{"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\/en\/qualita-e-conformita\/","title":{"rendered":"Quality and Compliance"},"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\">\nQuality and Compliance\n<\/p><h1 class=\"bde-f-text-31-101 bde-f-text asmed-page-h1\">\nCertified quality, consultable documents.\n<\/h1><p class=\"bde-f-text-31-102 bde-f-text asmed-page-lead\">\nASMED\u00ae quality management system is ISO 13485:2016 certified. Public device certification and registration documents can be found on this 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\">\nThe quality system\n<\/h2><p class=\"bde-f-text-31-106 bde-f-text asmed-t-body asmed-c-body\">\nASMED\u00ae designs, manufactures and services medical devices with a quality management system certified according to the international standard ISO 13485:2016, specific reference for medical device manufacturers.\n<\/p><p class=\"bde-f-text-31-107 bde-f-text asmed-t-body asmed-c-body\">\nCompliance covers the entire life cycle of the device: design, production, traceability, post-market surveillance and technical assistance.\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        Design and production in compliance with international standards\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        Traceability at every stage of the device life cycle\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        Comprehensive and up-to-date clinical and technical documentation\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        Post-market surveillance and ongoing assistance\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 ISO 13485:2016 certified quality management system\" loading=\"lazy\"><\/div><p class=\"bde-f-text-31-113 bde-f-text asmed-dark-text\">\nCertification issued by an independent body. The certificate can be downloaded below.\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\">\nPublic documents\n<\/p><h2 class=\"bde-f-text-31-118 bde-f-text asmed-t-h2 asmed-c-heading\">\nCertifications and registrations\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\">\nIMQ certificate \u2014 ISO 13485:2016\n<\/h3><p class=\"bde-f-text-31-122 bde-f-text asmed-doc-text\">\nQuality management system of ASMED S.r.l. IMQ certificate no. 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\">\nDownload the 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\">\nANVISA register \u2013 BENE Mod 110\n<\/h3><p class=\"bde-f-text-31-127 bde-f-text asmed-doc-text\">\nRegistration of the device BENE Mod 110 with the Brazilian regulatory agency, in the name of ASMED 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\">\nDownload the 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\">\nINMETRO Certification - BENE Mod 110\n<\/h3><p class=\"bde-f-text-31-132 bde-f-text asmed-doc-text\">\nCertification QC-2701-23 of the device BENE Mod 110 for the Brazilian market, applicant: 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\">\nDownload the 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\">\nEC declaration of conformity\n<\/h3><p class=\"bde-f-text-31-158 bde-f-text asmed-doc-text\">\nManufacturer\u2019s declaration, EC certificate ECM19MDD009 and Notified Body confirmation for the device BENE Mod 110: extended to 31 December 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\">\nDownload the PDF \u2192\n<\/a><\/div><\/div><p class=\"bde-f-text-31-141 bde-f-text asmed-note-inline\">\nDocuments are published in the most recent version available. For verifications or requests for additional documentation, <a class=\"asmed-inline-link\" href=\"https:\/\/asmed.net\/en\/contatti\/\">contact 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\">\nRegulatory compliance\n<\/h2><p class=\"bde-f-text-31-143 bde-f-text asmed-note-body-lg\">\nASMED\u00ae devices are placed on the market in accordance with the European regulatory framework for medical devices. The information on this site is intended for professional operators (Legislative Decree 46\/1997, art. 21) and does not replace the technical documentation: indications, contraindications and warnings are those given in the instructions for use of each device.\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\">\nNeed additional documentation?\n<\/h2><p class=\"bde-f-text-31-148 bde-f-text asmed-cta-text\">\nAsk for technical documents for your structure or for your market.\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\/en\/contatti\/\" target=\"_self\">\nContact us\n<\/a><\/div><\/section><\/main>","protected":false},"excerpt":{"rendered":"<p>Quality and Conformity Certified quality, documents that can be consulted. ASMED\u00ae quality management system is ISO 13485:2016 certified. Public device certification and registration documents can be found on this page. ASMED\u00ae quality system designs, manufactures and assists medical devices with a quality management system certified according to the international standard [\u2026]<\/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\/en\/wp-json\/wp\/v2\/pages\/31","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/asmed.net\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/asmed.net\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/asmed.net\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/asmed.net\/en\/wp-json\/wp\/v2\/comments?post=31"}],"version-history":[{"count":12,"href":"https:\/\/asmed.net\/en\/wp-json\/wp\/v2\/pages\/31\/revisions"}],"predecessor-version":[{"id":417,"href":"https:\/\/asmed.net\/en\/wp-json\/wp\/v2\/pages\/31\/revisions\/417"}],"wp:attachment":[{"href":"https:\/\/asmed.net\/en\/wp-json\/wp\/v2\/media?parent=31"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}