{"id":8446,"date":"2025-09-28T18:47:06","date_gmt":"2025-09-28T18:47:06","guid":{"rendered":"https:\/\/mdxcro.com\/realizacion-de-estudios-clinicos-segun-el-ivdr-lo-que-necesita-saber\/"},"modified":"2026-04-07T07:28:12","modified_gmt":"2026-04-07T07:28:12","slug":"realizacion-de-estudios-clinicos-segun-el-ivdr-lo-que-necesita-saber","status":"publish","type":"post","link":"https:\/\/mdxcro.com\/es\/realizacion-de-estudios-clinicos-segun-el-ivdr-lo-que-necesita-saber\/","title":{"rendered":"Realizaci\u00f3n de estudios cl\u00ednicos seg\u00fan el IVDR: lo que necesita saber"},"content":{"rendered":"\n<p>The In Vitro Diagnostic Regulation (IVDR EU 2017\/746) has redefined the requirements for bringing <strong>in<a href=\"https:\/\/mdxcro.com\/sectors\/ivd-end-to-end\/\">vitro diagnostic (IVD) devices<\/a> <\/strong>to the European market. Compared with the previous IVD Directive, most devices are now subject to higher classification, more rigorous oversight, and stricter evidence requirements.<\/p>\n\n<p>En el centro de estas nuevas obligaciones se encuentra el <strong>\n  <a href=\"https:\/\/mdxcro.com\/es\/que-se-debe-tener-en-cuenta-al-desarrollar-un-estudio-de-rendimiento-clinico-de-div-para-el-cumplimiento-del-ivdr\/\">estudio de rendimiento cl\u00ednico<\/a>\n<\/strong>. Para cumplir con el IVDR, los fabricantes deben demostrar que sus dispositivos funcionan de forma segura y eficaz en condiciones reales. La norma <strong>\n  <a href=\"https:\/\/mdxcro.com\/es\/estudios-de-rendimiento-ivdr-y-la-revision-de-la-norma-iso-209162024\/\">ISO 20916:2024<\/a>\n<\/strong> establece el punto de referencia para la realizaci\u00f3n de estos estudios seg\u00fan las buenas pr\u00e1cticas internacionales reconocidas.  <\/p>\n\n<p>En este art\u00edculo, exploraremos qu\u00e9 son los estudios de rendimiento cl\u00ednico, por qu\u00e9 son importantes seg\u00fan el IVDR, el papel de la norma ISO 20916 y c\u00f3mo los fabricantes pueden realizar estudios con \u00e9xito para obtener el marcado CE y mantener el acceso al mercado.<\/p>\n\n<h2 class=\"wp-block-heading\"><strong>\u00bfQu\u00e9 es un estudio de rendimiento cl\u00ednico?<\/strong><strong><\/strong><\/h2>\n\n<p>A <a href=\"https:\/\/mdxcro.com\/services\/clinical-research\/\" type=\"service\" id=\"648\">clinical performance study<\/a> is an investigation carried out to establish how an IVD performs using human specimens. Unlike laboratory-based <strong><a href=\"https:\/\/mdxcro.com\/services\/ivd-analytical-studies\/\">analytical performance<\/a><\/strong> tests, clinical performance studies focus on real-world clinical outcomes:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>\u00bfEl dispositivo detecta la condici\u00f3n prevista con precisi\u00f3n?<\/li>\n\n\n\n<li>\u00bfProporciona resultados reproducibles y fiables en la poblaci\u00f3n objetivo?<\/li>\n\n\n\n<li>\u00bfEs su rendimiento cl\u00ednicamente significativo para el diagn\u00f3stico o el seguimiento?<\/li>\n<\/ul>\n\n<p>En t\u00e9rminos regulatorios, <strong>rendimiento cl\u00ednico<\/strong> significa la <em>capacidad del dispositivo para producir resultados que se correlacionen con una condici\u00f3n cl\u00ednica o un estado fisiol\u00f3gico espec\u00edficos<\/em>. Seg\u00fan el IVDR, los estudios de rendimiento cl\u00ednico proporcionan evidencia esencial para confirmar este rendimiento. <\/p>\n\n<h2 class=\"wp-block-heading\"><strong>Por qu\u00e9 los estudios de rendimiento cl\u00ednico son cr\u00edticos seg\u00fan el IVDR<\/strong><\/h2>\n\n<p><strong>El IVDR aumenta dr\u00e1sticamente la necesidad de evidencia cl\u00ednica s\u00f3lida:<\/strong><\/p>\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li><strong>Mayor clasificaci\u00f3n de los dispositivos<\/strong>: muchos IVD que antes se autocertificaban seg\u00fan la Directiva sobre IVD ahora requieren la revisi\u00f3n de un organismo notificado.