{"id":3125,"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":"2026-02-02T14:23:15","modified_gmt":"2026-02-02T14:23:15","slug":"certifikace-hypertermie-andromedic","status":"publish","type":"page","link":"https:\/\/andromedichyperthermia.com\/cs\/certifikace-hypertermie-andromedic\/","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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Leadership Personas Sync *\/\n      \"@type\": \"Person\",\n      \"@id\": \"https:\/\/andromedichyperthermia.com\/ciro-zaccagnini-ceo\/\",\n      \"name\": \"Ciro Zaccagnini\",\n      \"jobTitle\": \"Gener\u00e1ln\u00ed \u0159editel (CEO), Andromedic Srl\"\n    },\n    {\n      \"@type\": \"Person\",\n      \"@id\": \"https:\/\/andromedichyperthermia.com\/hyperthermia-doctor-salvatore-conte\/\",\n      \"name\": \"Dr. Salvatore Conte\",\n      \"jobTitle\": \"Spoluzakladatel a obchodn\u00ed \u0159editel, 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;\">Certifikace pro pokro\u010dil\u00e9 onkologick\u00e9 hypertermick\u00e9 za\u0159\u00edzen\u00ed Andromedic HyDeep 600WM<\/h1>\n<p style=\"max-width: 800px; margin: 0 auto; font-size: 1.1em; color: #555;\">Za\u0159\u00edzen\u00ed HyDeep 600WM pro modulovanou RF hypertermii (mHT) pro\u0161lo p\u0159\u00edsn\u00fdm testov\u00e1n\u00edm, aby splnilo mezin\u00e1rodn\u00ed standardy zaji\u0161\u0165uj\u00edc\u00ed bezpe\u010dnost, kvalitu a \u00fa\u010dinnost pro pokro\u010dilou l\u00e9\u010dbu rakoviny.<\/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: Excelence v kvalit\u011b<\/h2>\n<h3 style=\"font-size: 1.1em; color: #444;\">Certifikace kvality UNI CEI EN <a href=\"https:\/\/www.iso.org\/standard\/59752.html\" target=\"_blank\" rel=\"noopener\">ISO 13485<\/a><\/h3>\n<p>Za\u0159\u00edzen\u00ed HyDeep 600WM mHT je hrd\u00fdm dr\u017eitelem <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/ISO13485.pdf\" target=\"_blank\" rel=\"noopener\"><strong>certifikace ISO 13485<\/strong><\/a>. To potvrzuje n\u00e1\u0161 z\u00e1vazek k pe\u010dliv\u00e9 kontrole kvality v pr\u016fb\u011bhu cel\u00e9ho \u017eivotn\u00edho cyklu \u2013 od n\u00e1vrhu a v\u00fdvoje a\u017e po v\u00fdrobu, instalaci a servis.<\/p>\n<p>Stanovuje robustn\u00ed r\u00e1mec pro bezpe\u010dnost pacient\u016f a excelenci produkt\u016f, kter\u00fd spl\u0148uje p\u0159\u00edsn\u00e9 glob\u00e1ln\u00ed regula\u010dn\u00ed po\u017eadavky.<\/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 certifik\u00e1t\" title=\"\"><figcaption style=\"font-size: 0.8em; margin-top: 10px; color: #888;\">Certifik\u00e1t ISO 13485 pro 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-3125 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-1-1200\" 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-1-1200'>\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-1-1179\" 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-1-1179'>\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-1-1158\" 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-1-1158'>\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;\">Certifikace MDR CE<\/h2>\n<p>Za\u0159\u00edzen\u00ed pro hlubokou lok\u00e1ln\u00ed hypertermii \u00fasp\u011b\u0161n\u011b z\u00edskalo <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-Andromedic-Hy-Deep-600-WM.pdf\" target=\"_blank\" rel=\"noopener\"><strong>certifikaci CE Evropsk\u00e9 rady<\/strong><\/a> podle nov\u00e9ho <strong>Na\u0159\u00edzen\u00ed o zdravotnick\u00fdch prost\u0159edc\u00edch (MDR)<\/strong>.