{"id":7098,"date":"2018-05-09T10:20:18","date_gmt":"2018-05-09T08:20:18","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=7098"},"modified":"2024-10-29T15:12:39","modified_gmt":"2024-10-29T14:12:39","slug":"apoyo-para-la-certificacion-ce","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/es\/servicios\/apoyo-para-la-certificacion-ce\/","title":{"rendered":"APOYO PARA EL MARCADO CE"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><div style=\"float: left; width: 70%;\">\n<h5 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 22; line-height: 1.2; --minfontsize: 22;\" data-fontsize=\"22\" data-lineheight=\"26.4px\"><img decoding=\"async\" class=\"alignnone size-medium wp-image-7766\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/08\/EU-Commission-300x169.jpg\" alt=\"\" width=\"300\" height=\"169\"><\/h5>\n<p><strong>Apoyo a la obtenci\u00f3n del marcado CE para dispositivos m\u00e9dicos <\/strong><strong>(Ref. MDR (UE) 2017\/745) e IVD (Ref. IVDR (UE) 2017\/746).<\/strong><\/p>\n<p><strong>La elecci\u00f3n correcta para un proceso complejo <\/strong><\/p>\n<p>El proceso para llegar al marcado CE de Dispositivos M\u00e9dicos e IVD, requiere un an\u00e1lisis exhaustivo y riguroso y preparaci\u00f3n de la documentaci\u00f3n t\u00e9cnica de referencia.<\/p>\n<p>Los expertos Thema acompa\u00f1an y apoyan los Fabricantes en el proceso de obtenci\u00f3n del marcado CE para los dispositivos m\u00e9dicos y productos IVD (Ref. MDR (UE) 2017\/745) e IVD (Ref. IVDR (UE) 2017\/746).<\/p>\n<p><strong>Algunos servicios:<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/kit-de-emergencia-ivdr\/\"><b>Kit de Emergencia IVDR: l<span class=\"JsGRdQ\">a soluci\u00f3n m\u00e1s r\u00e1pida de responder a las principales obligaciones del IVDR (UE) 2017\/746<\/span><span class=\"Y2IQFc\" lang=\"es\">.<\/span><\/b><\/a><\/li>\n<li><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/nuevo-kit-de-emergencia-mdr\/\"><b>Kit de Emergencia MDR: la soluci\u00f3n m\u00e1s r\u00e1pida para los Operadores Econ\u00f3micos de dispositivos m\u00e9dicos.<\/b><\/a><\/li>\n<li>An\u00e1lisis de viabilidad para verificar el cumplimiento de los requisitos generales de seguridad y eficacia necesarios para obtener el marcado CE.<\/li>\n<li><em>Gap-analysis<\/em>\/<em>orientative\/pre-screening <\/em>documental para la adaptaci\u00f3n de la Documentaci\u00f3n T\u00e9cnica de producto y de sistema relacionada.<\/li>\n<li>Elaboraci\u00f3n de Documentaci\u00f3n T\u00e9cnica de producto y de sistema relacionada.<\/li>\n<li>Elaboraci\u00f3n\/actualizaci\u00f3n del Plan de Evaluaci\u00f3n Cl\u00ednica (PEC), Informe de Evaluaci\u00f3n Cl\u00ednica (IEC), Post Market Clinical Follow up (PMCF).<\/li>\n<li>Adaptaci\u00f3n <em>labelling <\/em>(etiquetas, instrucciones de uso).<\/li>\n<li>Proceso de Vigilancia Post-Mercado (plan e informes PMS, IPS, an\u00e1lisis de tendencias).<\/li>\n<li>Implementaci\u00f3n de requisitos MDR e IVD relativos a la vigilancia post-mercado, vigilancia del mercado y obligaciones de registro del Fabricante y de los operadores econ\u00f3micos durante el <em>\u201cperiod of grace\u201d <\/em>de los certificados CE MDD e IVDD.<\/li>\n<li>Apoyo a la actividad de Validaci\u00f3n de Software M\u00e9dicos.<\/li>\n<\/ul>\n<\/div>\n<div id=\"serviceslist\" style=\"float: left; width: 27%; margin-left: 1.5%; padding-left: 1.5%; border-left: 1px solid;\">\n<p><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/kit-de-emergencia-ivdr\/\">Kit de Emergencia IVDR<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/nuevo-kit-de-emergencia-mdr\/\"><span style=\"color: #0099a8;\">Kit de Emergencia MDR<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\">Consultor\u00eda estrat\u00e9gico-regulatoria<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/apoyo-para-la-certificacion-ce\/\">Apoyo para el marcado CE<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/registros-ministeriales-italianos-y-europeos\/\">Registros ministeriales italianos y europeos<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\">Registros internacionales extra-UE<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/\">Representante Local<\/a><\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/callida-y-bpf-internacionales\/\">Calidad y BPF internacionales<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":10313,"parent":7086,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-7098","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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