<\/li>\n\n\n\n<li><strong>Performance evaluation requirements<\/strong> \u2013 Clinical performance is one of the three pillars of evidence (alongside <a href=\"https:\/\/mdxcro.com\/services\/scientific-validity-reports\/\">scientific validity reports for EU IVDR submission<\/a> and analytical performance) outlined in IVDR Article 56.<\/li>\n\n\n\n<li><strong>\n  <a href=\"https:\/\/mdxcro.com\/es\/services\/ra-y-documentacion-tecnica\/\">Aprobaci\u00f3n regulatoria y marcado CE<\/a>\n<\/strong>: sin un estudio de rendimiento cl\u00ednico conforme, los fabricantes corren el riesgo de retrasos o denegaci\u00f3n de la certificaci\u00f3n.<\/li>\n\n\n\n<li><strong>Competitividad en el mercado<\/strong>: los datos cl\u00ednicos s\u00f3lidos generan confianza entre los reguladores, los m\u00e9dicos y los usuarios finales.<\/li>\n<\/ol>\n\n<p><em>En pocas palabras: sin evidencia cl\u00ednica s\u00f3lida, no hay acceso al mercado de la UE.<\/em><\/p>\n\n<h2 class=\"wp-block-heading\"><strong>El papel de la norma ISO 20916<\/strong><\/h2>\n\n<p><strong>\n  <a href=\"https:\/\/mdxcro.com\/es\/estudios-de-rendimiento-ivdr-y-la-revision-de-la-norma-iso-209162024\/\">ISO 20916<\/a>\n<\/strong> proporciona el marco reconocido internacionalmente para la realizaci\u00f3n de estudios de rendimiento cl\u00ednico.<\/p>\n\n<p>La norma establece los requisitos en todo el ciclo de vida del estudio, incluyendo:<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>Planificaci\u00f3n<\/strong>: dise\u00f1o del protocolo, objetivos, criterios de valoraci\u00f3n, tama\u00f1o de la muestra y control de sesgos<\/li>\n\n\n\n<li><strong>\u00c9tica<\/strong>: protecci\u00f3n de los derechos de los participantes, la seguridad y la privacidad de los datos en l\u00ednea con la Declaraci\u00f3n de Helsinki y el RGPD<\/li>\n\n\n\n<li><strong>Realizaci\u00f3n<\/strong>: cualificaci\u00f3n del investigador, selecci\u00f3n del centro, manipulaci\u00f3n de muestras y seguimiento<\/li>\n\n\n\n<li><strong>Integridad de los datos<\/strong>: garantizar la calidad, la trazabilidad y la supervisi\u00f3n de las buenas pr\u00e1cticas cl\u00ednicas<\/li>\n\n\n\n<li><strong>Presentaci\u00f3n de informes<\/strong>: elaboraci\u00f3n de informes de estudio estructurados y listos para el regulador<\/li>\n<\/ul>\n\n<p>Siguiendo la norma <a href=\"https:\/\/knowledge.bsigroup.com\/products\/in-vitro-diagnostic-medical-devices-clinical-performance-studies-using-specimens-from-human-subjects-good-study-practice-1\">ISO 20916<\/a>, los fabricantes pueden asegurarse de que su estudio de rendimiento cl\u00ednico cumple tanto los requisitos del IVDR como las mejores pr\u00e1cticas globales. Esto reduce el riesgo de rechazo regulatorio. <\/p>\n\n<h2 class=\"wp-block-heading\"><strong>Componentes clave de un estudio de rendimiento cl\u00ednico<\/strong><\/h2>\n\n<h3 class=\"wp-block-heading\"><strong>1. Planificaci\u00f3n del estudio y desarrollo del protocolo<\/strong><\/h3>\n\n<p>Cada estudio de rendimiento cl\u00ednico comienza con un protocolo de estudio exhaustivo, que debe definir:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Objetivos y criterios de valoraci\u00f3n del estudio.