{"id":9345,"date":"2025-07-30T07:26:59","date_gmt":"2025-07-30T07:26:59","guid":{"rendered":"https:\/\/mdxcro.com\/services\/estudios-analiticos-de-ivd\/"},"modified":"2026-04-07T07:28:06","modified_gmt":"2026-04-07T07:28:06","slug":"estudios-analiticos-ivd","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/es\/servicios\/estudios-analiticos-ivd\/","title":{"rendered":"Estudios anal\u00edticos de IVD"},"content":{"rendered":"\n<section id=\"block_f3274057dc1600e2aac6bb849d88b00c\" class=\"hero\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/sectors-MDx-CRO.webp\" fetchpriority=\"high\" class=\"no-lazy\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Validaci\u00f3n anal\u00edtica de IVD que acelera la aprobaci\u00f3n global<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\">Estudios de rendimiento anal\u00edtico dirigidos por expertos para el cumplimiento de IVDR, FDA y CLSI, que cubren sensibilidad, especificidad, estabilidad e informes de rendimiento anal\u00edtico (APR). Desbloquee un acceso m\u00e1s r\u00e1pido al mercado con MDx CRO. <\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/es\/contacto\/?utm_source=ivd_analytical_studies\" class=\"button button--default\" target=\"_self\">\n                            Reserve una consulta                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/a-cros-guide-to-ivd-analytical-validation-best-practices-common-pitfalls\/\" class=\"button button--secondary\" target=\"_self\">\n                            Explore nuestra gu\u00eda de validaci\u00f3n anal\u00edtica de IVD                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_68e290f370603d96b3951e668b3495e3\" class=\"text-image\" style=\"margin-top: var(--wp--preset--spacing--regular); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Por qu\u00e9 es importante la <span class=\"blue-highlight\">validaci\u00f3n anal\u00edtica<\/span><\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">La validaci\u00f3n anal\u00edtica es la base de la evidencia cl\u00ednica y la aprobaci\u00f3n regulatoria de los DIV. Ya sea que est\u00e9 lanzando un nuevo ensayo de diagn\u00f3stico o realizando la transici\u00f3n de un producto heredado a IVDR, los datos s\u00f3lidos de rendimiento anal\u00edtico son esenciales para demostrar la fiabilidad, precisi\u00f3n y seguridad del ensayo. En MDx CRO, ofrecemos estudios anal\u00edticos que cumplen con los m\u00e1s altos est\u00e1ndares globales, lo que garantiza que sus declaraciones de rendimiento est\u00e9n respaldadas, las presentaciones tengan \u00e9xito y los plazos se cumplan.  <\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Alcance integral:<\/b><span style=\"font-weight: 400\"> Estudios de sensibilidad anal\u00edtica, especificidad, precisi\u00f3n, exactitud, LoD\/LoQ, linealidad y estabilidad.<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Alineaci\u00f3n regulatoria:<\/b><span style=\"font-weight: 400\"> Anexo I de IVDR, FDA 510(k)\/PMA y directrices de CLSI (EP05, EP17, EP25, etc.).<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Socios de laboratorio cualificados seg\u00fan la norma ISO 15189<\/b><span style=\"font-weight: 400\"> y un historial probado con organismos notificados y la FDA.<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/analytical-validation-scaled.jpg\" alt=\"Innovative scientist in a laboratory using a microscope, emphasizing MDX&#039;s role in accelerating MedTech development and innovation.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_23bf852ebec847b1207324c51d6be151\" class=\"flip-cards flip-cards--three-columns \" style=\"padding-bottom: var(--wp--preset--spacing--regular); \">\n            <div class=\"container\">\n        <div class=\"content\">\n                            <h3 class=\"subtitle\">Dise\u00f1o y ejecuci\u00f3n de estudios anal\u00edticos de servicio completo<\/h3>\n            \n                            <h2 class=\"title\">MDx CRO ofrece validaci\u00f3n anal\u00edtica integral para DIV<\/h2>\n            \n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-Black-61.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-61.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Planificaci\u00f3n y estrategia<\/div>\n                        <div class=\"back\"><ul>\n<li>Hoja de ruta regulatoria (IVDR\/FDA)<\/li>\n<li>Plan de rendimiento anal\u00edtico<\/li>\n<li>Desarrollo de protocolos<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-2.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-2.