{"id":3140,"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":"2026-02-02T15:08:54","modified_gmt":"2026-02-02T15:08:54","slug":"naprava-za-hipertermijo-certifikacije","status":"publish","type":"page","link":"https:\/\/andromedichyperthermia.com\/sl\/naprava-za-hipertermijo-certifikacije\/","title":{"rendered":"Certifikacije"},"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\": \"KGMP certifikat korejskega ministrstva za varnost hrane in zdravil (MFDF)\",\n      \"description\": \"Potrjuje spo\u0161tovanje proizvodnih in kakovostnih standardov, zahtevanih za korejski trg.\",\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\": \"Glavni 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\": \"Soustanovitelj in komercialni 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 napredno napravo za onkolo\u0161ko hipertermijo Andromedic HyDeep 600WM<\/h1>\n<p style=\"max-width: 800px; margin: 0 auto; font-size: 1.1em; color: #555;\">Naprava za modulirano RF hipertermijo (mHT) HyDeep 600WM je bila podvr\u017eena strogim testom za skladnost z mednarodnimi standardi, kar zagotavlja varnost, kakovost in u\u010dinkovitost pri naprednem zdravljenju 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: Odli\u010dnost v kakovosti<\/h2>\n<h3 style=\"font-size: 1.1em; color: #444;\">Certifikat kakovosti UNI CEI EN <a href=\"https:\/\/www.iso.org\/standard\/59752.html\" target=\"_blank\" rel=\"noopener\">ISO 13485<\/a><\/h3>\n<p>Naprava HyDeep 600WM mHT ponosno imetnik <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/ISO13485.pdf\" target=\"_blank\" rel=\"noopener\"><strong>certifikata ISO 13485<\/strong><\/a>. To poudarja na\u0161o zavezanost natan\u010dnemu nadzoru kakovosti skozi celoten \u017eivljenjski cikel \u2013 od zasnove in razvoja do proizvodnje, namestitve in servisiranja.<\/p>\n<p>Vzpostavlja trden okvir za varnost bolnikov in odli\u010dnost izdelkov, ki izpolnjuje stroge globalne regulativne zahteve.<\/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=\"Certifikat ISO 13485\" title=\"\"><figcaption style=\"font-size: 0.8em; margin-top: 10px; color: #888;\">Certifikat ISO 13485 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-3140 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-1-1216\" 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-1-1216'>\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-1-1195\" 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-1-1195'>\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-1-1174\" 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-1-1174'>\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>Naprava za globoko lokalno hipertermijo je uspe\u0161no pridobila <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-Andromedic-Hy-Deep-600-WM.pdf\" target=\"_blank\" rel=\"noopener\"><strong>certifikat CE Evropskega sveta<\/strong><\/a> v skladu z novo <strong>Uredbo o medicinskih pripomo\u010dkih (MDR)<\/strong>.<\/p>\n<p>MDR je stro\u017eja uredba od svoje predhodnice, ki zagotavlja ve\u010djo varnost bolnikov in preglednost trga. Pridobitev tega certifikata pomeni, da je bila naprava za RF hipertermijo HyDeep 600WM za zdravljenje raka podvr\u017eena strogi oceni klini\u010dne u\u010dinkovitosti in obvladovanja tveganj.<\/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;\">Skladnost z GMP<\/h2>\n<p>Vsak sistem hipertermije HyDeep 600WM je izdelan v skladu s standardi <strong>dobre proizvodne prakse (GMP)<\/strong>. To zagotavlja, da so izdelki dosledno proizvedeni in nadzorovani v skladu s standardi kakovosti.<\/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>certifikat KGMP<\/strong><\/a> potrjuje, da vsi vidiki proizvodnje \u2013 od materialov do usposabljanja osebja \u2013 izpolnjujejo najvi\u0161je kriterije zanesljivosti.<\/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=\"Certifikat KGMP\" 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;\">Odobritev MFDF (Koreja)<\/h2>\n<p style=\"color: #e0e0e0;\">Na\u0161a napredna naprava za onkolo\u0161ko hipertermijo je potrjena v skladu s strogimi standardi, ki jih je dolo\u010dilo <strong>Korejsko ministrstvo za varnost hrane in zdravil (MFDF)<\/strong>. Ta certifikacija je klju\u010dna za zagotavljanje skladnosti s specifi\u010dnimi nacionalnimi regulativnimi zahtevami za medicinske pripomo\u010dke, uvo\u017eene in uporabljene v Ju\u017eni 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=\"Certifikati MFDF\" title=\"\"><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Certifikati za napredno napravo za onkolo\u0161ko hipertermijo Andromedic HyDeep 600WM Naprava za modulirano RF hipertermijo (mHT) HyDeep 600WM je bila podvr\u017eena strogim testom za skladnost z mednarodnimi standardi, kar zagotavlja varnost, kakovost in u\u010dinkovitost pri naprednem zdravljenju raka. ISO 13485: Odli\u010dnost v kakovosti Certifikat kakovosti UNI CEI EN ISO 13485 Naprava HyDeep 600WM mHT ponosno&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-3140","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/andromedichyperthermia.com\/sl\/wp-json\/wp\/v2\/pages\/3140","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/andromedichyperthermia.com\/sl\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/andromedichyperthermia.com\/sl\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/sl\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/sl\/wp-json\/wp\/v2\/comments?post=3140"}],"version-history":[{"count":0,"href":"https:\/\/andromedichyperthermia.com\/sl\/wp-json\/wp\/v2\/pages\/3140\/revisions"}],"wp:attachment":[{"href":"https:\/\/andromedichyperthermia.com\/sl\/wp-json\/wp\/v2\/media?parent=3140"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}