{"id":9338,"date":"2025-07-30T07:21:40","date_gmt":"2025-07-30T07:21:40","guid":{"rendered":"https:\/\/mdxcro.com\/services\/soluciones-clinicas-de-medtech\/"},"modified":"2026-04-07T06:47:58","modified_gmt":"2026-04-07T06:47:58","slug":"soluciones-clinicas-medtech","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/es\/servicios\/soluciones-clinicas-medtech\/","title":{"rendered":"Soluciones cl\u00ednicas de MedTech"},"content":{"rendered":"\n<section id=\"block_e79bd2929db4ae997236b8bd271c7520\" class=\"hero\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/sectors-MDx-CRO-2.webp\" fetchpriority=\"high\" class=\"no-lazy\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Soluciones cl\u00ednicas de MedTech<\/h1>\n            \n                            <div class=\"description\"><p>Acelere sus ensayos de tecnolog\u00eda m\u00e9dica, desde el dise\u00f1o hasta la presentaci\u00f3n global<br \/>\n<span style=\"font-weight: 400;\">MDx ofrece investigaci\u00f3n e investigaciones cl\u00ednicas dirigidas por expertos y que cumplen con las normas ISO 14155\/20916 para DIV y dispositivos m\u00e9dicos, lo que respalda MDR, IVDR, FDA IDE y aprobaciones globales<\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/es\/contacto\/?utm_source=medtech_clinical_solutions\" class=\"button button--default\" target=\"_self\">\n                            Reserve una llamada de descubrimiento                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/es\/contacto\/?utm_source=services&#038;utm_content=MedTech_Clinical_Solutions\" class=\"button button--secondary\" target=\"_self\">\n                            Planifique su estudio con MDx                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_f9aa918352c5850b243ad9286cc2a40a\" class=\"text-image\" style=\"margin-top: var(--wp--preset--spacing--xxlarge); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Su socio <span class=\"blue-highlight\"> CRO <\/span> de tecnolog\u00eda m\u00e9dica<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">En MDx, ofrecemos <\/span><b>soluciones cl\u00ednicas integrales<\/b><span style=\"font-weight: 400\">  para fabricantes de DIV y dispositivos m\u00e9dicos. Desde  <\/span><b>el dise\u00f1o y la viabilidad del protocolo<\/b><span style=\"font-weight: 400\"> hasta <\/span><b>las presentaciones regulatorias y el monitoreo<\/b><span style=\"font-weight: 400\">, garantizamos el \u00e9xito cl\u00ednico: m\u00e1s r\u00e1pido, m\u00e1s inteligente y con cumplimiento global.<\/span><\/p>\n<p><b>Con la confianza de patrocinadores globales<\/b><span style=\"font-weight: 400\">, incluidos los 10 principales fabricantes de DIV y tecnolog\u00eda m\u00e9dica.<\/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\/Untitled-106-scaled.jpg\" alt=\"Optimized image for MDX Accelerating MedTech, showcasing professional checks and assessments, emphasizing compliance and innovation in medical technology development and review processes.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_60a2a72f5add9f592e8fb74e99c3c275\" class=\"text-image text-image--reverse\" style=\"margin-top: var(--wp--preset--spacing--xxlarge); margin-bottom: var(--wp--preset--spacing--xxlarge); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Por qu\u00e9 los patrocinadores eligen <span class=\"blue-highlight\"> MDx <\/span> <\/h2><div class=\"description wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Operaciones cl\u00ednicas ISO 14155 \/ ISO 20916<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Soporte de servicio completo para EU MDR, IVDR y FDA IDE<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Patrocinador delegado y representante legal de la UE<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Monitoreo interno, bioestad\u00edstica, gesti\u00f3n de datos<\/span><\/li>\n<li style=\"font-weight: 400\">eCRF, eTMF, QMS y preparaci\u00f3n para auditor\u00edas<\/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\/MDxCorporate_alta-calidad-5-scaled.jpg\" alt=\"\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_adbb103328cf48f97c1a1983da90edc9\" class=\"content-columns content-columns--four-columns \" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Nuestros servicios cl\u00ednicos<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Estrategia y planificaci\u00f3n<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">Estrategia cl\u00ednica<\/span><\/li>\n<li><span style=\"font-weight: 400\">Viabilidad del estudio y selecci\u00f3n del sitio<\/span><\/li>\n<li><span style=\"font-weight: 400\">Desarrollo de protocolos (CIP \/ CPSP)<\/span><\/li>\n<li><span style=\"font-weight: 400\">Planificaci\u00f3n de la gesti\u00f3n de riesgos<\/span><\/li>\n<li><span style=\"font-weight: 400\">Estrategia