">representantes autorizados<\/a> tambi\u00e9n tienen obligaciones reglamentarias en virtud del MDR 2017\/745 y deben garantizar que el producto cumple los requisitos del Marcado CE antes de su comercializaci\u00f3n. <\/p>\n<p><b>4. \u00bfQu\u00e9 es un an\u00e1lisis de deficiencias del marcado CE?<\/b><\/p>\n<p>Un an\u00e1lisis de deficiencias del marcado CE eval\u00faa si la documentaci\u00f3n y las evaluaciones existentes se ajustan a los requisitos del MDR 2017\/745. Ayuda a identificar los elementos que faltan, las incoherencias y los riesgos normativos antes de proceder a la actualizaci\u00f3n de la documentaci\u00f3n t\u00e9cnica o a la evaluaci\u00f3n de la conformidad. <\/p>\n<p><b>5. \u00bfPuede actualizarse la documentaci\u00f3n del marcado CE con los datos existentes?<\/b><\/p>\n<p>S\u00ed. En muchos casos, la documentaci\u00f3n del marcado CE puede compilarse o actualizarse a partir de los datos y pruebas existentes, siempre que cumpla los requisitos del MDR 2017\/745. Un an\u00e1lisis de deficiencias suele ser el primer paso para determinar si los materiales existentes son suficientes o requieren una correcci\u00f3n.  <\/p>\n<p><b>6. \u00bfCu\u00e1nto tiempo se tarda en obtener el marcado CE para los productos sanitarios?<\/b><\/p>\n<p>Los plazos var\u00edan en funci\u00f3n de la clase de producto, la preparaci\u00f3n de la documentaci\u00f3n y la participaci\u00f3n de un organismo notificado. Los productos de menor riesgo pueden seguir v\u00edas m\u00e1s cortas, mientras que los productos de mayor riesgo suelen requerir plazos m\u00e1s largos debido a la revisi\u00f3n de las pruebas cl\u00ednicas y la evaluaci\u00f3n de la conformidad. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Servicios reglamentarios para el marcado CE de productos sanitarios. An\u00e1lisis de deficiencias, documentaci\u00f3n t\u00e9cnica y apoyo normativo continuo. <\/p>\n","protected":false},"author":11,"featured_media":7227,"parent":7793,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-7977","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Marcado CE para productos sanitarios | Apoyo reglamentario<\/title>\n<meta name=\"description\" content=\"Servicios reglamentarios para el marcado CE de productos sanitarios. An\u00e1lisis de deficiencias, documentaci\u00f3n t\u00e9cnica y apoyo normativo continuo.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Apoyo en Asuntos Reglamentarios - Europa\" \/>\n<meta property=\"og:description\" content=\"Servicios reglamentarios para el marcado CE de productos sanitarios. An\u00e1lisis de deficiencias, documentaci\u00f3n t\u00e9cnica y apoyo normativo continuo.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-02T18:22:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-Support.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"657\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data1\" content=\"8 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/\",\"url\":\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/\",\"name\":\"Marcado CE para productos sanitarios | Apoyo reglamentario\",\"isPartOf\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-Support.webp\",\"datePublished\":\"2025-06-01T13:00:00+00:00\",\"dateModified\":\"2026-02-02T18:22:06+00:00\",\"description\":\"Servicios reglamentarios para el marcado CE de productos sanitarios. An\u00e1lisis de deficiencias, documentaci\u00f3n t\u00e9cnica y apoyo normativo continuo.\",\"breadcrumb\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/#primaryimage\",\"url\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-Support.webp\",\"contentUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-Support.webp\",\"width\":1000,\"height\":657,\"caption\":\"Businessman checking documents at table\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Inicio\",\"item\":\"https:\/\/sobelconsult.com\/es\/home\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Consultor\u00eda regulatoria en Europa\",\"item\":\"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Apoyo en Asuntos Reglamentarios &#8211; Europa\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/sobelconsult.com\/es\/#website\",\"url\":\"https:\/\/sobelconsult.com\/es\/\",\"name\":\"Sobel\",\"description\":\"Regulatory Consultancy\",\"publisher\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/sobelconsult.com\/es\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/sobelconsult.com\/es\/#organization\",\"name\":\"Sobel\",\"url\":\"https:\/\/sobelconsult.com\/es\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/sobelconsult.com\/es\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png\",\"contentUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png\",\"width\":741,\"height\":290,\"caption\":\"Sobel\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/es\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Marcado CE para productos sanitarios | Apoyo reglamentario","description":"Servicios reglamentarios para el marcado CE de productos sanitarios. An\u00e1lisis de deficiencias, documentaci\u00f3n t\u00e9cnica y apoyo normativo continuo.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/","og_locale":"es_ES","og_type":"article","og_title":"Apoyo en Asuntos Reglamentarios - Europa","og_description":"Servicios reglamentarios para el marcado CE de productos sanitarios. An\u00e1lisis de deficiencias, documentaci\u00f3n t\u00e9cnica y apoyo normativo continuo.","og_url":"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/","og_site_name":"Sobel","article_modified_time":"2026-02-02T18:22:06+00:00","og_image":[{"width":1000,"height":657,"url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-Support.webp","type":"image\/webp"}],"twitter_card":"summary_large_image","twitter_misc":{"Tiempo de lectura":"8 minuto"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/","url":"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/","name":"Marcado CE para productos sanitarios | Apoyo reglamentario","isPartOf":{"@id":"https:\/\/sobelconsult.com\/es\/#website"},"primaryImageOfPage":{"@id":"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/#primaryimage"},"image":{"@id":"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/#primaryimage"},"thumbnailUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-Support.webp","datePublished":"2025-06-01T13:00:00+00:00","dateModified":"2026-02-02T18:22:06+00:00","description":"Servicios reglamentarios para el marcado CE de productos sanitarios. An\u00e1lisis de deficiencias, documentaci\u00f3n t\u00e9cnica y apoyo normativo continuo.","breadcrumb":{"@id":"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/#primaryimage","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-Support.webp","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Regulatory-Support.webp","width":1000,"height":657,"caption":"Businessman checking documents at table"},{"@type":"BreadcrumbList","@id":"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/ce-mark-medical-devices-support\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Inicio","item":"https:\/\/sobelconsult.com\/es\/home\/"},{"@type":"ListItem","position":2,"name":"Consultor\u00eda regulatoria en Europa","item":"https:\/\/sobelconsult.com\/es\/our-solutions-europe\/"},{"@type":"ListItem","position":3,"name":"Apoyo en Asuntos Reglamentarios &#8211; Europa"}]},{"@type":"WebSite","@id":"https:\/\/sobelconsult.com\/es\/#website","url":"https:\/\/sobelconsult.com\/es\/","name":"Sobel","description":"Regulatory Consultancy","publisher":{"@id":"https:\/\/sobelconsult.com\/es\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/sobelconsult.com\/es\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/sobelconsult.com\/es\/#organization","name":"Sobel","url":"https:\/\/sobelconsult.com\/es\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/sobelconsult.com\/es\/#\/schema\/logo\/image\/","url":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png","contentUrl":"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.png","width":741,"height":290,"caption":"Sobel"},"image":{"@id":"https:\/\/sobelconsult.com\/es\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages\/7977","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/comments?post=7977"}],"version-history":[{"count":6,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages\/7977\/revisions"}],"predecessor-version":[{"id":28285,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages\/7977\/revisions\/28285"}],"up":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/pages\/7793"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/media\/7227"}],"wp:attachment":[{"href":"https:\/\/sobelconsult.com\/es\/wp-json\/wp\/v2\/media?parent=7977"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}