<\/li>\n\n\n\n<li>Poblaci\u00f3n objetivo y tipos de muestra.<\/li>\n\n\n\n<li>Metodolog\u00eda estad\u00edstica y tama\u00f1o de la muestra.<\/li>\n\n\n\n<li>Consideraciones \u00e9ticas y de protecci\u00f3n de datos.<\/li>\n<\/ul>\n\n<p>Un protocolo s\u00f3lido es la columna vertebral de un estudio de rendimiento cl\u00ednico exitoso.<\/p>\n\n<h3 class=\"wp-block-heading\"><strong>2. Aprobaciones regulatorias y \u00e9ticas<\/strong><\/h3>\n\n<p>Antes de comenzar, se deben obtener las aprobaciones de:<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>Comit\u00e9s de \u00e9tica<\/strong>: garantizar la protecci\u00f3n de los participantes.<\/li>\n\n\n\n<li><strong>Autoridades competentes<\/strong>: dependiendo de los requisitos del Estado miembro y del riesgo del estudio.<\/li>\n<\/ul>\n\n<p>Por ejemplo, los estudios de rendimiento cl\u00ednico intervencionistas requieren la aprobaci\u00f3n de la autoridad competente, mientras que los estudios observacionales no invasivos pueden requerir \u00fanicamente la aprobaci\u00f3n \u00e9tica.<\/p>\n\n<p>Los plazos var\u00edan en toda la UE, por lo que la planificaci\u00f3n temprana es esencial. MDx puede actuar como su <a href=\"https:\/\/mdxcro.com\/es\/servicios\/representante-autorizado-ue\/\">\n  <strong>representante legal<\/strong>\n<\/a> en la UE.  <\/p>\n\n<h3 class=\"wp-block-heading\"><strong>3. Opciones de dise\u00f1o del estudio<\/strong><\/h3>\n\n<p>Los enfoques comunes incluyen:<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>Estudios prospectivos<\/strong>: recogida de nuevas muestras directamente de los participantes.<\/li>\n\n\n\n<li><strong>Estudios retrospectivos<\/strong>: uso de muestras existentes, almacenadas o sobrantes.<\/li>\n\n\n\n<li><strong>Estudios multic\u00e9ntricos<\/strong>: aumento de la solidez y la diversidad de los datos.<\/li>\n<\/ul>\n\n<p>El dise\u00f1o elegido debe reflejar el uso previsto y la clase de riesgo del dispositivo.<\/p>\n\n<h3 class=\"wp-block-heading\"><strong>4. Gesti\u00f3n de muestras<\/strong><\/h3>\n\n<p>La validez de los resultados depende en gran medida de la correcta manipulaci\u00f3n de las muestras. La norma ISO 20916 exige: <\/p>\n\n<ul class=\"wp-block-list\">\n<li>Procedimientos de recogida documentados.<\/li>\n\n\n\n<li>Almacenamiento y transporte controlados.<\/li>\n\n\n\n<li>Trazabilidad completa desde el donante hasta el resultado.<\/li>\n<\/ul>\n\n<h3 class=\"wp-block-heading\"><strong>5. Captura y seguimiento de datos<\/strong><\/h3>\n\n<p>Los datos precisos y fiables no son negociables. El estudio de rendimiento cl\u00ednico debe utilizar: <\/p>\n\n<ul class=\"wp-block-list\">\n<li>Sistemas electr\u00f3nicos validados de captura de datos.<\/li>\n\n\n\n<li><strong>\n  <a href=\"https:\/\/mdxcro.com\/es\/services\/soluciones-clinicas-de-medtech\/\">Seguimiento<\/a>\n<\/strong> in situ y a distancia.<\/li>\n\n\n\n<li>Supervisi\u00f3n independiente cuando sea apropiado.<\/li>\n<\/ul>\n\n<h3 class=\"wp-block-heading\"><strong>6. An\u00e1lisis estad\u00edstico<\/strong><\/h3>\n\n<p>Los m\u00e9todos estad\u00edsticos predefinidos deben cubrir:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>C\u00e1lculos del tama\u00f1o de la muestra.<\/li>\n\n\n\n<li>Manejo de datos faltantes o no v\u00e1lidos.<\/li>\n\n\n\n<li>Evaluaci\u00f3n s\u00f3lida de los criterios de valoraci\u00f3n.