{"id":7184,"date":"2025-07-29T13:53:41","date_gmt":"2025-07-29T13:53:41","guid":{"rendered":"https:\/\/mdxcro.com\/?page_id=7184"},"modified":"2026-06-03T06:39:59","modified_gmt":"2026-06-03T06:39:59","slug":"recursos","status":"publish","type":"page","link":"https:\/\/mdxcro.com\/es\/recursos\/","title":{"rendered":"Recursos"},"content":{"rendered":"\n<section id=\"block_802a6c954c11482ba4eebbac89278318\" class=\"hero hero--with-form\">\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\" alt=\"\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"hero__grid\">\n            <div class=\"hero__content-col\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Blog y recursos<\/h1>\n            \n                            <div class=\"description\"><p 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class=\"slider-item-link\">\n                        <div class=\"image-wrapper\">\n                                                            <img decoding=\"async\" width=\"800\" height=\"530\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/ivdr-MDx-cRO-800x530.webp\" class=\"attachment-thumbnail size-thumbnail wp-post-image\" alt=\"Informe de Validez Cient\u00edfica (SVR) seg\u00fan el Reglamento IVD de la UE: De la revisi\u00f3n bibliogr\u00e1fica al argumento cient\u00edfico defendible\" \/>                                                    <\/div>\n                        <div class=\"content-wrapper\">\n                            <p class=\"text\">Informe de Validez Cient\u00edfica (SVR) seg\u00fan el Reglamento IVD de la UE: De la revisi\u00f3n bibliogr\u00e1fica al argumento cient\u00edfico defendible<\/p>\n                        <\/div>\n                    <\/a>\n                    <div class=\"slider-meta\">\n                        <div class=\"slider-meta-col\">\n                            1 de junio de 2026                        <\/div>\n                        <div class=\"slider-meta-col\">\n                            Noticias sobre IVD | IVDs                        <\/div>\n                    <\/div>\n                <\/div>\n                                <div class=\"slider-item\">\n                    <a href=\"https:\/\/mdxcro.com\/es\/iso-10993-1-2025-biocompatibilidad\/\" class=\"slider-item-link\">\n                        <div class=\"image-wrapper\">\n                                                            <img decoding=\"async\" width=\"800\" height=\"530\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/05\/iso-10993-1-2025-biocompatibility-800x530.webp\" class=\"attachment-thumbnail size-thumbnail wp-post-image\" alt=\"ISO 10993-1:2025: del cumplimiento, a la biocompatibilidad basada en riesgos\" \/>                                                    <\/div>\n                        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src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/Leading-IVD-CRO-in-Europe-MDx-CRO-800x530.webp\" class=\"attachment-thumbnail size-thumbnail wp-post-image\" alt=\"Diagn\u00f3stico complementario de la FDA: Gu\u00eda regulatoria completa para el desarrollo, aprobaci\u00f3n y estrategia de codesarrollo de CDx\" \/>                                                    <\/div>\n                        <div class=\"content-wrapper\">\n                            <p class=\"text\">Diagn\u00f3stico complementario de la FDA: Gu\u00eda regulatoria completa para el desarrollo, aprobaci\u00f3n y estrategia de codesarrollo de CDx<\/p>\n                        <\/div>\n                    <\/a>\n                    <div class=\"slider-meta\">\n                        <div class=\"slider-meta-col\">\n                            7 de mayo de 2026                        <\/div>\n                        <div class=\"slider-meta-col\">\n                            Actualizaciones normativas, whitepapers | Precision Medicine &amp; CDx                        <\/div>\n                    <\/div>\n                <\/div>\n                                <div class=\"slider-item\">\n                    <a href=\"https:\/\/mdxcro.com\/es\/ivdr-estudios-combinados\/\" class=\"slider-item-link\">\n                        <div class=\"image-wrapper\">\n                                                            <img decoding=\"async\" width=\"800\" height=\"530\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/Clinical-research-MDx-CRO-1-800x530.webp\" class=\"attachment-thumbnail size-thumbnail wp-post-image\" alt=\"Gu\u00eda pr\u00e1ctica: IVDR en estudios combinados desde 40+ programas de investigaci\u00f3n\" \/>                                                    <\/div>\n                        <div class=\"content-wrapper\">\n                            <p class=\"text\">Gu\u00eda pr\u00e1ctica: IVDR en estudios combinados desde 40+ programas de investigaci\u00f3n<\/p>\n                        <\/div>\n                    <\/a>\n                    <div class=\"slider-meta\">\n                        <div class=\"slider-meta-col\">\n                            13 de abril de 2026                        <\/div>\n                        <div