{"id":7173,"date":"2025-06-19T13:50:49","date_gmt":"2025-06-19T04:50:49","guid":{"rendered":"https:\/\/www.drgemhealthcare.com\/?p=7173"},"modified":"2025-06-23T09:13:12","modified_gmt":"2025-06-23T00:13:12","slug":"drgem-achieves-eu-mdr-certification","status":"publish","type":"post","link":"https:\/\/www.drgemhealthcare.com\/es\/drgem-achieves-eu-mdr-certification\/","title":{"rendered":"DRGEM obtiene la certificaci\u00f3n MDR de la UE"},"content":{"rendered":"<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/06\/image-10-1024x1024.png\" alt=\"\" class=\"wp-image-7174\" srcset=\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/06\/image-10-1024x1024.png 1024w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/06\/image-10-300x300.png 300w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/06\/image-10-150x150.png 150w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/06\/image-10-768x768.png 768w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/06\/image-10-12x12.png 12w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/06\/image-10.png 1080w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"translation-block\">DRGEM se complace en anunciar que la empresa ha obtenido la certificaci\u00f3n <strong>EU MDR (European Union Medical Device Regulation 2017\/745)<\/strong> a partir del 12 de junio de 2025.<\/p>\n\n\n\n<p>El MDR de la UE es un requisito obligatorio para vender productos sanitarios en Europa y es bien conocido por sus estrictas normas reglamentarias. Tras una serie de incidentes con productos sanitarios en Europa, estos requisitos se han hecho mucho m\u00e1s estrictos. Como se se\u00f1ala en la resoluci\u00f3n del Parlamento Europeo (TA-10-2024-0028), el MDR establece normas exigentes, lo que dificulta a muchos fabricantes conseguir la certificaci\u00f3n.<\/p>\n\n\n\n<p>A pesar de este dif\u00edcil entorno, DRGEM obtuvo con \u00e9xito la certificaci\u00f3n MDR al cumplir todas las normas exigidas. Este logro demuestra que sus productos cumplen los m\u00e1s altos niveles de seguridad, rendimiento y calidad a lo largo de todo su ciclo de vida, incluidos el dise\u00f1o, la fabricaci\u00f3n, la validaci\u00f3n cl\u00ednica y la gesti\u00f3n de la calidad.<\/p>\n\n\n\n<p>Los siguientes productos DRGEM cuentan ahora con la certificaci\u00f3n EU MDR:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Sistema de rayos X de diagn\u00f3stico<\/li>\n\n\n\n<li>Sistema digital de diagn\u00f3stico por rayos X<\/li>\n\n\n\n<li>Sistema m\u00f3vil de rayos X<\/li>\n\n\n\n<li>Sistema de imagen digital<\/li>\n\n\n\n<li>Generador de rayos X de alta tensi\u00f3n<\/li>\n\n\n\n<li>\u00c1nodo giratorio de rayos X Conjunto Tube<\/li>\n\n\n\n<li>Colimador de rayos X<\/li>\n<\/ul>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>Estos productos certificados est\u00e1n oficialmente autorizados para su distribuci\u00f3n en el mercado europeo y se reconoce que cumplen las expectativas normativas mundiales. La certificaci\u00f3n refuerza a\u00fan m\u00e1s la competitividad global de DRGEM y aumenta la confianza de socios y clientes en su cartera de productos en expansi\u00f3n, respaldada por una s\u00f3lida red mundial de m\u00e1s de 200 socios.<\/p>\n\n\n\n<p>Como socio comprometido y fiable, DRGEM seguir\u00e1 suministrando sistemas de rayos X que no s\u00f3lo satisfacen las expectativas cl\u00ednicas, sino que tambi\u00e9n cumplen las normas reglamentarias internacionales m\u00e1s avanzadas. La empresa valora las colaboraciones continuas a medida que avanza en su misi\u00f3n de hacer progresar la imagen m\u00e9dica.<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>DRGEM is pleased to announce that the company has achieved EU MDR (European Union Medical Device Regulation 2017\/745) certification as of June 12, 2025. EU MDR is a mandatory requirement for selling medical devices in Europe and is well known for its strict regulatory standards. Following a series of medical device incidents within Europe, these [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":7174,"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":[],"class_list":["post-7173","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drgem-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v27.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>DRGEM Achieves EU MDR Certification - DRGEM<\/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:\/\/www.drgemhealthcare.com\/es\/drgem-achieves-eu-mdr-certification\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"DRGEM Achieves EU MDR Certification\" \/>\n<meta property=\"og:description\" content=\"DRGEM is pleased to announce that the company has achieved EU MDR (European Union Medical Device Regulation 2017\/745) certification as of June 12, 2025. 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