<\/li>\n<\/ul>\n\n<h3 class=\"wp-block-heading\"><strong>7. Presentaci\u00f3n de informes y env\u00edo<\/strong><\/h3>\n\n<p>Al cierre del estudio, los resultados se documentan en un <strong>Informe del estudio de rendimiento cl\u00ednico (CPSR)<\/strong>. Esto se incorpora al Informe de evaluaci\u00f3n del rendimiento (PER), un elemento obligatorio de la <a href=\"https:\/\/mdxcro.com\/es\/services\/ra-y-documentacion-tecnica\/\">documentaci\u00f3n t\u00e9cnica del IVDR<\/a> revisada por los organismos notificados. <\/p>\n\n<h2 class=\"wp-block-heading\"><strong>Desaf\u00edos comunes en la realizaci\u00f3n de un estudio de rendimiento cl\u00ednico<\/strong><\/h2>\n\n<p><strong>Acoording to Floella Otudeko, many manufacturers encounter obstacles, including:<\/strong><\/p>\n\n<ul class=\"wp-block-list\">\n<li>Navegar por procesos de aprobaci\u00f3n complejos en diferentes Estados miembros de la UE.<\/li>\n\n\n\n<li>Reclutar suficientes participantes adecuados dentro de las poblaciones objetivo.<\/li>\n\n\n\n<li>Coordinar la recogida de muestras, el transporte y la log\u00edstica de almacenamiento.<\/li>\n\n\n\n<li>Abordar el cumplimiento del RGPD para los datos personales y de salud.<\/li>\n\n\n\n<li>Alinear las expectativas del estudio con los organismos notificados para evitar el retrabajo.<\/li>\n<\/ul>\n\n<p>Sin una planificaci\u00f3n cuidadosa, estos problemas pueden provocar retrasos costosos.<\/p>\n\n<h3 class=\"wp-block-heading\"><strong>Mejores pr\u00e1cticas para un estudio de rendimiento cl\u00ednico exitoso<\/strong><\/h3>\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\">Siempre que sea posible, colabore desde el principio con los reguladores y los organismos notificados para evitar sorpresas.<\/li>\n\n\n\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\">Desarrolle un protocolo s\u00f3lido que anticipe los desaf\u00edos operativos y estad\u00edsticos.<\/li>\n\n\n\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\">Invierta en la formaci\u00f3n de los investigadores para mantener la coherencia del estudio.<\/li>\n\n\n\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\">Implemente el seguimiento en tiempo real para detectar problemas antes de que se agraven.<\/li>\n\n\n\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\">Documente todo a fondo para estar preparado para la auditor\u00eda.<\/li>\n\n\n\n<li style=\"margin-top:var(--wp--preset--spacing--tiny);margin-bottom:var(--wp--preset--spacing--tiny)\">Busque experiencia externa cuando los recursos internos sean limitados.<\/li>\n<\/ol>\n\n<h3 class=\"wp-block-heading\"><strong>C\u00f3mo un CRO de tecnolog\u00eda m\u00e9dica IVD a\u00f1ade valor<\/strong><\/h3>\n\n<p><strong>La realizaci\u00f3n de un estudio de rendimiento cl\u00ednico conforme requiere muchos recursos. La asociaci\u00f3n con una consultor\u00eda especializada como MDx CRO puede ayudarle a: <\/strong><\/p>\n\n<ul class=\"wp-block-list\">\n<li>Designing protocols aligned with ISO 20916 and IVDR requirements. <\/li>\n\n\n\n<li>Gestionar las presentaciones a los comit\u00e9s de \u00e9tica y a las autoridades competentes.<\/li>\n\n\n\n<li>Supervisar la realizaci\u00f3n del estudio en m\u00faltiples centros y geograf\u00edas.<\/li>\n\n\n\n<li>Garantizar la gesti\u00f3n de datos conforme con el RGPD.<\/li>\n\n\n\n<li>Colaborar con los organismos notificados a trav\u00e9s de di\u00e1logos estructurados para alinear las expectativas desde el principio.<\/li>\n<\/ul>\n\n<p>Lo que lleva a aprobaciones m\u00e1s r\u00e1pidas, evidencia m\u00e1s s\u00f3lida y un acceso al mercado m\u00e1s fluido.