{"id":7104,"date":"2018-05-09T10:25:42","date_gmt":"2018-05-09T08:25:42","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=7104"},"modified":"2018-05-09T10:26:02","modified_gmt":"2018-05-09T08:26:02","slug":"callida-y-bpf-internacionales","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/es\/servicios\/callida-y-bpf-internacionales\/","title":{"rendered":"CALIDAD Y BPF INTERNACIONALES"},"content":{"rendered":"<div style=\"float: left; width: 70%;\">\n<p><img decoding=\"async\" class=\"wp-image-10388 alignnone\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/09\/compliance2-300x174.jpg\" alt=\"\" width=\"300\" height=\"174\" \/><\/p>\n<p><strong>Apoyamos la calidad <\/strong><\/p>\n<p>Gracias a nuestra experiencia plurianual, podemos ayudaros completamente a implementar el Sistema de Calidad para Dispositivos M\u00e9dicos y Good Manufacturing Practice (GMP), de conformidad con los requisitos establecidos en la normativa del Pa\u00eds destinatario.<\/p>\n<p><strong>Algunos servicios <\/strong><\/p>\n<ul>\n<li>Pre-auditor\u00eda \/ orientaci\u00f3n \/ an\u00e1lisis de brecha para verificar la conformidad del Sistema de Gesti\u00f3n de Calidad (SGC) de la empresa a los requisitos BPF internacionales;<\/li>\n<li>Adaptaci\u00f3n del SGC a los requisitos de la ISO 13485:2016;<\/li>\n<li>Implementaci\u00f3n \/ adaptaci\u00f3n del SGQ a los requisitos del MDSAP:<\/li>\n<\/ul>\n<p style=\"padding-left: 60px;\">\u2013 EE. UU. (US Quality System Regulations 21 CFR 820);<\/p>\n<p style=\"padding-left: 60px;\">\u2013 Jap\u00f3n (Ministerial Ordinance MHLW No.169);<\/p>\n<p style=\"padding-left: 60px;\">\u2013 Brasil (RDC ANVISA No.16\/2013);<\/p>\n<p style=\"padding-left: 60px;\">\u2013 Canad\u00e1 (CAN\/CSA-ISO 13485:16);<\/p>\n<p style=\"padding-left: 60px;\">\u2013 Australia [TG(MD)R 2002];<\/p>\n<ul>\n<li>Apoyo durante las inspecciones en la empresa efectuadas por las Autoridades Reguladoras.<\/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\/\">Kit de Emergencia MDR<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\">Consultor\u00eda estrat\u00e9gico-regulatoria<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/es\/servicios\/apoyo-para-la-certificacion-ce\/\">Apoyo para la certificaci\u00f3n CE<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/es\/servicios\/registros-ministeriales-italianos-y-europeos\/\">Registros ministeriales italianos y europeos<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\">Registros internacionales extra-UE<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/es\/servicios\/representante-local\/\">Representante Local<\/a><\/p>\n<p><a href=\"http:\/\/www.thema-med.com\/es\/servicios\/callida-y-bpf-internacionales\/\">Calidad y BPF internacionales<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Apoyamos la calidad Gracias a nuestra experiencia plurianual, podemos ayudaros completamente a implementar el Sistema de Calidad para Dispositivos M\u00e9dicos y  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":10313,"parent":7086,"menu_order":1,"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-7104","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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