{"id":3186,"date":"2017-08-14T12:44:25","date_gmt":"2017-08-14T12:44:25","guid":{"rendered":"https:\/\/andromedichyperthermia.com\/?page_id=3186"},"modified":"2026-02-02T15:16:38","modified_gmt":"2026-02-02T15:16:38","slug":"hipertermi-cihazi-sertifikalar","status":"publish","type":"page","link":"https:\/\/andromedichyperthermia.com\/tr\/hipertermi-cihazi-sertifikalar\/","title":{"rendered":"Sertifikalar"},"content":{"rendered":"<p><script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@graph\": [\n    {\n      \/* 1. 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Liderlik Persona Senkronizasyonu *\/\n      \"@type\": \"Person\",\n      \"@id\": \"https:\/\/andromedichyperthermia.com\/ciro-zaccagnini-ceo\/\",\n      \"name\": \"Ciro Zaccagnini\",\n      \"jobTitle\": \"CEO, Andromedic Srl\"\n    },\n    {\n      \"@type\": \"Person\",\n      \"@id\": \"https:\/\/andromedichyperthermia.com\/hyperthermia-doctor-salvatore-conte\/\",\n      \"name\": \"Dr. Salvatore Conte\",\n      \"jobTitle\": \"Kurucu Ortak ve Ticari Direkt\u00f6r, Andromedic Srl\"\n    }\n  ]\n}\n<\/script><\/p>\n<div style=\"max-width: 1100px; margin: 0 auto; font-family: 'Segoe UI', Roboto, Helvetica, Arial, sans-serif; color: #333; line-height: 1.6;\">\n<header style=\"text-align: center; margin-bottom: 60px; padding: 40px 20px; background: linear-gradient(135deg, #f0f7ff 0%, #ffffff 100%); border-radius: 20px;\">\n<h1 style=\"color: #004a99; font-size: 2.5em; margin-bottom: 20px;\">Andromedic HyDeep 600WM Geli\u015fmi\u015f Onkolojik Hipertermi Cihaz\u0131 Sertifikalar\u0131<\/h1>\n<p style=\"max-width: 800px; margin: 0 auto; font-size: 1.1em; color: #555;\">HyDeep 600WM mod\u00fcle edilmi\u015f RF hipertermi (mHT) cihaz\u0131, uluslararas\u0131 standartlara uygunluk i\u00e7in zorlu testlerden ge\u00e7mi\u015f olup, ileri evre kanser tedavisinde g\u00fcvenlik, kalite ve etkinli\u011fi garanti etmektedir.<\/p>\n<\/header>\n<div style=\"display: flex; flex-wrap: wrap; align-items: center; gap: 40px; margin-bottom: 80px;\">\n<div style=\"flex: 1; min-width: 300px;\">\n<h2 style=\"color: #004a99; border-left: 5px solid #004a99; padding-left: 15px;\">ISO 13485: Kalitede M\u00fckemmellik<\/h2>\n<h3 style=\"font-size: 1.1em; color: #444;\">UNI CEI EN <a href=\"https:\/\/www.iso.org\/standard\/59752.html\" target=\"_blank\" rel=\"noopener\">ISO 13485<\/a> Kalite Sertifikasyonu<\/h3>\n<p>HyDeep 600WM mHT cihaz\u0131, gururla <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/ISO13485.pdf\" target=\"_blank\" rel=\"noopener\"><strong>ISO 13485 sertifikas\u0131na<\/strong><\/a> sahiptir. Bu belge; tasar\u0131m ve geli\u015ftirmeden \u00fcretime, kurulumdan teknik servise kadar t\u00fcm ya\u015fam d\u00f6ng\u00fcs\u00fc boyunca titiz kalite kontrol taahh\u00fcd\u00fcm\u00fcz\u00fcn alt\u0131n\u0131 \u00e7izmektedir.<\/p>\n<p>S\u0131k\u0131 k\u00fcresel d\u00fczenleyici gereklilikleri kar\u015f\u0131layarak, hasta g\u00fcvenli\u011fi ve \u00fcr\u00fcn m\u00fckemmelli\u011fi i\u00e7in sa\u011flam bir \u00e7er\u00e7eve olu\u015fturur.