{"id":182,"date":"2025-07-25T16:43:59","date_gmt":"2025-07-25T14:43:59","guid":{"rendered":"https:\/\/www.gruppoflaem.it\/en\/?page_id=182"},"modified":"2026-06-29T11:56:05","modified_gmt":"2026-06-29T09:56:05","slug":"quality-certifications","status":"publish","type":"page","link":"https:\/\/www.gruppoflaem.it\/en\/quality-certifications\/","title":{"rendered":"Quality &#038; Certifications"},"content":{"rendered":"\n<div id=\"hero-cms\" class=\"row hero-cms pt-150 h-100vh bg-blu video-bg\" \n>\n        <video autoplay muted playsinline loop id=\"bgVideo\" class=\"bg-video\">\n      <source src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/sites\/2\/02-Video-per-Conferenza-5bit.mp4\" type=\"video\/mp4\">\n    <\/video>\n    \n    <div class=\"col-12 header-content align-self-end align-self-md-auto\">\n        <div class=\"row justify-content-start align-items-center align-cotnent-center\">\n                      <div class=\"col-5 d-none d-lg-block\">\n              \n            <\/div>\n                    <div class=\"col-1 d-none d-lg-block\"><\/div>\n          <div class=\"col-12 col-lg-6 px-80 py-3 py-md-5\">\n              <div class=\"breadcrumbs-container color-white f-14\" data-aos=\"fade-in\" data-aos-delay=\"200\">\n                  \n              <\/div>\n              <h1 class=\"f-79 fw-600 mb-0 color-white\" data-aos=\"fade-in\" data-aos-delay=\"200\">\n                <span>Quality &#038; Certifications<\/span>\n              <\/h1>\n          <\/div>\n        <\/div>\n                <div class=\"row pt-50 pb-3 overflow-hidden\" data-aos=\"fade-in\" data-aos-delay=\"200\">\n           \n            <div class=\"col\">\n                <!-- Blocco blu -->\n            <\/div>\n            <div class=\"col-6 d-none d-lg-block  pt-150 pb-150\" data-aos=\"fade-left\">\n                <!-- Blocco blu -->\n            <\/div>\n                    \n        <\/div>\n            <\/div>\n\n<\/div>\n\n\n<div id=\"fascia-descrizione\" class=\"row fascia-descrizione-colorata pt-150 pb-150 overflow-hidden bg-white  color-grey \">\n        \n    <div class=\"col-3 d-none d-lg-block\">\n\n    <\/div>\n    <div class=\"col-12 col-md px-180\">\n                <h2 class=\"f-45 fw-600 mb-3 mb-md-5  color-grey \" data-aos=\"fade-in\" data-aos-delay=\"200\">\n            Maximum safety is guaranteed only by the highest quality: <span>Gruppo Flaem&#8217;s standards and certifications. <\/span>\n        <\/h2>\n                <div class=\"row\">\n                        <div class=\"col-12 col-md pe-lg-4 pe-xxl-5\" data-aos=\"fade-in\" data-aos-delay=\"400\">\n                <div class=\"mb-2\">\n                    <p>Quality and reliability are the cornerstones of every production process at Gruppo Flaem. Our products are safe by design, thoroughly tested, and certified in compliance with the most rigorous international standards.<\/p>\n<p>We work constantly with<strong> independent certification bodies such as IMQ, T\u00dcV Rheinland, and Intertek<\/strong> to ensure <strong>regulatory compliance<\/strong> and to keep all <strong>necessary certification<\/strong>s up to date.<\/p>\n<p>Every electromedical device and vacuum system undergoes rigorous testing to ensure high performance and operational safety. A guarantee of protection for everyone who uses our products.<\/p>\n\n                <\/div>\n            <\/div>\n                                                                <div class=\"col-12 download-repeater mt-5\">\n                                            <div class=\"download-item mb-3\" data-aos=\"fade-in\" data-aos-delay=\"400\">\n                            <a href=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/ISO-9001-2015.pdf\" title=\"Download ISO-9001-2015\" alt=\"Download \" target=\"_blank\">\n                                <span class=\"color-blu d-block fw-700\">\n                                    ISO 9001 (certified by IMQ)\n                                <\/span>\n                                <span class=\"color-grey d-block\">\n                                    Certified Quality Management System for rigorous processes and excellent products that ensure an optimal customer experience.