{"id":10598,"date":"2025-09-12T17:06:10","date_gmt":"2025-09-12T17:06:10","guid":{"rendered":"https:\/\/mdxcro.com\/case-studies\/risk-management-remediation-for-class-iib-medical-device\/"},"modified":"2026-03-27T09:07:50","modified_gmt":"2026-03-27T09:07:50","slug":"risk-management-remediation-for-class-iib-medical-device","status":"publish","type":"case-studies","link":"https:\/\/mdxcro.com\/es\/casos-de-estudio\/risk-management-remediation-for-class-iib-medical-device\/","title":{"rendered":"Remediaci\u00f3n de la gesti\u00f3n de riesgos para un producto sanitario de clase IIb"},"content":{"rendered":"\n<p><strong>Desaf\u00edo:<\/strong> Un fabricante de productos sanitarios de clase IIb recibi\u00f3 no conformidades mayores relacionadas con la gesti\u00f3n de riesgos durante su auditor\u00eda de vigilancia del MDR, lo que amenazaba su estado de certificaci\u00f3n.<\/p>\n\n<p><strong>Soluci\u00f3n:<\/strong> MDx llev\u00f3 a cabo una revisi\u00f3n exhaustiva del archivo de gesti\u00f3n de riesgos, facilit\u00f3 nuevas sesiones de an\u00e1lisis de riesgos e implement\u00f3 un proceso de gesti\u00f3n de riesgos revisado conforme a la norma ISO 14971:2019.<\/p>\n\n<p><strong>Resultado:<\/strong> Todas las no conformidades se cerraron dentro del plazo requerido, y el enfoque de MDx recibi\u00f3 comentarios positivos del organismo notificado por su exhaustividad y cumplimiento.<\/p>\n","protected":false},"featured_media":6820,"template":"","meta":{"_acf_changed":false},"class_list":["post-10598","case-studies","type-case-studies","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Remediaci\u00f3n de la gesti\u00f3n de riesgos para un producto sanitario de clase IIb - 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\/risk-management-remediation-for-class-iib-medical-device\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Remediaci\u00f3n de la gesti\u00f3n de riesgos para un producto sanitario de clase IIb - MDx CRO\" \/>\n<meta property=\"og:description\" content=\"Desaf\u00edo: Un fabricante de productos sanitarios de clase IIb recibi\u00f3 no conformidades mayores relacionadas con la gesti\u00f3n de riesgos durante su auditor\u00eda de vigilancia del MDR, lo que amenazaba su estado de certificaci\u00f3n. Soluci\u00f3n: MDx llev\u00f3 a cabo una revisi\u00f3n exhaustiva del archivo de gesti\u00f3n de riesgos, facilit\u00f3 nuevas sesiones de an\u00e1lisis de riesgos e [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/mdxcro.com\/es\/casos-de-estudio\/risk-management-remediation-for-class-iib-medical-device\/\" \/>\n<meta property=\"og:site_name\" content=\"MDx CRO\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-27T09:07:50+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\\\/risk-management-remediation-for-class-iib-medical-device\\\/\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/casos-de-estudio\\\/risk-management-remediation-for-class-iib-medical-device\\\/\",\"name\":\"Remediaci\u00f3n de la gesti\u00f3n de riesgos para un producto sanitario de clase IIb - 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