{"id":3128,"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":"2026-02-02T14:34:07","modified_gmt":"2026-02-02T14:34:07","slug":"certifications-appareil-hyperthermie","status":"publish","type":"page","link":"https:\/\/andromedichyperthermia.com\/fr\/certifications-appareil-hyperthermie\/","title":{"rendered":"Certifications"},"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\": \"Directeur G\u00e9n\u00e9ral (CEO), Andromedic Srl\"\n    },\n    {\n      \"@type\": \"Person\",\n      \"@id\": \"https:\/\/andromedichyperthermia.com\/hyperthermia-doctor-salvatore-conte\/\",\n      \"name\": \"Dr. Salvatore Conte\",\n      \"jobTitle\": \"Co-fondateur & Directeur Commercial, 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;\">Certifications pour le dispositif d&rsquo;hyperthermie oncologique avanc\u00e9e Andromedic HyDeep 600WM<\/h1>\n<p style=\"max-width: 800px; margin: 0 auto; font-size: 1.1em; color: #555;\">Le dispositif d&rsquo;hyperthermie RF modul\u00e9e (mHT) HyDeep 600WM a subi des tests rigoureux pour se conformer aux normes internationales, garantissant s\u00e9curit\u00e9, qualit\u00e9 et efficacit\u00e9 pour le traitement avanc\u00e9 du cancer.<\/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 : Excellence Qualit\u00e9<\/h2>\n<h3 style=\"font-size: 1.1em; color: #444;\">Certification de Qualit\u00e9 UNI CEI EN <a href=\"https:\/\/www.iso.org\/standard\/59752.html\" target=\"_blank\" rel=\"noopener\">ISO 13485<\/a><\/h3>\n<p>Le dispositif mHT HyDeep 600WM d\u00e9tient avec fiert\u00e9 la <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/ISO13485.pdf\" target=\"_blank\" rel=\"noopener\"><strong>certification ISO 13485<\/strong><\/a>. Cela souligne notre engagement envers un contr\u00f4le qualit\u00e9 m\u00e9ticuleux tout au long du cycle de vie \u2014 de la conception et du d\u00e9veloppement \u00e0 la production, l&rsquo;installation et la maintenance.<\/p>\n<p>Elle \u00e9tablit un cadre robuste pour la s\u00e9curit\u00e9 des patients et l&rsquo;excellence des produits, r\u00e9pondant aux exigences r\u00e9glementaires mondiales les plus strictes.<\/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=\"Certificat ISO 13485\" title=\"\"><figcaption style=\"font-size: 0.8em; margin-top: 10px; color: #888;\">Certificat ISO 13485 pour 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-3128 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-1-1203\" 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-1-1203'>\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-1-1182\" 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-1-1182'>\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-1-1161\" 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-1-1161'>\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;\">Certification CE MDR<\/h2>\n<p>Le dispositif d&rsquo;hyperthermie locale profonde a obtenu avec succ\u00e8s la <a href=\"http:\/\/andromedichyperthermia.com\/wp-content\/uploads\/2025\/02\/CE-Andromedic-Hy-Deep-600-WM.pdf\" target=\"_blank\" rel=\"noopener\"><strong>certification CE du Conseil Europ\u00e9en<\/strong><\/a> selon le nouveau <strong>R\u00e8glement relatif aux Dispositifs M\u00e9dicaux (MDR)<\/strong>.<\/p>\n<p>Le MDR est une r\u00e9glementation plus stricte que la pr\u00e9c\u00e9dente, assurant une s\u00e9curit\u00e9 accrue des patients et une transparence du march\u00e9. L&rsquo;obtention de cette certification signifie que le dispositif d&rsquo;hyperthermie RF HyDeep 600WM pour la th\u00e9rapie du cancer a fait l&rsquo;objet d&rsquo;une \u00e9valuation rigoureuse de ses performances cliniques et de sa gestion des risques.<\/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;\">Conformit\u00e9 GMP<\/h2>\n<p>Chaque syst\u00e8me d&rsquo;hyperthermie HyDeep 600WM est construit conform\u00e9ment aux normes de <strong>Bonnes Pratiques de Fabrication (GMP)<\/strong>. Cela garantit que les produits sont fabriqu\u00e9s et contr\u00f4l\u00e9s de mani\u00e8re coh\u00e9rente selon les normes de qualit\u00e9.<\/p>\n<p>Notre <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>certificat KGMP<\/strong><\/a> confirme que tous les aspects de la production \u2014 des mat\u00e9riaux \u00e0 la formation du personnel \u2014 r\u00e9pondent aux crit\u00e8res de fiabilit\u00e9 les plus \u00e9lev\u00e9s.<\/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=\"Certificat 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;\">Approbation MFDF Cor\u00e9e<\/h2>\n<p style=\"color: #e0e0e0;\">Notre dispositif d&rsquo;hyperthermie oncologique avanc\u00e9e est valid\u00e9 conform\u00e9ment aux normes strictes \u00e9tablies par le <strong>Minist\u00e8re de la S\u00e9curit\u00e9 Alimentaire et Pharmaceutique de Cor\u00e9e (MFDF)<\/strong>. Cette certification est cruciale pour garantir que les exigences r\u00e9glementaires nationales sp\u00e9cifiques sont satisfaites pour les dispositifs m\u00e9dicaux import\u00e9s et utilis\u00e9s en Cor\u00e9e du Sud.<\/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=\"Certifications MFDF\" title=\"\"><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Certifications pour le dispositif d&rsquo;hyperthermie oncologique avanc\u00e9e Andromedic HyDeep 600WM Le dispositif d&rsquo;hyperthermie RF modul\u00e9e (mHT) HyDeep 600WM a subi des tests rigoureux pour se conformer aux normes internationales, garantissant s\u00e9curit\u00e9, qualit\u00e9 et efficacit\u00e9 pour le traitement avanc\u00e9 du cancer. ISO 13485 : Excellence Qualit\u00e9 Certification de Qualit\u00e9 UNI CEI EN ISO 13485 Le dispositif&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-3128","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/andromedichyperthermia.com\/fr\/wp-json\/wp\/v2\/pages\/3128","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/andromedichyperthermia.com\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/andromedichyperthermia.com\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/andromedichyperthermia.com\/fr\/wp-json\/wp\/v2\/comments?post=3128"}],"version-history":[{"count":0,"href":"https:\/\/andromedichyperthermia.com\/fr\/wp-json\/wp\/v2\/pages\/3128\/revisions"}],"wp:attachment":[{"href":"https:\/\/andromedichyperthermia.com\/fr\/wp-json\/wp\/v2\/media?parent=3128"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}