{"id":6606,"date":"2015-02-20T20:12:45","date_gmt":"2015-02-20T19:12:45","guid":{"rendered":"https:\/\/digiterm.hu\/calidad-y-seguridad\/"},"modified":"2024-10-07T00:04:28","modified_gmt":"2024-10-06T22:04:28","slug":"calidad-y-seguridad","status":"publish","type":"page","link":"https:\/\/digiterm.hu\/es\/calidad-y-seguridad\/","title":{"rendered":"Calidad y seguridad"},"content":{"rendered":"

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NORMATIVA DE LA UE SOBRE PRODUCTOS SANITARIOS<\/h2><\/div>

El nuevo Reglamento de Productos Sanitarios, 2017\/745 (MDR)<\/strong> entr\u00f3 en vigor en la UE el 26 de mayo de 2021. Todos los productos sanitarios de la clase I deben cumplir el MDR desde el primer d\u00eda.<\/p>\n

La mayor\u00eda de nuestras sillas pertenecen a este grupo. Tenemos el placer de informarte de que Digiterm ha finalizado la fase de preparaci\u00f3n y ya es conforme con el MDR.<\/p>\n

Actor ID\/SRN : HU-MF-000004201<\/strong><\/p>\n

Digitermen la Lista de Operadores Econ\u00f3micos de EDUAMED<\/a><\/p>\n

Productos Digtermen EDUAMED<\/a><\/p>\n<\/div><\/div><\/div>

Como efecto del registro, algunos cambios ser\u00e1n visibles en las etiquetas de las sillas. Estos contendr\u00e1n el identificador UDI-DI del tipo de silla y la denominaci\u00f3n de la silla en el idioma local del destino.<\/p>\n

Al ofrecer soluciones de asientos seguras y de alta calidad en todo el mundo, la satisfacci\u00f3n de nuestros socios siempre ha sido y ser\u00e1 un valor clave para nosotros.<\/p>\n

Si tienes alguna pregunta relacionada con la gesti\u00f3n de la calidad, ponte en contacto con nuestro Equipo de SGC y SGMA:<\/strong><\/p>\n

Correo electr\u00f3nico: quality@digiterm.hu<\/a><\/p>\n

P\u00f3ngase en contacto con <\/i><\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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<\/a>Sistema de gesti\u00f3n de la calidad<\/h2><\/span>
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Para alcanzar nuestros objetivos, se mantienen las normas ISO 9001:2015<\/strong> para la calidad de los productos y servicios, y EN ISO 13485:2016<\/strong>, especialmente para la calidad de los productos m\u00e9dicos.<\/p>\n

La conformidad con los requisitos de las normas se audita peri\u00f3dicamente.<\/p>\n

Sistema de Gesti\u00f3n de la Calidad ISO 9001:2015
\n<\/strong>Reg. N\u00ba: C603179
\nFecha de caducidad: 03.09.2026<\/p>\n

Ver certificado<\/a><\/h3>\n

ISO 13485:2016 Sistema de gesti\u00f3n de la calidad
\n<\/strong>Reg. N\u00ba: 145207
\nFecha de caducidad: 06.09.2026<\/p>\n

Ver certificado<\/a><\/h3>\n<\/div><\/div><\/div>
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Sistema de Gesti\u00f3n Medioambiental<\/h2><\/span>
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La direcci\u00f3n de Digiterm Ltd. declar\u00f3 su compromiso -de conformidad con los requisitos de la Norma ISO 14001:2015<\/strong> – hacia el desarrollo continuo del rendimiento medioambiental y la prevenci\u00f3n de la contaminaci\u00f3n.<\/p>\n

La conformidad con los requisitos de las normas se audita peri\u00f3dicamente.<\/p>\n

ISO 14001:2015 Sistema de Gesti\u00f3n Medioambiental
\n<\/strong>Reg. No: 24081586KIR
\n<\/strong>Fecha de caducidad: 14.09.2027<\/strong><\/p>\n