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Validaci\u00f3n de ensayos<\/div>\n                        <div class=\"back\"><ul>\n<li>Validaci\u00f3n de m\u00e9todos anal\u00edticos<\/li>\n<li>Dise\u00f1o de estudio conforme a CLSI<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-6.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-Black-6-1.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Ejecuci\u00f3n del estudio<\/div>\n                        <div class=\"back\"><ul>\n<li>Calificaci\u00f3n del sitio y del laboratorio, gesti\u00f3n de proyectos<\/li>\n<li>Monitorizaci\u00f3n<\/li>\n<li>Recopilaci\u00f3n de datos<\/li>\n<li>Preparaci\u00f3n para auditor\u00edas<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-46.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-46.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Informes y presentaci\u00f3n<\/div>\n                        <div class=\"back\"><ul>\n<li>Informe de rendimiento anal\u00edtico (APR)<\/li>\n<li>Paquetes de evidencia IVDR<\/li>\n<li>Soporte para la presentaci\u00f3n Q de la FDA<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-Black-4-1.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-4.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Tecnolog\u00edas admitidas<\/div>\n                        <div class=\"back\"><ul>\n<li>PCR<\/li>\n<li>NGS<\/li>\n<li>IHC, inmunoensayos<\/li>\n<li>Multiplex<\/li>\n<li>Flujo lateral<\/li>\n<li>SaMD<\/li>\n<li>y m\u00e1s<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Formaci\u00f3n y transferencia de conocimientos<\/div>\n                        <div class=\"back\"><ul>\n<li> Procesos de validaci\u00f3n anal\u00edtica<\/li>\n<li>Requisitos de evidencia de IVDR<\/li>\n<li>Transferencia de conocimientos para capacidades internas sostenibles<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n<section id=\"block_0a02b39f47c0816315641f01615a33e8\" class=\"content-columns content-columns--four-columns content-columns--background-white\" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: var(--wp--preset--spacing--regular); \">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Lo que ofrecemos<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Protocolos de validaci\u00f3n de ensayos<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Sensibilidad y especificidad anal\u00edticas<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Estudios de precisi\u00f3n y exactitud<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">L\u00edmite de detecci\u00f3n (LoD) \/ l\u00edmite de cuantificaci\u00f3n (LoQ) \/ linealidad<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Interferencia y reactividad cruzada<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Reproducibilidad y repetibilidad<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Soporte para la precalificaci\u00f3n de la OMS<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Dise\u00f1o de estudios de estabilidad<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Estudios de estabilidad acelerada y en tiempo real<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Desarrollo de protocolos (CLSI EP25)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">An\u00e1lisis de datos e informes<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Documentaci\u00f3n e informes<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Protocolos de validaci\u00f3n anal\u00edtica<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Informes de rendimiento anal\u00edtico (APR)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Paquetes de evidencia compatibles con IVDR<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Documentaci\u00f3n de presentaci\u00f3n Q de la FDA<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Tipos de ensayos admitidos<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Diagn\u00f3stico molecular (PCR, qPCR, NGS)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Inmunoensayos y plataformas multiplex<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Kits de diagn\u00f3stico basados en IHC<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Diagn\u00f3stico basado en software (SaMD)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Pruebas de flujo lateral y en el punto de atenci\u00f3n<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n                    <div class=\"button-wrapper\">\n                                    <a href=\"https:\/\/mdxcro.com\/es\/areas-terapeuticas\/\" class=\"button button--quaternary\" target=\"_self\">\n                        Explore todas las \u00e1reas terap\u00e9uticas                    <\/a>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_05684f414304e1152ad73d734b4fb2e2\" class=\"text-image text-image--background-frost-white text-image--reduced-spacing\" style=\"padding-top: var(--wp--preset--spacing--medium); padding-bottom: var(--wp--preset--spacing--medium); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Alineaci\u00f3n regulatoria<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">Sus estudios anal\u00edticos est\u00e1n asignados a todos los requisitos internacionales clave:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Anexo I, Cap\u00edtulo II, Parte A de IVDR<\/b><span style=\"font-weight: 400\"> \u2013 Requisitos de rendimiento anal\u00edtico<\/span><\/li>\n<li style=\"font-weight: 400\"><b>FDA 510(k), De Novo, PMA<\/b><span style=\"font-weight: 400\"> \u2013 Validaci\u00f3n anal\u00edtica y generaci\u00f3n de evidencia<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Directrices de CLSI<\/b><span style=\"font-weight: 400\"> \u2013 EP05, EP07, EP17, EP25 y m\u00e1s<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Sistema de gesti\u00f3n de calidad ISO 13485<\/b><span style=\"font-weight: 400\"> y <\/span><b>GSPR<\/b><span style=\"font-weight: 400\"> (UE)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>ISO 15189<\/b><span style=\"font-weight: 400\"> est\u00e1ndares de laboratorio<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/68778a52ad1ece5602fe45605fa28d420d1bd9a1-scaled.jpg\" alt=\"Innovative medical research scientists conducting laboratory experiments with microscopes and test tubes, advancing MedTech solutions to accelerate healthcare innovation.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n<section class=\"table\"><div class=\"container\"><div class=\"headline\">\u00bfPor qu\u00e9 elegir MDx CRO?<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Capacidad<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\"><strong>Validaci\u00f3n de m\u00e9todos anal\u00edticos<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Experiencia en IVDR y FDA<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Cumplimiento de las directrices de CLSI<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Desarrollo de APR<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Experiencia en ensayos<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Dise\u00f1o de estudios de estabilidad<\/strong><\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">Ventaja de MDx CRO<\/th><th class=\"column\">CRO t\u00edpicas<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\">Protocolos personalizados desarrollados internamente<\/td><td class=\"cell\">A menudo gen\u00e9rico<\/td><\/tr><tr><td class=\"cell highlight\">Historial probado, la mayor\u00eda de las tecnolog\u00edas<\/td><td class=\"cell\">Limitada<\/td><\/tr><tr><td class=\"cell highlight\">Alineaci\u00f3n con la FDA y la UE<\/td><td class=\"cell\">Parcial<\/td><\/tr><tr><td class=\"cell highlight\">Soporte completo, formato IVDR<\/td><td class=\"cell\">Rara vez se ofrece<\/td><\/tr><tr><td class=\"cell highlight\">PCR, NGS, IHC, SaMD, inmunoensayos, flujo lateral, etc.<\/td><td class=\"cell\">Tecnolog\u00eda limitada<\/td><\/tr><tr><td class=\"cell highlight\">En tiempo real y acelerado, soporte completo<\/td><td class=\"cell\">Rara vez se ofrece<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section id=\"block_6f8d79b12d70dd96125b8fa86660cf2f\" class=\"text-image text-image--background-frost-white\" style=\"padding-top: var(--wp--preset--spacing--medium); padding-bottom: var(--wp--preset--spacing--medium); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Resultados que importan<\/h2><div class=\"description wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><b>Tasa de \u00e9xito del 100%<\/b><span style=\"font-weight: 400\">: Sin hallazgos importantes del organismo notificado en el dise\u00f1o del estudio anal\u00edtico<\/span><\/li>\n<li style=\"font-weight: 400\"><b>M\u00e1s de 40 proyectos<\/b><span style=\"font-weight: 400\">: Estudios de rendimiento anal\u00edtico para DIV, CDx y diagn\u00f3sticos digitales<\/span><\/li>\n<\/ul>\n<p><b>Con la confianza de los 10 principales fabricantes de DIV<\/b><span style=\"font-weight: 400\">, empresas de diagn\u00f3stico en fase inicial y mediana<\/span><\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/yaiza-hugo-scaled.jpg\" alt=\"\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_8da75d1f1aa2a00a0a5c3ddbd6df1415\" class=\"testimonials\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg&#039;);\">\n        <div class=\"testimonials--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg\" \/>\n    <\/div>\n    <div class=\"container\">\n                    <div class=\"headline\">Testimonios de clientes<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00abMDx\u2019s analytical validation expertise enabled us to secure IVDR approval with zero major findings. Their tailored protocols and responsive team made all the difference.