{"id":841,"date":"2024-06-18T08:15:31","date_gmt":"2024-06-18T08:15:31","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?page_id=841"},"modified":"2026-01-21T11:13:25","modified_gmt":"2026-01-21T11:13:25","slug":"representacion-usa","status":"publish","type":"page","link":"https:\/\/cmcmedicaldevices.com\/es\/servicios\/representacion-usa\/","title":{"rendered":"Representaci\u00f3n USA"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background fusion-parallax-none nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:150px;--awb-padding-bottom:85px;--awb-background-color:var(--awb-color5);--awb-background-image:linear-gradient(168deg, rgba(6,43,33,0.96) 0%,rgba(6,43,33,0.22) 100%),url(https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/new-york-city-manhattan-midtown-dusk-with-brooklyn-bridge-usa-3000x1820.webp);;--awb-background-size:cover;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-center fusion-flex-justify-content-space-between fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:66.666666666667%;--awb-order-medium:0;--awb-spacing-right-medium:2.88%;--awb-spacing-left-medium:2.88%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-image-element \" style=\"--awb-margin-bottom:10px;--awb-max-width:30px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none fusion-animated\" data-animationType=\"rubberBand\" data-animationDuration=\"0.6\" data-animationOffset=\"top-into-view\"><img decoding=\"async\" width=\"2560\" height=\"2477\" title=\"ISOTIPO CMC MEDICAL DEVICES_AZUL\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-scaled.webp\" alt class=\"img-responsive wp-image-17\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-200x194.webp 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-400x387.webp 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-600x581.webp 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-768x743.webp 768w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-800x774.webp 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-1200x1161.webp 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-1536x1486.webp 1536w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-scaled.webp 2560w\" sizes=\"(max-width: 640px) 100vw, 600px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-one fusion-animated\" style=\"--awb-text-color:var(--awb-color3);--awb-font-size:20px;\" data-animationType=\"fadeInDown\" data-animationDuration=\"0.6\" data-animationOffset=\"top-into-view\"><h1 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Merriweather Sans&quot;;font-style:normal;font-weight:300;margin:0;font-size:1em;text-transform:uppercase;--fontSize:20;--minFontSize:20;line-height:var(--awb-typography1-line-height);\"><span data-sheets-root=\"1\">Agente FDA en US<\/span><\/h1><\/div><div class=\"fusion-title title fusion-title-2 fusion-sep-none fusion-title-text fusion-title-size-two fusion-animated\" style=\"--awb-text-color:var(--awb-color4);--awb-margin-bottom:20px;\" data-animationType=\"fadeInDown\" data-animationDuration=\"0.6\" data-animationOffset=\"top-into-view\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:40;line-height:var(--awb-typography1-line-height);\"><div class=\"page\" title=\"Page 2\">\n<div class=\"section\">\n<div class=\"layoutArea\">\n<div class=\"column\"><span data-sheets-root=\"1\">CMC Medical Devices ofrece servicios de representaci\u00f3n como Agente de la FDA en EE.UU. para dispositivos m\u00e9dicos<\/span><\/div>\n<\/div>\n<\/div>\n<\/div><\/h2><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-sizes-bottom:1px;--awb-border-color:var(--awb-color5);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:50px;--awb-padding-bottom:65px;--awb-padding-top-small:60px;--awb-background-color:var(--awb-color4);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-center fusion-flex-justify-content-space-between fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_2_3 2_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:66.666666666667%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.88%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:2.88%;--awb-width-medium:66.666666666667%;--awb-order-medium:0;--awb-spacing-right-medium:2.88%;--awb-spacing-left-medium:2.88%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-3 fusion-sep-none fusion-title-text fusion-title-size-paragraph\" style=\"--awb-margin-bottom:0px;\"><p class=\"fusion-title-heading title-heading-left title-heading-tag fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:15;--minFontSize:15;line-height:1.5;\">Ofrecemos servicios de Agente de la FDA en los Estados unidos para asegurar que sus productos cumplan con los requisitos de la FDA y puedan ingresar exitosamente al mercado estadounidense.