{"id":6318,"date":"2017-08-14T12:44:25","date_gmt":"2017-08-14T12:44:25","guid":{"rendered":"https:\/\/andromedichyperthermia.com\/certifications-rf-hyperthermia-device\/"},"modified":"2026-01-23T16:58:32","modified_gmt":"2026-01-23T16:58:32","slug":"certificeringen-rf-hyperthermie-apparaten","status":"publish","type":"page","link":"https:\/\/andromedichyperthermia.com\/nl\/certificeringen-rf-hyperthermie-apparaten\/","title":{"rendered":"Certificeringen"},"content":{"rendered":"<p><script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@graph\": [\n    {\n      \/* 1. 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Korea MFDF Certificering *\/\n      \"@type\": \"Certification\",\n      \"@id\": \"https:\/\/andromedichyperthermia.com\/#mfdf-korea-certification\",\n      \"name\": \"Korea Ministry of Food and Drug Safety (MFDF) KGMP Certificaat\",\n      \"description\": \"Valideert de naleving van de productie- en kwaliteitsnormen die vereist zijn voor de Koreaanse markt.\",\n      \"about\": { \"@id\": \"https:\/\/andromedichyperthermia.com\/#hydeep-600wm\" }\n    },\n    {\n      \/* 7. 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Dit onderstreept onze toewijding aan nauwgezette kwaliteitscontrole gedurende de gehele levenscyclus\u2014van ontwerp en ontwikkeling tot productie, installatie en onderhoud.<\/p>\n<p>Het biedt een robuust kader voor pati\u00ebntveiligheid en productexcellentie, in overeenstemming met strikte wereldwijde regelgevende vereisten.<\/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 certificaat\" title=\"\"><figcaption style=\"font-size: 0.8em; margin-top: 10px; color: #888;\">ISO 13485-certificaat voor 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-6318 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=\"CE MDR Andromedic certificate HyDeep 600WM hyperthermia device 1\" aria-describedby=\"gallery-1-13604\" 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-1-13604'>\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=\"CE MDR Andromedic certificate HyDeep 600WM hyperthermia device 2\" aria-describedby=\"gallery-1-13605\" 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-1-13605'>\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=\"CE MDR Andromedic certificate HyDeep 600WM hyperthermia device 3\" aria-describedby=\"gallery-1-13606\" 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-1-13606'>\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>Het apparaat voor diepe lokale hyperthermie heeft met succes de <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-Andromedic-Hy-Deep-600-WM.pdf\" target=\"_blank\" rel=\"noopener\"><strong>CE-certificering van de Europese Raad<\/strong><\/a> verkregen onder de nieuwe <strong>Medical Device Regulation (MDR)<\/strong>.<\/p>\n<p>De MDR is een strengere verordening dan de voorganger en waarborgt een hogere pati\u00ebntveiligheid en markttransparantie. Het behalen hiervan betekent dat het HyDeep 600WM RF-hyperthermie-apparaat voor oncologische therapie een rigoureuze evaluatie heeft ondergaan op het gebied van klinische prestaties en risicomanagement.<\/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-Compliance<\/h2>\n<p>Elk HyDeep 600WM hyperthermiesysteem is gebouwd in overeenstemming met <strong>Good Manufacturing Practice (GMP)<\/strong>-normen. Dit garandeert dat producten consistent worden geproduceerd en gecontroleerd volgens strikte kwaliteitsstandaarden.<\/p>\n<p>Ons <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-certificaat<\/strong><\/a> bevestigt dat alle aspecten van de productie\u2014van materialen tot de training van het personeel\u2014voldoen aan de hoogste maatstaven voor betrouwbaarheid.<\/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 certificaat\" 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 Goedkeuring<\/h2>\n<p style=\"color: #e0e0e0;\">Ons geavanceerde oncologische hyperthermie-apparaat is gevalideerd volgens de strenge normen van het <strong>Koreaanse Ministerie van Voedsel- en Drugveiligheid (MFDF)<\/strong>. Deze certificering is cruciaal voor het waarborgen dat specifieke nationale wettelijke vereisten worden nageleefd voor medische hulpmiddelen die in Zuid-Korea worden ge\u00efmporteerd en gebruikt.<\/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 Certificeringen\" title=\"\"><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Certificeringen voor het Andromedic HyDeep 600WM geavanceerde oncologische hyperthermie-apparaat Het HyDeep 600WM gemoduleerde RF-hyperthermie (mHT) apparaat heeft strenge tests ondergaan om te voldoen aan internationale normen, waarbij veiligheid, kwaliteit en werkzaamheid voor geavanceerde kankerbehandeling worden gewaarborgd. ISO 13485: Uitmuntende Kwaliteit UNI CEI EN ISO 13485 Kwaliteitscertificering Het HyDeep 600WM mHT-apparaat beschikt over de ISO 13485-certificering.&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-6318","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/andromedichyperthermia.com\/nl\/wp-json\/wp\/v2\/pages\/6318","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/andromedichyperthermia.com\/nl\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/andromedichyperthermia.com\/nl\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/nl\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/nl\/wp-json\/wp\/v2\/comments?post=6318"}],"version-history":[{"count":0,"href":"https:\/\/andromedichyperthermia.com\/nl\/wp-json\/wp\/v2\/pages\/6318\/revisions"}],"wp:attachment":[{"href":"https:\/\/andromedichyperthermia.com\/nl\/wp-json\/wp\/v2\/media?parent=6318"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}