{"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\/pt\/qualita-e-conformita\/","title":{"rendered":"Qualidade e conformidade"},"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\">\nQualidade e conformidade\n<\/p><h1 class=\"bde-f-text-31-101 bde-f-text asmed-page-h1\">\nQualidade certificada, documentos consult\u00e1veis.\n<\/h1><p class=\"bde-f-text-31-102 bde-f-text asmed-page-lead\">\nO sistema de gest\u00e3o da qualidade ASMED\u00ae \u00e9 certificado pela ISO 13485:2016. Os documentos de certifica\u00e7\u00e3o e registo de dispositivos p\u00fablicos podem ser encontrados nesta 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\">\nO sistema de qualidade\n<\/h2><p class=\"bde-f-text-31-106 bde-f-text asmed-t-body asmed-c-body\">\nA ASMED\u00ae concebe, fabrica e presta assist\u00eancia a dispositivos m\u00e9dicos com um sistema de gest\u00e3o da qualidade certificado de acordo com a norma internacional ISO 13485:2016, refer\u00eancia 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\">\nA conformidade abrange todo o ciclo de vida do dispositivo: conce\u00e7\u00e3o, produ\u00e7\u00e3o, rastreabilidade, fiscaliza\u00e7\u00e3o p\u00f3s-comercializa\u00e7\u00e3o e assist\u00eancia 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        Conce\u00e7\u00e3o e produ\u00e7\u00e3o em conformidade com as normas internacionais\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        Rastreabilidade em todas as fases do ciclo de vida do 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        Documenta\u00e7\u00e3o cl\u00ednica e t\u00e9cnica completa e atualizada\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        Vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o e assist\u00eancia cont\u00ednua\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=\"Certifica\u00e7\u00e3o IMQ \u2014 Sistema de gest\u00e3o da qualidade certificado ISO 13485:2016\" loading=\"lazy\"><\/div><p class=\"bde-f-text-31-113 bde-f-text asmed-dark-text\">\nCertifica\u00e7\u00e3o emitida por um organismo independente. O certificado pode ser descarregado abaixo.\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\">\nCertifica\u00e7\u00f5es e registos\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 gest\u00e3o da qualidade do certificado ASMED S.r.l. 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\">\nBaixe o 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\">\nRegisto ANVISA \u2013 BENE Mod 110\n<\/h3><p class=\"bde-f-text-31-127 bde-f-text asmed-doc-text\">\nRegisto do dispositivo BENE Mod 110 junto da ag\u00eancia reguladora brasileira, em nome da ASMED Latino Am\u00e9rica. Notifica\u00e7\u00e3o 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\">\nBaixe o 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\">\nCertifica\u00e7\u00e3o INMETRO - BENE Mod 110\n<\/h3><p class=\"bde-f-text-31-132 bde-f-text asmed-doc-text\">\nCertifica\u00e7\u00e3o QC-2701-23 do aparelho BENE Mod 110 para o mercado brasileiro, a pedido da 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\">\nBaixe o 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\">\nDeclara\u00e7\u00e3o CE de conformidade\n<\/h3><p class=\"bde-f-text-31-158 bde-f-text asmed-doc-text\">\nDeclara\u00e7\u00e3o do fabricante, certificado CE ECM19MDD009 e confirma\u00e7\u00e3o do organismo notificado para o dispositivo BENE Mod 110: prorrogada at\u00e9 31 de dezembro 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\">\nBaixe o PDF \u2192\n<\/a><\/div><\/div><p class=\"bde-f-text-31-141 bde-f-text asmed-note-inline\">\nOs documentos s\u00e3o publicados na vers\u00e3o mais recente dispon\u00edvel. Para verifica\u00e7\u00f5es ou pedidos de documenta\u00e7\u00e3o adicional, <a class=\"asmed-inline-link\" href=\"https:\/\/asmed.net\/pt\/contatti\/\">Contacte a 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\">\nConformidade regulamentar\n<\/h2><p class=\"bde-f-text-31-143 bde-f-text asmed-note-body-lg\">\nOs dispositivos ASMED\u00ae s\u00e3o colocados no mercado de acordo com o quadro regulamentar europeu para dispositivos m\u00e9dicos. As informa\u00e7\u00f5es contidas neste site destinam-se aos operadores profissionais (Decreto Legislativo 46\/1997, art. 21) e n\u00e3o substituem a documenta\u00e7\u00e3o t\u00e9cnica: As indica\u00e7\u00f5es, contraindica\u00e7\u00f5es e advert\u00eancias s\u00e3o as indicadas nas instru\u00e7\u00f5es de utiliza\u00e7\u00e3o de cada dispositivo.\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\">\nPreciso de documenta\u00e7\u00e3o adicional?\n<\/h2><p class=\"bde-f-text-31-148 bde-f-text asmed-cta-text\">\nPe\u00e7a documentos t\u00e9cnicos para a sua estrutura ou para o seu 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\/pt\/contatti\/\" target=\"_self\">\nContacte-nos\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\/pt\/wp-json\/wp\/v2\/pages\/31","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/asmed.net\/pt\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/asmed.net\/pt\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/asmed.net\/pt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/asmed.net\/pt\/wp-json\/wp\/v2\/comments?post=31"}],"version-history":[{"count":12,"href":"https:\/\/asmed.net\/pt\/wp-json\/wp\/v2\/pages\/31\/revisions"}],"predecessor-version":[{"id":417,"href":"https:\/\/asmed.net\/pt\/wp-json\/wp\/v2\/pages\/31\/revisions\/417"}],"wp:attachment":[{"href":"https:\/\/asmed.net\/pt\/wp-json\/wp\/v2\/media?parent=31"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}