{"id":9343,"date":"2025-07-30T07:24:22","date_gmt":"2025-07-30T07:24:22","guid":{"rendered":"https:\/\/mdxcro.com\/services\/medicina-de-precision-y-cdx\/"},"modified":"2026-04-29T07:57:59","modified_gmt":"2026-04-29T07:57:59","slug":"medicina-de-precision-diagnosticos-complementarios","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/es\/servicios\/medicina-de-precision-diagnosticos-complementarios\/","title":{"rendered":"Medicina de precisi\u00f3n y CDx"},"content":{"rendered":"\n<section id=\"block_44789d4e10901ba8f93a085f364506e7\" class=\"hero\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/Services-MDx-CRO.webp\" fetchpriority=\"high\" class=\"no-lazy\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Su socio de precisi\u00f3n para diagn\u00f3sticos complementarios y ensayos basados en biomarcadores<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\">MDx CRO es una CRO de medicina de precisi\u00f3n y diagn\u00f3sticos complementarios que ayuda a los equipos de IVD y farmac\u00e9uticos a dise\u00f1ar y ejecutar estudios cl\u00ednicos de CDx. Gestionamos el desarrollo de CDx desde la validaci\u00f3n de biomarcadores hasta el cumplimiento del IVDR, las presentaciones Q de la FDA y la ejecuci\u00f3n cl\u00ednica conforme a la norma ISO 20916. <\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/es\/contacto\/?utm_source=prec_med_cdx\" class=\"button button--default\" target=\"_self\">\n                            Reserve una consulta de CDx                        <\/a>\n                                            <a href=\"#popup-7743\" class=\"button button--secondary\" target=\"_self\">\n                            Descargar PDF de servicios de CDx                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_96a963d310e77c2964aa22f3a3950f5b\" class=\"text-image text-image--wide text-image--video-player\" style=\"\">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">CRO de CDx servicio completo para <span class=\"blue-highlight\">medicina de precisi\u00f3n<\/span> <\/h2><div class=\"description wysiwyg\"><p data-start=\"1804\" data-end=\"2126\">MDx CRO es una <strong>CRO especializada en diagn\u00f3sticos complementarios<\/strong> que ayuda a los equipos farmac\u00e9uticos y de IVD a planificar y ejecutar estudios cl\u00ednicos de diagn\u00f3sticos complementarios. Alineamos la estrategia de biomarcadores y la validaci\u00f3n de ensayos con el <strong>Anexo XIV del IVDR<\/strong> y las <strong>v\u00edas de presentaci\u00f3n PMA\/Q de la FDA<\/strong> para acelerar el acceso al mercado en Europa (UE\/Reino Unido) y en los EE. UU. <\/p>\n<p data-start=\"1804\" data-end=\"2126\">Desde la selecci\u00f3n de la v\u00eda SRD frente a NSRD y la preparaci\u00f3n de la presentaci\u00f3n Q hasta el dise\u00f1o y la monitorizaci\u00f3n del estudio ISO 20916, nuestro equipo ofrece una ejecuci\u00f3n <strong>CRO de CDx integral<\/strong>, que incluye la delegaci\u00f3n del patrocinador y los servicios de representante legal en la UE\/Reino Unido.<\/p>\n<\/div><a class=\"button\" href=\"https:\/\/mdxcro.com\/es\/contacto\/\" target=\"_self\">Aprenda a planificar un PSA en virtud del Anexo XIV del IVDR<\/a><\/div><\/div>                            <div class=\"column column--image\"><div class=\"video-player video-player--youtube\" data-youtube-url=\"https:\/\/www.youtube.com\/embed\/E8RbCzAtJtY\"><div class=\"youtube-container\"><div class=\"youtube-poster\"><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDx-CRO-CDx-services.jpg\" alt=\"Video Poster\" \/><button class=\"play-btn youtube-play-btn\"><\/button><\/div><div class=\"youtube-iframe-container\" style=\"display: none\"><!-- Iframe will be created here dynamically --><\/div><\/div><\/div><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_c922e9b124181d2cee8d710553503599\" class=\"flip-cards flip-cards--three-columns flip-cards--grayscale \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n                            <h3 class=\"subtitle\">Su viaje de diagn\u00f3stico complementario<br>Totalmente gestionado, paso a paso<\/h3>\n            \n                            <h2 class=\"title\">UN OBJETIVO<\/h2>\n            \n                            <div class=\"teaser wysiwyg\"><p>Aprobaciones regulatorias sin demora. Primer paciente, primera muestra, m\u00e1s r\u00e1pido.<\/p>\n<\/div>\n            \n                            <div class=\"description wysiwyg\"><p>Guiamos a los patrocinadores de medicina de precisi\u00f3n a trav\u00e9s de cada fase cr\u00edtica, alineando los flujos de trabajo cl\u00ednicos, regulatorios y operativos para acelerar su camino hacia la aprobaci\u00f3n.