{"id":17802,"date":"2019-09-11T12:38:14","date_gmt":"2019-09-11T11:38:14","guid":{"rendered":"https:\/\/www.rhein83.com\/?page_id=17802"},"modified":"2026-06-03T09:35:29","modified_gmt":"2026-06-03T07:35:29","slug":"certifications","status":"publish","type":"page","link":"https:\/\/www.rhein83.com\/en\/certifications\/","title":{"rendered":"CERTIFICATIONS"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6e2d6-5b379227db17c5bcfe0878a27565f969\">\n.flex_column.av-6e2d6-5b379227db17c5bcfe0878a27565f969{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-6e2d6-5b379227db17c5bcfe0878a27565f969 av_one_third  avia-builder-el-0  el_before_av_one_third  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-jocalkqk-328fbfb8e4557d3b98681d6e3ba052dc '  ><div class='avia_textblock' ><p><img decoding=\"async\" class=\"alignnone wp-image-1530\" src=\"https:\/\/www.rhein83.com\/wp-content\/uploads\/2018\/09\/rhein83-logo-web-300x61.png\" alt=\"\" width=\"290\" height=\"59\" srcset=\"https:\/\/www.rhein83.com\/wp-content\/uploads\/2018\/09\/rhein83-logo-web-300x61.png 300w, https:\/\/www.rhein83.com\/wp-content\/uploads\/2018\/09\/rhein83-logo-web.png 423w\" sizes=\"(max-width: 290px) 100vw, 290px\" \/><\/p>\n<\/div><\/section><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1d8vi-1d681c4e2c00cdb8330bea1151f032fd\">\n.flex_column.av-1d8vi-1d681c4e2c00cdb8330bea1151f032fd{\nborder-radius:0px 0px 0px 0px;\npadding:20px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-1d8vi-1d681c4e2c00cdb8330bea1151f032fd av_one_third  avia-builder-el-2  el_after_av_one_third  el_before_av_hr  flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kfz8iarw-c575d2025ebc56938d21ac9056a03f4d\">\n#top .av-special-heading.av-kfz8iarw-c575d2025ebc56938d21ac9056a03f4d{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kfz8iarw-c575d2025ebc56938d21ac9056a03f4d .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kfz8iarw-c575d2025ebc56938d21ac9056a03f4d .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kfz8iarw-c575d2025ebc56938d21ac9056a03f4d av-special-heading-h1  avia-builder-el-3  avia-builder-el-no-sibling  av-linked-heading'><h1 class='av-special-heading-tag '  >CERTIFICATION<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-joo8ewa9-4585baec1252bef46a63a2f0ccb97789\">\n#top .hr.hr-invisible.av-joo8ewa9-4585baec1252bef46a63a2f0ccb97789{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-joo8ewa9-4585baec1252bef46a63a2f0ccb97789 hr-invisible  avia-builder-el-4  el_after_av_one_third  el_before_av_one_fifth '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-53avm-f62fe279bfd76d564129164978b3fc92\">\n.flex_column.av-53avm-f62fe279bfd76d564129164978b3fc92{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-53avm-f62fe279bfd76d564129164978b3fc92 av_one_fifth  avia-builder-el-5  el_after_av_hr  el_before_av_three_fifth  first flex_column_div av-zero-column-padding  '     ><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-53avm-20-52720799b219b55c23e55639fe2ba2bd\">\n.flex_column.av-53avm-20-52720799b219b55c23e55639fe2ba2bd{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-53avm-20-52720799b219b55c23e55639fe2ba2bd av_three_fifth  avia-builder-el-6  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k0f2kqgo-fe6d57fa2a3ec80fbc87f2acfb458718\">\n.avia-image-container.av-k0f2kqgo-fe6d57fa2a3ec80fbc87f2acfb458718 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-k0f2kqgo-fe6d57fa2a3ec80fbc87f2acfb458718 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-k0f2kqgo-fe6d57fa2a3ec80fbc87f2acfb458718 av-styling- av-img-linked avia-align-center  avia-builder-el-7  avia-builder-el-no-sibling '  ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><a href=\"https:\/\/www.rhein83.com\/wp-content\/uploads\/2019\/09\/ACCREDIA_ICIM_9001__13485_ALLINEATI-1030x260.png\" class='avia_image '  aria-label='ACCREDIA_ICIM_9001_&amp;_13485_ALLINEATI'><img class='avia_image ' src='https:\/\/www.rhein83.com\/wp-content\/uploads\/2019\/09\/ACCREDIA_ICIM_9001__13485_ALLINEATI.png' alt='' title='ACCREDIA_ICIM_9001_&amp;_13485_ALLINEATI'  height=\"401\" width=\"1586\"  \/><\/a><\/div><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-53avm-19-4d175e48dae3cef2a1d4271368e5d75d\">\n.flex_column.av-53avm-19-4d175e48dae3cef2a1d4271368e5d75d{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-53avm-19-4d175e48dae3cef2a1d4271368e5d75d av_one_fifth  avia-builder-el-8  el_after_av_three_fifth  el_before_av_one_full  flex_column_div av-zero-column-padding  '     ><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-53avm-18-5a2c2cd824adcc367e3fc78ea408d48c\">\n.flex_column.av-53avm-18-5a2c2cd824adcc367e3fc78ea408d48c{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px -20px 0px;\n}\n<\/style>\n<div  class='flex_column av-53avm-18-5a2c2cd824adcc367e3fc78ea408d48c av_one_full  avia-builder-el-9  el_after_av_one_fifth  el_before_av_section  avia-builder-el-last  first flex_column_div  column-top-margin'     ><section  class='av_textblock_section av-k0f2pidj-82b58ed4e97bf8539e21019f6d58150c '  ><div class='avia_textblock' ><h4>Rhein 83 began a process of &#8220;Quality System&#8221; in 1994, becoming ISO 9001 certified since 1996. In the same year the company obtained the first product accreditations from the FDA \/ USA and continued with certification: 1998-93 \/ 42 CEE &#8211; ISO 9001: 2015 &#8211; ISO 13485: 2016 &#8211; MDSAP<\/h4>\n<h4>The &#8220;regulatory&#8221; activity is always monitored and constantly updated, for the maintenance of the current certifications, their renewal and the adaptation to the new rules for medical devices.