{"id":31,"date":"2026-08-31T13:02:52","date_gmt":"2026-08-31T11:02:52","guid":{"rendered":"https:\/\/asmed.net\/qualita-e-conformita\/"},"modified":"2026-09-11T19:03:14","modified_gmt":"2026-09-11T17:03:14","slug":"qualita-e-conformita","status":"publish","type":"page","link":"https:\/\/asmed.net\/es\/qualita-e-conformita\/","title":{"rendered":"Calidad y Cumplimiento"},"content":{"rendered":"<main id='bde-main'><section class=\"bde-f-container-31-104 bde-f-container asmed-page-header\"><div class=\"bde-f-container-31-103 bde-f-container asmed-container asmed-page-header-inner\"><p class=\"bde-f-text-31-100 bde-f-text asmed-t-caption asmed-c-accent\">\nCalidad y Cumplimiento\n<\/p><h1 class=\"bde-f-text-31-101 bde-f-text asmed-page-h1\">\nCalidad certificada, documentos consultables.\n<\/h1><p class=\"bde-f-text-31-102 bde-f-text asmed-page-lead\">\nEl sistema de gesti\u00f3n de calidad ASMED\u00ae cuenta con la certificaci\u00f3n ISO 13485:2016. Los documentos p\u00fablicos de certificaci\u00f3n y registro de dispositivos se pueden encontrar en esta p\u00e1gina.\n<\/p><\/div><\/section><section class=\"bde-f-container-31-116 bde-f-container asmed-section asmed-container\"><div class=\"bde-f-container-31-115 bde-f-container asmed-split-top\"><div class=\"bde-f-container-31-109 bde-f-container asmed-prose\"><h2 class=\"bde-f-text-31-105 bde-f-text asmed-t-h2 asmed-c-heading\">\nEl sistema de calidad\n<\/h2><p class=\"bde-f-text-31-106 bde-f-text asmed-t-body asmed-c-body\">\nASMED\u00ae dise\u00f1a, fabrica y asiste dispositivos m\u00e9dicos con un sistema de gesti\u00f3n de calidad certificado seg\u00fan la norma internacional ISO 13485:2016, referencia espec\u00edfica para fabricantes de dispositivos m\u00e9dicos.\n<\/p><p class=\"bde-f-text-31-107 bde-f-text asmed-t-body asmed-c-body\">\nEl cumplimiento cubre todo el ciclo de vida del dispositivo: dise\u00f1o, producci\u00f3n, trazabilidad, vigilancia poscomercializaci\u00f3n y asistencia t\u00e9cnica.\n<\/p><div class=\"bde-f-container-31-108 bde-f-container asmed-qs-check\"><div class=\"bde-checkmark-list-31-153 bde-checkmark-list asmed-check\">\n<ul>\n  \n              \n              \n    <li>\n      <span class='bde-checkmark-list__icon bde-checkmark-list__icon_yes'>\n                  <svg viewbox=\"0 0 24 24\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><circle cx=\"12\" cy=\"12\" r=\"12\" fill=\"currentColor\"\/><path d=\"M7 12.6l3.2 3.2 6.8-7.4\" fill=\"none\" style=\"stroke:var(--c-surface)\" stroke-width=\"2.4\" stroke-linecap=\"round\" stroke-linejoin=\"round\"\/><\/svg>\n              <\/span>\n      <div >\n        Dise\u00f1o y producci\u00f3n de acuerdo con las normas internacionales\n      <\/div>\n\n    <\/li>\n\n  \n              \n              \n    <li>\n      <span class='bde-checkmark-list__icon bde-checkmark-list__icon_yes'>\n                  <svg viewbox=\"0 0 24 24\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><circle cx=\"12\" cy=\"12\" r=\"12\" fill=\"currentColor\"\/><path d=\"M7 12.6l3.2 3.2 