class=\"slider-meta-col\">\n                            blog, Eventos y congresos | IVDs                        <\/div>\n                    <\/div>\n                <\/div>\n                                <div class=\"slider-item\">\n                    <a href=\"https:\/\/mdxcro.com\/es\/iso-14155-2026\/\" class=\"slider-item-link\">\n                        <div class=\"image-wrapper\">\n                                                            <img decoding=\"async\" width=\"800\" height=\"530\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/regulatory-cpmpliance-technical-documentation-MDx-CRO-800x530.webp\" class=\"attachment-thumbnail size-thumbnail wp-post-image\" alt=\"ISO 14155:2026: \u00bfQu\u00e9 ha cambiado y qu\u00e9 implica para su investigaci\u00f3n cl\u00ednica?\" \/>                                                    <\/div>\n                        <div class=\"content-wrapper\">\n                            <p class=\"text\">ISO 14155:2026: \u00bfQu\u00e9 ha cambiado y qu\u00e9 implica para su investigaci\u00f3n cl\u00ednica?<\/p>\n                        <\/div>\n                    <\/a>\n                    <div class=\"slider-meta\">\n                        <div class=\"slider-meta-col\">\n                            8 de abril de 2026                        <\/div>\n                        <div class=\"slider-meta-col\">\n                            blog | Medical Devices                        <\/div>\n                    <\/div>\n                <\/div>\n                                <div class=\"slider-item\">\n                    <a href=\"https:\/\/mdxcro.com\/es\/nueva-ley-ensayos-clinicos-portugal-2026\/\" 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                                                                                <div class=\"value\">Blog &amp; recursos<\/div>\n                                                            <\/div>\n                                                                                                                    <div class=\"teaser wysiwyg\"><p>Donde nuestro equipo desglosa lo \u00faltimo en la regulaci\u00f3n de productos sanitarios de la UE, con an\u00e1lisis pr\u00e1cticos, comentarios de expertos y las perspectivas que aportamos al trabajar con fabricantes cada d\u00eda.<\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost card--value\">\n                                            <div class=\"top\">\n                                                          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Vea c\u00f3mo hemos ayudado a los fabricantes a navegar por evaluaciones cl\u00ednicas, transiciones al IVDR y evaluaciones de conformidad complejas en toda Europa.<\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost card--value\">\n                                            <div class=\"top\">\n                                                          <div class=\"circle\">\n                                                                                              <div class=\"value\">Actualizaciones normativas<\/div>\n                                                            <\/div>\n                                                                                                                    <div class=\"teaser wysiwyg\"><p>Nuevas gu\u00edas del MDCG, normas armonizadas revisadas, plazos regulatorios; realizamos un seguimiento de los cambios para que pueda actuar sobre ellos antes de que se conviertan en problemas.<\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost card--value\">\n                                            <div class=\"top\">\n                                                          <div class=\"circle\">\n                                                                                              <div class=\"value\">Recursos gratuitos<\/div>\n                                                            <\/div>\n                                                                                                                    <div class=\"teaser wysiwyg\"><p>Plantillas, listas de verificaci\u00f3n, libros blancos y grabaciones de seminarios web. Las mismas herramientas que nuestro equipo utiliza internamente, disponibles para ayudarle a avanzar m\u00e1s r\u00e1pido.<\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n\n\n<section class=\"latest-resources\"  style=\"\">\n    <div class=\"container\">\n      <\/div>\n\n      <div class=\"slider\">\n      <div class=\"slider-inner\">\n                            <a href=\"https:\/\/mdxcro.com\/fda-human-factors-guidance-2026\/\" class=\"slider-item\">\n            <div class=\"image-wrapper\">\n                              <img decoding=\"async\" width=\"800\" height=\"530\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/06\/Usability-Medical-Devices-MDx-CRO-800x530.webp\" class=\"attachment-thumbnail size-thumbnail wp-post-image\" alt=\"Diverse 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revisi\u00f3n bibliogr\u00e1fica al argumento cient\u00edfico defendible<\/p>\n            <\/div>\n          <\/a>\n                            <a href=\"https:\/\/mdxcro.com\/scientific-validity-report-ivdr\/\" class=\"slider-item\">\n            <div class=\"image-wrapper\">\n                              <img decoding=\"async\" width=\"800\" height=\"530\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/ivdr-MDx-cRO-800x530.webp\" class=\"attachment-thumbnail size-thumbnail wp-post-image\" alt=\"Female scientist in a lab holding a holographic virus model, emphasizing advanced medical technology and research in the healthcare industry.