{"id":8580,"date":"2023-08-10T16:09:13","date_gmt":"2023-08-10T16:09:13","guid":{"rendered":"https:\/\/mdxcro.com\/carlos-galamba-su-consultor-de-div-de-confianza-y-experto-en-ivdr\/"},"modified":"2026-01-22T10:38:09","modified_gmt":"2026-01-22T10:38:09","slug":"carlos-galamba-su-consultor-de-div-de-confianza-y-experto-en-ivdr","status":"publish","type":"post","link":"https:\/\/mdxcro.com\/es\/carlos-galamba-su-consultor-de-div-de-confianza-y-experto-en-ivdr\/","title":{"rendered":"Carlos Galamba: su consultor de DIV de confianza y experto en IVDR"},"content":{"rendered":"\n<figure class=\"wp-block-image alignleft size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Carlos-Galamba.jpg\" alt=\"Profesional m&#xE9;dico innovador especializado en avances de tecnolog&#xED;a m&#xE9;dica en MDX, centrado en acelerar la innovaci&#xF3;n en la atenci&#xF3;n sanitaria y mejorar los resultados de los pacientes a trav&#xE9;s de tecnolog&#xED;a de vanguardia.\" class=\"wp-image-7380\" style=\"width:212px;height:auto\" srcset=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Carlos-Galamba.jpg 1024w, https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Carlos-Galamba-600x600.jpg 600w, https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Carlos-Galamba-768x768.jpg 768w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><figcaption class=\"wp-element-caption\">Carlos Galamba, CEO de MDx CRO<\/figcaption><\/figure>\n\n<h3 class=\"wp-block-heading\">Carlos Galamba, consultor de DIV &#8211; Fundador de MDx CRO<\/h3>\n\n<p>En el intrincado panorama del diagn\u00f3stico in vitro (DIV) y la evoluci\u00f3n del Reglamento de diagn\u00f3stico in vitro (IVDR), un nombre destaca como un faro de experiencia y orientaci\u00f3n: <strong>Carlos Galamba<\/strong>. Con una gran experiencia que abarca <strong>m\u00e1s de 18 a\u00f1os en el sector de los DIV<\/strong>, Carlos es un consultor experimentado que ha dejado una huella imborrable en el mundo del diagn\u00f3stico. <\/p>\n\n<h3 class=\"wp-block-heading\">Camino pionero hacia el dominio normativo<\/h3>\n\n<p>La trayectoria de Carlos comenz\u00f3 como cient\u00edfico biom\u00e9dico, preparando el terreno para una notable trayectoria profesional. Su papel pionero como el primer m\u00e9dico interno para DIV en <a href=\"https:\/\/www.bsigroup.com\/en-SE\/medical-devices\/our-services\/ivdr-revision\/\"><strong>BSI (British Standards Institution)<\/strong><\/a>, un organismo notificado de renombre, desempe\u00f1\u00f3 un papel fundamental en la configuraci\u00f3n del proceso de supervisi\u00f3n cl\u00ednica de cientos de diagn\u00f3sticos. Desde pruebas gen\u00e9ticas hasta ensayos moleculares, diagn\u00f3sticos en el punto de atenci\u00f3n, CDx, LDT\/ensayos internos, NGS y m\u00e1s, la experiencia de Carlos es inigualable. Esta innovadora contribuci\u00f3n ha influido significativamente en la forma en que la industria aborda el cumplimiento normativo.   <\/p>\n\n<h3 class=\"wp-block-heading\"><strong>Dominar el panorama de IVDR<\/strong><\/h3>\n\n<p>La experiencia de Carlos Galamba se extiende mucho m\u00e1s all\u00e1 de su funci\u00f3n en BSI. Sus conocimientos lo han posicionado como un <strong>experto externo distinguido para la Comisi\u00f3n Europea<\/strong>, donde proporciona una valiosa orientaci\u00f3n para desenvolverse en el intrincado terreno de IVDR. Su perspicacia estrat\u00e9gica ha impulsado a empresas destacadas como <strong>Biomerieux, Cepheid, Leica, Hologic, Abbott, Thermofisher, Werfen<\/strong> y m\u00e1s hacia el logro de la excelencia en el cumplimiento de IVDR.  <\/p>\n\n<h3 class=\"wp-block-heading\"><strong>Guiar la innovaci\u00f3n en DIV<\/strong><\/h3>\n\n<p>Al frente de la innovaci\u00f3n, Carlos Galamba fue vicepresidente de Inteligencia e Innovaci\u00f3n de DIV en RQM+. Su liderazgo de pensamiento t\u00e9cnico abarc\u00f3 una variedad de tecnolog\u00edas de DIV, que van desde inmunoensayos hasta pruebas de secuenciaci\u00f3n de nueva generaci\u00f3n m\u00e1s complejas y software de DIV. Los conocimientos de Carlos han llevado al desarrollo de estrategias de inteligencia competitiva que impulsan la expansi\u00f3n y la comercializaci\u00f3n dentro del sector de la consultor\u00eda de DIV.  <\/p>\n\n<h3 class=\"wp-block-heading\"><strong>Un catalizador para el \u00e9xito normativo<\/strong><\/h3>\n\n<p>La dedicaci\u00f3n de Carlos a <strong>simplificar lo complejo<\/strong> es la piedra angular de su enfoque. Sus <strong>soluciones a medida<\/strong> permiten a las empresas desenvolverse en el cambiante panorama normativo al tiempo que obtienen una ventaja competitiva. Sus notables logros, incluido el liderazgo de la transici\u00f3n a la nueva legislaci\u00f3n de la UE sobre productos sanitarios (IVDR) en varias empresas y la implementaci\u00f3n exitosa de cambios normativos fundamentales, posicionan a <strong>Carlos Galamba como un catalizador para proyectos de DIV transformadores<\/strong>.  <\/p>\n\n<h3 class=\"wp-block-heading\"><strong><a href=\"\/es\/?page_id=8492\">Conecte<\/a> con MDx CRO para la excelencia normativa<\/strong><\/h3>\n\n<p>Tanto si es una empresa emergente de DIV con objetivos ambiciosos como si es un fabricante mundial de diagn\u00f3sticos que busca optimizar los procesos normativos, la experiencia de Carlos Galamba es su br\u00fajula para el dominio normativo. Si su empresa busca una consultor\u00eda de DIV sin igual, no dude en ponerse en contacto con Carlos y su <g id=\"gid_0\">equipo<\/g> en <g id=\"gid_1\">MDx CRO<\/g>. Juntos, aportan una gran cantidad de conocimientos para guiarle a trav\u00e9s de las complejidades de las <a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/ip_21_6965\">regulaciones de DIV<\/a>.  <\/p>\n\n<h3 class=\"wp-block-heading\"><strong>Conecte con Carlos en <a href=\"https:\/\/www.linkedin.com\/in\/carlos-galamba\/\">LinkedIn<\/a><\/strong><\/h3>\n\n<p>En el complejo panorama del diagn\u00f3stico in vitro y el marco IVDR en evoluci\u00f3n, <strong>la experiencia de Carlos Galamba sigue estableciendo el est\u00e1ndar para la excelencia normativa<\/strong>. Su amplia experiencia y liderazgo ejemplifican c\u00f3mo una profunda visi\u00f3n normativa y una orientaci\u00f3n pr\u00e1ctica pueden dar forma a estrategias de DIV exitosas y garantizar el cumplimiento duradero en virtud del IVDR. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Carlos Galamba, consultor de DIV &#8211; Fundador de MDx CRO En el intrincado panorama del diagn\u00f3stico in vitro (DIV) y la evoluci\u00f3n del Reglamento de diagn\u00f3stico in vitro (IVDR), un nombre destaca como un faro de experiencia y orientaci\u00f3n: Carlos Galamba. Con una gran experiencia que abarca m\u00e1s de 18 a\u00f1os en el sector de [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":6713,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[216],"tags":[273,278,272,233,234,281,276,277,279,274,270,275,280,271,269],"resources-sector":[178],"class_list":["post-8580","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-consultoria-de-div","tag-consultoria-de-tecnologia-medica","tag-cumplimiento-de-la-normativa-de-div","tag-cumplimiento-normativo","tag-diagnostico-in-vitro","tag-estrategia-normativa","tag-experto-en-ivdr","tag-implementacion-de-ivdr","tag-industria-de-tecnologia-medica","tag-informacion-sobre-la-industria-de-los-div","tag-innovacion-diagnostica","tag-regulacion-de-los-div","tag-retos-normativos","tag-soluciones-de-diagnostico","tag-supervision-clinica","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>Carlos Galamba: su consultor de DIV de confianza y experto en IVDR - MDx CRO<\/title>\n<meta name=\"description\" content=\"Explore la experiencia de Carlos Galamba, un consultor de DIV experimentado y experto en IVDR. 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