{"id":15272,"date":"2020-08-18T11:33:15","date_gmt":"2020-08-18T09:33:15","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=15272"},"modified":"2022-07-27T09:21:43","modified_gmt":"2022-07-27T07:21:43","slug":"nuevo-kit-emergencia-mdr-operadores-economicos-dispositivos-medicos","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/es\/servicios\/apoyo-para-la-certificacion-ce\/nuevo-kit-emergencia-mdr-operadores-economicos-dispositivos-medicos\/","title":{"rendered":"Kit de Emergencia MDR 1"},"content":{"rendered":"\r\n<p><strong>Kit de Emergencia MDR: la soluci\u00f3n m\u00e1s r\u00e1pida para los Operadores Econ\u00f3micos de Dispositivos M\u00e9dicos <\/strong><\/p>\r\n\r\n\r\n\r\n<p>\u00bfA\u00fan no has pensado en c\u00f3mo aplicar el MDR (UE) 2017\/745? \u00bfLas limitaciones debidas a la emergencia COVID-19 no te permiten mantener todas las citas con tu asesor? \u00bfQuieres ahorrar tiempo y costes?<\/p>\r\n\r\n\r\n\r\n<div class=\"wp-block-image\">\r\n<figure class=\"aligncenter\"><img decoding=\"async\" class=\"wp-image-14561\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/05\/MDR-Emergency-Kit-eng-1024x535.png\" alt=\"MDR Emergency Kit\" \/><\/figure>\r\n<\/div>\r\n\r\n\r\n\r\n<p>Los expertos Thema proponen una r\u00e1pida y eficaz soluci\u00f3n: Kit de Emergencia MDR, una especie de \u201ccaja de herramientas S.O.S.\u201d en formato digital\u00a0para adaptarse r\u00e1pidamente a las disposiciones restrictivas del MDR (UE) 2017\/745.<\/p>\r\n\r\n\r\n\r\n<p class=\"has-text-color has-background has-medium-font-size has-very-light-gray-color\" style=\"background-color: #0099a8; text-align: center;\"><strong>A disposici\u00f3n del cliente plantilla y documentos t\u00e9cnicos est\u00e1ndar <\/strong><\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>plantilla base est\u00e1ndar de los documentos m\u00e1s importantes (CTD; carta PRRC);<\/li>\r\n<li>plantilla de Documentaci\u00f3n T\u00e9cnica (expediente t\u00e9cnico) con las instrucciones de cumplimentaci\u00f3n;<\/li>\r\n<li>procedimientos de Sistema de Calidad fundamentales.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p class=\"has-text-color has-background has-medium-font-size has-very-light-gray-color\" style=\"background-color: #0099a8; text-align: center;\"><strong>Cuatro versiones de Kit de Emergencia MDR seg\u00fan necesidades especificas<\/strong><\/p>\r\n\r\n\r\n\r\n<p>1. <strong>FABBRICANTE<\/strong> &#8211; MDR Emergency Kit<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><em>plantilla <\/em>carta de delegaci\u00f3n Persona Responsable del Cumplimento de la Reglamentaci\u00f3n (PRCR);<\/li>\r\n<li><em>plantilla <\/em>Documentaci\u00f3n T\u00e9cnica (DT MDR);<\/li>\r\n<li>p<em>lantilla <\/em>procedimientos de Vigilancia Post-Mercado (VPM), Vigilancia, Comunicaciones a las Autoridades Reguladoras (AR) ;<\/li>\r\n<li><em>plantilla<\/em>Nota informativa para el Distribuidor;<\/li>\r\n<li>Quality Technical Agreement (QTA) Fabricante\/Distribuidor UE.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>2. <strong>REPRESENTANTE AUTORIZADO <\/strong>\u2013 Kit de Emergencia MDR<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><em>plantilla <\/em>carta de delegaci\u00f3n Persona Responsable del Cumplimento de la Reglamentaci\u00f3n PRCR (distinta de la del Fabricante);<\/li>\r\n<li>p<em>lantilla <\/em>procedimientos de Vigilancia Post-Mercado (VPM), Vigilancia, Comunicaci\u00f3n a las Autoridades Reguladoras (AR);<\/li>\r\n<li>Quality Technical Agreement (QTA) Fabricante\/Representante Autorizado solo en ingl\u00e9s.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>3. <strong>IMPORTADOR \u2013 <\/strong>Kit de Emergencia MDR<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><em>plantilla<\/em>procedimientos No Conformidad , CAPA, VPM, Comunicaciones a las Autoridades Reguladoras (AR) y Fabricante, Controles de aceptaci\u00f3n DM terminado;<\/li>\r\n<li><em>plantilla <\/em>formulario de control de aceptaci\u00f3n Importador.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>4. <strong>DISTRIBUITOR \u2013 <\/strong>Kit de Emergencia MDR<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><em>plantilla <\/em>procedimientos No Conformidad, CAPA, Vigilancia Post-Mercado, Comunicaci\u00f3n a las Autoridades Reguladoras (AR) y al Fabricante, Controles de Aceptaci\u00f3n de los Dispositivos M\u00e9dicos terminados;<\/li>\r\n<li>p<em>lantilla <\/em>formulario Controles en Aceptaci\u00f3n.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>El kit est\u00e1 disponible en italiano e ingl\u00e9s.<\/p>\r\n\r\n\r\n\r\n<p class=\"has-text-color has-background has-medium-font-size has-very-light-gray-color\" style=\"background-color: #0099a8; text-align: center;\"><strong>Las ventajas <\/strong><\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>ahorrar tiempo<\/strong>, a partir de una base elaborada por los expertos Thema;<\/li>\r\n<li><strong>personalizar<\/strong>, adaptando el contenido est\u00e1ndar a su realidad;<\/li>\r\n<li><strong>ahorrar los costes del asesoramiento, <\/strong>si no es necesario.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p class=\"has-text-color has-background has-medium-font-size has-very-light-gray-color\" style=\"background-color: #0099a8; text-align: center;\"><strong>Servicio adicional <\/strong><\/p>\r\n\r\n\r\n\r\n<p>\u00bfNecesitas apoyo calificado? \u00bfNecesitas alguna aclaraci\u00f3n? Los expertos Thema se mantienen disponibles para servicios de asesoramiento, tambi\u00e9n remotamente.<\/p>\r\n\r\n\r\n\r\n<p class=\"has-text-color has-background has-very-dark-gray-color\" style=\"background-color: #ffbd4a;\"><strong>\u00a1Cont\u00e1ctenos y recibe tu Kit de Emergencia MDR por correo electr\u00f3nico!<\/strong><br \/>Thema Staff: t. 0542 643496 \/ <a href=\"mailto:sales@thema-med.com\">sales@thema-med.com<\/a> <\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>Kit de Emergencia MDR: la soluci\u00f3n m\u00e1s r\u00e1pida para los Operadores Econ\u00f3micos de Dispositivos M\u00e9dicos \u00bfA\u00fan no has pensado en c\u00f3mo  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7098,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-15272","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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