Ver certificado<\/a><\/h3>\n<\/div><\/div><\/div>
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Registro y listado de dispositivos de la FDA<\/span><\/b><\/h2><\/h2><\/span>
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\n<\/td>\n

Los productos de Digiterm pertenecen a una categor\u00eda gen\u00e9rica de dispositivos de clase I exentos, tal como se definen en 21 CFR Partes 862-892, por lo que no se requiere una solicitud de notificaci\u00f3n previa a la comercializaci\u00f3n ni la autorizaci\u00f3n de la FDA antes de comercializar el dispositivo en U.S.<\/span><\/p>\n

Sin embargo, como fabricante, debe registrar su establecimiento:<\/span><\/p>\n

El registro de establecimiento de Digiterm ante la FDA se puede encontrar aqu\u00ed<\/span><\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div><\/div><\/div>

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<\/a>Certificado SFDA<\/h2><\/h2><\/span>
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\n\n\n
\n

\"\"<\/p>\n<\/td>\n

Digiterm Ltd., como fabricante de productos sanitarios, tambi\u00e9n est\u00e1 registrada por la Autoridad Saud\u00ed de Alimentos y Medicamentos<\/strong>. ( N\u00ba Reg.: M00370 )<\/p>\n

La autorizaci\u00f3n permite comercializar las sillas Comfort en el Reino de Arabia Saud\u00ed.
\nEl certificado se expide de conformidad con el Reglamento provisional sobre productos sanitarios (MDIR) y, en particular, con la norma de aplicaci\u00f3n MDS-IR6 para la Autorizaci\u00f3n de Comercializaci\u00f3n de Productos Sanitarios (MDMA).<\/p>\n

N\u00famero de autorizaci\u00f3n:<\/strong>MDMA-1-2018-1153
\nFecha de<\/strong> caducidad<\/strong>: 26.02.2027.<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div><\/div><\/div>

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<\/a>Certificado GOST-R<\/h2><\/h2><\/span>
<\/div><\/div><\/div>
\n\n\n
\n

\"\"<\/p>\n<\/td>\n

Digiterm Ltd., como fabricante de productos sanitarios, tambi\u00e9n est\u00e1 registrada por el Ministerio de Sanidad ruso. (N\u00ba Reg.: F33 2012\/11522)<\/p>\n

Las sillas de Terapia Confort son probadas por SGS International Certification Services S. A.<\/strong> y justifican el cumplimiento de las normas rusas correspondientes en el certificado GOST-R.<\/p>\n

N\u00ba de certificado POCC HU. IM 24 N Q5939<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div><\/div><\/div><\/div><\/main>

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DO YOU HAVE QUESTIONS ABOUT OUR PRODUCTS?<\/h2><\/span>
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We work as a united team around the world and give our clients the highest quality products and solutions possible. Our sales team will be happy to help you!<\/h3>\n<\/div>
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Contacte con nosotros<\/span><\/a><\/div><\/div><\/div><\/div><\/div>\n<\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"100-width.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-6606","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nCalidad y seguridad - Digiterm Ltd.<\/title>\n<meta name=\"description\" content=\"Digiterm Dialysis chairs are designed to provide a comfortable and supportive seating arrangement for patients.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/digiterm.hu\/es\/calidad-y-seguridad\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Calidad y seguridad - Digiterm Ltd.\" \/>\n<meta property=\"og:description\" content=\"Digiterm Dialysis chairs are designed to provide a comfortable and supportive seating arrangement for patients.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/digiterm.hu\/es\/calidad-y-seguridad\/\" \/>\n<meta property=\"og:site_name\" content=\"Digiterm Ltd.\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/digiterm.hu\/\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-06T22:04:28+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/digiterm.hu\/wp-content\/uploads\/2022\/01\/SFDA_Logo_Digiterm.png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/digiterm.hu\\\/es\\\/calidad-y-seguridad\\\/\",\"url\":\"https:\\\/\\\/digiterm.hu\\\/es\\\/calidad-y-seguridad\\\/\",\"name\":\"Calidad y seguridad - 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