<\/p>\n\n<h2 class=\"wp-block-heading\"><strong>Observaciones finales<\/strong><\/h2>\n\n<p>La realizaci\u00f3n de un estudio de rendimiento cl\u00ednico seg\u00fan el IVDR no es solo un ejercicio de marcar casillas regulatorias, sino que es la base de la aprobaci\u00f3n del mercado y la confianza a largo plazo en su dispositivo. La norma ISO 20916 proporciona el est\u00e1ndar global para las buenas pr\u00e1cticas de estudio, garantizando que la evidencia se recopile de forma \u00e9tica, cient\u00edficamente s\u00f3lida y lista para el regulador. <\/p>\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-medium-font-size\">Para los fabricantes de IVD, el viaje puede ser desafiante, pero con la planificaci\u00f3n y el apoyo adecuados, se convierte en una oportunidad para demostrar valor, acelerar las aprobaciones y generar credibilidad entre los m\u00e9dicos y los pacientes por igual.<\/p>\n<\/blockquote>\n\n<p>As an experienced full service IVD MedTech CRO partner, <strong>MDx helps companies design, conduct, and report clinical performance studies.<\/strong> We pay special attention to <strong>meet both regulatory demands and business objectives.<\/strong> Whether you are preparing your first IVDR submission or adapting existing devices, <a href=\"https:\/\/mdxcro.com\/about-us\/our-team\/\">our team<\/a> provides the expertise and operational support you need to succeed.<\/p>\n\n<p>Read more about our <a href=\"https:\/\/mdxcro.com\/services\/ivd-clinical-studies\/\" type=\"service\" id=\"7143\">IVD clinical performance study services.<\/a><\/p>\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link has-white-frost-color has-blue-background-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/mdxcro.com\/es\/contacto\/?utm_content=IVDR_clinical_perf_studied\"><strong>Contact MDx CRO today<\/strong> to discuss your IVD Clinical Study needs.<\/a><\/div>\n<\/div>\n\n<div style=\"height:66px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-white-frost-color has-text-color\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">FAQ<\/mark><\/h2>\n\n<div class=\"schema-faq wp-block-yoast-faq-block\"><div class=\"schema-faq-section\" id=\"faq-question-1771493923535\"><strong class=\"schema-faq-question\"><strong>Do all IVDs require a clinical performance study under IVDR?<\/strong><\/strong> <p class=\"schema-faq-answer\">Not always. The need depends on the device\u2019s risk class, intended use, and existing evidence. However, most devices now require stronger clinical evidence than under the previous directive, and many will need new or updated clinical performance data reviewed by a Notified Body.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1771493937836\"><strong class=\"schema-faq-question\"><strong>What is the difference between analytical performance and clinical performance?<\/strong><\/strong> <p class=\"schema-faq-answer\">Analytical performance shows how well the test works in controlled laboratory conditions (accuracy, precision, limits of detection). Clinical performance demonstrates that the device\u2019s results correlate with a specific clinical condition or physiological state in the intended population. Both are mandatory components of the IVDR performance evaluation, alongside<a href=\"https:\/\/mdxcro.com\/services\/scientific-validity-reports\/\" type=\"service\" id=\"6919\"> scientific validity<\/a>.