\n                                <\/span>\n                            <\/a>\n                        <\/div>\n                                            <div class=\"download-item mb-3\" data-aos=\"fade-in\" data-aos-delay=\"400\">\n                            <a href=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/ISO-13485-2016.pdf\" title=\"Download ISO-13485-2016\" alt=\"Download \" target=\"_blank\">\n                                <span class=\"color-blu d-block fw-700\">\n                                    ISO 13485 (certified by IMQ)\n                                <\/span>\n                                <span class=\"color-grey d-block\">\n                                    Specific standard for medical devices ensuring the safety, reliability, and regulatory compliance of our electromedical equipment.\n                                <\/span>\n                            <\/a>\n                        <\/div>\n                                    <\/div>\n            \n                        <div class=\"col-12 mt-5\" data-aos-delay=\"400\" data-aos=\"fade-in\">\n                <div class=\"row justify-content-start align-items-center align-content-center\">\n                    <div class=\"col-12 col-md-8\">\n                        <div class=\"color-blu fw-600 mb-2 mb-md-3\">\n                            MDR (Medical Device Regulation)\u00a0\n                        <\/div>\n                        <div class=\"color-grey\">\n                            <p>Full compliance with the new EU Medical Device Regulation (MDR), ensuring certified safety and efficacy in accordance with the latest standards.<\/p>\n\n                        <\/div>\n                        \n                    <\/div>\n                    <div class=\"col-12 col-md-4 text-md-end\">\n                                                    <img decoding=\"async\" class=\"mw-100\" src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/medical-regulation.webp\" alt=\"\" title=\"medical-regulation\" \/>\n                                            <\/div>\n                    \n                <\/div>\n                \n            <\/div>\n            \n            \n        <\/div>\n    <\/div>\n\n        \n<\/div>\n\n\n<div id=\"description-not-full\" class=\"row pt-50 pb-100 px-180\">\n    <div class=\"col-1 d-none d-lg-block\"><\/div>\n    <div class=\"col\">\n        <h2 class=\"color-grey f-79 fw-600 mb-0 pb-4 pb-md-5\" data-aos=\"fade-in\" data-aos-delay=\"200\">\n            Gruppo Flaem: <span>patented quality.<\/span>\n        <\/h2>\n        <div class=\"color-grey\" data-aos=\"fade-in\" data-aos-delay=\"300\">\n            <p>The Group&#8217;s vast patent portfolio represents one of the cornerstones of our industrial identity. With over 75 international registrations filed over our 60-year history, we have built a legacy of innovation that testifies to our unwavering commitment to research and technological development.<\/p>\n<p>Each patent is not just a formal achievement, but a fundamental building block of our journey: a step forward toward increasingly precise and reliable medical devices, and toward more efficient food preservation solutions.<\/p>\n<p>This wealth of knowledge and technological protection is the foundation upon which we continue to design the future, ensuring quality, safety, and performance in every product bearing the Gruppo Flaem name.<\/p>\n\n        <\/div>\n    <\/div>\n    <div class=\"col-4 d-none d-lg-block\"><\/div>\n<\/div>\n\n\n<div id=\"certificazioni\" class=\"row px-80 pt-50 pb-50 justify-content-start align-items-center align-content-center\">\n  <div class=\"col-12 col-md-6 mb-4 mb-md-0 order-2 order-md-1\" data-aos=\"fade-in\" data-aos-delay=\"200\">\n    <img decoding=\"async\" class=\"mw-100\" src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/marcatura-ce-macchine-elettromedicali.webp\" alt=\"\" title=\"marcatura-ce-macchine-elettromedicali\" \/>\n  <\/div>\n  <div class=\"col-12 col-md-6 px-lg-5 order-1 order-md-2 mb-3 mb-md-0\">\n      <h2 class=\"mb-4 mb-md-5 color-grey f-45 fw-600\" data-aos=\"fade-in\" data-aos-delay=\"400\">\n        European and international <br> <span> markings<\/span>\n      <\/h2>\n      <div class=\"certificazioni-loop pt-lg-5\">\n                      <div class=\"mb-4 mb-md-4 mb-lg-5 certificazione-item\" data-aos=\"fade-in\" data-aos-delay=\"600\">\n              <div class=\"item-logo\">\n                  <img decoding=\"async\" class=\"\" src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/ce_logo.png\" alt=\"\" title=\"ce_logo\" \/>\n              <\/div>\n              <div class=\"mt-2 color-grey fw-400\">\n                  <p>Mandatory marking for sale in Europe, certifying compliance with EU safety directives.