{"id":7860,"date":"2022-06-30T09:48:04","date_gmt":"2022-06-30T09:48:04","guid":{"rendered":"https:\/\/r-biopharm.com\/?p=7860"},"modified":"2022-07-01T11:36:10","modified_gmt":"2022-07-01T11:36:10","slug":"r-biopharm-cuenta-con-la-certificacion-ivdr","status":"publish","type":"post","link":"https:\/\/r-biopharm.com\/es\/r-biopharm-cuenta-con-la-certificacion-ivdr\/","title":{"rendered":"R-Biopharm cuenta con la certificaci\u00f3n IVDR"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row][vc_column][vc_single_image image=\u00bb7811&#8243; img_size=\u00bbfull\u00bb alignment=\u00bbcenter\u00bb][mk_padding_divider size=\u00bb20&#8243;][vc_column_text css=\u00bb.vc_custom_1656675306942{margin-bottom: 0px !important;}\u00bb]La orientaci\u00f3n hacia la calidad es una parte integral de la cultura y los procesos en R-Biopharm AG. La empresa biotecnol\u00f3gica del sur de Hesse garantiza as\u00ed que la calidad est\u00e9 incorporada en toda la empresa y se mejore continuamente, a fin de suministrar productos confiables a largo plazo. La empresa familiar se somete a auditor\u00edas peri\u00f3dicas realizadas para verificar la adecuada y funcionalidad de todos los elementos relacionados con la calidad. En oto\u00f1o de 2021, R-Biopharm fue una de las empresas que se someti\u00f3 a una exhaustiva auditor\u00eda para la nueva certificaci\u00f3n IVDR por parte de T\u00dcV S\u00dcD y acaba de recibir esa certificaci\u00f3n.[\/vc_column_text][mk_padding_divider size=\u00bb20&#8243;][vc_single_image image=\u00bb7826&#8243; img_size=\u00bbfull\u00bb alignment=\u00bbright\u00bb][mk_padding_divider size=\u00bb20&#8243;][vc_column_text css=\u00bb.vc_custom_1656675320351{margin-bottom: 0px !important;}\u00bb]Lo que es obligatorio para los fabricantes de productos para diagn\u00f3stico <em>in vitro<\/em> en toda Europa tras una fase de transici\u00f3n de cinco a\u00f1os desde finales de mayo de 2022, seg\u00fan el reglamento europeo sobre los productos sanitarios para diagn\u00f3stico <em>in vitro<\/em>, es algo que la empresa biotecnol\u00f3gica ya ha demostrado en oto\u00f1o de 2021. La certificaci\u00f3n IVDR garantizar\u00e1 que R-Biopharm pueda continuar ofreciendo sus productos para diagn\u00f3stico <em>in vitro<\/em> en Europa y el mundo entero conforme a los requisitos legislativos m\u00e1s estrictos. La recertificaci\u00f3n simult\u00e1nea conforme al MDSAP (siglas en ingles del Programa de Auditor\u00eda \u00danica de Dispositivos M\u00e9dicos), las normas ISO 9001:2015 y DIN EN ISO 13485:2016, as\u00ed como la directiva 98\/79\/CE para diagn\u00f3sticos <em>in vitro<\/em>, hacen de R-Biopharm una de las pocas empresas en el mundo que est\u00e1n actualmente certificadas conforme a estas cuatro normas.<\/p>\n<p>Con su sistema de gesti\u00f3n de la calidad hol\u00edstico, R-Biopharm garantiza que los requisitos normativos y reglamentarios se cumplan desde el desarrollo de la aplicaci\u00f3n de productos y que se apliquen las correspondientes normas de alta calidad. \u201cEn nuestra empresa, la calidad no es la acci\u00f3n de unos cuantos, sino la actitud de todos nuestros empleados\u201d, dice el Dr. Hans Frickel, miembro de la junta directiva. \u201cNuestro enfoque en la calidad es tambi\u00e9n sumamente relevante a nivel interno. Al aplicar normas orientadas a la calidad, podemos detectar riesgos y errores, dise\u00f1ar con eficiencia m\u00e9todos de trabajo, identificar nuestras fortalezas y potenciales y derivar las necesidades de acci\u00f3n que nos ayudar\u00e1n a seguir mejorando\u201d.