<\/p>\n<p>MDR je p\u0159\u00edsn\u011bj\u0161\u00ed na\u0159\u00edzen\u00ed ne\u017e jeho p\u0159edch\u016fdce, kter\u00e9 zaji\u0161\u0165uje v\u011bt\u0161\u00ed bezpe\u010dnost pacient\u016f a transparentnost trhu. Dosa\u017een\u00ed t\u00e9to certifikace znamen\u00e1, \u017ee p\u0159\u00edstroj HyDeep 600WM pro RF hypertermii v onkologick\u00e9 terapii pro\u0161el p\u0159\u00edsn\u00fdm hodnocen\u00edm klinick\u00e9ho v\u00fdkonu a \u0159\u00edzen\u00ed rizik.<\/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;\">Soulad s GMP<\/h2>\n<p>Ka\u017ed\u00fd hypertermick\u00fd syst\u00e9m HyDeep 600WM je zkonstruov\u00e1n v souladu se standardy <strong>spr\u00e1vn\u00e9 v\u00fdrobn\u00ed praxe (GMP)<\/strong>. To zaji\u0161\u0165uje, \u017ee produkty jsou d\u016fsledn\u011b vyr\u00e1b\u011bny a kontrolov\u00e1ny podle norem kvality.<\/p>\n<p>N\u00e1\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>certifik\u00e1t KGMP<\/strong><\/a> potvrzuje, \u017ee v\u0161echny aspekty v\u00fdroby \u2013 od materi\u00e1l\u016f a\u017e po \u0161kolen\u00ed person\u00e1lu \u2013 spl\u0148uj\u00ed nejvy\u0161\u0161\u00ed m\u011b\u0159\u00edtka spolehlivosti.<\/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 certifik\u00e1t\" 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;\">Schv\u00e1len\u00ed korejsk\u00fdm MFDF<\/h2>\n<p style=\"color: #e0e0e0;\">N\u00e1\u0161 pokro\u010dil\u00fd onkologick\u00fd hypertermick\u00fd p\u0159\u00edstroj je validov\u00e1n v souladu s p\u0159\u00edsn\u00fdmi normami stanoven\u00fdmi <strong>korejsk\u00fdm Ministerstvem pro bezpe\u010dnost potravin a l\u00e9\u010div (MFDF)<\/strong>. Tato certifikace je kl\u00ed\u010dov\u00e1 pro zaji\u0161t\u011bn\u00ed spln\u011bn\u00ed specifick\u00fdch vnitrost\u00e1tn\u00edch regula\u010dn\u00edch po\u017eadavk\u016f pro zdravotnick\u00e9 prost\u0159edky dov\u00e1\u017een\u00e9 a pou\u017e\u00edvan\u00e9 v Ji\u017en\u00ed 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 certifikace\" title=\"\"><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Certifikace pro pokro\u010dil\u00e9 onkologick\u00e9 hypertermick\u00e9 za\u0159\u00edzen\u00ed Andromedic HyDeep 600WM Za\u0159\u00edzen\u00ed HyDeep 600WM pro modulovanou RF hypertermii (mHT) pro\u0161lo p\u0159\u00edsn\u00fdm testov\u00e1n\u00edm, aby splnilo mezin\u00e1rodn\u00ed standardy zaji\u0161\u0165uj\u00edc\u00ed bezpe\u010dnost, kvalitu a \u00fa\u010dinnost pro pokro\u010dilou l\u00e9\u010dbu rakoviny. ISO 13485: Excelence v kvalit\u011b Certifikace kvality UNI CEI EN ISO 13485 Za\u0159\u00edzen\u00ed HyDeep 600WM mHT je hrd\u00fdm dr\u017eitelem certifikace ISO 13485.&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-3125","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/pages\/3125","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/comments?post=3125"}],"version-history":[{"count":0,"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/pages\/3125\/revisions"}],"wp:attachment":[{"href":"https:\/\/andromedichyperthermia.com\/cs\/wp-json\/wp\/v2\/media?parent=3125"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}