<\/p>\n\n              <\/div>\n            <\/div>\n                      <div class=\"mb-4 mb-md-4 mb-lg-5 certificazione-item\" data-aos=\"fade-in\" data-aos-delay=\"600\">\n              <div class=\"item-logo\">\n                  <img decoding=\"async\" class=\"\" src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/fda_logo.png\" alt=\"\" title=\"fda_logo\" \/>\n              <\/div>\n              <div class=\"mt-2 color-grey fw-400\">\n                  <p>Registration with the US regulatory agency, authorizing commercialization in the United States.<\/p>\n\n              <\/div>\n            <\/div>\n                <\/div>  \n  <\/div>\n<\/div>\n\n\n<div id=\"download-dichiarazione\" class=\"download-dichiarazione row px-180 pt-100 pb-100 justify-content-between align-items-end align-content-end\">\n    <div class=\"col-12\">\n        <h2 class=\"f-79 color-grey fw-600 mb-3 mb-md-5\" data-aos=\"fade-in\" data-aos-delay=\"100\">\n            Reach  <br\/><span>Declaration<\/span>\n        <\/h2>\n    <\/div>\n    <div class=\"col-12 col col-lg-7 pt-lg-3\">\n        <div class=\"row justify-content-start align-items-center align-content-center\">\n            <div class=\"col-12 col-md-auto col-lg-3 mb-2 mb-md-0\" data-aos=\"fade-in\" data-aos-delay=\"200\">\n                <img decoding=\"async\" class=\"logo-reach mw-100\" src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/logo-reach.png\" alt=\"\" title=\"logo-reach\" \/>\n            <\/div>\n            <div class=\"col\" data-aos=\"fade-in\" data-aos-delay=\"400\">\n                <div class=\"texto-reach color-grey\">\n                    <p>Gruppo Flaem complies with the <strong>European REACH Regulation<\/strong> for the registration, evaluation, and authorization of chemicals. Our products do not contain Substances of Very High Concern (SVHC) in concentrations exceeding the 0.1% limit. We continuously monitor updates to the European Chemicals Agency Candidate List to ensure full regulatory compliance and environmental protection.<\/p>\n\n                <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n    <div class=\"col-1 d-none d-lg-block\">\n        <!-- empty -->\n    <\/div>\n    <div class=\"col-12 col-lg-auto\">\n        <div class=\"download-item mb-0 mb-md-0 mt-4 mt-lg-0\" data-aos=\"fade-in\" data-aos-delay=\"600\">\n            <a class=\"w-100 w-md-auto mb-0 d-inline-block\" href=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/sites\/2\/reach25en.pdf\" title=\"Download reach25en\" alt=\"Download \" target=\"_blank\">\n                \n            <\/a> \n        <\/div>\n    <\/div>\n<\/div>\n\n\n<div id=\"download-dichiarazione\" class=\"download-dichiarazione row px-180 pt-100 pb-100 justify-content-between align-items-end align-content-end\">\n    <div class=\"col-12\">\n        <h2 class=\"f-79 color-grey fw-600 mb-3 mb-md-5\" data-aos=\"fade-in\" data-aos-delay=\"100\">\n            <span>PPWR<\/span><br\/>Compliance\n        <\/h2>\n    <\/div>\n    <div class=\"col-12 col col-lg-7 pt-lg-3\">\n        <div class=\"row justify-content-start align-items-center align-content-center\">\n            <div class=\"col-12 col-md-auto col-lg-3 mb-2 mb-md-0\" data-aos=\"fade-in\" data-aos-delay=\"200\">\n                <img decoding=\"async\" class=\"logo-reach mw-100\" src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/sites\/2\/riciclo.png\" alt=\"\" title=\"riciclo\" \/>\n            <\/div>\n            <div class=\"col\" data-aos=\"fade-in\" data-aos-delay=\"400\">\n                <div class=\"texto-reach color-grey\">\n                    <p>Flaem Group complies with the new European PPWR Regulation (EU No. 40\/2025) on packaging and packaging waste. We design our packaging applying a strict minimization approach, reducing dimensions while fully respecting environmental sustainability. We are committed to collaborating with our suppliers and providing consumers with all the necessary information for the correct disposal of materials.<\/p>\n\n                <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n    <div class=\"col-1 d-none d-lg-block\">\n        <!