cl\u00ednica<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-black\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Ejecuci\u00f3n y supervisi\u00f3n<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">Dise\u00f1o de eCRF y recopilaci\u00f3n de datos<\/span><\/li>\n<li><span style=\"font-weight: 400\">Gesti\u00f3n de eTMF<\/span><\/li>\n<li><span style=\"font-weight: 400\">Monitoreo central, in situ y basado en riesgos<\/span><\/li>\n<li><span style=\"font-weight: 400\">Bioestad\u00edstica y gesti\u00f3n de datos<\/span><\/li>\n<li><span style=\"font-weight: 400\">Informes de progreso e informes de fin de estudio (CIR, CPSR)<\/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\">Regulaci\u00f3n y cumplimiento<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">MDR, IVDR, FDA<\/span><\/li>\n<li><span style=\"font-weight: 400\">Presentaciones ante la \u00e9tica y la autoridad competente (UE, Reino Unido, EE. UU.)<\/span><\/li>\n<li><span style=\"font-weight: 400\">Representaci\u00f3n legal en la UE\/Reino Unido<\/span><\/li>\n<li><span style=\"font-weight: 400\">Registro en EUDAMED<\/span><\/li>\n<li><span style=\"font-weight: 400\">CAPA y preparaci\u00f3n para auditor\u00edas<\/span><\/li>\n<li><span style=\"font-weight: 400\">Cumplimiento de GCP, ISO 14155\/20916<\/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\">Usabilidad y factores humanos<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">Estudios formativos y sumativos<\/span><\/li>\n<li><span style=\"font-weight: 400\">Cumplimiento de IEC 62366 y FDA Human Factors<\/span><\/li>\n<li><span style=\"font-weight: 400\">Usabilidad y factores humanos<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n<section class=\"table\"><div class=\"container\"><div class=\"headline\">Tabla comparativa de CRO<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Servicios CRO<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\">Gesti\u00f3n de proyectos cl\u00ednicos<\/td><\/tr><tr><td class=\"feature-cell\">Desarrollo de protocolos<\/td><\/tr><tr><td class=\"feature-cell\">Soporte regulatorio (MDR e IVDR)<\/td><\/tr><tr><td class=\"feature-cell\">Auditor\u00edas de estudio (ISO 14155 \/ ISO 20916)<\/td><\/tr><tr><td class=\"feature-cell\">Representante legal en la UE\/Reino Unido<\/td><\/tr><tr><td class=\"feature-cell\">Bioestad\u00edstica y gesti\u00f3n de datos<\/td><\/tr><tr><td class=\"feature-cell\">Herramientas eTMF y eCRF<\/td><\/tr><tr><td class=\"feature-cell\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Cumplimiento cl\u00ednico<\/mark><\/strong><\/td><\/tr><tr><td class=\"feature-cell\">PNT para GCP, ISO 14155 e ISO 20916<\/td><\/tr><tr><td class=\"feature-cell\">Equipo cl\u00ednico multiling\u00fce<\/td><\/tr><tr><td class=\"feature-cell\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Experiencia y participaci\u00f3n de las partes interesadas<\/mark><\/strong><\/td><\/tr><tr><td class=\"feature-cell\">Estrategia MDR, IVDR, FDA, CA<\/td><\/tr><tr><td class=\"feature-cell\">Experiencia con dispositivos complejos de alto riesgo<\/td><\/tr><tr><td class=\"feature-cell\">Experiencia en software como dispositivo m\u00e9dico (SaMD)<\/td><\/tr><tr><td class=\"feature-cell\">Participaci\u00f3n de la UE (EMA, MDCG, organismos notificados)<\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">MDx<\/th><th class=\"column\">Otras CRO<\/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=\"\">S\u00ed<\/td><td class=\"cell\"><img loading=\"lazy\" decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7064 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-blue.svg\" alt=\"\">S\u00ed<\/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=\"\">Experiencia interna<\/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=\"\">A menudo subcontratado<\/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=\"\">Soporte especializado<\/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=\"\">Soporte generalista<\/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=\"\">Realizadas por expertos de MDx<\/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 se ofrece<\/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=\"\">Incluido<\/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=\"\">Disponibilidad limitada<\/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=\"\">Totalmente interno<\/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=\"\">A menudo subcontratado<\/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=\"\">Sistemas certificados<\/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=\"\">Limitada<\/td><\/tr><tr><td class=\"cell highlight\"><\/td><td class=\"cell\"><\/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=\"\">S\u00f3lido y armonizado<\/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<\/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=\"\">M\u00e1s