{"id":1165,"date":"2021-01-29T15:31:47","date_gmt":"2021-01-29T14:31:47","guid":{"rendered":"http:\/\/bionok.proyectosrank.com\/?page_id=1165"},"modified":"2021-02-19T11:48:44","modified_gmt":"2021-02-19T10:48:44","slug":"active-implants","status":"publish","type":"page","link":"https:\/\/bionok.com\/es\/active-implants\/","title":{"rendered":"Implantes activos"},"content":{"rendered":"

[vc_row css=”.vc_custom_1606733631624{margin-top: 55px !important;}”][vc_column][vc_column_text]<\/p>\n

IMPLANTES ACTIVOS<\/h1>\n

[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_single_image image=”2421″ img_size=”full” el_id=”imagedesign”][vc_column_text]Los implantes activos son productos sanitarios dentro de las categor\u00edas de mayor riesgo y est\u00e1n regulados de acuerdo con la Directiva 90\/385 \/ EEC sobre dispositivos m\u00e9dicos implantables activos (AIMD por sus siglas en ingl\u00e9s). Estos dispositivos m\u00e9dicos deben fabricarse y evaluarse mediante controles muy rigurosos para garantizar su seguridad.<\/p>\n

Los fabricantes, importadores y distribuidores deben adaptar sus sistemas de calidad a los requisitos espec\u00edficos de estos productos que suelen ser m\u00e1s exigentes.<\/p>\n

Como cualquier otro dispositivo m\u00e9dico, requieren un Representante Autorizado (EC REP) para representar al fabricante (extranjero o no) ante las Autoridades.<\/p>\n

Para cada producto ser\u00e1 necesario estudiar y analizar los aspectos que determinan su seguridad y eficacia. Siempre es recomendable crear una estrategia que haga que el proceso sea lo m\u00e1s eficiente posible y en el menor tiempo posible.<\/p>\n

Desde Bionok le ofrecemos todos los servicios necesarios para desarrollar sus Productos Sanitarios gui\u00e1ndole a lo largo de todo el proceso:<\/p>\n

– Dise\u00f1o y desarrollo, para su adaptaci\u00f3n a la normativa.<\/p>\n

-Asesor\u00eda y desarrollo de pruebas cl\u00ednicas seguridad y eficacia.<\/p>\n

– Elaboraci\u00f3n de dosieres cient\u00edfico-t\u00e9cnicos requeridos.<\/p>\n

– Sistemas de calidad.<\/p>\n

– Presentaci\u00f3n ante autoridades o centros de evaluaci\u00f3n.<\/p>\n

– Etiquetado<\/p>\n

– Representante o Agente Autorizado.<\/p>\n

– Puesta en el mercado.<\/p>\n

El Identificador unido de producto (UDI) es un c\u00f3digo num\u00e9rico o alfanum\u00e9rico que identifica el producto sanitario de manera inequ\u00edvoca. Este c\u00f3digo consta de 2 partes: device identifier<\/em> (DI) espec\u00edfico para un fabricante y un producto y un identificador de producci\u00f3n (PI) que identifica la unidad de producci\u00f3n del producto. Bionok puede ayudarle a conseguir el c\u00f3digo UDI para su Producto Sanitario.[\/vc_column_text][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1606726985955{margin-top: 0px !important;margin-bottom: 25px !important;border-top-width: 6px !important;border-top-color: #807002 !important;}” el_id=”contactview”][vc_column width=”1\/2″ css=”.vc_custom_1601110535248{border-left-width: 3px !important;border-left-color: #00184e !important;}”][vc_column_text css=”.vc_custom_1612874185280{border-left-width: 3px !important;border-left-color: #00184e !important;}”]<\/p>\n

\u00bfTienes dudas o necesitas asistencia?<\/h4>\n

+34911371170<\/strong>[\/vc_column_text][\/vc_column][vc_column width=”1\/2″][vc_btn title=”CONTACTA CON NOSOTROS” style=”flat” shape=”square” color=”sandy-brown” size=”lg” align=”right” el_id=”buttons”][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1606729171993{margin-top: 45px !important;margin-bottom: 75px !important;}”][vc_column]

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    [vc_row css=”.vc_custom_1606733631624{margin-top: 55px !important;}”][vc_column][vc_column_text] IMPLANTES ACTIVOS [\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_single_image image=”2421″ img_size=”full” el_id=”imagedesign”][vc_column_text]Los implantes activos son productos sanitarios dentro de las categor\u00edas de mayor riesgo y est\u00e1n regulados de [\u2026]<\/span><\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"nf_dc_page":"","footnotes":""},"class_list":["post-1165","page","type-page","status-publish","hentry","types-medical-device-es"],"acf":[],"yoast_head":"\nImplantes activos - Bionok<\/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:\/\/bionok.com\/active-implants\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Implantes activos - 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