-- empty -->\n    <\/div>\n    <div class=\"col-12 col-lg-auto\">\n        <div class=\"download-item mb-0 mb-md-0 mt-4 mt-lg-0\" data-aos=\"fade-in\" data-aos-delay=\"600\">\n            <a class=\"w-100 w-md-auto mb-0 d-inline-block\" href=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/sites\/2\/PPWR-Conformita-alle-normative-ambientali-rev01.pdf\" title=\"Download PPWR-Conformit\u00e0-alle-normative-ambientali-rev01\" alt=\"Download \" target=\"_blank\">\n                \n            <\/a> \n        <\/div>\n    <\/div>\n<\/div>\n\n\n<div id=\"gallery-img-video-container\" class=\"row\">\n    <div class=\"col-12 px-0\">\n        <div id=\"gallery-img-video\" class=\"splide\" role=\"group\" aria-label=\"Gallery\">\n            <div class=\"splide__track\">\n                <ul class=\"splide__list\">\n                                                                            <li class=\"splide__slide slide-1 position-relative text-center\">\n                                                                    <img decoding=\"async\" class=\"w-100 mw-100 d-none d-md-block\" src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/sites\/2\/da-rinominare.webp\" alt=\"\" title=\"da rinominare\" \/>\n                                    <img decoding=\"async\" class=\"w-100 mw-100 d-block d-md-none\" src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/sites\/2\/da-rinominare-mobile.webp\" alt=\"\" title=\"da rinominare-mobile\" \/>\n                                                            <\/li>\n                                                                                                        <li class=\"splide__slide slide-2 position-relative text-center\">\n                                                                    <img decoding=\"async\" class=\"w-100 mw-100 d-none d-md-block\" src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/componente-meccanico-macchina-elettromedicale-flaem-nuova.webp\" alt=\"\" title=\"componente-meccanico-macchina-elettromedicale-flaem-nuova\" \/>\n                                    <img decoding=\"async\" class=\"w-100 mw-100 d-block d-md-none\" src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/componente-meccanico-macchina-elettromedicale-flaem-nuova-1.webp\" alt=\"\" title=\"componente-meccanico-macchina-elettromedicale-flaem-nuova-1\" \/>\n                                                            <\/li>\n                                                                                                        <li class=\"splide__slide slide-3 position-relative text-center\">\n                                                                    <img decoding=\"async\" class=\"w-100 mw-100 d-none d-md-block\" src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/mascherine-aerosol-flaem.webp\" alt=\"\" title=\"mascherine-aerosol-flaem\" \/>\n                                    <img decoding=\"async\" class=\"w-100 mw-100 d-block d-md-none\" src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/mascherine-aerosol-flaem-1.webp\" alt=\"\" title=\"mascherine-aerosol-flaem-1\" \/>\n                                                            <\/li>\n                                                                                                        <li class=\"splide__slide slide-4 position-relative text-center\">\n                                                                    <img decoding=\"async\" class=\"w-100 mw-100 d-none d-md-block\" src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/sites\/2\/componenti-respirazione-articoli-elettromedicali-2.webp\" alt=\"\" title=\"componenti-respirazione-articoli-elettromedicali\" \/>\n  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src=\"https:\/\/www.gruppoflaem.it\/\/wp-content\/uploads\/componenti-respirazione-articoli-elettromedicali-1.webp\" alt=\"\" title=\"componenti-respirazione-articoli-elettromedicali-1\" \/>\n                                                            <\/li>\n                                                                <\/ul>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n\n\n<div id=\"cta\" class=\"row cta pt-150 pb-150 px-180\">\n    <div class=\"col-5 d-none d-lg-block\"><\/div>\n    <div class=\"col\">\n        <a class=\"cta-link\" href=\"https:\/\/www.gruppoflaem.it\/en\/contact\/\" target=\"\" title=\"Contact\">\n            <h2 class=\"f-79 color-blu fw-600\" data-aos=\"fade-in\" data-aos-duration=\"200\">\n                Want to learn more<br\/>about our solutions?\n            <\/h2>\n            <span class=\"icon-arrow\" data-aos=\"fade-in\" data-aos-duration=\"300\"><\/span><span class=\"color-grey f-79 fw-600 contact-txt-bottom\" data-aos=\"fade-in\" data-aos-duration=\"400\">Contact us<\/span>\n        <\/a>\n    <\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":5,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-182","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Quality &amp; Certifications - Gruppo Flaem EN<\/title>\n<meta name=\"description\" content=\"Flaem Quality and Certifications: ISO standards, MDR, CE and FDA markings for safe electromedical devices compliant with international regulations.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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