<\/p>\n<\/div>\n<div style=\"flex: 1; min-width: 300px; text-align: center;\">\n<figure style=\"margin: 0; padding: 10px; background: #fff; box-shadow: 0 10px 30px rgba(0,0,0,0.1); border-radius: 10px;\"><img decoding=\"async\" style=\"max-width: 100%; height: auto; border-radius: 5px;\" src=\"https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/ISO-13485-Andromedic-HyDeep600WM-hyperthermia.jpg\" alt=\"ISO 13485 Sertifikas\u0131\" title=\"\"><figcaption style=\"font-size: 0.8em; margin-top: 10px; color: #888;\">HyDeep 600WM i\u00e7in ISO 13485 Sertifikas\u0131<\/figcaption><\/figure>\n<\/div>\n<\/div>\n<div style=\"display: flex; flex-wrap: wrap-reverse; align-items: center; gap: 40px; margin-bottom: 80px; background: #f9f9f9; padding: 40px; border-radius: 20px;\">\n<div style=\"flex: 1; min-width: 300px;\">\n<div style=\"padding: 10px; background: #fff; border-radius: 10px; box-shadow: 0 5px 15px rgba(0,0,0,0.05);\">\n<div id='gallery-1' class='gallery galleryid-3186 gallery-columns-3 gallery-size-full'><figure class='gallery-item'>\n\t\t\t<div class='gallery-icon portrait'>\n\t\t\t\t<a href=\"https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-MDR-Andromedic-certificate-HyDeep-600WM-hyperthermia-device-1.jpg\"><img loading=\"lazy\" decoding=\"async\" width=\"586\" height=\"826\" src=\"https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-MDR-Andromedic-certificate-HyDeep-600WM-hyperthermia-device-1.jpg\" class=\"attachment-full size-full\" alt=\"\" aria-describedby=\"gallery-1-1218\" srcset=\"https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-MDR-Andromedic-certificate-HyDeep-600WM-hyperthermia-device-1.jpg 586w, https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-MDR-Andromedic-certificate-HyDeep-600WM-hyperthermia-device-1-213x300.jpg 213w\" sizes=\"auto, (max-width: 586px) 100vw, 586px\" title=\"\"><\/a>\n\t\t\t<\/div>\n\t\t\t\t<figcaption class='wp-caption-text gallery-caption' id='gallery-1-1218'>\n\t\t\t\tCE MDR Andromedic certificate HyDeep 600WM hyperthermia device 1\n\t\t\t\t<\/figcaption><\/figure><figure class='gallery-item'>\n\t\t\t<div class='gallery-icon portrait'>\n\t\t\t\t<a href=\"https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-MDR-Andromedic-certificate-HyDeep-600WM-hyperthermia-device-2.jpg\"><img loading=\"lazy\" decoding=\"async\" width=\"589\" height=\"830\" src=\"https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-MDR-Andromedic-certificate-HyDeep-600WM-hyperthermia-device-2.jpg\" class=\"attachment-full size-full\" alt=\"\" aria-describedby=\"gallery-1-1197\" srcset=\"https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-MDR-Andromedic-certificate-HyDeep-600WM-hyperthermia-device-2.jpg 589w, https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-MDR-Andromedic-certificate-HyDeep-600WM-hyperthermia-device-2-213x300.jpg 213w\" sizes=\"auto, (max-width: 589px) 100vw, 589px\" title=\"\"><\/a>\n\t\t\t<\/div>\n\t\t\t\t<figcaption class='wp-caption-text gallery-caption' id='gallery-1-1197'>\n\t\t\t\tCE MDR Andromedic certificate HyDeep 