<\/p>\n<\/div>\n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-blue card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">01<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Estrategia cl\u00ednica de CDx y hoja de ruta regulatoria (FDA + IVDR)<\/div>\n                        <div class=\"back\"><p>Defina su v\u00eda de desarrollo con la orientaci\u00f3n de expertos sobre los requisitos de la FDA y el IVDR, incluidas las determinaciones <strong>SRD frente a NSRD<\/strong>, las reuniones de presentaci\u00f3n Q y las presentaciones PMA. Nuestra inteligencia regulatoria abarca los EE. UU. y la UE. <\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--value\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/biomarker-assay-validation-scaled.jpg&#039;);\"                         >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">02<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Validaci\u00f3n de biomarcadores y ensayos<\/div>\n                        <div class=\"back\"><p>Soporte para el descubrimiento de biomarcadores, el desarrollo de ensayos cl\u00ednicos, la validaci\u00f3n anal\u00edtica y la estrategia de biomarcadores traslacionales. Incluye la validaci\u00f3n de ensayos para plataformas qPCR, NGS, IHC y SaMD. <\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">03<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Diligencia debida de laboratorios y socios de diagn\u00f3stico<\/div>\n                        <div class=\"back\"><p>Calificamos a los proveedores de laboratorio, LDT y centros de pruebas seg\u00fan los requisitos de la norma ISO 15189 y el marcado CE, realizando la diligencia debida para la idoneidad de las pruebas y el cumplimiento del IVDR para los <strong data-start=\"3134\" data-end=\"3159\">ensayos cl\u00ednicos<\/strong> destinados a las declaraciones <strong data-start=\"3173\" data-end=\"3180\">CDx<\/strong>.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--value\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/design-sponsor-scaled.jpg&#039;);\"                         >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">04<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Dise\u00f1o de estudios cl\u00ednicos y delegaci\u00f3n del patrocinador<\/div>\n                        <div class=\"back\"><p>Desde la definici\u00f3n de CPSP y puntos finales hasta la gesti\u00f3n de riesgos y el consentimiento informado, dise\u00f1amos y ejecutamos <a href=\"https:\/\/mdxcro.com\/es\/servicios\/estudios-clinicos-ivd\/\"><strong>ensayos cl\u00ednicos conformes a la norma ISO 20916<\/strong><\/a>. MDx puede actuar como su <a href=\"https:\/\/mdxcro.com\/es\/servicios\/representante-autorizado-ue\/\">representante legal en la UE\/Reino Unido<\/a>. <\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">05<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Gesti\u00f3n y monitorizaci\u00f3n del centro de pruebas (ISO 20916)<\/div>\n                        <div class=\"back\"><p>Operaciones cl\u00ednicas integrales: calificaci\u00f3n, formaci\u00f3n, monitorizaci\u00f3n y preparaci\u00f3n para auditor\u00edas del centro, lo que garantiza la adhesi\u00f3n al protocolo y la alineaci\u00f3n con las BPC con la <strong data-start=\"3469\" data-end=\"3482\">ISO 20916<\/strong> en la monitorizaci\u00f3n in situ y remota.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--value\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/data-collection-scaled.jpg&#039;);\"                         >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">06<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Recopilaci\u00f3n de datos, bioestad\u00edstica e informes conformes con el IVDR<\/div>\n                        <div class=\"back\"><p>Gestionamos el dise\u00f1o de eCRF, el an\u00e1lisis estad\u00edstico y el desarrollo de informes de estudios de rendimiento cl\u00ednico para las presentaciones del IVDR, incluidos los <strong data-start=\"3620\" data-end=\"3658\">informes de estudios de rendimiento cl\u00ednico<\/strong> para el <strong data-start=\"3663\" data-end=\"3681\">Anexo XIV del IVDR<\/strong>.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">07<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Presentaciones regulatorias (UE y EE. UU.)<\/div>\n                        <div class=\"back\"><p>Desde <a href=\"https:\/\/mdxcro.com\/es\/servicios\/asuntos-regulatorios-documentacion-tecnica\/\"><strong>paquetes de presentaci\u00f3n Q y PMA de la FDA<\/strong><\/a>; aplicaciones del Anexo XIV del IVDR, gestionamos todas las comunicaciones con las autoridades \u00e9ticas y competentes, las RFI y las modificaciones.