{"id":999,"date":"2024-05-21T12:18:06","date_gmt":"2024-05-21T10:18:06","guid":{"rendered":"https:\/\/lenus.site\/scbest\/dispositivi-medici\/"},"modified":"2025-01-08T11:04:58","modified_gmt":"2025-01-08T10:04:58","slug":"productos-sanitario","status":"publish","type":"page","link":"https:\/\/sc-best.eu\/es\/productos-sanitario\/","title":{"rendered":"PRODUCTOS SANITARIO"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_wp_custommenu nav_menu=&#8221;4&#8243; el_class=&#8221;menu_servizi_tossicologici menu_servizi_tossicologici_magico&#8221; title=&#8221;X&#8221;][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJ0cmlnZ2VyX21hZ2ljbyUyMiUzRUV4cGxvcmElMjBvdHJvcyUyMHNlcnZpY2lvcyUzQyUyRmRpdiUzRQ==[\/vc_raw_html][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJjb250YWluZXJfdHJpZ2dlcl9tb2JpbGUlMjIlM0UlMEElMjAlMjAlM0NkaXYlMjBjbGFzcyUzRCUyMnRyaWdnZXJfbWFnaWNvX21vYmlsZSUyMiUzRSUwQSUyMCUyMCUyMCUyMEV4cGxvcmElMjBvdHJvcyUyMHNlcnZpY2lvcyUwQSUyMCUyMCUzQyUyRmRpdiUzRSUwQSUzQyUyRmRpdiUzRQ==[\/vc_raw_html][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][\/vc_column][vc_column width=&#8221;2\/3&#8243;][vc_column_text]Como equipo de toxic\u00f3logos expertos, realizamos una evaluaci\u00f3n precl\u00ednica adecuada de la seguridad de su producto sanitario final de acuerdo con las normas internacionales. Durante la fase de desarrollo, proporcionamos orientaci\u00f3n para garantizar la biocompatibilidad de su producto. Nuestro amplio conocimiento de las diferentes normas y directrices, incluidas, entre otras, las series ISO 10993 e ISO 14971, nos permite respaldar sus presentaciones no s\u00f3lo en Europa seg\u00fan la MDR, sino tambi\u00e9n en otros pa\u00edses, como Estados Unidos, de acuerdo con los requisitos de la FDA.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/6&#8243;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1719851308027{background-color: #f7f7f7 !important;}&#8221;][vc_column width=&#8221;1\/6&#8243;][\/vc_column][vc_column width=&#8221;2\/3&#8243;][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li class=\"li1\"><span class=\"s2\">Evaluaci\u00f3n biol\u00f3gica conforme a la norma <b>ISO 10993-1<\/b>, basada en los componentes individuales y el uso previsto (duraci\u00f3n y naturaleza del contacto con el cuerpo). Evaluaci\u00f3n de otros factores, como la fabricaci\u00f3n, incluida la esterilizaci\u00f3n y el envasado, para mitigar el riesgo biol\u00f3gico<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li class=\"li1\"><span class=\"s2\">Preparaci\u00f3n del <b>Plan de Evaluaci\u00f3n Biol\u00f3gica<\/b> (<b>BEP<\/b>): identificaci\u00f3n de las pruebas necesarias para evaluar la biocompatibilidad del producto; preparaci\u00f3n de la justificaci\u00f3n cient\u00edfica para abordar y renunciar a algunas pruebas indicadas por las normas<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li class=\"li1\"><span class=\"s2\"><b>Informe de evaluaci\u00f3n biol\u00f3gica <\/b>(<b>BER<\/b>): elaboraci\u00f3n de un documento en el que se recogen todos los resultados obtenidos en las pruebas (qu\u00edmicas, de biocompatibilidad), as\u00ed como la informaci\u00f3n cient\u00edfica procedente de la bibliograf\u00eda de dominio p\u00fablico que avala la seguridad del producto<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li class=\"li1\"><span class=\"s2\">Evaluaci\u00f3n del riesgo toxicol\u00f3gico de los componentes de los productos sanitarios de acuerdo con las normas <b>ISO 10993-17:2023<\/b>, <b>ISO 18562 <\/b>y otras normas afines<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li class=\"li1\"><span class=\"s2\">Bas\u00e1ndose en los nuevos requisitos del MDR, preparaci\u00f3n de un dictamen pericial para evaluar cualquier acci\u00f3n farmacol\u00f3gica de los ingredientes de los productos basados en sustancias<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><span class=\"s2\">Seg\u00fan lo solicitado por MDR, identificaci\u00f3n de CMR y ED presentes en el producto o declaraci\u00f3n de ausencia<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li class=\"li1\"><span class=\"s2\">Evaluaci\u00f3n de componentes y materiales con informaci\u00f3n procedente de bibliograf\u00eda