{"id":3796,"date":"2017-07-27T16:41:07","date_gmt":"2017-07-27T14:41:07","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=3796\/"},"modified":"2023-01-24T15:05:32","modified_gmt":"2023-01-24T14:05:32","slug":"gestionar-el-software-medico-en-cualidad-en-cuatro-pasos","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2017\/07\/27\/gestionar-el-software-medico-en-cualidad-en-cuatro-pasos\/","title":{"rendered":"Gestionar el software m\u00e9dico \u201cen terminos de calidad\u201d en cuatro pasos"},"content":{"rendered":"<p>Gestionar el software m\u00e9dico, un tipo de dispositivo m\u00e1s intangible y dif\u00edcil de controlar , seg\u00fan procesos adecuados, seguridad y eficacia no es tarea f\u00e1cil. Una importante ayuda puede ser el <em>International Medical Device Regulators Forum (IMDRF)<\/em> que ha elaborado una directriz sobre el tema, la IMDRF SAMD WG N23, \u201c<a href=\"http:\/\/www.imdrf.org\/docs\/imdrf\/final\/technical\/imdrf-tech-151002-samd-qms.pdf\">Software as a Medical Device (SaMD): Application of Quality Management System<\/a>\u201d (publicada el 2 de octubre de 2015 y descargable gratuitamente de la p\u00e1gina web).<\/p>\n<p>La directriz propone esencialmente un tipo de organizaci\u00f3n eficaz para la \u00abproducci\u00f3n\u00bb de SaMD que podr\u00eda garantizarse en cuatro pasos:<\/p>\n<p>1. Identificar el liderazgo apropiado, comprometerse para cumplir con las normas y proporcionar los recursos adecuados para garantizar la eficacia y el rendimiento del SaMD (Software as Medical Device);.<br \/>\n2. Establecer un conjunto de reglas (adaptadas por dimensi\u00f3n, estructura y tipo de producto realizado) que pueden aplicarse al ciclo de vida del software.<br \/>\n3. Definir las principales actividades a lo largo del ciclo de vida del SaMD, que consideran los elementos importantes, necesarios para garantizar la seguridad, la eficacia y el rendimiento.<br \/>\n4. Prestar mucha atenci\u00f3n al t\u00edtulo de los socios externos y a los controles necesarios, con el objetivo de garantizar la calidad de cualquier producto o proceso de externalizaci\u00f3n.<\/p>\n<p>\u00bfParecen reglas demasiado generales? Pues no es as\u00ed.<\/p>\n<p>Naturalmente, el grado de extensi\u00f3n y la profundidad de un sistema de calidad debe adaptarse al tipo de dispositivo m\u00e9dico, al riesgo asociado al producto, a la dimensi\u00f3n de la organizaci\u00f3n, a la tecnolog\u00eda utilizada, y a otros factores determinados por el fabricante para el control correcto de los aspectos de funcionalidad y fiabilidad.<br \/>\nAdem\u00e1s, la directriz IMDRF proporciona claros ejemplos de buena gesti\u00f3n de las grandes y peque\u00f1as empresas, mostrando que no es el \u00abtama\u00f1o\u00bb lo que determina la correcta gesti\u00f3n del ciclo de vida del software.<\/p>\n<p>Por lo tanto, si el software como dispositivo m\u00e9dico forma parte del negocio de la empresa, la directriz IMDRF puede ser una gran ayuda para facilitar la gesti\u00f3n diaria de los procesos del sistema.<\/p>\n<p>Para consultar la directriz ver: \u201c<a href=\"http:\/\/www.imdrf.org\/docs\/imdrf\/final\/technical\/imdrf-tech-151002-samd-qms.pdf\">Software as a Medical Device (SaMD): Application of Quality Management System<\/a>\u201d.<\/p>\n<p><strong>\u00bfQuieres estar siempre al d\u00eda de las actividades de Thema?<\/strong><br \/>\n<strong> <a href=\"http:\/\/www.thema-med.com\/es\/newsletter\/\">\u00a1Suscr\u00edbete a nuestro bolet\u00edn de noticias<\/a>!<\/strong><\/p>\n<p style=\"text-align: justify;\"><strong><img decoding=\"async\" class=\" wp-image-10 alignleft\" src=\"https:\/\/publicationsthema.files.wordpress.com\/2012\/08\/thema-logo-trasparente_small.png\" alt=\"THEMA - Logo TRASPARENTE_small\" width=\"51\" height=\"51\" \/><\/strong><\/p>\n<p><em><strong>Paride Bruni<\/strong><strong><br \/>\n<\/strong>Quality Manager<\/em><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gestionar el software m\u00e9dico, un tipo de dispositivo m\u00e1s intangible y dif\u00edcil de controlar , seg\u00fan procesos adecuados, seguridad y eficacia  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[680,3],"tags":[],"class_list":["post-3796","post","type-post","status-publish","format-standard","hentry","category-blog-es","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Gestionar el software m\u00e9dico \u201cen terminos de calidad\u201d en cuatro pasos<\/title>\n<meta name=\"description\" content=\"Gestionar el software m\u00e9dico, un tipo de dispositivo m\u00e1s intangible y dif\u00edcil de controlar , seg\u00fan procesos adecuados, seguridad y eficacia no es tarea...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/es\/2017\/07\/27\/gestionar-el-software-medico-en-cualidad-en-cuatro-pasos\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Gestionar el software m\u00e9dico \u201cen terminos de calidad\u201d en cuatro pasos\" \/>\n<meta property=\"og:description\" content=\"Gestionar el software m\u00e9dico, un tipo de dispositivo m\u00e1s intangible y dif\u00edcil de controlar , seg\u00fan procesos adecuados, seguridad y eficacia no es tarea...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/es\/2017\/07\/27\/gestionar-el-software-medico-en-cualidad-en-cuatro-pasos\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema - 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