\" \/>                          <\/div>\n            <div class=\"content-wrapper\">\n              <p class=\"text\">Scientific Validity Report (SVR) Under EU IVDR: From Literature Review to Defensible Scientific Argument<\/p>\n            <\/div>\n          <\/a>\n                            <a href=\"https:\/\/mdxcro.com\/mdcg-2021-24-rev-1-mdr-classification\/\" class=\"slider-item\">\n            <div class=\"image-wrapper\">\n                              <img decoding=\"async\" width=\"800\" height=\"530\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/03\/MDCG-Documentations-MDx-CRO-800x530.webp\" class=\"attachment-thumbnail size-thumbnail wp-post-image\" alt=\"A tall stack of organized medical device documentation and regulatory papers against a blue background, emphasizing compliance and regulatory standards in MedTech.\" \/>                          <\/div>\n            <div class=\"content-wrapper\">\n              <p class=\"text\">MDCG 2021-24 Rev.1: What Changed in EU MDR Device Classification (April 2026)<\/p>\n            <\/div>\n          <\/a>\n              <\/div>\n    <\/div>\n  \n  <\/section>\n\n\n\n<style>.mdx-banner {\n  margin-left:  calc(var(--container-padding, 20px) * -1);\n  margin-right: calc(var(--container-padding, 20px) * -1);\n  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img {\n  width: 100%;\n  height: 100%;\n  object-fit: cover;\n  object-position: top center;\n  filter: grayscale(100%);\n  display: block;\n}\n\n@media (max-width: 860px) {\n  .mdx-banner-photo { width: calc((100vw - 9px) \/ 4); }\n}\n@media (max-width: 520px) {\n  .mdx-banner-photo { width: calc((100vw - 6px) \/ 3); }\n}\n<\/style><div class=\"mdx-banner\"><div class=\"mdx-banner-carousel\"><div class=\"mdx-banner-track\"><div class=\"mdx-banner-photo\"><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/Carlos-Galamba-2.jpg\" alt=\"Carlos Galamba\" loading=\"lazy\"\/><\/div><div class=\"mdx-banner-photo\"><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/01\/Joana-Martins-Team-MDxCRO.png.webp\" alt=\"Joana Martins\" loading=\"lazy\"\/><\/div><div class=\"mdx-banner-photo\"><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Yaiza-Benito.jpeg\" alt=\"Yaiza Benito\" 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src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/01\/Joana-Martins-Team-MDxCRO.png.webp\" alt=\"\" loading=\"lazy\"\/><\/div><div class=\"mdx-banner-photo\"><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Yaiza-Benito.jpeg\" alt=\"\" loading=\"lazy\"\/><\/div><div class=\"mdx-banner-photo\"><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Callum-Pickett.jpeg\" alt=\"\" loading=\"lazy\"\/><\/div><div class=\"mdx-banner-photo\"><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Floella-Otudeko.jpeg\" alt=\"\" loading=\"lazy\"\/><\/div><div class=\"mdx-banner-photo\"><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Alberto-Bardaji.jpeg\" alt=\"\" loading=\"lazy\"\/><\/div><div class=\"mdx-banner-photo\"><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Andre-Moreira.jpeg\" alt=\"\" loading=\"lazy\"\/><\/div><\/div><\/div><\/div>\n\n\n\n<section id=\"block_b316301f88a75df8a287ae89326409b4\" class=\"text-image\" style=\"\">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Inteligencia regulatoria de m\u00e1s de 40 especialistas<\/h2><div class=\"description wysiwyg\"><p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Nuestro contenido est\u00e1 escrito por un equipo multidisciplinar de m\u00e1s de 40 profesionales: antiguos revisores de autoridades competentes nacionales, auditores de organismos notificados, asociados de investigaci\u00f3n cl\u00ednica e ingenieros biom\u00e9dicos, cada uno con experiencia pr\u00e1ctica navegando el MDR y el IVDR.<\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Cada art\u00edculo, libro blanco y recurso que publicamos se basa en el trabajo que realizamos a diario para los fabricantes: redacci\u00f3n de informes de evaluaci\u00f3n cl\u00ednica, dise\u00f1o de investigaciones cl\u00ednicas, compilaci\u00f3n de documentaci\u00f3n t\u00e9cnica y apoyo en evaluaciones de conformidad en toda Europa.<\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Esto no es un comentario regulatorio reciclado. Es material pr\u00e1ctico centrado en el fabricante, creado a partir de la experiencia en proyectos reales, la misma pericia que aplicamos al trabajar con nuestros clientes.