de 14 idiomas<\/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=\"\">Cobertura limitada<\/td><\/tr><tr><td class=\"cell highlight\"><\/td><td class=\"cell\"><\/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=\"\">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=\"\">Parcial<\/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=\"\">Extensa<\/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=\"\">Limitada<\/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<\/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 se admite<\/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=\"\">Participaci\u00f3n activa<\/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=\"\">Sin acceso directo<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section id=\"block_cb8131398217f5ef34900e2e700fbcec\" 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\"><span class=\"blue-highlight\"> Experiencia <\/span> terap\u00e9utica <\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">Oncolog\u00eda<\/span><\/li>\n<li><span style=\"font-weight: 400\">Cardiovascular<\/span><\/li>\n<li><span style=\"font-weight: 400\">Ortopedia y odontolog\u00eda<\/span><\/li>\n<li><span style=\"font-weight: 400\">Enfermedades infecciosas<\/span><\/li>\n<li><span style=\"font-weight: 400\">Cuidado de heridas<\/span><\/li>\n<li><span style=\"font-weight: 400\">Salud reproductiva<\/span><\/li>\n<li><span style=\"font-weight: 400\">Neurolog\u00eda y salud mental<\/span><\/li>\n<li><span style=\"font-weight: 400\">Cuidados cr\u00edticos<\/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<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">SaMD y salud digital<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Dispositivos implantables<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Tecnolog\u00edas de imagen<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Productos combinados<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Diagn\u00f3stico in vitro (DIV): PCR, NGS, IHC, inmunoensayos, etc.<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n                    <div class=\"button-wrapper\">\n                                    <a href=\"\/expertise\/therapeutic-areas\" class=\"button button--default\" target=\"_self\">\n                        Explore todas las \u00e1reas terap\u00e9uticas                     <\/a>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_e580bc39198d27871c3560c4a55c3ed4\" class=\"text-image\" style=\"margin-top: var(--wp--preset--spacing--xxlarge); margin-bottom: var(--wp--preset--spacing--xxlarge); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Nuestro impacto cl\u00ednico<\/h2><div class=\"description wysiwyg\"><ul>\n<li><b>Tasa de \u00e9xito del 100%<\/b><span style=\"font-weight: 400\"> en las presentaciones de estudios IVDR y MDR<\/span><\/li>\n<li><b>M\u00e1s de 30 ensayos complejos<\/b><span style=\"font-weight: 400\"> gestionados para DIV de clase II\/III y de alto riesgo<\/span><\/li>\n<li><b>M\u00e1s de 60<\/b><span style=\"font-weight: 400\"> presentaciones de estudios de rendimiento de DIV en toda Europa<\/span><\/li>\n<li><b>SaMD <\/b><span style=\"font-weight: 400\">y terapias digitales totalmente gestionadas hasta su presentaci\u00f3n<\/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\/Untitled-12-scaled.jpg\" alt=\"Optimized for medical technology and innovation, the image shows healthcare professionals in a surgical setting utilizing advanced medical monitoring equipment and digital health solutions for patient care.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_9cc0379506a123c3364f9b0a4f6f8b18\" class=\"charts\" style=\"padding-top: Predeterminado; padding-bottom: Predeterminado; margin-top: Predeterminado; margin-bottom: Predeterminado; \">\n    <div class=\"container\">\n\t\t  <h2 class=\"headline\">Tipos de proyectos que gestionamos<\/h2>\n\t\n\t\t  \t\t<h3 class=\"subtitle\"> Estudios de rendimiento de DIV<\/h3>\n\t  \n\t  <div class=\"grid\">\n\t\t\t\t  <div\n\t\t\tclass=\"chart\"\n\t\t\tdata-chart=\"doughnut\"\n\t\t\tdata-colors=\"#0000f0, #2c59d9, #05a1b3, #8eebe1, #79c4bd\"\n\t\t\tdata-values=\"35.8, 25.5, 21.3, 9.2, 8.2\"\n\t\t\tdata-labels=\"Infecci\u00f3n\/Inmunidad, CDx, Pruebas gen\u00e9ticas, Marcadores fisiol\u00f3gicos, Otros\"\n\t\t\tdata-legend=\"true\">\n\t\t\t<canvas><\/canvas>\n\t\t  <\/div>\n\t\t\t\t  <div\n\t\t\tclass=\"chart\"\n\t\t\tdata-chart=\"doughnut\"\n\t\t\tdata-colors=\"#0000f0, #2c59d9, #05a1b3\"\n\t\t\tdata-values=\"85, 11, 4\"\n\t\t\tdata-labels=\"Clase c, clase b, clase d\"\n\t\t\tdata-legend=\"true\">\n\t\t\t<canvas><\/canvas>\n\t\t  <\/div>\n\t\t\t  <\/div>\n\t\t  \t\t<h3 class=\"subtitle\">Investigaciones cl\u00ednicas de dispositivos m\u00e9dicos<\/h3>\n\t  \n\t  <div class=\"grid\">\n\t\t\t\t  <div\n\t\t\tclass=\"chart\"\n\t\t\tdata-chart=\"doughnut\"\n\t\t\tdata-colors=\"#0000f0, #2c59d9, #05a1b3, #8eebe1\"\n\t\t\tdata-values=\"62.5, 19.3, 8, 10.2\"\n\t\t\tdata-labels=\"Implantable, General, implantable activo, activo\"\n\t\t\tdata-legend=\"true\">\n\t\t\t<canvas><\/canvas>\n\t\t  <\/div>\n\t\t\t\t  <div\n\t\t\tclass=\"chart\"\n\t\t\tdata-chart=\"doughnut\"\n\t\t\tdata-colors=\"#0000f0, #2c59d9, #05a1b3\"\n\t\t\tdata-values=\"29.6, 29.6, 40.8\"\n\t\t\tdata-labels=\"Clase III, Clase IIb, Clase IIa\"\n\t\t\tdata-legend=\"true\">\n\t\t\t<canvas><\/canvas>\n\t\t  <\/div>\n\t\t\t  <\/div>\n\t  <\/div>\n<\/section>\n<section id=\"block_4d319d6ad14b094a3dc1de6ba43281a1\" 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\">Con la confianza de patrocinadores globales<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00abMDx delivered exceptional clinical execution for our MDR Class III implantable. Their ISO 14155 expertise, monitoring, and submission support helped us gain approval faster than expected.\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                \u2014 VP, Clinical Affairs, Top 25 Global Device Manufacturer                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00abThe team\u2019s ability to translate technical needs into compliant documentation was invaluable.\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                \u2014 Director, Regulatory Affairs, SME MedTech Firm                                        \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_a12f570fc7f5a4f3bd16576e4dbd9432\" 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\">\u00bfGestionan estudios de DIV y de dispositivos m\u00e9dicos?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">S\u00ed, en MDR, IVDR, FDA IDE, IRB y m\u00e1s.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfPuede MDx actuar como representante legal 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, seg\u00fan MDR (Art. 62.2) e IVDR (Art. 58.4), podemos actuar como representante legal o patrocinador delegado. Tambi\u00e9n proporcionamos servicios de RP del Reino Unido. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfAdmite software como dispositivo m\u00e9dico (SaMD)?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\"> S\u00ed. Apoyamos las terapias digitales, los diagn\u00f3sticos y los estudios SaMD con pruebas de usabilidad alineadas con IEC 62366 y la gu\u00eda de factores humanos de la FDA. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfCu\u00e1l es la diferencia entre un ensayo cl\u00ednico, una investigaci\u00f3n y un estudio de rendimiento?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><i><span style=\"font-weight: 400\">Ensayo cl\u00ednico<\/span><\/i><span style=\"font-weight: 400\"> = t\u00e9rmino general<\/span><span style=\"font-weight: 400\"><br \/>\n<\/span><i><span style=\"font-weight: 400\">Investigaci\u00f3n cl\u00ednica<\/span><\/i><span style=\"font-weight: 400\"> = para dispositivos m\u00e9dicos<\/span><span style=\"font-weight: 400\"><br \/>\n<\/span><i><span style=\"font-weight: 400\">Estudio de rendimiento<\/span><\/i><span style=\"font-weight: 400\"> = para DIV<br \/>\n<\/span><span style=\"font-weight: 400\">Apoyamos todo, desde la viabilidad hasta las presentaciones completas.<\/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\":\"\u00bfGestionan estudios de DIV y de dispositivos m\u00e9dicos?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"S\u00ed, en MDR, IVDR, FDA IDE, IRB y m\u00e1s.\"}},{\"@type\":\"Question\",\"name\":\"\u00bfPuede MDx actuar como representante legal en la UE?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"S\u00ed, seg\u00fan MDR (Art. 62.2) e IVDR (Art. 58.4), podemos actuar como representante legal o patrocinador delegado. 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Nuestra precisi\u00f3n regulatoria. <\/b><\/p>\n<p><span style=\"font-weight: 400;\">Ya sea que est\u00e9 lanzando un estudio de DIV complejo o prepar\u00e1ndose para presentaciones globales, MDx es su CRO de servicio completo para obtener resultados cl\u00ednicos de alto impacto.<\/span><\/p>\n<p><strong>  Su dispositivo. Nuestra experiencia. Impacto global. <\/strong><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/es\/contacto\/?utm_source=medtech_clinical_solutions\" class=\"button button--tertiary\" target=\"\">\n                                Reserve una llamada de descubrimiento                            <\/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  \"@id\": \"https:\/\/mdxcro.com\/services\/medtech-clinical-solutions\/#service\",\n  \"name\": \"MedTech Clinical Solutions\",\n  \"serviceType\": \"End-to-end clinical research solutions for medical devices and IVD clinical investigations\",\n  \"url\": 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