6.8-7.4\" fill=\"none\" style=\"stroke:var(--c-surface)\" stroke-width=\"2.4\" stroke-linecap=\"round\" stroke-linejoin=\"round\"\/><\/svg>\n              <\/span>\n      <div >\n        Trazabilidad en cada etapa del ciclo de vida del dispositivo\n      <\/div>\n\n    <\/li>\n\n  \n              \n              \n    <li>\n      <span class='bde-checkmark-list__icon bde-checkmark-list__icon_yes'>\n                  <svg viewbox=\"0 0 24 24\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><circle cx=\"12\" cy=\"12\" r=\"12\" fill=\"currentColor\"\/><path d=\"M7 12.6l3.2 3.2 6.8-7.4\" fill=\"none\" style=\"stroke:var(--c-surface)\" stroke-width=\"2.4\" stroke-linecap=\"round\" stroke-linejoin=\"round\"\/><\/svg>\n              <\/span>\n      <div >\n        Documentaci\u00f3n cl\u00ednica y t\u00e9cnica completa y actualizada\n      <\/div>\n\n    <\/li>\n\n  \n              \n              \n    <li>\n      <span class='bde-checkmark-list__icon bde-checkmark-list__icon_yes'>\n                  <svg viewbox=\"0 0 24 24\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><circle cx=\"12\" cy=\"12\" r=\"12\" fill=\"currentColor\"\/><path d=\"M7 12.6l3.2 3.2 6.8-7.4\" fill=\"none\" style=\"stroke:var(--c-surface)\" stroke-width=\"2.4\" stroke-linecap=\"round\" stroke-linejoin=\"round\"\/><\/svg>\n              <\/span>\n      <div >\n        Vigilancia poscomercializaci\u00f3n y asistencia continua\n      <\/div>\n\n    <\/li>\n\n  <\/ul>\n\n<\/div><\/div><\/div><div class=\"bde-f-container-31-114 bde-f-container asmed-card-dark asmed-qs-card\"><div class=\"bde-f-container-31-112 bde-f-container asmed-cert-panel\"><img decoding=\"async\" class=\"bde-f-image-31-154 bde-f-image asmed-cert-panel-logo\" src=\"https:\/\/asmed.net\/wp-content\/uploads\/2026\/09\/imq-iso-13485-2016_high-contrast-on-navy-trim-255x300.webp\" alt=\"Sistema de gesti\u00f3n de la calidad certificado por IMQ \u2014 ISO 13485:2016\" loading=\"lazy\"><\/div><p class=\"bde-f-text-31-113 bde-f-text asmed-dark-text\">\nCertificaci\u00f3n expedida por un organismo independiente. El certificado se puede descargar a continuaci\u00f3n.\n<\/p><\/div><\/div><\/section><section class=\"bde-f-container-31-146 bde-f-container asmed-bg-surface asmed-section\"><div class=\"bde-f-container-31-145 bde-f-container asmed-container\"><div class=\"bde-f-container-31-119 bde-f-container asmed-sec-head\"><p class=\"bde-f-text-31-117 bde-f-text asmed-t-caption asmed-c-secondary\">\nDocumentos p\u00fablicos\n<\/p><h2 class=\"bde-f-text-31-118 bde-f-text asmed-t-h2 asmed-c-heading\">\nCertificaciones e inscripciones\n<\/h2><\/div><div class=\"bde-f-container-31-140 bde-f-container asmed-grid-4\"><div class=\"bde-f-container-31-124 bde-f-container asmed-doc-card\"><div class=\"bde-f-svg-icon2-31-120 bde-f-svg-icon2 asmed-icon-30\">\n<svg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.5\" aria-hidden=\"true\"><path d=\"M6 3h9l4 4v14H6V3z\"><\/path><path d=\"M15 3v4h4M9 12h6M9 16h6\"><\/path><\/svg>\n<\/div><h3 class=\"bde-f-text-31-121 bde-f-text asmed-doc-title\">\nCertificado IMQ \u2014 ISO 13485:2016\n<\/h3><p class=\"bde-f-text-31-122 bde-f-text asmed-doc-text\">\nSistema de gesti\u00f3n de calidad de ASMED S.r.l. Certificado IMQ n.o 9124.ASM5.