<\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/marketa-huiwen-scaled.jpg\" alt=\"\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section class=\"latest-resources\"  style=\"\">\n    <div class=\"container\">\n          <div class=\"headline\">Perspectivas y actualizaciones<a href=\"#\" class=\"slider-nav slider-nav-left\"><\/a><a href=\"#\" class=\"slider-nav slider-nav-right\"><\/a><\/div>\n      <\/div>\n\n      <div class=\"slider\">\n      <div class=\"slider-inner\">\n                            <a href=\"https:\/\/mdxcro.com\/es\/iso-10993-1-2025-biocompatibilidad\/\" class=\"slider-item\">\n            <div class=\"image-wrapper\">\n                              <img decoding=\"async\" width=\"800\" height=\"530\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/05\/iso-10993-1-2025-biocompatibility-800x530.webp\" class=\"attachment-thumbnail size-thumbnail wp-post-image\" alt=\"Primer plano de un modelo transparente de doble h\u00e9lice de ADN que simboliza la biocompatibilidad y la innovaci\u00f3n en tecnolog\u00eda m\u00e9dica.\" \/>                          <\/div>\n            <div class=\"content-wrapper\">\n              <p class=\"text\">ISO 10993-1:2025: del cumplimiento, a la biocompatibilidad basada en riesgos<\/p>\n            <\/div>\n          <\/a>\n                            <a href=\"https:\/\/mdxcro.com\/es\/ivdr-estudios-combinados\/\" class=\"slider-item\">\n            <div class=\"image-wrapper\">\n                              <img decoding=\"async\" width=\"800\" height=\"530\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/Clinical-research-MDx-CRO-1-800x530.webp\" class=\"attachment-thumbnail size-thumbnail wp-post-image\" alt=\"Investigadores realizando experimentos avanzados de tecnolog\u00eda m\u00e9dica en un entorno de laboratorio, centrados en la investigaci\u00f3n cl\u00ednica y en soluciones innovadoras para la atenci\u00f3n sanitaria.\" \/>                          <\/div>\n            <div class=\"content-wrapper\">\n              <p class=\"text\">Gu\u00eda pr\u00e1ctica: IVDR en estudios combinados desde 40+ programas de investigaci\u00f3n<\/p>\n            <\/div>\n          <\/a>\n                            <a href=\"https:\/\/mdxcro.com\/es\/iso-14155-2026\/\" class=\"slider-item\">\n            <div class=\"image-wrapper\">\n                              <img decoding=\"async\" width=\"800\" height=\"530\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/regulatory-cpmpliance-technical-documentation-MDx-CRO-800x530.webp\" class=\"attachment-thumbnail size-thumbnail wp-post-image\" alt=\"Fabricaci\u00f3n automatizada de viales m\u00e9dicos en un entorno de sala limpia, destacando los avances de MedTech por MDX para las industrias de dispositivos m\u00e9dicos y farmac\u00e9utica.\" \/>                          <\/div>\n            <div class=\"content-wrapper\">\n              <p class=\"text\">ISO 14155:2026: \u00bfQu\u00e9 ha cambiado y qu\u00e9 implica para su investigaci\u00f3n cl\u00ednica?<\/p>\n            <\/div>\n          <\/a>\n                            <a href=\"https:\/\/mdxcro.com\/es\/nueva-ley-ensayos-clinicos-portugal-2026\/\" class=\"slider-item\">\n            <div class=\"image-wrapper\">\n                              <img decoding=\"async\" width=\"800\" height=\"530\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/clinical-research-MDx-CRO-800x530.webp\" class=\"attachment-thumbnail size-thumbnail wp-post-image\" alt=\"Primer plano de un cient\u00edfico manipulando un tubo de ensayo con cadenas de ADN y superposiciones de datos m\u00e9dicos digitales, enfatizando la tecnolog\u00eda m\u00e9dica avanzada y la investigaci\u00f3n.\" \/>                          <\/div>\n            <div class=\"content-wrapper\">\n              <p class=\"text\">Nueva Ley de Ensayos Cl\u00ednicos de Portugal n.\u00ba 9\/2026: Lo que los patrocinadores deben saber<\/p>\n            <\/div>\n          <\/a>\n                            <a href=\"https:\/\/mdxcro.com\/es\/imdrf-n91-evidencia-clinica-ivd-2026\/\" class=\"slider-item\">\n            <div class=\"image-wrapper\">\n                              <img decoding=\"async\" width=\"800\" height=\"530\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/03\/MDCG-Documentations-MDx-CRO-800x530.webp\" class=\"attachment-thumbnail size-thumbnail wp-post-image\" alt=\"A tall stack of organized medical device documentation and regulatory papers against a blue background, emphasizing compliance and regulatory standards in MedTech.\" \/>                          <\/div>\n            <div class=\"content-wrapper\">\n              <p class=\"text\">IMDRF N91 2026: Nuevos Requisitos de Evidencia Cl\u00ednica para Dispositivos IVD<\/p>\n            <\/div>\n          <\/a>\n              <\/div>\n    <\/div>\n  \n  <\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":10067,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-7184","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Recursos: MedTech, CDx, Informaci\u00f3n sobre IVDR\/MDR | MDx CRO<\/title>\n<meta name=\"description\" content=\"Blogs, casos pr\u00e1cticos y actualizaciones regulatorias sobre IVDR, MDR, NGS y diagn\u00f3sticos complementarios. 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