<\/p><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-3 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:75px;--awb-padding-bottom:0px;--awb-background-color:var(--awb-color5);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-4 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-text-color:var(--awb-color3);\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:40;line-height:var(--awb-typography1-line-height);\">Agente de la FDA en los Estados Unidos<\/h2><\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-custom fusion-button-default button-1 fusion-button-default-span fusion-button-default-type awb-b-icon-pos-right\" style=\"--button_accent_color:var(--awb-color3);--button_border_color:var(--awb-color4);--button_accent_hover_color:var(--awb-color3);--button_border_hover_color:var(--awb-color3);--button_gradient_top_color:rgba(0,0,0,0);--button_gradient_bottom_color:rgba(0,0,0,0);--button_gradient_top_color_hover:rgba(0,0,0,0);--button_gradient_bottom_color_hover:rgba(0,0,0,0);--button_font_size:16px;--button_padding-left:8px;--button_typography-font-family:&quot;Merriweather Sans&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-bottom:20px;\" target=\"_self\" data-hover=\"icon_position\" href=\"https:\/\/cmcmedicaldevices.com\/es\/servicios\/representacion-usa\/#contact\"><span class=\"fusion-button-text\">Te ayudamos<\/span><i class=\"fa-angle-right fas button-icon-right\" aria-hidden=\"true\"><\/i><i class=\"fa-angle-right fas button-icon-right\" aria-hidden=\"true\"><\/i><\/a><\/div><div class=\"fusion-separator\" style=\"align-self: flex-start;margin-right:auto;margin-bottom:30px;width:100%;max-width:200px;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;border-color:var(--awb-color3);border-top-width:1px;\"><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:3.84%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-margin-bottom-small:0px;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-text-color:var(--awb-color4);\"><p>Como fabricante extranjero de productos sanitarios y\/o IVD con destino a los Estados Unidos, debe asegurar su camino hacia el \u00e9xito en el mercado asoci\u00e1ndose con nuestros servicios exclusivos de agentes de la FDA en EE. UU.<\/p>\n<p>Con CMC como su agente de confianza en EE. UU., puede concentrarse en su negocio principal mientras nosotros manejamos las complejidades regulatorias.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-4 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:3.84%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2\" style=\"--awb-text-color:var(--awb-color4);\"><p>Asegure su lugar en el mercado de los Estados Unidos, garantizando que sus dispositivos se importen con facilidad y cumplimiento.<\/p>\n<p class=\"p1\">CMC MEDICAL DEVICES LLC, con nuestro equipo de profesionales que tiene un amplio conocimiento y experiencia en las regulaciones y requisitos de la FDA. Navegaremos por las complejidades en su nombre.<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-4 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-sizes-bottom:1px;--awb-border-color:rgba(197,252,84,0.5);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:50px;--awb-padding-bottom:90px;--awb-background-color:var(--awb-color5);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-5 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-5 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-text-color:var(--awb-color3);--awb-margin-bottom:30px;\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:40;line-height:var(--awb-typography1-line-height);\">Nuestras funciones como su Agente de la FDA en EE.UU.:<\/h2><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-6 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:3.84%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-margin-bottom-small:0px;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><ul style=\"--awb-size:15px;--awb-iconcolor:var(--awb-color3);--awb-textcolor:var(--awb-color4);--awb-line-height:25.5px;--awb-icon-width:25.5px;--awb-icon-height:25.5px;--awb-icon-margin:10.5px;--awb-content-margin:36px;\" class=\"fusion-checklist fusion-checklist-1 fusion-checklist-default type-icons\"><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Verificar sus etiquetas y documentaci\u00f3n t\u00e9cnica para garantizar el cumplimiento<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Asesoramiento en el establecimiento de fundamentaci\u00f3n de seguridad del producto.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Tener documentaci\u00f3n que justifique la seguridad.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Registrar sus instalaciones y productos<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Mantener actualizados los registros anteriores.