\n<\/p><a class=\"bde-f-text-link-31-123 bde-f-text-link asmed-doc-link\" href=\"https:\/\/asmed.net\/wp-content\/uploads\/2026\/09\/cert-imq-iso13485-9124asm5-2029.pdf\" target=\"_blank\" rel=\"noopener\">\nDescargar el PDF \u2192\n<\/a><\/div><div class=\"bde-f-container-31-129 bde-f-container asmed-doc-card\"><div class=\"bde-f-svg-icon2-31-125 bde-f-svg-icon2 asmed-icon-30\">\n<svg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.5\" aria-hidden=\"true\"><path d=\"M6 3h9l4 4v14H6V3z\"><\/path><path d=\"M15 3v4h4M9 12h6M9 16h6\"><\/path><\/svg>\n<\/div><h3 class=\"bde-f-text-31-126 bde-f-text asmed-doc-title\">\nRegistro ANVISA \u2013 BENE Mod 110\n<\/h3><p class=\"bde-f-text-31-127 bde-f-text asmed-doc-text\">\nRegistro del dispositivo BENE Mod 110 ante la agencia reguladora brasile\u00f1a, a nombre de ASMED Latino Am\u00e9rica. Notificaci\u00f3n 25351369484202435.\n<\/p><a class=\"bde-f-text-link-31-128 bde-f-text-link asmed-doc-link\" href=\"https:\/\/asmed.net\/wp-content\/uploads\/2026\/08\/cert-anvisa-bene.pdf\" target=\"_blank\" rel=\"noopener\">\nDescargar el PDF \u2192\n<\/a><\/div><div class=\"bde-f-container-31-134 bde-f-container asmed-doc-card\"><div class=\"bde-f-svg-icon2-31-130 bde-f-svg-icon2 asmed-icon-30\">\n<svg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.5\" aria-hidden=\"true\"><path d=\"M6 3h9l4 4v14H6V3z\"><\/path><path d=\"M15 3v4h4M9 12h6M9 16h6\"><\/path><\/svg>\n<\/div><h3 class=\"bde-f-text-31-131 bde-f-text asmed-doc-title\">\nCertificaci\u00f3n INMETRO - BENE Mod 110\n<\/h3><p class=\"bde-f-text-31-132 bde-f-text asmed-doc-text\">\nCertificaci\u00f3n QC-2701-23 del dispositivo BENE Mod 110 para el mercado brasile\u00f1o, solicitante ASMED Latino Am\u00e9rica.\n<\/p><a class=\"bde-f-text-link-31-133 bde-f-text-link asmed-doc-link\" href=\"https:\/\/asmed.net\/wp-content\/uploads\/2026\/08\/cert-inmetro-bene.pdf\" target=\"_blank\" rel=\"noopener\">\nDescargar el PDF \u2192\n<\/a><\/div><div class=\"bde-f-container-31-155 bde-f-container asmed-doc-card\"><div class=\"bde-f-svg-icon2-31-156 bde-f-svg-icon2 asmed-icon-30\">\n<svg viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.5\" aria-hidden=\"true\"><path d=\"M6 3h9l4 4v14H6V3z\"><\/path><path d=\"M15 3v4h4M9 12h6M9 16h6\"><\/path><\/svg>\n<\/div><h3 class=\"bde-f-text-31-157 bde-f-text asmed-doc-title\">\nDeclaraci\u00f3n CE de conformidad\n<\/h3><p class=\"bde-f-text-31-158 bde-f-text asmed-doc-text\">\nDeclaraci\u00f3n del fabricante, certificado CE ECM19MDD009 y confirmaci\u00f3n del organismo notificado para el producto BENE Mod 110: prorrogado hasta el 31 de diciembre de 2028.\n<\/p><a class=\"bde-f-text-link-31-159 bde-f-text-link asmed-doc-link\" href=\"https:\/\/asmed.net\/wp-content\/uploads\/2026\/09\/cert-ce-ecm19mdd009-esteso-2028.pdf\" target=\"_blank\" rel=\"noopener\">\nDescargar el PDF \u2192\n<\/a><\/div><\/div><p class=\"bde-f-text-31-141 bde-f-text asmed-note-inline\">\nLos documentos se publican en la versi\u00f3n m\u00e1s reciente disponible. Para verificaciones o solicitudes de documentaci\u00f3n adicional, <a class=\"asmed-inline-link\" href=\"https:\/\/asmed.net\/es\/contatti\/\">ponerse en contacto con ASMED\u00ae<\/a>.