600WM hyperthermia device 2\n\t\t\t\t<\/figcaption><\/figure><figure class='gallery-item'>\n\t\t\t<div class='gallery-icon portrait'>\n\t\t\t\t<a href=\"https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-MDR-Andromedic-certificate-HyDeep-600WM-hyperthermia-device-3.jpg\"><img loading=\"lazy\" decoding=\"async\" width=\"585\" height=\"830\" src=\"https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-MDR-Andromedic-certificate-HyDeep-600WM-hyperthermia-device-3.jpg\" class=\"attachment-full size-full\" alt=\"\" aria-describedby=\"gallery-1-1176\" srcset=\"https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-MDR-Andromedic-certificate-HyDeep-600WM-hyperthermia-device-3.jpg 585w, https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-MDR-Andromedic-certificate-HyDeep-600WM-hyperthermia-device-3-211x300.jpg 211w\" sizes=\"auto, (max-width: 585px) 100vw, 585px\" title=\"\"><\/a>\n\t\t\t<\/div>\n\t\t\t\t<figcaption class='wp-caption-text gallery-caption' id='gallery-1-1176'>\n\t\t\t\tCE MDR Andromedic certificate HyDeep 600WM hyperthermia device 3\n\t\t\t\t<\/figcaption><\/figure>\n\t\t<\/div>\n\n<\/div>\n<\/div>\n<div style=\"flex: 1; min-width: 300px;\">\n<h2 style=\"color: #004a99; border-left: 5px solid #004a99; padding-left: 15px;\">MDR CE Sertifikasyonu<\/h2>\n<p>Derin lokal hipertermi cihaz\u0131, yeni <strong>T\u0131bbi Cihaz Y\u00f6netmeli\u011fi (MDR)<\/strong> kapsam\u0131nda <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-Andromedic-Hy-Deep-600-WM.pdf\" target=\"_blank\" rel=\"noopener\"><strong>Avrupa Konseyi CE sertifikas\u0131n\u0131<\/strong><\/a> ba\u015far\u0131yla alm\u0131\u015ft\u0131r.<\/p>\n<p>MDR, \u00f6nceki y\u00f6netmeliklere g\u00f6re \u00e7ok daha kat\u0131 bir d\u00fczenleme olup, daha y\u00fcksek hasta g\u00fcvenli\u011fi ve pazar \u015feffafl\u0131\u011f\u0131 sa\u011flar. Bu sertifikaya sahip olmak, kanser tedavisine y\u00f6nelik HyDeep 600WM RF hipertermi cihaz\u0131n\u0131n klinik performans ve risk y\u00f6netimi a\u00e7\u0131s\u0131ndan zorlu de\u011ferlendirmelerden ge\u00e7ti\u011fi anlam\u0131na gelir.<\/p>\n<\/div>\n<\/div>\n<div style=\"display: flex; flex-wrap: wrap; align-items: center; gap: 40px; margin-bottom: 80px;\">\n<div style=\"flex: 1; min-width: 300px;\">\n<h2 style=\"color: #004a99; border-left: 5px solid #004a99; padding-left: 15px;\">GMP Uyumlulu\u011fu<\/h2>\n<p>Her HyDeep 600WM hipertermi sistemi, <strong>\u0130yi \u00dcretim Uygulamalar\u0131 (GMP)<\/strong> standartlar\u0131na uygun olarak \u00fcretilmektedir. Bu durum, \u00fcr\u00fcnlerin kalite standartlar\u0131na g\u00f6re tutarl\u0131 bir \u015fekilde \u00fcretilmesini ve kontrol edilmesini sa\u011flar.<\/p>\n<p><a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/KGMP-certificate-June-27-2024-Andromedic-HyDeep-600-WM.pdf\" target=\"_blank\" rel=\"noopener\"><strong>KGMP sertifikam\u0131z<\/strong><\/a>, malzemelerden personel e\u011fitimine kadar \u00fcretimin t\u00fcm y\u00f6nlerinin en y\u00fcksek g\u00fcvenilirlik kriterlerini kar\u015f\u0131lad\u0131\u011f\u0131n\u0131 do\u011frular.