<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Asesorarlo sobre los requisitos reglamentarios<\/p>\n<\/div><\/li><\/ul><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-7 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:3.84%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><ul style=\"--awb-size:15px;--awb-iconcolor:var(--awb-color3);--awb-textcolor:var(--awb-color4);--awb-line-height:25.5px;--awb-icon-width:25.5px;--awb-icon-height:25.5px;--awb-icon-margin:10.5px;--awb-content-margin:36px;\" class=\"fusion-checklist fusion-checklist-2 fusion-checklist-default type-icons\"><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Recibir, evaluar y registrar eventos adversos<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Informar y registrar eventos adversos graves<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Representarlo ante la FDA<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Apoyarlo en caso de retiros del mercado, suspensiones de registro, inspecciones<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-no\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Informar sobre novedades regulatorias<\/p>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div><div id=\"contact\" class=\"fusion-container-anchor\"><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-5 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-sizes-top:1px;--awb-border-sizes-bottom:1px;--awb-border-color:var(--awb-color4);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:80px;--awb-padding-bottom:100px;--awb-padding-top-small:65px;--awb-padding-bottom-small:50px;--awb-background-color:var(--awb-color5);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-8 fusion_builder_column_2_5 2_5 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:40%;--awb-margin-top-large:0px;--awb-spacing-right-large:4.8%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:4.8%;--awb-width-medium:40%;--awb-order-medium:0;--awb-spacing-right-medium:4.8%;--awb-spacing-left-medium:4.8%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-margin-bottom-small:50px;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-0 fusion_builder_column_inner_1_1 1_1 fusion-flex-column fusion-no-small-visibility\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-motion-effects=\"[{&quot;type&quot;:&quot;infinite&quot;,&quot;scroll_type&quot;:&quot;rotate&quot;,&quot;infinite_animation&quot;:&quot;float&quot;,&quot;infinite_animation_speed&quot;:&quot;2.0&quot;}]\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-image-element \" style=\"text-align:right;--awb-margin-left:5px;--awb-max-width:40px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-2 hover-type-none fusion-animated\" data-animationType=\"rubberBand\" data-animationDuration=\"1.0\" data-animationDelay=\"0.1\" data-animationOffset=\"top-into-view\"><img decoding=\"async\" width=\"2560\" height=\"2477\" title=\"ISOTIPO CMC MEDICAL DEVICES_AZUL\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-scaled.webp\" alt class=\"img-responsive wp-image-17\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-200x194.webp 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-400x387.webp 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-600x581.webp 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-768x743.webp 768w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-800x774.webp 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-1200x1161.webp 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-1536x1486.webp 1536w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-scaled.webp 2560w\" sizes=\"(max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><div class=\"fusion-title title fusion-title-6 fusion-sep-none fusion-title-text fusion-title-size-two fusion-animated\" style=\"--awb-text-color:var(--awb-color4);--awb-margin-bottom:30px;--awb-margin-bottom-small:20px;\" data-animationType=\"fadeInDown\" data-animationDuration=\"0.6\" data-animationOffset=\"top-into-view\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Merriweather&quot;;font-style:normal;font-weight:300;margin:0;--fontSize:40;line-height:var(--awb-typography1-line-height);\">Elige CMC como tu agente FDA en los Estados Unidos<\/h2><\/div><div class=\"fusion-text fusion-text-3 fusion-animated fusion-text-no-margin\" style=\"--awb-text-color:var(--awb-color3);--awb-margin-bottom:30px;\" data-animationType=\"fadeInDown\" data-animationDuration=\"0.6\" data-animationDelay=\"0.3\" data-animationOffset=\"top-into-view\"><p>Completa el formulario de contacto y uno de nuestros consultores se pondr\u00e1 en contacto lo antes posible.