{"id":3137,"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":"2026-02-02T14:59:42","modified_gmt":"2026-02-02T14:59:42","slug":"certificacoes-hipertermia-rf","status":"publish","type":"page","link":"https:\/\/andromedichyperthermia.com\/pt-pt\/certificacoes-hipertermia-rf\/","title":{"rendered":"Certifica\u00e7\u00f5es"},"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\": \"Certificado KGMP do Minist\u00e9rio da Seguran\u00e7a Alimentar e Farmac\u00eautica da Coreia (MFDF)\",\n      \"description\": \"Valida a ades\u00e3o aos padr\u00f5es de fabrico e qualidade exigidos para o mercado coreano.\",\n      \"about\": { \"@id\": \"https:\/\/andromedichyperthermia.com\/#hydeep-600wm\" }\n    },\n    {\n      \/* 7. 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Esta norma sublinha o nosso compromisso com um controlo de qualidade meticuloso em todo o ciclo de vida \u2014 desde o design e desenvolvimento at\u00e9 \u00e0 produ\u00e7\u00e3o, instala\u00e7\u00e3o e assist\u00eancia t\u00e9cnica.<\/p>\n<p>Estabelece uma estrutura robusta para a seguran\u00e7a do paciente e excel\u00eancia do produto, cumprindo os rigorosos requisitos regulamentares globais.<\/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=\"Certificado ISO 13485\" title=\"\"><figcaption style=\"font-size: 0.8em; margin-top: 10px; color: #888;\">Certificado ISO 13485 para o 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-3137 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-1-1212\" 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-1-1212'>\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-1-1191\" 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-1-1191'>\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-1-1170\" 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-1-1170'>\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;\">Certifica\u00e7\u00e3o MDR CE<\/h2>\n<p>O dispositivo de hipertermia local profunda obteve com sucesso a <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-Andromedic-Hy-Deep-600-WM.pdf\" target=\"_blank\" rel=\"noopener\"><strong>certifica\u00e7\u00e3o CE do Conselho Europeu<\/strong><\/a> ao abrigo do novo <strong>Regulamento de Dispositivos M\u00e9dicos (MDR)<\/strong>.<\/p>\n<p>O MDR \u00e9 um regulamento mais rigoroso que o seu antecessor, garantindo maior seguran\u00e7a para o paciente e transpar\u00eancia no mercado. Alcan\u00e7ar esta certifica\u00e7\u00e3o significa que o dispositivo de hipertermia por RF HyDeep 600WM para terapia oncol\u00f3gica passou por uma avalia\u00e7\u00e3o rigorosa de desempenho cl\u00ednico e gest\u00e3o de risco.<\/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;\">Conformidade GMP<\/h2>\n<p>Cada sistema de hipertermia HyDeep 600WM \u00e9 constru\u00eddo de acordo com as normas de <strong>Boas Pr\u00e1ticas de Fabrico (GMP)<\/strong>. Isso garante que os produtos sejam produzidos e controlados de forma consistente, segundo padr\u00f5es de qualidade.<\/p>\n<p>O nosso <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>certificado KGMP<\/strong><\/a> confirma que todos os aspetos da produ\u00e7\u00e3o \u2014 desde os materiais at\u00e9 \u00e0 forma\u00e7\u00e3o do pessoal \u2014 cumprem os mais elevados padr\u00f5es de fiabilidade.<\/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=\"Certificado 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;\">Aprova\u00e7\u00e3o MFDF Coreia<\/h2>\n<p style=\"color: #e0e0e0;\">O nosso dispositivo avan\u00e7ado de hipertermia oncol\u00f3gica est\u00e1 validado de acordo com as normas rigorosas estabelecidas pelo <strong>Minist\u00e9rio da Seguran\u00e7a Alimentar e Farmac\u00eautica da Coreia (MFDF)<\/strong>. Esta certifica\u00e7\u00e3o \u00e9 crucial para garantir o cumprimento dos requisitos regulamentares nacionais espec\u00edficos para dispositivos m\u00e9dicos importados e utilizados na Coreia do Sudeste.<\/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=\"Certifica\u00e7\u00f5es MFDF\" title=\"\"><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Certifica\u00e7\u00f5es para o Dispositivo de Hipertermia Oncol\u00f3gica Avan\u00e7ada Andromedic HyDeep 600WM O dispositivo de hipertermia por RF modulada (mHT) HyDeep 600WM foi submetido a testes rigorosos para cumprir as normas internacionais, garantindo seguran\u00e7a, qualidade e efic\u00e1cia no tratamento oncol\u00f3gico avan\u00e7ado. ISO 13485: Excel\u00eancia em Qualidade Certifica\u00e7\u00e3o de Qualidade UNI CEI EN ISO 13485 O dispositivo&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-3137","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/andromedichyperthermia.com\/pt-pt\/wp-json\/wp\/v2\/pages\/3137","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/andromedichyperthermia.com\/pt-pt\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/andromedichyperthermia.com\/pt-pt\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/pt-pt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/pt-pt\/wp-json\/wp\/v2\/comments?post=3137"}],"version-history":[{"count":0,"href":"https:\/\/andromedichyperthermia.com\/pt-pt\/wp-json\/wp\/v2\/pages\/3137\/revisions"}],"wp:attachment":[{"href":"https:\/\/andromedichyperthermia.com\/pt-pt\/wp-json\/wp\/v2\/media?parent=3137"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}