{"id":3126,"date":"2017-08-14T12:44:25","date_gmt":"2017-08-14T12:44:25","guid":{"rendered":"https:\/\/andromedichyperthermia.com\/certifications-andromedic-hydeep600wm-RF-hyperthermia-device\/"},"modified":"2026-02-02T14:26:02","modified_gmt":"2026-02-02T14:26:02","slug":"certificeringer-hypertermi-enheder","status":"publish","type":"page","link":"https:\/\/andromedichyperthermia.com\/da\/certificeringer-hypertermi-enheder\/","title":{"rendered":"Certificeringer"},"content":{"rendered":"<p><script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@graph\": [\n    {\n      \/* 1. 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Dette understreger vores engagement i omhyggelig kvalitetskontrol gennem hele livscyklussen \u2013 fra design og udvikling til produktion, installation og service.<\/p>\n<p>Det etablerer en robust ramme for patientsikkerhed og produktekscellence, der opfylder strenge globale regulatoriske krav.<\/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 certifikat\" title=\"\"><figcaption style=\"font-size: 0.8em; margin-top: 10px; color: #888;\">ISO 13485 certifikat for HyDeep 600WM<\/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-3126 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-1-1201\" 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-1-1201'>\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-1-1180\" 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-1-1180'>\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-1-1159\" 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-1-1159'>\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-certificering<\/h2>\n<p>Enheden til dyb lokal hypertermi har med succes opn\u00e5et <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-Andromedic-Hy-Deep-600-WM.pdf\" target=\"_blank\" rel=\"noopener\"><strong>Europa-R\u00e5dets CE-certificering<\/strong><\/a> under den nye <strong>Medical Device Regulation (MDR)<\/strong>.<\/p>\n<p>MDR er en strengere forordning end sin forg\u00e6nger, hvilket sikrer st\u00f8rre patientsikkerhed og markedstransparens. At opn\u00e5 dette betyder, at HyDeep 600WM RF-hypertermi-enheden til kr\u00e6ftbehandling har gennemg\u00e5et en streng evaluering af klinisk ydeevne og risikostyring.<\/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-overholdelse<\/h2>\n<p>Hvert HyDeep 600WM hypertermi-system er bygget i overensstemmelse med <strong>Good Manufacturing Practice (GMP)<\/strong> standarder. Dette sikrer, at produkterne konsekvent produceres og kontrolleres i henhold til kvalitetsstandarder.<\/p>\n<p>Vores <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-certifikat<\/strong><\/a> bekr\u00e6fter, at alle aspekter af produktionen \u2013 fra materialer til personaletr\u00e6ning \u2013 opfylder de h\u00f8jeste standarder for p\u00e5lidelighed.<\/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 certifikat\" 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;\">Korea MFDF-godkendelse<\/h2>\n<p style=\"color: #e0e0e0;\">Vores avancerede onkologiske hypertermi-enhed er valideret i overensstemmelse med de strenge standarder fastsat af det <strong>koreanske ministerium for f\u00f8devare- og l\u00e6gemiddelsikkerhed (MFDF)<\/strong>. Denne certificering er afg\u00f8rende for at sikre, at specifikke nationale regulatoriske krav er opfyldt for medicinsk udstyr, der importeres og anvendes i Sydkorea.<\/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 certificeringer\" title=\"\"><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Certificeringer for Andromedic HyDeep 600WM avanceret onkologisk hypertermi-enhed HyDeep 600WM moduleret RF-hypertermi (mHT) enheden har gennemg\u00e5et strenge tests for at overholde internationale standarder, hvilket sikrer sikkerhed, kvalitet og effektivitet til avanceret kr\u00e6ftbehandling. ISO 13485: Kvalitet i verdensklasse UNI CEI EN ISO 13485 Kvalitetscertificering HyDeep 600WM mHT-enheden er stolte indehavere af ISO 13485-certificeringen. Dette understreger vores&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-3126","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/andromedichyperthermia.com\/da\/wp-json\/wp\/v2\/pages\/3126","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/andromedichyperthermia.com\/da\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/andromedichyperthermia.com\/da\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/da\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/da\/wp-json\/wp\/v2\/comments?post=3126"}],"version-history":[{"count":0,"href":"https:\/\/andromedichyperthermia.com\/da\/wp-json\/wp\/v2\/pages\/3126\/revisions"}],"wp:attachment":[{"href":"https:\/\/andromedichyperthermia.com\/da\/wp-json\/wp\/v2\/media?parent=3126"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}