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--value\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/safety-evaluation-reporting-scaled.jpg&#039;);\"                         >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">08<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Evaluaci\u00f3n e informes de seguridad<\/div>\n                        <div class=\"back\"><p>Clasificaci\u00f3n y respuesta de eventos adversos, incluidas las comunicaciones con el organismo notificado y el comit\u00e9 de \u00e9tica. Cubre la notificaci\u00f3n de seguridad del IVDR en los ensayos cl\u00ednicos. <\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--image-only\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/logo-for-cards-scaled.jpg&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\"><\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section><section class=\"table\"><div class=\"container\"><div class=\"headline\">\u00bfQu\u00e9 diferencia a nuestra CRO de CDx para los patrocinadores de medicina de precisi\u00f3n?<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Caracter\u00edstica &#8211; capacidad<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\">Soporte para las presentaciones del Anexo XIV del IVDR (CDx)<\/td><\/tr><tr><td class=\"feature-cell\">Consultor\u00eda de CDx (FDA + UE)<\/td><\/tr><tr><td class=\"feature-cell\">Monitorizaci\u00f3n ISO 20916 (CDx)<\/td><\/tr><tr><td class=\"feature-cell\">Delegaci\u00f3n del patrocinador y representante legal en la UE\/Reino Unido<\/td><\/tr><tr><td class=\"feature-cell\">Desarrollo de documentaci\u00f3n de IVD<\/td><\/tr><tr><td class=\"feature-cell\">Experiencia traslacional y en biomarcadores<\/td><\/tr><tr><td class=\"feature-cell\">Inteligencia regulatoria<\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">MDx CRO<\/th><th class=\"column\">Otras CRO<\/th><th class=\"column\">Equipos internos<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Historial probado<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Limitado o subcontratado<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Rara vez experimentado<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Especializado en CDx<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Generalistas<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">De uso intensivo de recursos<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Expertos en laboratorio internos<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Falta de experiencia en laboratorio<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">No permitido<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Cobertura total de la UE\/Reino Unido<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Parcial o solo local<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">No permitido<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Desarrollado internamente<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Subcontratado<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Lagunas en la experiencia<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Oncolog\u00eda, enfermedades raras, NGS<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Profundidad limitada<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">No siempre especializado<\/td><\/tr><tr><td class=\"cell highlight\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Base de datos central de la UE\/CE<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Visibilidad parcial<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Ancho de banda limitado<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section id=\"block_13f806c3a9eebb93be203247e6093c6a\" class=\"content-columns content-columns--three-columns \" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">\u00c1reas terap\u00e9uticas y tecnolog\u00edas<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Enfoque terap\u00e9utico<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Oncolog\u00eda<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">CPNM, VPH, c\u00e1ncer de mama, tumores PIWIL1+, tumores con deleci\u00f3n de MTAP, CCR<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Trastornos retinianos y hereditarios<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Terapia g\u00e9nica y celular<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">S\u00edndromes mielodispl\u00e1sicos<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Tecnolog\u00edas y plataformas<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">PCR (KRAS, EGFR, ESR1, BRAF)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Paneles NGS, biopsia l\u00edquida<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Inmunoensayos (p. ej., AAV8)<\/span><\/li>\n<li style=\"font-weight: 400\">Ensayos de diagn\u00f3stico complementario (NGS, qPCR, IHC)<\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">SaMD\/Diagn\u00f3stico digital<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Secuenciaci\u00f3n HLA<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Aplicaciones de biomarcadores<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Biomarcadores predictivos y pron\u00f3sticos<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Ensayos de diagn\u00f3stico<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Software de CDx<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Desarrollo de ensayos traslacionales<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n<section id=\"block_b27b666ffc106e166f08bb22a74fe45d\" 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\">Lo que dicen nuestros clientes<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00abDelegating device sponsor responsibilities to MDx significantly improved our clinical trial operations. Their team filled critical knowledge gaps on ISO 20916, streamlined ethics submissions, and helped us secure approvals in multiple EU countries.