<\/p>\n<\/div>\n<div style=\"flex: 1; min-width: 300px; text-align: center;\">\n<figure style=\"margin: 0; padding: 10px; background: #fff; box-shadow: 0 10px 30px rgba(0,0,0,0.1); border-radius: 10px;\"><img decoding=\"async\" style=\"max-width: 100%; height: auto; border-radius: 5px;\" src=\"https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/KGMP-Andromedic-certificate-HyDeep-600WM-hyperthermia-device.jpg\" alt=\"KGMP Sertifikas\u0131\" title=\"\"><\/figure>\n<\/div>\n<\/div>\n<div style=\"background: #004a99; color: #fff; padding: 40px; border-radius: 20px; margin-bottom: 60px; display: flex; flex-wrap: wrap; align-items: center; gap: 30px;\">\n<div style=\"flex: 2; min-width: 300px;\">\n<h2 style=\"color: #ffffff; margin-top: 0;\">G\u00fcney Kore MFDF Onay\u0131<\/h2>\n<p style=\"color: #e0e0e0;\">Geli\u015fmi\u015f onkolojik hipertermi cihaz\u0131m\u0131z, <strong>Kore G\u0131da ve \u0130la\u00e7 G\u00fcvenli\u011fi Bakanl\u0131\u011f\u0131 (MFDF)<\/strong> taraf\u0131ndan belirlenen kat\u0131 standartlara g\u00f6re onaylanm\u0131\u015ft\u0131r. Bu sertifikasyon, G\u00fcney Kore&#8217;de ithal edilen ve kullan\u0131lan t\u0131bbi cihazlar i\u00e7in ulusal d\u00fczenleyici gerekliliklerin kar\u015f\u0131land\u0131\u011f\u0131ndan emin olmak a\u00e7\u0131s\u0131ndan kritiktir.<\/p>\n<\/div>\n<div style=\"flex: 1; min-width: 250px; text-align: center;\"><img decoding=\"async\" style=\"background: #fff; padding: 10px; border-radius: 5px; width: 100%; max-width: 300px;\" src=\"https:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/Andromedic-HYDEPP-600w-meht-oncohyperthermia-certifications-1-1-300x74.jpg\" alt=\"MFDF Sertifikalar\u0131\" title=\"\"><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Andromedic HyDeep 600WM Geli\u015fmi\u015f Onkolojik Hipertermi Cihaz\u0131 Sertifikalar\u0131 HyDeep 600WM mod\u00fcle edilmi\u015f RF hipertermi (mHT) cihaz\u0131, uluslararas\u0131 standartlara uygunluk i\u00e7in zorlu testlerden ge\u00e7mi\u015f olup, ileri evre kanser tedavisinde g\u00fcvenlik, kalite ve etkinli\u011fi garanti etmektedir. ISO 13485: Kalitede M\u00fckemmellik UNI CEI EN ISO 13485 Kalite Sertifikasyonu HyDeep 600WM mHT cihaz\u0131, gururla ISO 13485 sertifikas\u0131na sahiptir. Bu&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-gutentor-full-width.php","meta":{"footnotes":""},"class_list":["post-3186","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/andromedichyperthermia.com\/tr\/wp-json\/wp\/v2\/pages\/3186","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/andromedichyperthermia.com\/tr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/andromedichyperthermia.com\/tr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/tr\/wp-json\/wp\/v2\/comments?post=3186"}],"version-history":[{"count":0,"href":"https:\/\/andromedichyperthermia.com\/tr\/wp-json\/wp\/v2\/pages\/3186\/revisions"}],"wp:attachment":[{"href":"https:\/\/andromedichyperthermia.com\/tr\/wp-json\/wp\/v2\/media?parent=3186"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}