{"id":3124,"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":"2026-02-02T14:20:59","modified_gmt":"2026-02-02T14:20:59","slug":"certifikacije-uredaje-hipertermiju","status":"publish","type":"page","link":"https:\/\/andromedichyperthermia.com\/hr\/certifikacije-uredaje-hipertermiju\/","title":{"rendered":"Certifikace"},"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 Certification *\/\n      \"@type\": \"Certification\",\n      \"@id\": \"https:\/\/andromedichyperthermia.com\/#mfdf-korea-certification\",\n      \"name\": \"Korejsko ministarstvo sigurnosti hrane i lijekova (MFDF) KGMP certifikat\",\n      \"description\": \"Potvr\u0111uje pridr\u017eavanje standarda proizvodnje i kvalitete potrebnih za korejsko tr\u017ei\u0161te.\",\n      \"about\": { \"@id\": \"https:\/\/andromedichyperthermia.com\/#hydeep-600wm\" }\n    },\n    {\n      \/* 7. Leadership Personas Sync *\/\n      \"@type\": \"Person\",\n      \"@id\": \"https:\/\/andromedichyperthermia.com\/ciro-zaccagnini-ceo\/\",\n      \"name\": \"Ciro Zaccagnini\",\n      \"jobTitle\": \"Izvr\u0161ni direktor (CEO), Andromedic Srl\"\n    },\n    {\n      \"@type\": \"Person\",\n      \"@id\": \"https:\/\/andromedichyperthermia.com\/hyperthermia-doctor-salvatore-conte\/\",\n      \"name\": \"Dr. Salvatore Conte\",\n      \"jobTitle\": \"Suosniva\u010d i komercijalni direktor, 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;\">Certifikati za Andromedic HyDeep 600WM ure\u0111aj za naprednu onkolo\u0161ku hipertermiju<\/h1>\n<p style=\"max-width: 800px; margin: 0 auto; font-size: 1.1em; color: #555;\">Ure\u0111aj za moduliranu RF hipertermiju (mHT) HyDeep 600WM pro\u0161ao je rigorozna testiranja kako bi se uskladio s me\u0111unarodnim standardima, osiguravaju\u0107i sigurnost, kvalitetu i u\u010dinkovitost za napredno lije\u010denje raka.<\/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: Izvrsnost kvalitete<\/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> Certifikat kvalitete<\/h3>\n<p>Ure\u0111aj za hipertermiju HyDeep 600WM mHT s ponosom posjeduje <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/ISO13485.pdf\" target=\"_blank\" rel=\"noopener\"><strong>ISO 13485 certifikat<\/strong><\/a>. To nagla\u0161ava na\u0161u predanost pedantnoj kontroli kvalitete tijekom cijelog \u017eivotnog ciklusa \u2014 od dizajna i razvoja do proizvodnje, instalacije i servisiranja.<\/p>\n<p>On uspostavlja \u010dvrst okvir za sigurnost pacijenata i izvrsnost proizvoda, ispunjavaju\u0107i stroge globalne regulatorne zahtjeve.<\/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 za 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-3124 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-1-1199\" 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-1-1199'>\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-1-1178\" 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-1-1178'>\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-1-1157\" 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-1-1157'>\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 Certifikacija<\/h2>\n<p>Ure\u0111aj za duboku lokalnu hipertermiju uspje\u0161no je dobio <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-Andromedic-Hy-Deep-600-WM.pdf\" target=\"_blank\" rel=\"noopener\"><strong>CE certifikat Europskog vije\u0107a<\/strong><\/a> prema novoj <strong>Uredbi o medicinskim proizvodima (MDR)<\/strong>.<\/p>\n<p>MDR je stro\u017ea regulativa od svoje prethodnice, koja osigurava ve\u0107u sigurnost pacijenata i transparentnost tr\u017ei\u0161ta. Postizanje ovoga zna\u010di da je HyDeep 600WM RF ure\u0111aj za hipertermiju u onkolo\u0161koj terapiji pro\u0161ao rigoroznu procjenu klini\u010dke u\u010dinkovitosti i upravljanja rizicima.<\/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 Uskla\u0111enost<\/h2>\n<p>Svaki HyDeep 600WM sustav za hipertermiju izra\u0111en je u skladu sa standardima <strong>Dobre proizvo\u0111a\u010dke prakse (GMP)<\/strong>. To osigurava da se proizvodi dosljedno proizvode i kontroliraju prema standardima kvalitete.<\/p>\n<p>Na\u0161 <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> potvr\u0111uje da svi aspekti proizvodnje \u2014 od materijala do obuke osoblja \u2014 zadovoljavaju najvi\u0161e standarde pouzdanosti.<\/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;\">Odobrenje korejskog MFDF-a<\/h2>\n<p style=\"color: #e0e0e0;\">Na\u0161 napredni onkolo\u0161ki ure\u0111aj za hipertermiju validiran je u skladu sa strogim standardima koje je postavilo <strong>Korejsko ministarstvo sigurnosti hrane i lijekova (MFDF)<\/strong>. Ova certifikacija klju\u010dna je za osiguravanje uskla\u0111enosti s posebnim nacionalnim regulatornim zahtjevima za medicinske ure\u0111aje koji se uvoze i koriste u Ju\u017enoj Koreji.<\/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 certifikati\" title=\"\"><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Certifikati za Andromedic HyDeep 600WM ure\u0111aj za naprednu onkolo\u0161ku hipertermiju Ure\u0111aj za moduliranu RF hipertermiju (mHT) HyDeep 600WM pro\u0161ao je rigorozna testiranja kako bi se uskladio s me\u0111unarodnim standardima, osiguravaju\u0107i sigurnost, kvalitetu i u\u010dinkovitost za napredno lije\u010denje raka. ISO 13485: Izvrsnost kvalitete UNI CEI EN ISO 13485 Certifikat kvalitete Ure\u0111aj za hipertermiju HyDeep 600WM mHT&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-3124","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/andromedichyperthermia.com\/hr\/wp-json\/wp\/v2\/pages\/3124","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/andromedichyperthermia.com\/hr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/andromedichyperthermia.com\/hr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/hr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/hr\/wp-json\/wp\/v2\/comments?post=3124"}],"version-history":[{"count":0,"href":"https:\/\/andromedichyperthermia.com\/hr\/wp-json\/wp\/v2\/pages\/3124\/revisions"}],"wp:attachment":[{"href":"https:\/\/andromedichyperthermia.com\/hr\/wp-json\/wp\/v2\/media?parent=3124"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}