\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                \u2014 Senior Director, Clinical Projects, Global Pharma                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00abMDx\u2019s clinical and regulatory knowledge filled critical gaps. Their team worked tirelessly to help us reach IVD study approvals across Europe.\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Senior Director, Clinical Projects                                                                <br>\n                                Global Pharma                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00abTruly the EU extension of our team. Their responsiveness and attention to detail drove our CDx transition success.\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Regulatory Director                                                                <br>\n                                US-Based Precision Medicine Company                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00abWe relied on MDx to lead our Annex XIV application and clinical performance study. Their integrated approach across regulatory, clinical, and lab operations accelerated our EU timeline and avoided costly validation rework. They are more than a CRO \u2014 they\u2019re a strategic CDx partner.\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                VP, Diagnostic Strategy                                                                <br>\n                                European Oncology Biotech                                        \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\n<section id=\"block_c0f5b6af8f84032349900680cb2ef789\" class=\"text-image\" style=\"padding-top: var(--wp--preset--spacing--xxlarge); \">\n    \t<div \n\t\tclass=\"component-top-icon\"\n\t\tstyle=\"--component-top-icon-height: 60px\"\n\t>\n\t\t<img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-icon.svg\" alt=\"\" \/>\n\t<\/div>\n\t    <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">A qui\u00e9n servimos<\/h2><div class=\"description wysiwyg\"><ul>\n<li>Empresas farmac\u00e9uticas globales que codesarrollan diagn\u00f3sticos complementarios<\/li>\n<li>Fabricantes de IVD y CDx<\/li>\n<li>Desarrolladores de diagn\u00f3sticos centrados en la oncolog\u00eda<\/li>\n<li>Patrocinadores con sede en EE. UU. que realizan estudios cl\u00ednicos de diagn\u00f3sticos complementarios en Europa<\/li>\n<li><a href=\"https:\/\/mdxcro.com\/es\/servicios\/software-salud-digital-ia\/\">Plataformas de software y diagn\u00f3stico digital<\/a><\/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\n<section class=\"key-stats\"  style=\"\">\n    <div class=\"container\">\n          <div class=\"headline\">Nuestro historial en n\u00fameros<\/div>\n    \n    <div class=\"main-wrapper\">\n              <div class=\"box-grid\">\n                                    <div class=\"box\">\n                                  <div class=\"value\">30+<\/div>\n                                                  <div class=\"legend\">Estudios combinados<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">400+<\/div>\n                                                  <div class=\"legend\">Documentos esenciales desarrollados<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">Fases I-III<\/div>\n                                                  <div class=\"legend\">Ensayos cl\u00ednicos<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">UE27\/Reino Unido<\/div>\n                                                  <div class=\"legend\">presentaciones<\/div>\n                              <\/div>\n                              <\/div>\n      \n              <img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/world-map-left-text.jpg\" alt=\"Advanced CDx innovation driving healthcare solutions across Europe.\" \/>\n          <\/div>\n\n    <div class=\"data\">\n              <div class=\"description wysiwyg\">\n          <p><b>Programas comerciales de CDx entregados<\/b><\/p>\n<p><span style=\"font-weight: 400\">MDx ha apoyado con \u00e9xito la ejecuci\u00f3n de estudios de rendimiento y las presentaciones regulatorias para programas de CDx comercializados en todo el mundo.