[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_single_image image=\u00bb7811&#8243; img_size=\u00bbfull\u00bb alignment=\u00bbcenter\u00bb][mk_padding_divider size=\u00bb20&#8243;][vc_column_text css=\u00bb.vc_custom_1656675306942{margin-bottom: 0px !important;}\u00bb]La orientaci\u00f3n hacia la calidad es una parte integral de la cultura y los procesos en R-Biopharm AG. La empresa biotecnol\u00f3gica del sur de Hesse garantiza as\u00ed que la calidad est\u00e9 incorporada en toda la empresa y se mejore continuamente, a fin de suministrar productos confiables a largo [&hellip;]<\/p>\n","protected":false},"author":1114,"featured_media":7838,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[357],"tags":[],"class_list":["post-7860","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noticias"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>R-Biopharm cuenta con la certificaci\u00f3n IVDR - R-Biopharm AG<\/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:\/\/r-biopharm.com\/es\/r-biopharm-cuenta-con-la-certificacion-ivdr\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"R-Biopharm cuenta con la certificaci\u00f3n IVDR - R-Biopharm AG\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][vc_single_image image=\u00bb7811&#8243; img_size=\u00bbfull\u00bb alignment=\u00bbcenter\u00bb][mk_padding_divider size=\u00bb20&#8243;][vc_column_text css=\u00bb.vc_custom_1656675306942{margin-bottom: 0px !important;}\u00bb]La orientaci\u00f3n hacia la calidad es una parte integral de la cultura y los procesos en R-Biopharm AG. La empresa biotecnol\u00f3gica del sur de Hesse garantiza as\u00ed que la calidad est\u00e9 incorporada en toda la empresa y se mejore continuamente, a fin de suministrar productos confiables a largo [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/r-biopharm.com\/es\/r-biopharm-cuenta-con-la-certificacion-ivdr\/\" \/>\n<meta property=\"og:site_name\" content=\"R-Biopharm AG\" \/>\n<meta property=\"article:published_time\" content=\"2022-06-30T09:48:04+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-07-01T11:36:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/r-biopharm.com\/wp-content\/uploads\/220630_rbio_ivdr-grafik_neu_v04_1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1667\" \/>\n\t<meta property=\"og:image:height\" content=\"1667\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"niclas\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"niclas\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/r-biopharm.com\\\/es\\\/r-biopharm-cuenta-con-la-certificacion-ivdr\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/r-biopharm.com\\\/es\\\/r-biopharm-cuenta-con-la-certificacion-ivdr\\\/\"},\"author\":{\"name\":\"niclas\",\"@id\":\"https:\\\/\\\/r-biopharm.com\\\/#\\\/schema\\\/person\\\/1f2853ffae1847d6375c365a249e8cb4\"},\"headline\":\"R-Biopharm cuenta con la certificaci\u00f3n IVDR\",\"datePublished\":\"2022-06-30T09:48:04+00:00\",\"dateModified\":\"2022-07-01T11:36:10+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/r-biopharm.com\\\/es\\\/r-biopharm-cuenta-con-la-certificacion-ivdr\\\/\"},\"wordCount\":455,\"image\":{\"@id\":\"https:\\\/\\\/r-biopharm.com\\\/es\\\/r-biopharm-cuenta-con-la-certificacion-ivdr\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/r-biopharm.com\\\/wp-content\\\/uploads\\\/220630_rbio_ivdr-grafik_neu_v04_1.jpg\",\"articleSection\":[\"Noticias\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/r-biopharm.com\\\/es\\\/r-biopharm-cuenta-con-la-certificacion-ivdr\\\/\",\"url\":\"https:\\\/\\\/r-biopharm.com\\\/es\\\/r-biopharm-cuenta-con-la-certificacion-ivdr\\\/\",\"name\":\"R-Biopharm cuenta con la certificaci\u00f3n IVDR - 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