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1771493948059\"><strong class=\"schema-faq-question\"><strong>When is Competent Authority approval required?<\/strong><\/strong> <p class=\"schema-faq-answer\">Interventional clinical performance studies generally require approval from both an ethics committee and the relevant Competent Authority. Observational, non-interventional studies may only require ethics approval, depending on the Member State. Early planning is essential because timelines vary across the EU.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1771493961806\"><strong class=\"schema-faq-question\"><strong>How does ISO 20916 support IVDR compliance?<\/strong><\/strong> <p class=\"schema-faq-answer\"><a href=\"https:\/\/mdxcro.com\/iso-20916-2024-ivdr-harmonization-ivd-studies\/\" type=\"post\" id=\"4712\">ISO 20916<\/a> provides the internationally recognised framework for designing, conducting, monitoring, and reporting clinical performance studies. Following it helps ensure ethical conduct, data integrity, and regulator-ready documentation aligned with IVDR expectations.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1771493973065\"><strong class=\"schema-faq-question\"><strong>What are the most common reasons studies face delays?<\/strong><\/strong> <p class=\"schema-faq-answer\">Delays often stem from incomplete protocols, misalignment with Notified Bodies, slow ethics or authority approvals, recruitment challenges, and GDPR-related data issues. Clear planning, predefined statistical methods, and strong documentation reduce the risk of rework.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1771493980009\"><strong class=\"schema-faq-question\"><strong>What happens after the study is completed?<\/strong><\/strong> <p class=\"schema-faq-answer\">Results are compiled into a Clinical Performance Study Report (CPSR), which feeds into the Performance Evaluation Report (PER). The PER forms part of the IVDR technical documentation reviewed by the Notified Body for CE marking.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1771493994886\"><strong class=\"schema-faq-question\"><strong>Can a CRO support the process?<\/strong><\/strong> <p class=\"schema-faq-answer\">Yes. A specialised IVD MedTech CRO can design IVDR-aligned protocols, manage regulatory submissions, oversee multicentre operations, ensure GDPR-compliant data management, and engage early with Notified Bodies\u2014reducing risk and accelerating time to market.<\/p> <\/div> <\/div>\n","protected":false},"excerpt":{"rendered":"<p>The In Vitro Diagnostic Regulation (IVDR EU 2017\/746) has redefined the requirements for bringing invitro diagnostic (IVD) devices to the European market. Compared with the previous IVD Directive, most devices are now subject to higher classification, more rigorous oversight, and stricter evidence requirements. En el centro de estas nuevas obligaciones se encuentra el estudio de [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6854,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[216],"tags":[],"resources-sector":[178],"class_list":["post-8446","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","resources-sector-ivds"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Realizaci\u00f3n de estudios cl\u00ednicos seg\u00fan el IVDR: lo que necesita saber - MDx CRO<\/title>\n<meta name=\"description\" content=\"Aprenda a realizar un estudio de rendimiento cl\u00ednico conforme con el IVDR utilizando la norma ISO 20916. 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