<\/p>\n<\/div><div class=\"fusion-social-links fusion-social-links-1\" style=\"--awb-margin-top:30px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;--awb-box-border-top:0px;--awb-box-border-right:0px;--awb-box-border-bottom:0px;--awb-box-border-left:0px;--awb-icon-colors-hover:var(--awb-color3);--awb-box-colors-hover:var(--awb-color1);--awb-box-border-color:var(--awb-color3);--awb-box-border-color-hover:var(--awb-color4);\"><div class=\"fusion-social-networks color-type-custom\"><div class=\"fusion-social-networks-wrapper\"><a class=\"fusion-social-network-icon fusion-tooltip fusion-facebook awb-icon-facebook\" style=\"color:var(--awb-color4);font-size:17px;\" title=\"Facebook\" aria-label=\"facebook\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/www.facebook.com\/profile.php?id=61561382190867\"><\/a><a class=\"fusion-social-network-icon fusion-tooltip fusion-instagram awb-icon-instagram\" style=\"color:var(--awb-color4);font-size:17px;\" title=\"Instagram\" aria-label=\"instagram\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/www.instagram.com\/cmc_medical_devices\/\"><\/a><a class=\"fusion-social-network-icon fusion-tooltip fusion-linkedin awb-icon-linkedin\" style=\"color:var(--awb-color4);font-size:17px;\" title=\"LinkedIn\" aria-label=\"linkedin\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/www.linkedin.com\/company\/cmc-medical-devices-consulting\/?viewAsMember=true\"><\/a><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-9 fusion_builder_column_3_5 3_5 fusion-flex-column fusion-animated\" style=\"--awb-overflow:hidden;--awb-bg-size:cover;--awb-border-color:var(--awb-color4);--awb-border-style:solid;--awb-border-radius:20px 20px 20px 20px;--awb-width-large:60%;--awb-margin-top-large:70px;--awb-spacing-right-large:3.2%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:8%;--awb-width-medium:60%;--awb-order-medium:0;--awb-spacing-right-medium:3.2%;--awb-spacing-left-medium:8%;--awb-width-small:100%;--awb-order-small:0;--awb-margin-top-small:0px;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-animationType=\"fadeInRight\" data-animationDuration=\"0.6\" data-animationOffset=\"top-into-view\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\">\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f4059-o1\" lang=\"en-US\" dir=\"ltr\" data-wpcf7-id=\"4059\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/es\/wp-json\/wp\/v2\/pages\/841#wpcf7-f4059-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Contact form\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"4059\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.1\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"en_US\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f4059-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><input type=\"hidden\" name=\"_wpcf7_recaptcha_response\" value=\"\" \/>\n<\/fieldset>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"your-name\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Nombre*\" value=\"\" type=\"text\" name=\"your-name\" \/><\/span>\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"your-email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Email*\" value=\"\" type=\"email\" name=\"your-email\" \/><\/span>\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"telefono\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-tel wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-tel\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Tel\u00e9fono*\" value=\"\" type=\"tel\" name=\"telefono\" \/><\/span>\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"mensaje\"><textarea cols=\"40\" rows=\"10\" maxlength=\"2000\" class=\"wpcf7-form-control wpcf7-textarea wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"\u00bfC\u00f3mo podemos ayudarte?*\" name=\"mensaje\"><\/textarea><\/span>\n<\/p>\n<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner\" type=\"submit\" value=\"Enviar\" \/>\n<\/p><div class=\"fusion-alert alert custom alert-custom fusion-alert-center wpcf7-response-output awb-alert-native-link-color alert-dismissable awb-alert-close-boxed\" style=\"--awb-border-size:1px;--awb-border-top-left-radius:0px;--awb-border-top-right-radius:0px;--awb-border-bottom-left-radius:0px;--awb-border-bottom-right-radius:0px;\" role=\"alert\"><div class=\"fusion-alert-content-wrapper\"><span class=\"fusion-alert-content\"><\/span><\/div><button type=\"button\" class=\"close toggle-alert\" data-dismiss=\"alert\" aria-label=\"Close\">&times;<\/button><\/div>\n<\/form>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-6 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-sizes-bottom:1px;--awb-border-color:var(--awb-color5);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:20px;--awb-padding-bottom:10px;--awb-background-color:var(--awb-color4);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-center fusion-flex-justify-content-space-between fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-10 fusion_builder_column_1_5 1_5 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-spacing-right-large:9.6%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:9.6%;--awb-width-medium:20%;--awb-order-medium:0;--awb-spacing-right-medium:9.6%;--awb-spacing-left-medium:9.6%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-image-element \" style=\"--awb-max-width:150px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-3 hover-type-none fusion-animated\" data-animationType=\"fadeInLeft\" data-animationDuration=\"0.3\" data-animationOffset=\"top-into-view\"><img decoding=\"async\" width=\"2560\" height=\"2477\" title=\"ISOTIPO CMC MEDICAL DEVICES_VERDE\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-scaled.webp\" alt