{"id":3732,"date":"2017-07-18T09:56:08","date_gmt":"2017-07-18T07:56:08","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=3732\/"},"modified":"2017-07-18T09:56:08","modified_gmt":"2017-07-18T07:56:08","slug":"que-es-un-contrato-obl","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2017\/07\/18\/que-es-un-contrato-obl\/","title":{"rendered":"\u00bfQu\u00e9 es un contrato OBL?"},"content":{"rendered":"<p>El t\u00e9rmino Own Brand Labelling (OBL) se refiere al proceso espec\u00edfico que un fabricante de dispositivos m\u00e9dicos sigue cuando introduce en el mercado bajo su responsabilidad un dispositivo ya marcado CE ( un dispositivo \u201cme too\u201d). La legislaci\u00f3n europea considera el fabricante en OBL como el fabricante legal aun cuando el sujeto no tiene nada que ver con la producci\u00f3n f\u00edsica del dispositivo.<br \/>\nPor lo tanto, la relaci\u00f3n entre la empresa que f\u00edsicamente produce el dispositivo y tiene el marcado CE, conocida como fabricante de equipos originales (OEM), y la empresa que desea comercializarlo en OBL debe ser regulado por un contrato. En este contrato se deben identificar las funciones de las partes involucradas, as\u00ed como el m\u00e9todo de comunicaci\u00f3n y acceso a la informaci\u00f3n sensible del dispositivo sujeto del contrato, as\u00ed como la obligaci\u00f3n por parte del OEM de proporcionar toda la documentaci\u00f3n t\u00e9cnica, requerida por la parte interesada.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>El t\u00e9rmino Own Brand Labelling (OBL) se refiere al proceso espec\u00edfico que un fabricante de dispositivos m\u00e9dicos sigue cuando introduce en  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","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-3732","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 - 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