<\/span><\/p>\n<p>Apoyamos los diagn\u00f3sticos complementarios desde la validaci\u00f3n cl\u00ednica hasta la presentaci\u00f3n Q\/PMA de la FDA y las aplicaciones del Anexo XIV del IVDR, alineando los plazos de CDx con el desarrollo de f\u00e1rmacos, incluidas las <a href=\"https:\/\/mdxcro.com\/es\/consultoria-de-div-in-vitro-para-diagnostico-complementario-dentro-del-marco-de-la-ema-guia-exhaustiva\/\"><b>consultas con la EMA y el organismo notificado.<\/b><\/a><\/p>\n        <\/div>\n      \n              <div class=\"description wysiwyg\">\n          <p><span style=\"font-weight: 400\">Nuestro historial incluye:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Ensayos IHC HER2<\/b><span style=\"font-weight: 400\"> para c\u00e1ncer de mama y g\u00e1strico<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Kits de detecci\u00f3n de mutaciones EGFR<\/b><span style=\"font-weight: 400\"> para CPNM<\/span><\/li>\n<li style=\"font-weight: 400\"><a href=\"https:\/\/mdxcro.com\/es\/servicios\/secuenciacion-nueva-generacion\/\"><b>Paneles NGS<\/b><\/a><span style=\"font-weight: 400\"><strong> con declaraciones de CDx<\/strong> (CCR y tumores s\u00f3lidos)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Ensayos multiplex y qPCR<\/b><span style=\"font-weight: 400\"> validados seg\u00fan IVDR y FDA<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n        <\/div>\n          <\/div>\n  <\/div>\n<\/section>\n<section id=\"block_100d2e75eeed2efd36fd7e0eae05c540\" 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\">\u00bfQu\u00e9 es la decisi\u00f3n SRD frente a NSRD para CDx en los EE. UU.?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>La FDA distingue entre estudios de <strong data-start=\"6266\" data-end=\"6299\">dispositivo de riesgo significativo (SRD)<\/strong> y de <strong data-start=\"6305\" data-end=\"6343\">dispositivo de riesgo no significativo (NSRD)<\/strong>. Guiamos a los patrocinadores de CDx a trav\u00e9s de las interacciones de la <strong data-start=\"6383\" data-end=\"6392\">presentaci\u00f3n Q<\/strong> y determinamos el camino correcto hacia la <strong data-start=\"6442\" data-end=\"6449\">PMA<\/strong> u otras presentaciones. <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfQu\u00e9 es el Anexo XIV del IVDR para los diagn\u00f3sticos complementarios?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>El Anexo XIV define los requisitos del <strong data-start=\"5956\" data-end=\"5986\">estudio de rendimiento cl\u00ednico<\/strong> para los IVD, incluidos los <strong data-start=\"6020\" data-end=\"6027\">CDx<\/strong>, en la UE. Cubre las presentaciones, los procesos \u00e9ticos\/de la autoridad competente y las expectativas de evidencia para la evaluaci\u00f3n de la conformidad del <strong data-start=\"6131\" data-end=\"6139\">IVDR<\/strong>. <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfPuede MDx actuar como representante legal para los estudios de rendimiento de CDx e IVDR en la UE?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">S\u00ed. Ofrecemos servicios de patrocinador delegados, presentaciones a autoridades \u00e9ticas\/competentes y <a href=\"https:\/\/mdxcro.com\/es\/servicios\/representante-autorizado-ue\/\">representaci\u00f3n legal<\/a>, gestionando la documentaci\u00f3n y las comunicaciones en su nombre.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfApoyan tanto el IVDR como la presentaci\u00f3n Q o PMA de la FDA para CDx?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Absolutamente. Definimos estrategias de presentaci\u00f3n, coordinamos la generaci\u00f3n de evidencia y gestionamos las comunicaciones integrales con los organismos notificados de la UE, la EMA y la FDA, incluidas las <strong data-start=\"6568\" data-end=\"6593\">presentaciones Q\/PMA de la FDA<\/strong> y las aplicaciones del <strong data-start=\"6598\" data-end=\"6616\">Anexo XIV del IVDR<\/strong>. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfQu\u00e9 desaf\u00edos existen al ejecutar estudios combinados bajo el CTR y el IVDR?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Los estudios combinados se enfrentan a una desalineaci\u00f3n regulatoria: el IVDR y el CTR tienen diferentes requisitos, plazos y v\u00edas de presentaci\u00f3n. MDx ayuda a los patrocinadores a navegar por estas complejidades mediante el desarrollo de estrategias integradas, asegurando que tanto los datos cl\u00ednicos como los de rendimiento cumplan con las distintas expectativas de los reguladores de productos sanitarios y medicamentos. <\/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\":\"\u00bfQu\u00e9 es la decisi\u00f3n SRD frente a NSRD para CDx en los EE. UU.?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"La FDA distingue entre estudios de dispositivo de riesgo significativo (SRD) y de dispositivo de riesgo no significativo (NSRD). Guiamos a los patrocinadores de CDx a trav\u00e9s de las interacciones de la presentaci\u00f3n Q y determinamos el camino correcto hacia la PMA u otras presentaciones.