class=\"img-responsive wp-image-19\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-200x194.webp 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-400x387.webp 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-600x581.webp 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-768x743.webp 768w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-800x774.webp 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-1200x1161.webp 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-1536x1486.webp 1536w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_VERDE-scaled.webp 2560w\" sizes=\"(max-width: 640px) 100vw, 200px\" \/><\/span><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-11 fusion_builder_column_4_5 4_5 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:80%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.4%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:2.4%;--awb-width-medium:80%;--awb-order-medium:0;--awb-spacing-right-medium:2.4%;--awb-spacing-left-medium:2.4%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-7 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-font-size:35px;\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Merriweather&quot;;font-style:normal;font-weight:400;margin:0;font-size:1em;--fontSize:35;line-height:var(--awb-typography1-line-height);\">Preguntas Frecuentes sobre el Agente FDA<\/h2><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-7 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-sizes-bottom:1px;--awb-border-color:rgba(197,252,84,0.5);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:75px;--awb-padding-bottom:85px;--awb-background-color:var(--awb-color5);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-12 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"accordian fusion-accordian\" style=\"--awb-padding-top:10px;--awb-padding-bottom:10px;--awb-border-size:1px;--awb-icon-size:16px;--awb-content-font-size:var(--awb-typography4-font-size);--awb-icon-alignment:left;--awb-hover-color:var(--awb-color2);--awb-border-color:var(--awb-color3);--awb-background-color:var(--awb-color1);--awb-divider-color:var(--awb-color3);--awb-divider-hover-color:var(--awb-color3);--awb-icon-color:var(--awb-color1);--awb-title-color:var(--awb-color3);--awb-content-color:var(--awb-color4);--awb-icon-box-color:var(--awb-color4);--awb-toggle-hover-accent-color:var(--awb-color4);--awb-title-font-family:&quot;Merriweather&quot;;--awb-title-font-weight:400;--awb-title-font-style:normal;--awb-title-font-size:16px;--awb-content-font-family:&quot;Merriweather Sans&quot;;--awb-content-font-style:normal;--awb-content-font-weight:400;\"><div class=\"panel-group fusion-toggle-icon-unboxed\" id=\"accordion-841-1\"><div class=\"fusion-panel panel-default panel-37a7fd8e70423dcd4 fusion-toggle-has-divider\" style=\"--awb-content-font-family:&quot;Merriweather Sans&quot;;--awb-content-font-style:normal;--awb-content-font-weight:400;--awb-title-font-family:&quot;Merriweather&quot;;--awb-title-font-weight:400;--awb-title-font-style:normal;--awb-title-font-size:20px;--awb-title-color:var(--awb-color3);\"><div class=\"panel-heading\"><h3 class=\"panel-title toggle\" id=\"toggle_37a7fd8e70423dcd4\"><a aria-expanded=\"false\" aria-controls=\"37a7fd8e70423dcd4\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-841-1\" data-target=\"#37a7fd8e70423dcd4\" href=\"#37a7fd8e70423dcd4\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">\u00bfEs obligatorio tener un agente de la FDA si mi empresa est\u00e1 fuera de EE.UU.?<\/span><\/a><\/h3><\/div><div id=\"37a7fd8e70423dcd4\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_37a7fd8e70423dcd4\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p><span data-sheets-root=\"1\">S\u00ed, cualquier empresa extranjera que desee vender productos regulados por la FDA en el mercado de EE.UU. debe designar a un agente de la FDA con sede en EE.UU.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-648a2c0a69f6da19f fusion-toggle-has-divider\" style=\"--awb-content-font-family:&quot;Merriweather Sans&quot;;--awb-content-font-style:normal;--awb-content-font-weight:400;--awb-title-font-family:&quot;Merriweather&quot;;--awb-title-font-weight:400;--awb-title-font-style:normal;--awb-title-font-size:20px;--awb-title-color:var(--awb-color3);\"><div class=\"panel-heading\"><h3 class=\"panel-title toggle\" id=\"toggle_648a2c0a69f6da19f\"><a aria-expanded=\"false\" aria-controls=\"648a2c0a69f6da19f\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-841-1\" data-target=\"#648a2c0a69f6da19f\" href=\"#648a2c0a69f6da19f\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">\u00bfQu\u00e9 responsabilidades tiene el agente de la FDA?