{"id":10593,"date":"2025-09-12T17:03:00","date_gmt":"2025-09-12T17:03:00","guid":{"rendered":"https:\/\/mdxcro.com\/case-studies\/so-13485-implementation-for-precision-medicine-startup\/"},"modified":"2026-03-27T09:07:05","modified_gmt":"2026-03-27T09:07:05","slug":"so-13485-implementation-for-precision-medicine-startup","status":"publish","type":"case-studies","link":"https:\/\/mdxcro.com\/es\/casos-de-estudio\/so-13485-implementation-for-precision-medicine-startup\/","title":{"rendered":"Implementaci\u00f3n de la ISO 13485 para una empresa emergente de medicina de precisi\u00f3n"},"content":{"rendered":"\n<p><strong>Desaf\u00edo:<\/strong> Una empresa emergente de medicina de precisi\u00f3n con recursos limitados necesitaba establecer un SGC conforme a la ISO 13485 para respaldar el marcado CE de su primera prueba diagn\u00f3stica avanzada de NGS seg\u00fan el IVDR.<\/p>\n\n<p><strong>Soluci\u00f3n:<\/strong> MDx implement\u00f3 un enfoque de desarrollo de SGC por fases, priorizando los procesos clave necesarios para los requisitos regulatorios inmediatos, al tiempo que constru\u00eda un marco escalable para el crecimiento futuro.<\/p>\n\n<p><strong>Resultado:<\/strong> Certificaci\u00f3n ISO 13485 obtenida en 6 meses sin no conformidades mayores, lo que permiti\u00f3 al cliente proceder con la presentaci\u00f3n de la documentaci\u00f3n t\u00e9cnica del IVDR a tiempo.<\/p>\n","protected":false},"featured_media":6820,"template":"","meta":{"_acf_changed":false},"class_list":["post-10593","case-studies","type-case-studies","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Implementaci\u00f3n de la ISO 13485 para una empresa emergente de medicina de precisi\u00f3n - MDx CRO<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mdxcro.com\/es\/casos-de-estudio\/so-13485-implementation-for-precision-medicine-startup\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Implementaci\u00f3n de la ISO 13485 para una empresa emergente de medicina de precisi\u00f3n - MDx CRO\" \/>\n<meta property=\"og:description\" content=\"Desaf\u00edo: Una empresa emergente de medicina de precisi\u00f3n con recursos limitados necesitaba establecer un SGC conforme a la ISO 13485 para respaldar el marcado CE de su primera prueba diagn\u00f3stica avanzada de NGS seg\u00fan el IVDR. Soluci\u00f3n: MDx implement\u00f3 un enfoque de desarrollo de SGC por fases, priorizando los procesos clave necesarios para los requisitos [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/mdxcro.com\/es\/casos-de-estudio\/so-13485-implementation-for-precision-medicine-startup\/\" \/>\n<meta property=\"og:site_name\" content=\"MDx CRO\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-27T09:07:05+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/medical-device-expertise-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1074\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/casos-de-estudio\\\/so-13485-implementation-for-precision-medicine-startup\\\/\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/casos-de-estudio\\\/so-13485-implementation-for-precision-medicine-startup\\\/\",\"name\":\"Implementaci\u00f3n de la ISO 13485 para una empresa emergente de medicina de precisi\u00f3n - 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