{"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\/tr\/drgem-achieves-eu-mdr-certification\/","title":{"rendered":"DRGEM AB MDR Sertifikas\u0131n\u0131 Ald\u0131"},"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, 12 Haziran 2025 tarihi itibariyle <strong>AB MDR (Avrupa Birli\u011fi T\u0131bbi Cihaz Y\u00f6netmeli\u011fi 2017\/745)<\/strong> sertifikas\u0131na sahip oldu\u011funu duyurmaktan memnuniyet duyar.<\/p>\n\n\n\n<p>EU MDR, Avrupa'da t\u0131bbi cihaz sat\u0131\u015f\u0131 i\u00e7in zorunlu bir gerekliliktir ve kat\u0131 d\u00fczenleyici standartlar\u0131yla tan\u0131n\u0131r. Avrupa'da ya\u015fanan bir dizi t\u0131bbi cihaz vakas\u0131n\u0131n ard\u0131ndan bu gereklilikler \u00e7ok daha kat\u0131 hale gelmi\u015ftir. Avrupa Parlamentosu'nun karar\u0131nda (TA-10-2024-0028) belirtildi\u011fi gibi, MDR zorlu standartlar getirmekte ve bir\u00e7ok \u00fcreticinin sertifika almas\u0131n\u0131 zorla\u015ft\u0131rmaktad\u0131r.<\/p>\n\n\n\n<p>Bu zorlu ortama ra\u011fmen DRGEM, gerekli t\u00fcm standartlar\u0131 kar\u015f\u0131layarak MDR sertifikas\u0131n\u0131 ba\u015far\u0131yla ald\u0131. Bu ba\u015far\u0131, \u00fcr\u00fcnlerinin tasar\u0131m, \u00fcretim, klinik do\u011frulama ve kalite y\u00f6netimi dahil olmak \u00fczere t\u00fcm ya\u015fam d\u00f6ng\u00fcs\u00fc boyunca en y\u00fcksek g\u00fcvenlik, performans ve kalite seviyelerini kar\u015f\u0131lad\u0131\u011f\u0131n\u0131 g\u00f6stermektedir.<\/p>\n\n\n\n<p>A\u015fa\u011f\u0131daki DRGEM \u00fcr\u00fcnleri art\u0131k EU MDR kapsam\u0131nda sertifikaland\u0131r\u0131lm\u0131\u015ft\u0131r:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Tan\u0131sal X-ray Sistemi<\/li>\n\n\n\n<li>Dijital Diagnostik X-ray Sistemi<\/li>\n\n\n\n<li>Mobil X-ray Sistemi<\/li>\n\n\n\n<li>Dijital G\u00f6r\u00fcnt\u00fcleme Sistemi<\/li>\n\n\n\n<li>Y\u00fcksek Gerilim X-ray Jenerat\u00f6r\u00fc<\/li>\n\n\n\n<li>D\u00f6ner Anot X-ray Tube Tertibat\u0131<\/li>\n\n\n\n<li>X-\u0131\u015f\u0131n\u0131 Kolimat\u00f6r\u00fc<\/li>\n<\/ul>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>Bu sertifikal\u0131 \u00fcr\u00fcnler Avrupa pazar\u0131nda da\u011f\u0131t\u0131m i\u00e7in resmi olarak yetkilendirilmi\u015ftir ve k\u00fcresel d\u00fczenleyici beklentilerle uyumlu olarak kabul edilmektedir. Sertifika, DRGEM'nin k\u00fcresel rekabet g\u00fcc\u00fcn\u00fc daha da g\u00fc\u00e7lendirmekte ve 200'den fazla i\u015f orta\u011f\u0131ndan olu\u015fan g\u00fc\u00e7l\u00fc bir k\u00fcresel a\u011f taraf\u0131ndan desteklenen geni\u015fleyen \u00fcr\u00fcn portf\u00f6y\u00fcne ortaklar\u0131n ve m\u00fc\u015fterilerin g\u00fcvenini art\u0131rmaktad\u0131r.<\/p>\n\n\n\n<p>Kararl\u0131 ve g\u00fcvenilir bir ortak olarak DRGEM, yaln\u0131zca klinik beklentileri kar\u015f\u0131lamakla kalmay\u0131p ayn\u0131 zamanda en geli\u015fmi\u015f uluslararas\u0131 d\u00fczenleme standartlar\u0131na uygun X-ray sistemleri sunmaya devam edecektir. \u015eirket, t\u0131bbi g\u00f6r\u00fcnt\u00fclemeyi ilerletme misyonunda ilerlerken devam eden ortakl\u0131klara de\u011fer veriyor.<\/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\/tr\/drgem-achieves-eu-mdr-certification\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\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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