<\/span><\/a><\/h3><\/div><div id=\"648a2c0a69f6da19f\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_648a2c0a69f6da19f\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p><span data-sheets-root=\"1\">El agente es responsable de recibir y reenviar las comunicaciones de la FDA, coordinar las inspecciones y responder a las consultas en nombre de la empresa extranjera. No toma decisiones operativas, pero es esencial para asegurar el cumplimiento con las normativas de la FDA.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-b8b1d5d31d09556bf fusion-toggle-has-divider\" style=\"--awb-content-font-family:&quot;Merriweather Sans&quot;;--awb-content-font-style:normal;--awb-content-font-weight:400;--awb-title-font-family:&quot;Merriweather&quot;;--awb-title-font-weight:400;--awb-title-font-style:normal;--awb-title-font-size:20px;--awb-title-color:var(--awb-color3);\"><div class=\"panel-heading\"><h3 class=\"panel-title toggle\" id=\"toggle_b8b1d5d31d09556bf\"><a aria-expanded=\"false\" aria-controls=\"b8b1d5d31d09556bf\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-841-1\" data-target=\"#b8b1d5d31d09556bf\" href=\"#b8b1d5d31d09556bf\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">\u00bfEs el agente de la FDA responsable de la calidad o seguridad de mis productos?<\/span><\/a><\/h3><\/div><div id=\"b8b1d5d31d09556bf\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_b8b1d5d31d09556bf\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p><span data-sheets-root=\"1\">No, el agente act\u00faa solo como enlace de comunicaci\u00f3n entre la empresa y la FDA. La empresa sigue siendo totalmente responsable de la calidad, seguridad y conformidad de sus productos.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-c77590e204f31debc fusion-toggle-has-divider\" style=\"--awb-content-font-family:&quot;Merriweather Sans&quot;;--awb-content-font-style:normal;--awb-content-font-weight:400;--awb-title-font-family:&quot;Merriweather&quot;;--awb-title-font-weight:400;--awb-title-font-style:normal;--awb-title-font-size:20px;--awb-title-color:var(--awb-color3);\"><div class=\"panel-heading\"><h3 class=\"panel-title toggle\" id=\"toggle_c77590e204f31debc\"><a aria-expanded=\"false\" aria-controls=\"c77590e204f31debc\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-841-1\" data-target=\"#c77590e204f31debc\" href=\"#c77590e204f31debc\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">\u00bfPuede mi distribuidor en EE.UU. actuar como mi agente de la FDA?<\/span><\/a><\/h3><\/div><div id=\"c77590e204f31debc\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_c77590e204f31debc\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p><span data-sheets-root=\"1\">S\u00ed, su distribuidor u otra persona o entidad con sede en EE.UU. puede ser designada como su agente, siempre y cuando est\u00e9n dispuestos a asumir las responsabilidades que conlleva el rol.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-472ef62a8ffadd9bb fusion-toggle-has-divider\" style=\"--awb-content-font-family:&quot;Merriweather Sans&quot;;--awb-content-font-style:normal;--awb-content-font-weight:400;--awb-title-font-family:&quot;Merriweather&quot;;--awb-title-font-weight:400;--awb-title-font-style:normal;--awb-title-font-size:20px;--awb-title-color:var(--awb-color3);\"><div class=\"panel-heading\"><h3 class=\"panel-title toggle\" id=\"toggle_472ef62a8ffadd9bb\"><a aria-expanded=\"false\" aria-controls=\"472ef62a8ffadd9bb\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-841-1\" data-target=\"#472ef62a8ffadd9bb\" href=\"#472ef62a8ffadd9bb\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">\u00bfCu\u00e1nto cuesta contratar un agente de la FDA?<\/span><\/a><\/h3><\/div><div id=\"472ef62a8ffadd9bb\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_472ef62a8ffadd9bb\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p><span data-sheets-root=\"1\">El coste var\u00eda seg\u00fan el proveedor de servicios y el nivel de soporte ofrecido, pero es importante contratar a un agente confiable ya que desempe\u00f1a un papel crucial en la comunicaci\u00f3n con la FDA.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-27bbaa353c6b1257f fusion-toggle-has-divider\" style=\"--awb-content-font-family:&quot;Merriweather Sans&quot;;--awb-content-font-style:normal;--awb-content-font-weight:400;--awb-title-font-family:&quot;Merriweather&quot;;--awb-title-font-weight:400;--awb-title-font-style:normal;--awb-title-font-size:20px;--awb-title-color:var(--awb-color3);\"><div class=\"panel-heading\"><h3 class=\"panel-title toggle\" id=\"toggle_27bbaa353c6b1257f\"><a aria-expanded=\"false\" aria-controls=\"27bbaa353c6b1257f\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-841-1\" data-target=\"#27bbaa353c6b1257f\" href=\"#27bbaa353c6b1257f\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">\u00bfEl agente de la FDA tambi\u00e9n recibe las notificaciones oficiales sobre mis dispositivos m\u00e9dicos e IVD?