abierta<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li class=\"li1\"><span class=\"s2\">Supervisi\u00f3n del estudio y asistencia durante la fase de ensayo y contacto con las instalaciones de ensayo<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li class=\"li1\"><span class=\"s2\">Supervisi\u00f3n del estudio y asistencia en la preparaci\u00f3n de BEP y BER de acuerdo con los requisitos de la FDA, cumplimentaci\u00f3n del modelo e-star<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li class=\"li1\"><span class=\"s2\">Identificaci\u00f3n de sustancias que podr\u00edan llegar a clasificarse como CMR y ED en un futuro pr\u00f3ximo<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li class=\"li1\"><span class=\"s2\">An\u00e1lisis de carencias para comprender las pruebas\/an\u00e1lisis que pueden faltar o que deben aplicarse (comparando las versiones antiguas y m\u00e1s recientes de las normas ISO), para cumplir los requisitos del MDR<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li class=\"li1\"><span class=\"s2\">Evaluaci\u00f3n del riesgo de los productos que contienen <b>nanopart\u00edculas<\/b><\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li class=\"li2\"><span class=\"s2\">Tambi\u00e9n se ofrece asesoramiento normativo a trav\u00e9s de terceros<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/6&#8243;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1716367939388{background-image: url(https:\/\/sc-best.eu\/wp-content\/uploads\/2024\/05\/SC-BEST_template_servizi-tox.jpg?id=215) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221;][vc_column][vc_empty_space][vc_row_inner][vc_column_inner width=&#8221;2\/3&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;][vc_column_text]<\/p>\n<h2><span style=\"color: #663300;\">HABILIDADES<br \/>\nBIOTECNOLOGICAS<\/span><\/h2>\n<p><span style=\"color: #663300;\">Somos expertos en la optimizaci\u00f3n de procesos biol\u00f3gicos y en la creaci\u00f3n de productos innovadores, personalizados y de vanguardia<\/span>[\/vc_column_text][vc_btn title=&#8221;Descubre m\u00e1s&#8221; style=&#8221;flat&#8221; color=&#8221;warning&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-chevron-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fsc-best.eu%2Fes%2Fhabilidades-biotecnologicas%2F|title:Habilidades%20biotecnologicas&#8221;][\/vc_column_inner][\/vc_row_inner][vc_empty_space height=&#8221;100px&#8221;][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_wp_custommenu nav_menu=&#8221;4&#8243; el_class=&#8221;menu_servizi_tossicologici menu_servizi_tossicologici_magico&#8221; title=&#8221;X&#8221;][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJ0cmlnZ2VyX21hZ2ljbyUyMiUzRUV4cGxvcmElMjBvdHJvcyUyMHNlcnZpY2lvcyUzQyUyRmRpdiUzRQ==[\/vc_raw_html][vc_raw_html]JTNDZGl2JTIwY2xhc3MlM0QlMjJjb250YWluZXJfdHJpZ2dlcl9tb2JpbGUlMjIlM0UlMEElMjAlMjAlM0NkaXYlMjBjbGFzcyUzRCUyMnRyaWdnZXJfbWFnaWNvX21vYmlsZSUyMiUzRSUwQSUyMCUyMCUyMCUyMEV4cGxvcmElMjBvdHJvcyUyMHNlcnZpY2lvcyUwQSUyMCUyMCUzQyUyRmRpdiUzRSUwQSUzQyUyRmRpdiUzRQ==[\/vc_raw_html][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][\/vc_column][vc_column width=&#8221;2\/3&#8243;][vc_column_text]Como equipo de toxic\u00f3logos expertos, realizamos una evaluaci\u00f3n precl\u00ednica adecuada de la seguridad de su producto sanitario final de acuerdo con las normas internacionales. Durante la fase de desarrollo, proporcionamos orientaci\u00f3n para garantizar la biocompatibilidad de su producto. Nuestro amplio conocimiento de las diferentes normas y directrices, incluidas, entre [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":959,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-999","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>PRODUCTOS SANITARIO - S&amp;C BEST<\/title>\n<meta name=\"description\" content=\"S&amp;C BEST proporciona una correcta evaluaci\u00f3n de seguridad precl\u00ednica de su dispositivo m\u00e9dico de acuerdo con los est\u00e1ndares internacionales.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sc-best.eu\/dispositivi-medici\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PRODUCTOS SANITARIO - 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