{"id":7430,"date":"2018-07-03T16:06:22","date_gmt":"2018-07-03T14:06:22","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=7430"},"modified":"2018-07-03T16:06:22","modified_gmt":"2018-07-03T14:06:22","slug":"ee-uu-pronto-armonizado-el-sistema-de-gestion-de-calidad-de-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/07\/03\/ee-uu-pronto-armonizado-el-sistema-de-gestion-de-calidad-de-dispositivos-medicos\/","title":{"rendered":"EE.UU.: Pronto armonizado el Sistema de Gesti\u00f3n de Calidad de dispositivos m\u00e9dicos"},"content":{"rendered":"<p><strong>\u00a0<\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignleft size-full wp-image-7425\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/06\/FDA.jpg\" alt=\"\" width=\"281\" height=\"180\" \/><\/p>\n<p>La FDA ha declarado su intenci\u00f3n de armonizar y modernizar el <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=820\" target=\"_blank\" rel=\"noopener\">21CFR 820<\/a>, la regulaci\u00f3n del Sistema de Gesti\u00f3n de Calidad (SGC) de dispositivos m\u00e9dicos.<\/p>\n<p>&nbsp;<\/p>\n<p>Los requisitos del Sistema de Calidad existente ser\u00e1n reemplazados por las especificaciones de la norma internacional armonizada\u00a0<strong>EN<\/strong> <strong>ISO 13485:2016<\/strong>.<\/p>\n<p>Esta revisi\u00f3n pretende reducir las obligaciones de cumplimiento y retenci\u00f3n de documentaci\u00f3n para los fabricantes de dispositivos mediante la armonizaci\u00f3n de los requisitos nacionales e internacionales.<\/p>\n<p>De hecho, estos cambios alinear\u00e1n el 21CFR 820 con la norma armonizada <strong>ISO 13485:2016<\/strong>.<\/p>\n<p>En abril de 2019, la FDA publicar\u00e1 una primera propuesta bajo consulta p\u00fablica a trav\u00e9s de un anuncio de propuesta de reglamentaci\u00f3n (<a href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/RulesRegulations\/default.htm\" target=\"_blank\" rel=\"noopener\">NPRM<\/a>).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00a0 La FDA ha declarado su intenci\u00f3n de armonizar y modernizar el 21CFR 820, la regulaci\u00f3n del Sistema de Gesti\u00f3n de  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","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":[679],"tags":[],"class_list":["post-7430","post","type-post","status-publish","format-standard","hentry","category-blog-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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