{"id":7288,"date":"2018-05-18T17:14:50","date_gmt":"2018-05-18T15:14:50","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=7288"},"modified":"2018-05-18T17:14:50","modified_gmt":"2018-05-18T15:14:50","slug":"como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/","title":{"rendered":"\u00bfC\u00f3mo afectar\u00e1 el IVDR 2017\/746 a la Gesti\u00f3n del Sistema de Calidad?"},"content":{"rendered":"<p>Una vez finalizado el periodo de transici\u00f3n, todos los dispositivos IVD deber\u00e1n cumplir con los requisitos del IVDR para ser comercializados en la Uni\u00f3n Europea. Sin embargo, para obtener el certificado CE de IVDR, es necesario que los fabricantes y otros operadores involucrados, seg\u00fan corresponda, posean un sistema de gesti\u00f3n de calidad certificado.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Una vez finalizado el periodo de transici\u00f3n, todos los dispositivos IVD deber\u00e1n cumplir con los requisitos del IVDR para ser comercializados  [&#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":[1559,891],"tags":[],"class_list":["post-7288","post","type-post","status-publish","format-standard","hentry","category-porque-es-necesario-el-marcado-ce","category-faq-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u00bfC\u00f3mo afectar\u00e1 el IVDR 2017\/746 a la Gesti\u00f3n del Sistema de Calidad? - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u00bfC\u00f3mo afectar\u00e1 el IVDR 2017\/746 a la Gesti\u00f3n del Sistema de Calidad? - Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"og:description\" content=\"Una vez finalizado el periodo de transici\u00f3n, todos los dispositivos IVD deber\u00e1n cumplir con los requisitos del IVDR para ser comercializados [...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"article:published_time\" content=\"2018-05-18T15:14:50+00:00\" \/>\n<meta name=\"author\" content=\"redazione\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"redazione\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/\"},\"author\":{\"name\":\"redazione\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\"},\"headline\":\"\u00bfC\u00f3mo afectar\u00e1 el IVDR 2017\/746 a la Gesti\u00f3n del Sistema de Calidad?\",\"datePublished\":\"2018-05-18T15:14:50+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/\"},\"wordCount\":71,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#organization\"},\"articleSection\":[\"\u00bfPorqu\u00e9 es necesario el marcado CE?\",\"FAQ\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/\",\"url\":\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/\",\"name\":\"\u00bfC\u00f3mo afectar\u00e1 el IVDR 2017\/746 a la Gesti\u00f3n del Sistema de Calidad? - Thema - Medical Regulatory Consultancy\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#website\"},\"datePublished\":\"2018-05-18T15:14:50+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.thema-med.com\/es\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"\u00bfC\u00f3mo afectar\u00e1 el IVDR 2017\/746 a la Gesti\u00f3n del Sistema de Calidad?\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#website\",\"url\":\"https:\/\/www.thema-med.com\/es\/\",\"name\":\"Thema - Medical Regulatory Consultancy\",\"description\":\"Quality and Regulatory Affairs for Medical Devices\",\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.thema-med.com\/es\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":[\"Organization\",\"Place\"],\"@id\":\"https:\/\/www.thema-med.com\/es\/#organization\",\"name\":\"Thema\",\"alternateName\":\"Thema\",\"url\":\"https:\/\/www.thema-med.com\/es\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"contentUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"width\":2440,\"height\":2851,\"caption\":\"Thema\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/\"],\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\",\"name\":\"redazione\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g\",\"caption\":\"redazione\"},\"sameAs\":[\"http:\/\/www.thema-med.eu\"],\"url\":\"https:\/\/www.thema-med.com\/es\/author\/emanuele\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"\u00bfC\u00f3mo afectar\u00e1 el IVDR 2017\/746 a la Gesti\u00f3n del Sistema de Calidad? - Thema - Medical Regulatory Consultancy","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/","og_locale":"es_ES","og_type":"article","og_title":"\u00bfC\u00f3mo afectar\u00e1 el IVDR 2017\/746 a la Gesti\u00f3n del Sistema de Calidad? - Thema - Medical Regulatory Consultancy","og_description":"Una vez finalizado el periodo de transici\u00f3n, todos los dispositivos IVD deber\u00e1n cumplir con los requisitos del IVDR para ser comercializados [...]","og_url":"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/","og_site_name":"Thema - Medical Regulatory Consultancy","article_published_time":"2018-05-18T15:14:50+00:00","author":"redazione","twitter_card":"summary_large_image","twitter_misc":{"Escrito por":"redazione"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/#article","isPartOf":{"@id":"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/"},"author":{"name":"redazione","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e"},"headline":"\u00bfC\u00f3mo afectar\u00e1 el IVDR 2017\/746 a la Gesti\u00f3n del Sistema de Calidad?","datePublished":"2018-05-18T15:14:50+00:00","mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/"},"wordCount":71,"commentCount":0,"publisher":{"@id":"https:\/\/www.thema-med.com\/es\/#organization"},"articleSection":["\u00bfPorqu\u00e9 es necesario el marcado CE?","FAQ"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/","url":"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/","name":"\u00bfC\u00f3mo afectar\u00e1 el IVDR 2017\/746 a la Gesti\u00f3n del Sistema de Calidad? - Thema - Medical Regulatory Consultancy","isPartOf":{"@id":"https:\/\/www.thema-med.com\/es\/#website"},"datePublished":"2018-05-18T15:14:50+00:00","breadcrumb":{"@id":"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.thema-med.com\/es\/"},{"@type":"ListItem","position":2,"name":"\u00bfC\u00f3mo afectar\u00e1 el IVDR 2017\/746 a la Gesti\u00f3n del Sistema de Calidad?"}]},{"@type":"WebSite","@id":"https:\/\/www.thema-med.com\/es\/#website","url":"https:\/\/www.thema-med.com\/es\/","name":"Thema - Medical Regulatory Consultancy","description":"Quality and Regulatory Affairs for Medical Devices","publisher":{"@id":"https:\/\/www.thema-med.com\/es\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.thema-med.com\/es\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":["Organization","Place"],"@id":"https:\/\/www.thema-med.com\/es\/#organization","name":"Thema","alternateName":"Thema","url":"https:\/\/www.thema-med.com\/es\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/","url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","contentUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","width":2440,"height":2851,"caption":"Thema"},"image":{"@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/"],"mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/como-afectara-el-ivdr-2017746-la-gestion-del-sistema-de-calidad\/"}},{"@type":"Person","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e","name":"redazione","image":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g","caption":"redazione"},"sameAs":["http:\/\/www.thema-med.eu"],"url":"https:\/\/www.thema-med.com\/es\/author\/emanuele\/"}]}},"_links":{"self":[{"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/posts\/7288","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/comments?post=7288"}],"version-history":[{"count":0,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/posts\/7288\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/media?parent=7288"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/categories?post=7288"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.thema-med.com\/es\/wp-json\/wp\/v2\/tags?post=7288"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}