\"}},{\"@type\":\"Question\",\"name\":\"\u00bfQu\u00e9 es el Anexo XIV del IVDR para los diagn\u00f3sticos complementarios?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"El Anexo XIV define los requisitos del estudio de rendimiento cl\u00ednico para los IVD, incluidos los CDx, en la UE. Cubre las presentaciones, los procesos \u00e9ticos\/de la autoridad competente y las expectativas de evidencia para la evaluaci\u00f3n de la conformidad del IVDR.\"}},{\"@type\":\"Question\",\"name\":\"\u00bfPuede MDx actuar como representante legal para los estudios de rendimiento de CDx e IVDR en la UE?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"S\u00ed. 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Definimos estrategias de presentaci\u00f3n, coordinamos la generaci\u00f3n de evidencia y gestionamos las comunicaciones integrales con los organismos notificados de la UE, la EMA y la FDA, incluidas las presentaciones Q\/PMA de la FDA y las aplicaciones del Anexo XIV del IVDR.\"}},{\"@type\":\"Question\",\"name\":\"\u00bfQu\u00e9 desaf\u00edos existen al ejecutar estudios combinados bajo el CTR y el IVDR?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Los estudios combinados se enfrentan a una desalineaci\u00f3n regulatoria: el IVDR y el CTR tienen diferentes requisitos, plazos y v\u00edas de presentaci\u00f3n. MDx ayuda a los patrocinadores a navegar por estas complejidades mediante el desarrollo de estrategias integradas, asegurando que tanto los datos cl\u00ednicos como los de rendimiento cumplan con las distintas expectativas de los reguladores de productos sanitarios y medicamentos.\"}}]}  <\/script>\n\n<section id=\"block_e638a5805e0a3fb69038de5d70e2e5c9\" class=\"call-to-action\" style=\"padding-top: Predeterminado; padding-bottom: Predeterminado; margin-top: Predeterminado; margin-bottom: Predeterminado; \">\n        <div class=\"call-to-action--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/mdx-cta-bg.png\" \/>\n    <\/div>\n    <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"content\">\n                                    <h2 class=\"title\">Aceleremos su CDx al mercado<\/h2>\n                \n                                    <div class=\"description wysiwyg\">\n                        <p>Tanto si est\u00e1 codesarrollando un CDx con un socio farmac\u00e9utico como si est\u00e1 preparando su primera presentaci\u00f3n del Anexo XIV del IVDR, MDx es su CRO de diagn\u00f3sticos complementarios de servicio completo para el \u00e9xito regulatorio y la aprobaci\u00f3n global, ofreciendo estudios ISO 20916, representante legal en la UE\/Reino Unido y soporte para la presentaci\u00f3n Q\/PMA de la FDA.<\/p>\n<p><b>Su CDx. Nuestra experiencia. Impacto global.  <\/b><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/es\/contacto\/?utm_source=prec_med_cdx\" class=\"button button--tertiary\" target=\"\">\n                                Reserve una consulta de CDx                            <\/a>\n                                                            <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n\n<script type=\"application\/ld+json\">{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"Service\",\n  \"serviceType\": \"Companion Diagnostics (CDx) and Precision Medicine Services\",\n  \"provider\": {\n    \"@type\": \"Organization\",\n    \"name\": \"MDx CRO\",\n    \"url\": \"https:\/\/www.mdxcro.com\",\n    \"logo\": \"https:\/\/www.mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX.svg\"\n  },\n  \"areaServed\": [\n    {\n      \"@type\": \"Place\",\n      \"name\": \"European Union\"\n    },\n    {\n      \"@type\": \"Place\", \n      \"name\": \"United States\"\n    },\n    {\n      \"@type\": \"Place\",\n      \"name\": \"Asia\"\n    }\n  ],\n  \"description\": \"End-to-end companion diagnostics development services including clinical validation, FDA and IVDR regulatory strategy, and co-development support for pharmaceutical and diagnostic partners.\",\n  \"hasOfferCatalog\": {\n    \"@type\": \"OfferCatalog\",\n    \"name\": \"Companion Diagnostics Services\",\n    \"itemListElement\": [\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"CDx Clinical Validation Studies\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"FDA CDx Regulatory Strategy\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"Pharma-Diagnostic Co-Development\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"Biomarker Validation Studies\"\n        }\n      }\n    ]\n  }\n}\n<\/script>\n","protected":false},"featured_media":0,"parent":0,"menu_order":0,"template":"","meta":{"_acf_changed":true},"class_list":["post-9343","service","type-service","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CRO para Diagn\u00f3sticos Complementarios CDx | IVDR y FDA<\/title>\n<meta name=\"description\" content=\"CDx CRO para UE\/EE. 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