<\/span><\/a><\/h3><\/div><div id=\"27bbaa353c6b1257f\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_27bbaa353c6b1257f\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p>S\u00ed. El agente de la FDA act\u00faa como punto de contacto oficial en Estados Unidos y recibe las comunicaciones y notificaciones de la FDA relacionadas con su empresa y sus productos. Su funci\u00f3n es asegurar que cualquier mensaje llegue de manera r\u00e1pida y efectiva al fabricante.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-88c92a9e28d69016c fusion-toggle-has-divider\" style=\"--awb-content-font-family:&quot;Merriweather Sans&quot;;--awb-content-font-style:normal;--awb-content-font-weight:400;--awb-title-font-family:&quot;Merriweather&quot;;--awb-title-font-weight:400;--awb-title-font-style:normal;--awb-title-font-size:20px;--awb-title-color:var(--awb-color3);\"><div class=\"panel-heading\"><h3 class=\"panel-title toggle\" id=\"toggle_88c92a9e28d69016c\"><a aria-expanded=\"false\" aria-controls=\"88c92a9e28d69016c\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-841-1\" data-target=\"#88c92a9e28d69016c\" href=\"#88c92a9e28d69016c\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">\u00bfQu\u00e9 informaci\u00f3n debe tener mi agente de la FDA sobre mi empresa y mis productos?<\/span><\/a><\/h3><\/div><div id=\"88c92a9e28d69016c\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_88c92a9e28d69016c\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p>El agente de la FDA debe contar con los datos de contacto de la empresa, la direcci\u00f3n legal, la informaci\u00f3n de los dispositivos m\u00e9dicos e IVD registrados y cualquier detalle necesario para recibir y transmitir notificaciones oficiales de la FDA. Esto garantiza una comunicaci\u00f3n fluida y el cumplimiento normativo.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-8 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-sizes-bottom:1px;--awb-border-color:rgba(197,252,84,0.5);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-bottom:0px;--awb-margin-bottom:0px;--awb-background-color:var(--awb-color5);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-13 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-8 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-text-color:var(--awb-color3);--awb-margin-top:50px;--awb-margin-top-small:30px;--awb-font-size:28px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"font-family:&quot;Merriweather&quot;;font-style:normal;font-weight:400;margin:0;font-size:1em;--fontSize:28;line-height:var(--awb-typography1-line-height);\">\u00bfPor qu\u00e9 elegir a CMC Medical Devices como Agente FDA?<\/h2><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-14 fusion_builder_column_1_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:7.68%;--awb-width-medium:25%;--awb-order-medium:0;--awb-spacing-right-medium:7.68%;--awb-spacing-left-medium:7.68%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-content-boxes content-boxes columns row fusion-columns-1 fusion-columns-total-1 fusion-content-boxes-1 content-boxes-icon-on-top content-left\" style=\"--awb-body-color:var(--awb-color4);--awb-title-color:var(--awb-color4);--awb-margin-bottom:20px;--awb-hover-accent-color:var(--awb-color4);--awb-circle-hover-accent-color:transparent;--awb-item-margin-bottom:40px;\" data-animationOffset=\"top-into-view\"><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);--awb-iconcolor:var(--awb-color4);\" class=\"fusion-column content-box-column content-box-column content-box-column-1 col-lg-12 col-md-12 col-sm-12 fusion-content-box-hover content-box-column-last content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-link-icon icon-hover-animation-none\" data-animationOffset=\"top-into-view\"><div class=\"heading heading-with-icon icon-left\"><div class=\"icon\"><i style=\"background-color:transparent;border-color:transparent;height:auto;width: 34px;line-height:normal;font-size:34px;\" aria-hidden=\"true\" class=\"fontawesome-icon fa-envelope-open fas circle-no\"><\/i><\/div><p class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--body_typography-font-size:24px;--fontSize:24;line-height:1.5;\">Respuesta r\u00e1pida <\/p><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<p>Atendemos de manera r\u00e1pida y eficiente cualquier consulta de las autoridades o cuerpos regulatorios en los pa\u00edses donde operamos.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-15 fusion_builder_column_1_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:7.68%;--awb-width-medium:25%;--awb-order-medium:0;--awb-spacing-right-medium:7.68%;--awb-spacing-left-medium:7.68%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-content-boxes content-boxes columns row fusion-columns-1 fusion-columns-total-1 fusion-content-boxes-2 content-boxes-icon-on-top content-left\" style=\"--awb-body-color:var(--awb-color4);--awb-title-color:var(--awb-color4);--awb-margin-bottom:20px;--awb-hover-accent-color:var(--awb-color4);--awb-circle-hover-accent-color:transparent;--awb-item-margin-bottom:40px;\" data-animationOffset=\"top-into-view\"><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);--awb-iconcolor:var(--awb-color4);\" class=\"fusion-column