\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Regulatory Affairs Director, Global IVD Manufacturer                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00abAs a US-based diagnostics company, MDx CRO was our bridge to European IVDR compliance. Their analytical study design team and APR support were world-class.\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                VP, Clinical Development, Molecular Diagnostics SME                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00abMDx helped us navigate analytical validation under very tight timelines. Their team was hands-on, pragmatic, and always available when issues came up.\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Director of Clinical Operations                                                                <br>\n                                European IVD Company                                        \n                            <\/p>\n                                            <\/div>\n                            <\/div>\n        \n        <div class=\"footer\">\n            <div class=\"slider-dots\"><\/div>\n            <div class=\"button-wrapper\">\n                            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_bb59b8e4a8372489c1cfd32b1fa83539\" class=\"faqs\" style=\"padding-top: Predeterminado; padding-bottom: Predeterminado; margin-top: Predeterminado; margin-bottom: Predeterminado; \">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Preguntas frecuentes<\/h2>\n                          <a class=\"button button--quaternary\" href=\"https:\/\/mdxcro.com\/es\/contacto\/\" target=\"\">\n            Haga una pregunta          <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfCu\u00e1l es la diferencia entre la validaci\u00f3n anal\u00edtica y la validaci\u00f3n cl\u00ednica?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">La validaci\u00f3n anal\u00edtica confirma que un DIV mide de forma precisa, fiable y consistente el analito de inter\u00e9s (por ejemplo, sensibilidad, especificidad, precisi\u00f3n). La validaci\u00f3n cl\u00ednica eval\u00faa qu\u00e9 tan bien la prueba identifica una condici\u00f3n cl\u00ednica en la poblaci\u00f3n objetivo. Ambos son necesarios para las presentaciones de IVDR y FDA.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfPuede MDx ayudar con la creaci\u00f3n de APR e informes de rendimiento anal\u00edtico de IVDR?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">S\u00ed. Proporcionamos un desarrollo completo de APR, incluido el an\u00e1lisis estad\u00edstico, la redacci\u00f3n de res\u00famenes y el formato para los requisitos de IVDR y FDA. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfAdmite documentaci\u00f3n compatible con CLSI?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Absolutamente. Nuestros protocolos e informes est\u00e1n alineados con los est\u00e1ndares de CLSI (EP05, EP17, EP25, etc.), lo que garantiza la aceptaci\u00f3n regulatoria global. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfQu\u00e9 tipos de tecnolog\u00edas admiten?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Cubrimos PCR, NGS, inmunoensayos, IHC, multiplex, flujo lateral, SaMD y m\u00e1s.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfCon qu\u00e9 rapidez se puede completar un estudio de validaci\u00f3n anal\u00edtica?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Los plazos dependen de la complejidad del ensayo y la disponibilidad de muestras, pero la mayor\u00eda de los estudios se completan en 2 a 6 meses con la gesti\u00f3n de proyectos de MDx CRO.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                      <\/ul>\n              <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n  <script type=\"application\/ld+json\">\n    {\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"\u00bfCu\u00e1l es la diferencia entre la validaci\u00f3n anal\u00edtica y la validaci\u00f3n cl\u00ednica?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"La validaci\u00f3n anal\u00edtica confirma que un DIV mide de forma precisa, fiable y consistente el analito de inter\u00e9s (por ejemplo, sensibilidad, especificidad, precisi\u00f3n). 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