{"id":11043,"date":"2026-06-22T09:45:26","date_gmt":"2026-06-22T00:45:26","guid":{"rendered":"https:\/\/www.drgemhealthcare.com\/?p=11043"},"modified":"2026-06-22T09:46:39","modified_gmt":"2026-06-22T00:46:39","slug":"drgem-wins-eu-ce-mdr-certification-for-raymo","status":"publish","type":"post","link":"https:\/\/www.drgemhealthcare.com\/es\/drgem-wins-eu-ce-mdr-certification-for-raymo\/","title":{"rendered":"DRGEM obtiene la certificaci\u00f3n CE MDR de la UE para RAYMO"},"content":{"rendered":"
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Cumpliendo con los Est\u00e1ndares Europeos de Seguridad y Calidad, Sentando las Bases para la Expansi\u00f3n en el Mercado Global de Rayos X M\u00f3viles<\/h2>\n\n\n\n

DRGEM (director ejecutivo: J. B. Park), una empresa global de soluciones de imagen m\u00e9dica, ha anunciado que su sistema DR m\u00f3vil de \u00faltima generaci\u00f3n, \u2018RAYMO\u2019, ha obtenido la certificaci\u00f3n CE MDR (Reglamento sobre productos sanitarios) de la Uni\u00f3n Europea. Este logro se produce tras la obtenci\u00f3n de la autorizaci\u00f3n de la FDA de EE. UU. el pasado mes de mayo. Gracias a este hito, DRGEM cruzar\u00e1 la puerta clave de acceso al mercado europeo y acelerar\u00e1 la expansi\u00f3n global de su negocio.<\/p>\n\n\n\n

La UE exige la certificaci\u00f3n CE MDR para garantizar que los productos cumplan con estrictas normas de seguridad, calidad y rendimiento. Se trata de un requisito imprescindible para comercializar productos sanitarios en el Espacio Econ\u00f3mico Europeo (EEE) y en muchos otros pa\u00edses. Con esta certificaci\u00f3n, DRGEM se asegura una base s\u00f3lida para sus ventas en Europa y refuerza su posici\u00f3n para ampliar su cartera de clientes y sus colaboraciones a nivel mundial.<\/p>\n<\/div>\n\n\n\n

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DRGEM: Impulso del crecimiento internacional gracias a una red global presente en m\u00e1s de 130 pa\u00edses<\/h2>\n\n\n\n

RAYMO es el nuevo sistema de radiodiagn\u00f3stico m\u00f3vil presentado por DRGEM. Permite obtener im\u00e1genes de forma r\u00e1pida y precisa en diversos entornos cl\u00ednicos. El sistema cuenta con una funci\u00f3n de reconocimiento de usuarios basada en RFID que aplica autom\u00e1ticamente los ajustes personalizados de cada miembro del personal sanitario. Adem\u00e1s, diversas funciones inteligentes mejoran la movilidad y la comodidad del usuario para aumentar la eficiencia en el trabajo.<\/p>\n\n\n\n

La demanda mundial de equipos m\u00f3viles de rayos X est\u00e1 creciendo r\u00e1pidamente. En este mercado, la certificaci\u00f3n CE MDR pone de relieve la excelencia tecnol\u00f3gica y la competitividad de los productos de RAYMO. Aprovechando esta oportunidad, DRGEM tiene previsto reforzar sus actividades de venta en los principales pa\u00edses europeos y ampliar activamente sus colaboraciones locales.<\/p>\n\n\n\n

Esta certificaci\u00f3n hace m\u00e1s que simplemente asegurar las calificaciones de ventas; verifica objetivamente la seguridad, calidad y confiabilidad del producto. Por lo tanto, la compa\u00f1\u00eda espera que impulse la adopci\u00f3n por parte de instituciones m\u00e9dicas y socios de distribuci\u00f3n en el extranjero.<\/p>\n\n\n\n

J. B. Park, director ejecutivo de DRGEM, afirm\u00f3: \u201cLa obtenci\u00f3n de la certificaci\u00f3n CE MDR supone un reconocimiento oficial de la tecnolog\u00eda y la calidad de RAYMO a nivel mundial\u201d. A\u00f1adi\u00f3: \u201cAmpliaremos nuestras alianzas internacionales centr\u00e1ndonos en el mercado europeo y reforzaremos a\u00fan m\u00e1s la posici\u00f3n de DRGEM en el mercado de los equipos de rayos X port\u00e1tiles\u201d.\u201d<\/p>\n\n\n\n

Por su parte, DRGEM se especializa en soluciones de diagn\u00f3stico por imagen radiogr\u00e1fica digital. La empresa ampl\u00eda su negocio en el extranjero a trav\u00e9s de una red global de ventas y socios presente en m\u00e1s de 130 pa\u00edses. Aprovechando el impulso que le da la certificaci\u00f3n CE MDR de RAYMO, la empresa tiene previsto entrar a gran escala en el mercado europeo para garantizar un crecimiento continuo a nivel mundial.<\/p>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"

Meeting European Safety and Quality Standards, Laying the Foundation for Expanding in the Global Mobile X-ray Market DRGEM (CEO J. B. Park), a global medical imaging solutions company, announced that its next-generation mobile DR system, \u2018RAYMO\u2019, has obtained the European Union’s CE MDR (Medical Device Regulation) certification. This achievement follows the acquisition of US FDA […]<\/p>\n","protected":false},"author":8,"featured_media":11047,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[14],"tags":[287,286,89,26,30,91,37,197,343,53],"class_list":["post-11043","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drgem-news","tag-ce-certification","tag-ce-certified","tag-digitalradiography","tag-drgem","tag-medicalimaging","tag-mobilexray","tag-radiography","tag-raymo","tag-raymo-ce","tag-xraysystems"],"yoast_head":"\nDRGEM wins EU CE MDR Certification for RAYMO - DRGEM<\/title>\n<meta name=\"description\" content=\"RAYMO CE certification marks a milestone for DRGEM. 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