{"id":848,"date":"2021-01-29T16:32:29","date_gmt":"2021-01-29T15:32:29","guid":{"rendered":"http:\/\/bionok.proyectosrank.com\/?page_id=848"},"modified":"2021-02-18T19:33:48","modified_gmt":"2021-02-18T18:33:48","slug":"productos-sanitarios-para-diagnostico-in-vitro","status":"publish","type":"page","link":"https:\/\/bionok.com\/es\/productos-sanitarios-para-diagnostico-in-vitro\/","title":{"rendered":"Productos sanitarios para diagn\u00f3stico in-vitro"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row css=&#8221;.vc_custom_1606733631624{margin-top: 55px !important;}&#8221;][vc_column][vc_column_text]<\/p>\n<h1 style=\"text-align: center;\">PRODUCTOS SANITARIOS PARA DIAGN\u00d3STICO IN-VITRO<\/h1>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_single_image image=&#8221;2352&#8243; img_size=&#8221;full&#8221; el_id=&#8221;imagedesign&#8221;][vc_column_text]Ya sea que el producto est\u00e9 destinado a ser utilizado por profesionales de la salud en hospitales o por consumidores en el hogar, los fabricantes e importadores deben garantizar la conformidad de los productos de acuerdo con la regulaci\u00f3n aplicable y, para hacerlo, se debe tomar un enfoque caso por caso. Solo despu\u00e9s de que el producto haya sido sometido a la evaluaci\u00f3n antes mencionada, el fabricante o importador podr\u00e1 poner su producto sanitario en el mercado.<\/p>\n<p>En Europa los IVD tienen una reglamentaci\u00f3n espec\u00edfica, Reglamento (UE) 2017\/746, que establece las normas relativas a la fabricaci\u00f3n, comercializaci\u00f3n y puesta en servicio de IVDMD) \u00a0en otros pa\u00edses como USA y CHINA est\u00e1n integrados dentro de la reglamentaci\u00f3n de dispositivos m\u00e9dicos.<\/p>\n<p>La participaci\u00f3n de la autoridad o de un organismo notificado en la evaluaci\u00f3n de la conformidad depender\u00e1 del tipo de producto con el que estemos tratando en funci\u00f3n del uso previsto y el riesgo que implica.<\/p>\n<p>El equipo de Bionok lo ayudar\u00e1 a recopilar toda la informaci\u00f3n necesaria y evaluar\u00e1 la seguridad y conformidad del producto, presentaci\u00f3n ante las autoridades y organismo de evaluaci\u00f3n.<\/p>\n<p>Bionok tambi\u00e9n puede actuar como representante autorizado de sus dispositivos m\u00e9dicos de diagn\u00f3stico in vitro.[\/vc_column_text][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1606726985955{margin-top: 0px !important;margin-bottom: 25px !important;border-top-width: 6px !important;border-top-color: #807002 !important;}&#8221; el_id=&#8221;contactview&#8221;][vc_column width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1601110535248{border-left-width: 3px !important;border-left-color: #00184e !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1612867942206{border-left-width: 3px !important;border-left-color: #00184e !important;}&#8221;]<\/p>\n<h4>\u00bfTienes dudas o necesitas asistencia?<\/h4>\n<p><strong>+34911371170<\/strong>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_btn title=&#8221;CONTACTANOS&#8221; style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;sandy-brown&#8221; size=&#8221;lg&#8221; align=&#8221;right&#8221; el_id=&#8221;buttons&#8221;][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1606729171993{margin-top: 45px !important;margin-bottom: 75px !important;}&#8221;][vc_column]<ul class=\"clients clearfix \"><li style=\"width:16.667%\"><div class=\"client_wrapper\"><div class=\"gs-wrapper\"><img decoding=\"async\" width=\"135\" height=\"75\" src=\"https:\/\/i0.wp.com\/bionok.com\/wp-content\/uploads\/2020\/09\/china-machine-vision-industry-union-vector-logo.png?fit=135%2C75&amp;ssl=1\" class=\"scale-with-grid wp-post-image\" alt=\"\" srcset=\"https:\/\/i0.wp.com\/bionok.com\/wp-content\/uploads\/2020\/09\/china-machine-vision-industry-union-vector-logo.png?w=900&amp;ssl=1 900w, https:\/\/i0.wp.com\/bionok.com\/wp-content\/uploads\/2020\/09\/china-machine-vision-industry-union-vector-logo.png?resize=300%2C167&amp;ssl=1 300w, https:\/\/i0.wp.com\/bionok.com\/wp-content\/uploads\/2020\/09\/china-machine-vision-industry-union-vector-logo.png?resize=768%2C427&amp;ssl=1 768w, 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https:\/\/i0.wp.com\/bionok.com\/wp-content\/uploads\/2020\/09\/GRS.jpg?resize=50%2C26&amp;ssl=1 50w, https:\/\/i0.wp.com\/bionok.com\/wp-content\/uploads\/2020\/09\/GRS.jpg?resize=143%2C75&amp;ssl=1 143w\" sizes=\"(max-width: 143px) 100vw, 143px\" \/><\/div><\/div><\/li><\/ul>\n[\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row css=&#8221;.vc_custom_1606733631624{margin-top: 55px !important;}&#8221;][vc_column][vc_column_text] PRODUCTOS SANITARIOS PARA DIAGN\u00d3STICO IN-VITRO [\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_single_image image=&#8221;2352&#8243; img_size=&#8221;full&#8221; el_id=&#8221;imagedesign&#8221;][vc_column_text]Ya sea que el producto est\u00e9 destinado a ser utilizado por profesionales de la<span class=\"excerpt-hellip\"> [\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-848","page","type-page","status-publish","hentry","types-medical-device-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Productos sanitarios para diagn\u00f3stico in-vitro - 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\/in-vitro-diagnostic-medical-devoces\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Productos sanitarios para diagn\u00f3stico in-vitro - Bionok\" \/>\n<meta property=\"og:description\" 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