{"id":3135,"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":"2026-02-02T14:55:12","modified_gmt":"2026-02-02T14:55:12","slug":"sertifiseringer-enhet-hypertermi","status":"publish","type":"page","link":"https:\/\/andromedichyperthermia.com\/no\/sertifiseringer-enhet-hypertermi\/","title":{"rendered":"Sertifiseringer"},"content":{"rendered":"<p><script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@graph\": [\n    {\n      \/* 1. 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Dette understreker v\u00e5r forpliktelse til n\u00f8yaktig kvalitetskontroll gjennom hele livssyklusen \u2013 fra design og utvikling til produksjon, installasjon og service.<\/p>\n<p>Det etablerer et robust rammeverk for pasientsikkerhet og produktekstremitet, som oppfyller 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-sertifikat\" title=\"\"><figcaption style=\"font-size: 0.8em; margin-top: 10px; color: #888;\">ISO 13485-sertifikat 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-3135 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-1-1210\" 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-1-1210'>\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-1-1189\" 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-1-1189'>\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-1-1168\" 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-1-1168'>\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-sertifisering<\/h2>\n<p>Enheten for dyp lokal hypertermi har med suksess oppn\u00e5dd <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-Andromedic-Hy-Deep-600-WM.pdf\" target=\"_blank\" rel=\"noopener\"><strong>EU-r\u00e5dets CE-sertifisering<\/strong><\/a> under den nye <strong>Medical Device Regulation (MDR)<\/strong>.<\/p>\n<p>MDR er en strengere forordning enn sin forgjenger, noe som sikrer st\u00f8rre pasientsikkerhet og markedstransparens. \u00c5 oppn\u00e5 dette betyr at HyDeep 600WM RF-hypertermienheten for kreftbehandling har gjennomg\u00e5tt en streng evaluering av klinisk ytelse 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-samsvar<\/h2>\n<p>Hvert HyDeep 600WM hypertermisystem er bygget i samsvar med standarder for <strong>god produksjonspraksis (GMP)<\/strong>. Dette sikrer at produktene konsekvent produseres og kontrolleres i henhold til kvalitetsstandarder.<\/p>\n<p>V\u00e5rt <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-sertifikat<\/strong><\/a> bekrefter at alle aspekter av produksjonen \u2013 fra materialer til oppl\u00e6ring av ansatte \u2013 oppfyller de h\u00f8yeste standardene for p\u00e5litelighet.<\/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-sertifikat\" 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;\">S\u00f8r-Koreansk MFDF-godkjenning<\/h2>\n<p style=\"color: #e0e0e0;\">V\u00e5r avanserte onkologiske hypertermi-enhet er validert i samsvar med de strenge standardene satt av det <strong>koreanske departementet for mat- og legemiddelsikkerhet (MFDF)<\/strong>. Denne sertifiseringen er avgj\u00f8rende for \u00e5 sikre at spesifikke nasjonale regulatoriske krav er oppfylt for medisinsk utstyr som importeres og brukes i S\u00f8r-Korea.<\/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-sertifiseringer\" title=\"\"><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Sertifiseringer for Andromedic HyDeep 600WM avansert onkologisk hypertermi-enhet HyDeep 600WM modulert RF-hypertermi (mHT) enheten har gjennomg\u00e5tt strenge tester for \u00e5 overholde internasjonale standarder, noe som sikrer sikkerhet, kvalitet og effektivitet for avansert kreftbehandling. ISO 13485: Kvalitetsstandard UNI CEI EN ISO 13485 kvalitetssertifisering HyDeep 600WM mHT-enheten er stolt innehaver av ISO 13485-sertifiseringen. Dette understreker v\u00e5r forpliktelse&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-3135","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/andromedichyperthermia.com\/no\/wp-json\/wp\/v2\/pages\/3135","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/andromedichyperthermia.com\/no\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/andromedichyperthermia.com\/no\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/no\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/no\/wp-json\/wp\/v2\/comments?post=3135"}],"version-history":[{"count":0,"href":"https:\/\/andromedichyperthermia.com\/no\/wp-json\/wp\/v2\/pages\/3135\/revisions"}],"wp:attachment":[{"href":"https:\/\/andromedichyperthermia.com\/no\/wp-json\/wp\/v2\/media?parent=3135"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}