{"id":1152,"date":"2025-06-27T12:49:47","date_gmt":"2025-06-27T11:49:47","guid":{"rendered":"https:\/\/www.md-amconsulting.es\/?p=1152"},"modified":"2025-07-04T07:41:47","modified_gmt":"2025-07-04T06:41:47","slug":"gestion-riesgos-sanitarios-diseno","status":"publish","type":"post","link":"https:\/\/www.md-amconsulting.es\/index.php\/2025\/06\/27\/gestion-riesgos-sanitarios-diseno\/","title":{"rendered":"Gesti\u00f3n de riesgos en productos sanitarios desde el dise\u00f1o."},"content":{"rendered":"\n<h2 class=\"wp-block-heading has-kubio-color-5-color has-text-color has-link-color wp-elements-36e5300f9e55c34969a19ba6b167e23a\">.<\/h2>\n\n\n\n<h1 class=\"wp-block-heading\" style=\"letter-spacing:2px\">Gesti\u00f3n de riesgos en productos sanitarios desde el dise\u00f1o.<\/h1>\n\n\n\n<p style=\"border-radius:0px;letter-spacing:2px\">La gesti\u00f3n de riesgos en productos sanitarios desde el dise\u00f1o no es una opci\u00f3n, sino una necesidad y una obligaci\u00f3n. Es un hilo conductor que debe estar presente desde el inicio del dise\u00f1o y desarrollo del dispositivo m\u00e9dico. Sin embargo, en muchos casos, se sigue tratando como una tarea de \u00faltima hora.<\/p>\n\n\n\n<p style=\"letter-spacing:2px\">Para cumplir con la normativa y tomar mejores decisiones de dise\u00f1o, es imprescindible integrar la gesti\u00f3n de riesgos de forma continua y estructurada. A continuaci\u00f3n, te mostramos una hoja de ruta pr\u00e1ctica para empezar incluso <strong>antes del dise\u00f1o<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"letter-spacing:2px\">1. Observar antes de dise\u00f1ar<\/h2>\n\n\n\n<p style=\"letter-spacing:2px\">Antes de comenzar cualquier an\u00e1lisis t\u00e9cnico, <strong>observa a los usuarios en su entorno real<\/strong>. Comprender c\u00f3mo se usar\u00e1 el dispositivo desde el principio te ayudar\u00e1 a detectar riesgos reales de uso. Implementar la <strong>gesti\u00f3n de riesgos en productos sanitarios desde el dise\u00f1o<\/strong> permite tomar mejores decisiones t\u00e9cnicas, asegurar el cumplimiento normativo y evitar redise\u00f1os costosos.<\/p>\n\n\n\n<p style=\"letter-spacing:2px\"><strong>Evita confiar solo en encuestas<\/strong>: la observaci\u00f3n directa permite identificar problemas que los usuarios no reportan.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"letter-spacing:2px\">2. Documenta el estado del arte<\/h2>\n\n\n\n<p style=\"letter-spacing:2px\">Escribe una descripci\u00f3n detallada del <strong>estado del arte<\/strong> t\u00e9cnico y cl\u00ednico:<\/p>\n\n\n\n<ul style=\"letter-spacing:2px\" class=\"wp-block-list\">\n<li>Qu\u00e9 productos similares existen.<\/li>\n\n\n\n<li>Qu\u00e9 tecnolog\u00edas o procesos se usan actualmente.<\/li>\n\n\n\n<li>Qu\u00e9 publicaciones o estudios pueden aportar datos consolidados.<\/li>\n<\/ul>\n\n\n\n<p style=\"letter-spacing:2px\"> Este paso es clave para anticipar posibles riesgos cl\u00ednicos y t\u00e9cnicos desde el principio.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"letter-spacing:2px\">3. Elabora tu lista de riesgos cl\u00ednicos <\/h2>\n\n\n\n<p style=\"letter-spacing:2px\">Antes de redactar el an\u00e1lisis formal, crea una <strong>lista preliminar de riesgos<\/strong> que te sirva de punto de partida. Esto te evitar\u00e1 el s\u00edndrome de la hoja en blanco.<\/p>\n\n\n\n<p style=\"letter-spacing:2px\">Incluye:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"letter-spacing:2px\">Riesgos relacionados con el uso.