content-box-column content-box-column content-box-column-1 col-lg-12 col-md-12 col-sm-12 fusion-content-box-hover content-box-column-last content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-link-icon icon-hover-animation-none\" data-animationOffset=\"top-into-view\"><div class=\"heading heading-with-icon icon-left\"><div class=\"icon\"><i style=\"background-color:transparent;border-color:transparent;height:auto;width: 34px;line-height:normal;font-size:34px;\" aria-hidden=\"true\" class=\"fontawesome-icon fa-envelope-open fas circle-no\"><\/i><\/div><p class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--body_typography-font-size:24px;--fontSize:24;line-height:1.5;\">Comunicaci\u00f3n eficiente<\/p><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<p>Nuestro equipo ofrece respuestas r\u00e1pidas y claras a cualquier pregunta o inquietud, minimizando demoras y garantizando un proceso de aprobaci\u00f3n sin contratiempos.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-16 fusion_builder_column_1_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:7.68%;--awb-width-medium:25%;--awb-order-medium:0;--awb-spacing-right-medium:7.68%;--awb-spacing-left-medium:7.68%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-content-boxes content-boxes columns row fusion-columns-1 fusion-columns-total-1 fusion-content-boxes-3 content-boxes-icon-on-top content-left\" style=\"--awb-body-color:var(--awb-color4);--awb-title-color:var(--awb-color4);--awb-margin-bottom:20px;--awb-hover-accent-color:var(--awb-color4);--awb-circle-hover-accent-color:transparent;--awb-item-margin-bottom:40px;\" data-animationOffset=\"top-into-view\"><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);--awb-iconcolor:var(--awb-color4);\" class=\"fusion-column content-box-column content-box-column content-box-column-1 col-lg-12 col-md-12 col-sm-12 fusion-content-box-hover content-box-column-last content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-link-icon icon-hover-animation-none\" data-animationOffset=\"top-into-view\"><div class=\"heading heading-with-icon icon-left\"><div class=\"icon\"><i style=\"background-color:transparent;border-color:transparent;height:auto;width: 34px;line-height:normal;font-size:34px;\" aria-hidden=\"true\" class=\"fontawesome-icon fa-user-clock fas circle-no\"><\/i><\/div><p class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--body_typography-font-size:24px;--fontSize:24;line-height:1.5;\">Soporte inmediato <\/p><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<p>Gestionamos consultas y solicitudes tanto de fabricantes como de organismos regulatorios con velocidad y precisi\u00f3n.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-17 fusion_builder_column_1_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:7.68%;--awb-width-medium:25%;--awb-order-medium:0;--awb-spacing-right-medium:7.68%;--awb-spacing-left-medium:7.68%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-content-boxes content-boxes columns row fusion-columns-1 fusion-columns-total-1 fusion-content-boxes-4 content-boxes-icon-on-top content-left\" style=\"--awb-body-color:var(--awb-color4);--awb-title-color:var(--awb-color4);--awb-margin-bottom:20px;--awb-hover-accent-color:var(--awb-color4);--awb-circle-hover-accent-color:transparent;--awb-item-margin-bottom:40px;\" data-animationOffset=\"top-into-view\"><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);--awb-iconcolor:var(--awb-color4);\" class=\"fusion-column content-box-column content-box-column content-box-column-1 col-lg-12 col-md-12 col-sm-12 fusion-content-box-hover content-box-column-last content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-link-icon icon-hover-animation-none\" data-animationOffset=\"top-into-view\"><div class=\"heading heading-with-icon icon-left\"><div class=\"icon\"><i style=\"background-color:transparent;border-color:transparent;height:auto;width: 34px;line-height:normal;font-size:34px;\" aria-hidden=\"true\" class=\"fontawesome-icon fa-cogs fas circle-no\"><\/i><\/div><p class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--body_typography-font-size:24px;--fontSize:24;line-height:1.5;\">Resoluci\u00f3n r\u00e1pida <\/p><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<p>Cualquier pregunta de cumplimiento o necesidad de documentaci\u00f3n se aborda de inmediato, asegurando que su producto avance a trav\u00e9s del proceso regulatorio de la manera m\u00e1s r\u00e1pida y fluida posible.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":660,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-841","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Servicios de Representaci\u00f3n como Agente de la FDA en US para Dispositivos M\u00e9dicos | CMC<\/title>\n<meta name=\"description\" content=\"Servicios de Agente de la FDA en EE.UU. para dispositivos m\u00e9dicos. 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