\n<\/p><div class=\"bde-f-container-31-144 bde-f-container asmed-note asmed-note-reg\"><h2 class=\"bde-f-text-31-142 bde-f-text asmed-note-title\">\nCumplimiento normativo\n<\/h2><p class=\"bde-f-text-31-143 bde-f-text asmed-note-body-lg\">\nLos dispositivos ASMED\u00ae se comercializan de acuerdo con el marco regulatorio europeo para dispositivos m\u00e9dicos. La informaci\u00f3n de este sitio est\u00e1 destinada a operadores profesionales (Decreto Legislativo 46\/1997, art. 21) y no sustituye a la documentaci\u00f3n t\u00e9cnica: Las indicaciones, contraindicaciones y advertencias son las que figuran en las instrucciones de uso de cada producto.\n<\/p><\/div><\/div><\/section><section class=\"bde-f-container-31-152 bde-f-container asmed-cta-strip\"><div class=\"bde-f-container-31-151 bde-f-container asmed-container asmed-cta-row\"><div class=\"bde-f-container-31-149 bde-f-container asmed-cta-copy\"><h2 class=\"bde-f-text-31-147 bde-f-text asmed-cta-title\">\n\u00bfNecesitas documentaci\u00f3n adicional?\n<\/h2><p class=\"bde-f-text-31-148 bde-f-text asmed-cta-text\">\nSolicite documentos t\u00e9cnicos para su estructura o para su mercado.\n<\/p><\/div><a class=\"bde-f-text-link-31-150 bde-f-text-link asmed-btn asmed-btn-primary asmed-btn-hero\" href=\"https:\/\/asmed.net\/es\/contatti\/\" target=\"_self\">\nP\u00f3ngase en contacto con nosotros\n<\/a><\/div><\/section><\/main>","protected":false},"excerpt":{"rendered":"<p>Qualit\u00e0 e Conformit\u00e0 Qualit\u00e0 certificata, documenti consultabili. Il sistema di gestione della qualit\u00e0 di ASMED\u00ae \u00e8 certificato ISO 13485:2016. I documenti pubblici di certificazione e registrazione dei dispositivi sono consultabili in questa pagina. Il sistema qualit\u00e0 ASMED\u00ae progetta, produce e assiste dispositivi medici con un sistema di gestione della qualit\u00e0 certificato secondo la norma internazionale [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_breakdance_hide_in_design_set":false,"_breakdance_tags":"","footnotes":""},"class_list":["post-31","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/asmed.net\/es\/wp-json\/wp\/v2\/pages\/31","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/asmed.net\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/asmed.net\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/asmed.net\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/asmed.net\/es\/wp-json\/wp\/v2\/comments?post=31"}],"version-history":[{"count":12,"href":"https:\/\/asmed.net\/es\/wp-json\/wp\/v2\/pages\/31\/revisions"}],"predecessor-version":[{"id":417,"href":"https:\/\/asmed.net\/es\/wp-json\/wp\/v2\/pages\/31\/revisions\/417"}],"wp:attachment":[{"href":"https:\/\/asmed.net\/es\/wp-json\/wp\/v2\/media?parent=31"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}