<\/li>\n\n\n\n<li style=\"letter-spacing:2px\">Situaciones peligrosas previsibles.<\/li>\n\n\n\n<li style=\"letter-spacing:2px\">Posibles da\u00f1os directos e indirectos.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"letter-spacing:2px\">4. Integra los GSPR desde el principio<\/h2>\n\n\n\n<p style=\"letter-spacing:2px\">Los <strong>Requisitos Generales de Seguridad y Funcionamiento (GSPR)<\/strong> deben tenerse en cuenta desde la fase inicial. No esperes al final del proyecto para comprobar si cumples.<\/p>\n\n\n\n<p style=\"letter-spacing:2px\"> Consejo: <strong>cada medida de control de riesgos<\/strong> debe alinearse con los GSPR y con los objetivos de seguridad y rendimiento del producto.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"letter-spacing:2px\">\u00bfY durante el desarrollo? Iteraci\u00f3n y trazabilidad<\/h2>\n\n\n\n<p style=\"letter-spacing:2px\">La <strong>gesti\u00f3n de riesgos en productos sanitarios<\/strong> debe evolucionar con cada modificaci\u00f3n del dise\u00f1o. Cada salida (por ejemplo, una soluci\u00f3n t\u00e9cnica) debe estar vinculada a una entrada (riesgo identificado).<\/p>\n\n\n\n<p style=\"letter-spacing:2px\">No es un entregable \u00fanico, es un <strong>sistema rastreable<\/strong> de decisiones y actualizaciones continuas.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"letter-spacing:2px\">Herramientas y metodolog\u00eda: c\u00f3mo hacerlo bien (y m\u00e1s f\u00e1cil)<\/h2>\n\n\n\n<p style=\"letter-spacing:2px\">Aplicar correctamente la gesti\u00f3n de riesgos en productos sanitarios te permite no solo cumplir con la normativa, sino tambi\u00e9n ahorrar tiempo y mejorar tu producto.<\/p>\n\n\n\n<p style=\"letter-spacing:2px\">Los siguientes documentos te ayudar\u00e1n a realizar el proceso<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"letter-spacing:2px\"><a href=\"https:\/\/www.une.org\/encuentra-tu-norma\/busca-tu-norma\/norma?c=N0064637\">ISO 14971<\/a> <\/li>\n\n\n\n<li style=\"letter-spacing:2px\"><a href=\"https:\/\/www.une.org\/encuentra-tu-norma\/busca-tu-norma\/norma?c=norma-une-cen-iso-tr-24971-2020-n0064499\">UNE-CEN ISO\/TR 24971:2020&nbsp;<\/a><\/li>\n<\/ul>\n\n\n\n<p style=\"letter-spacing:2px\">Si tiene alguna pregunta o desea que le ayudemos con la gesti\u00f3n de riesgos de su empresa, no dude en <a href=\"https:\/\/www.md-amconsulting.es\/index.php\/pagina-de-contacto\/\">contactarnos<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>. Gesti\u00f3n de riesgos en productos sanitarios desde el dise\u00f1o. La gesti\u00f3n de riesgos en productos sanitarios desde el dise\u00f1o no es una opci\u00f3n, sino una necesidad y una obligaci\u00f3n. Es un hilo conductor que debe estar presente desde el inicio del dise\u00f1o y desarrollo del dispositivo m\u00e9dico. Sin embargo, en muchos casos, se sigue [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1153,"comment_status":"open","ping_status":"open","sticky":false,"template":"page-blog","format":"standard","meta":{"saved_in_kubio":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[50],"tags":[26,12,69,59,28,36],"class_list":["post-1152","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-auditoria","tag-consultoria","tag-formacion","tag-mdr","tag-poscomercializacion","tag-productos-sanitarios"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Gesti\u00f3n de riesgos sanitarios: c\u00f3mo aplicarla desde el dise\u00f1o<\/title>\n<meta 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