{"id":31,"date":"2026-08-31T13:02:52","date_gmt":"2026-08-31T11:02:52","guid":{"rendered":"https:\/\/asmed.net\/qualita-e-conformita\/"},"modified":"2026-10-14T16:07:51","modified_gmt":"2026-10-14T14:07:51","slug":"qualita-e-conformita","status":"publish","type":"page","link":"https:\/\/asmed.net\/fr\/qualita-e-conformita\/","title":{"rendered":"Qualit\u00e9 et conformit\u00e9"},"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\">\nQualit\u00e9 et conformit\u00e9\n<\/p><h1 class=\"bde-f-text-31-101 bde-f-text asmed-page-h1\">\nQualit\u00e9 certifi\u00e9e, documents consultables.\n<\/h1><p class=\"bde-f-text-31-102 bde-f-text asmed-page-lead\">\nLe syst\u00e8me de management de la qualit\u00e9 d\u2019ASMED\u00ae est certifi\u00e9 ISO 13485:2016. Les documents publics de certification et d\u2019enregistrement des dispositifs sont consultables sur cette page.\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\">\nLe syst\u00e8me qualit\u00e9\n<\/h2><p class=\"bde-f-text-31-106 bde-f-text asmed-t-body asmed-c-body\">\nASMED\u00ae con\u00e7oit, fabrique et assure l\u2019assistance de dispositifs m\u00e9dicaux selon un syst\u00e8me de management de la qualit\u00e9 certifi\u00e9 conforme \u00e0 la norme internationale ISO 13485:2016, r\u00e9f\u00e9rence sp\u00e9cifique pour les fabricants de dispositifs m\u00e9dicaux.\n<\/p><p class=\"bde-f-text-31-107 bde-f-text asmed-t-body asmed-c-body\">\nLa conformit\u00e9 couvre l\u2019ensemble du cycle de vie du dispositif\u00a0: conception, production, tra\u00e7abilit\u00e9, surveillance apr\u00e8s commercialisation et assistance technique.\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        Conception et production conformes aux normes internationales\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        Tra\u00e7abilit\u00e9 \u00e0 chaque \u00e9tape du cycle de vie du dispositif\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        Documentation technique et clinique compl\u00e8te et \u00e0 jour\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        Surveillance apr\u00e8s commercialisation et assistance continue\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=\"IMQ Certified \u2014 syst\u00e8me de management de la qualit\u00e9 certifi\u00e9 ISO 13485:2016\" loading=\"lazy\"><\/div><p class=\"bde-f-text-31-113 bde-f-text asmed-dark-text\">\nCertification d\u00e9livr\u00e9e par un organisme ind\u00e9pendant. Le certificat peut \u00eatre t\u00e9l\u00e9charg\u00e9 ci-dessous.\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\">\nDocuments publics\n<\/p><h2 class=\"bde-f-text-31-118 bde-f-text asmed-t-h2 asmed-c-heading\">\nCertifications et enregistrements\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\">\nCertificat IMQ \u2014 ISO 13485:2016\n<\/h3><p class=\"bde-f-text-31-122 bde-f-text asmed-doc-text\">\nSyst\u00e8me de management de la qualit\u00e9 d\u2019ASMED S.r.l. Certificat IMQ n\u00b0 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\">\nT\u00e9l\u00e9charger le 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\">\nEnregistrement ANVISA \u2014 BENE Mod 110\n<\/h3><p class=\"bde-f-text-31-127 bde-f-text asmed-doc-text\">\nEnregistrement du dispositif BENE Mod 110 aupr\u00e8s de l\u2019agence r\u00e9glementaire br\u00e9silienne, au nom d\u2019ASMED Latino Am\u00e9rica. Notification 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\">\nT\u00e9l\u00e9charger le 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\">\nCertification INMETRO \u2014 BENE Mod 110\n<\/h3><p class=\"bde-f-text-31-132 bde-f-text asmed-doc-text\">\nCertification QC-2701-23 du dispositif BENE Mod 110 pour le march\u00e9 br\u00e9silien, demandeur 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\">\nT\u00e9l\u00e9charger le 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\">\nD\u00e9claration de conformit\u00e9 CE\n<\/h3><p class=\"bde-f-text-31-158 bde-f-text asmed-doc-text\">\nD\u00e9claration du fabricant, certificat CE ECM19MDD009 et confirmation de l\u2019organisme notifi\u00e9 pour le dispositif BENE Mod 110\u00a0: validit\u00e9 prolong\u00e9e jusqu\u2019au 31 d\u00e9cembre 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\">\nT\u00e9l\u00e9charger le PDF \u2192\n<\/a><\/div><\/div><p class=\"bde-f-text-31-141 bde-f-text asmed-note-inline\">\nLes documents sont publi\u00e9s dans la version la plus r\u00e9cente disponible. Pour les v\u00e9rifications ou les demandes de documents suppl\u00e9mentaires, <a class=\"asmed-inline-link\" href=\"https:\/\/asmed.net\/fr\/contatti\/\">contactez 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\">\nConformit\u00e9 r\u00e9glementaire\n<\/h2><p class=\"bde-f-text-31-143 bde-f-text asmed-note-body-lg\">\nLes dispositifs ASMED\u00ae sont mis sur le march\u00e9 conform\u00e9ment au cadre r\u00e9glementaire europ\u00e9en des dispositifs m\u00e9dicaux. Les informations pr\u00e9sentes sur ce site sont destin\u00e9es aux professionnels de sant\u00e9 (r\u00e8glement (UE) 2017\/745 et D.Lgs. 137\/2022) et ne remplacent pas la documentation technique\u00a0: les indications, contre-indications et mises en garde sont celles figurant dans la notice d\u2019utilisation de chaque dispositif.\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\">\nBesoin de documentation suppl\u00e9mentaire\u00a0?\n<\/h2><p class=\"bde-f-text-31-148 bde-f-text asmed-cta-text\">\nDemandez les documents techniques pour votre structure ou pour votre march\u00e9.\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\/fr\/contatti\/\" target=\"_self\">\nContactez-nous\n<\/a><\/div><\/section><\/main>","protected":false},"excerpt":{"rendered":"<p>Qualit\u00e9 et conformit\u00e9 Qualit\u00e9 certifi\u00e9e, documents disponibles. Le syst\u00e8me de gestion de la qualit\u00e9 ASMED\u00ae est certifi\u00e9 ISO 13485:2016. Les documents publics de certification et d'enregistrement des appareils se trouvent sur cette page. Le syst\u00e8me de qualit\u00e9 ASMED\u00ae con\u00e7oit, fabrique et assiste les dispositifs m\u00e9dicaux avec un syst\u00e8me de gestion de la qualit\u00e9 certifi\u00e9 selon la norme internationale [...]<\/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\/fr\/wp-json\/wp\/v2\/pages\/31","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/asmed.net\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/asmed.net\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/asmed.net\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/asmed.net\/fr\/wp-json\/wp\/v2\/comments?post=31"}],"version-history":[{"count":13,"href":"https:\/\/asmed.net\/fr\/wp-json\/wp\/v2\/pages\/31\/revisions"}],"predecessor-version":[{"id":586,"href":"https:\/\/asmed.net\/fr\/wp-json\/wp\/v2\/pages\/31\/revisions\/586"}],"wp:attachment":[{"href":"https:\/\/asmed.net\/fr\/wp-json\/wp\/v2\/media?parent=31"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}