{"id":6320,"date":"2017-08-14T12:44:25","date_gmt":"2017-08-14T12:44:25","guid":{"rendered":"https:\/\/andromedichyperthermia.com\/certifications-rf-hyperthermia-device\/"},"modified":"2026-02-02T15:12:01","modified_gmt":"2026-02-02T15:12:01","slug":"certificaciones-dispozitivos-hipertermia","status":"publish","type":"page","link":"https:\/\/andromedichyperthermia.com\/es\/certificaciones-dispozitivos-hipertermia\/","title":{"rendered":"Certificaciones"},"content":{"rendered":"<p><script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@graph\": [\n    {\n      \/* 1. 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Esto subraya nuestro compromiso con un control de calidad meticuloso durante todo el ciclo de vida: desde el dise\u00f1o y desarrollo hasta la producci\u00f3n, instalaci\u00f3n y servicio.<\/p>\n<p>Establece un marco s\u00f3lido para la seguridad del paciente y la excelencia del producto, cumpliendo con los estrictos requisitos reglamentarios mundiales.<\/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 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-6320 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-1-13944\" 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-1-13944'>\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-1-13945\" 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-1-13945'>\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-1-13946\" 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-1-13946'>\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;\">Certificaci\u00f3n CE MDR<\/h2>\n<p>El dispositivo de hipertermia local profunda obtuvo con \u00e9xito la <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-Andromedic-Hy-Deep-600-WM.pdf\" target=\"_blank\" rel=\"noopener\"><strong>certificaci\u00f3n CE del Consejo Europeo<\/strong><\/a> conforme al nuevo <strong>Reglamento de Dispositivos M\u00e9dicos (MDR)<\/strong>.<\/p>\n<p>El MDR es una normativa m\u00e1s estricta que su predecesora, lo que garantiza una mayor seguridad del paciente y transparencia en el mercado. Lograr esto significa que el dispositivo de hipertermia por RF HyDeep 600WM para terapia contra el c\u00e1ncer se ha sometido a una evaluaci\u00f3n rigurosa de rendimiento cl\u00ednico y gesti\u00f3n de riesgos.<\/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;\">Cumplimiento de GMP<\/h2>\n<p>Cada sistema de hipertermia HyDeep 600WM se construye de acuerdo con las normas de <strong>Buenas Pr\u00e1cticas de Fabricaci\u00f3n (GMP)<\/strong>. Esto garantiza que los productos se produzcan y controlen de forma coherente seg\u00fan los est\u00e1ndares de calidad.<\/p>\n<p>Nuestro <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 los aspectos de la producci\u00f3n \u2014desde los materiales hasta la formaci\u00f3n del personal\u2014 cumplen los m\u00e1s altos criterios de fiabilidad.<\/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;\">Aprobaci\u00f3n MFDF Corea<\/h2>\n<p style=\"color: #e0e0e0;\">Nuestro dispositivo avanzado de hipertermia oncol\u00f3gica est\u00e1 validado conforme a los estrictos est\u00e1ndares establecidos por el <strong>Ministerio de Seguridad de Alimentos y Medicamentos de Corea (MFDF)<\/strong>. Esta certificaci\u00f3n es crucial para garantizar el cumplimiento de los requisitos reglamentarios nacionales espec\u00edficos para dispositivos m\u00e9dicos importados y utilizados en Corea del Sur.<\/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=\"Certificaciones MFDF\" title=\"\"><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Certificaciones del dispositivo de hipertermia oncol\u00f3gica avanzada Andromedic HyDeep 600WM El dispositivo de hipertermia por RF modulada (mHT) HyDeep 600WM ha sido sometido a rigurosas pruebas para cumplir con las normas internacionales, garantizando seguridad, calidad y eficacia para el tratamiento avanzado del c\u00e1ncer. ISO 13485: Excelencia en Calidad Certificaci\u00f3n de Calidad UNI CEI EN ISO&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-6320","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/andromedichyperthermia.com\/es\/wp-json\/wp\/v2\/pages\/6320","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/andromedichyperthermia.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/andromedichyperthermia.com\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/es\/wp-json\/wp\/v2\/comments?post=6320"}],"version-history":[{"count":0,"href":"https:\/\/andromedichyperthermia.com\/es\/wp-json\/wp\/v2\/pages\/6320\/revisions"}],"wp:attachment":[{"href":"https:\/\/andromedichyperthermia.com\/es\/wp-json\/wp\/v2\/media?parent=6320"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}