<\/h4>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-joo8ewa9-21-4422e1e0d613e57402fb282f4733d3ac\">\n#top .hr.hr-invisible.av-joo8ewa9-21-4422e1e0d613e57402fb282f4733d3ac{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-joo8ewa9-21-4422e1e0d613e57402fb282f4733d3ac hr-invisible  avia-builder-el-11  el_after_av_textblock  el_before_av_textblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-k0f2pidj-16-f9c56899e6b5a6aa14e29f15cd47facd '  ><div class='avia_textblock' ><h4><\/h4>\n<h4><span style=\"color: #2d7ac6;\"><strong>Below, the links to ISO and CE marking documents:<\/strong><\/span><\/h4>\n<\/div><\/section><\/p><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-k0f2wfm0-ee02b40e5de1447c58feca7df508a2fd\">\n.avia-section.av-k0f2wfm0-ee02b40e5de1447c58feca7df508a2fd{\nbackground-color:#2d7ac6;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-k0f2wfm0-ee02b40e5de1447c58feca7df508a2fd main_color avia-section-small avia-no-border-styling  avia-builder-el-13  el_after_av_one_full  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-17802'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-joo8ewa9-15-6b9f016f2f1aab3ebf68b88c1d54fd01\">\n#top .hr.hr-invisible.av-joo8ewa9-15-6b9f016f2f1aab3ebf68b88c1d54fd01{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-joo8ewa9-15-6b9f016f2f1aab3ebf68b88c1d54fd01 hr-invisible  avia-builder-el-14  el_before_av_one_fifth  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-53avm-17-978c22c0ce75e5ba82165b53db1f3c33\">\n.flex_column.av-53avm-17-978c22c0ce75e5ba82165b53db1f3c33{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-53avm-17-978c22c0ce75e5ba82165b53db1f3c33 av_one_fifth  avia-builder-el-15  el_after_av_hr  el_before_av_one_fifth  first flex_column_div av-zero-column-padding  '     ><p><div  class='avia-button-wrap av-k0f2tboy-99425f04b7306095931366cc3910f7ae-wrap avia-button-center  avia-builder-el-16  el_before_av_hr  avia-builder-el-first '><a href='https:\/\/www.rhein83.com\/wp-content\/uploads\/2019\/09\/CE-n.-0425-MED-003705-00.pdf'  class='avia-button av-k0f2tboy-99425f04b7306095931366cc3910f7ae av-link-btn avia-icon_select-yes-left-icon avia-size-medium avia-position-center avia-color-light'   aria-label=\"CE - MDD\"><span class='avia_button_icon avia_button_icon_left avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue84b' data-av_iconfont='entypo-fontello' ><\/span><span class='avia_iconbox_title' >CE - MDD<\/span><\/a><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lye2l7z1-929d59fa161d5cf58e2461c50a2d4a26\">\n#top .hr.hr-invisible.av-lye2l7z1-929d59fa161d5cf58e2461c50a2d4a26{\nheight:10px;\n}\n<\/style>\n<div  class='hr av-lye2l7z1-929d59fa161d5cf58e2461c50a2d4a26 hr-invisible  avia-builder-el-17  el_after_av_button  el_before_av_button '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='avia-button-wrap av-lye2ltuv-1679df575595bd34c25213897d81db35-wrap avia-button-center  avia-builder-el-18  el_after_av_hr  el_before_av_hr '><a href='https:\/\/www.rhein83.com\/wp-content\/uploads\/2024\/07\/2.-MDR-Confirmation-Letter_EN_firmato.pdf'  class='avia-button av-lye2ltuv-1679df575595bd34c25213897d81db35 av-link-btn avia-icon_select-yes-left-icon avia-size-medium avia-position-center avia-color-light'   aria-label=\"Confirmation letter\"><span class='avia_button_icon avia_button_icon_left avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue84b' data-av_iconfont='entypo-fontello' ><\/span><span class='avia_iconbox_title' >Confirmation letter<\/span><\/a><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3m75iru-b9600117338ef012cea080bed9e18ca5\">\n#top .hr.hr-invisible.av-3m75iru-b9600117338ef012cea080bed9e18ca5{\nheight:10px;\n}\n<\/style>\n<div  class='hr av-3m75iru-b9600117338ef012cea080bed9e18ca5 hr-invisible  avia-builder-el-19  el_after_av_button  el_before_av_button '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='avia-button-wrap av-lye2mcf9-33910c3bb113d5949f657f79898ced62-wrap avia-button-center  avia-builder-el-20  el_after_av_hr  avia-builder-el-last '><a href='https:\/\/www.rhein83.com\/wp-content\/uploads\/2024\/07\/230609-final_mdr_manufacturer-declaration_28-02-2024.pdf'  class='avia-button av-lye2mcf9-33910c3bb113d5949f657f79898ced62 av-link-btn avia-icon_select-yes-left-icon avia-size-medium avia-position-center avia-color-light'   aria-label=\"Manufacturer Declaration\"><span class='avia_button_icon avia_button_icon_left avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue84b' data-av_iconfont='entypo-fontello' ><\/span><span class='avia_iconbox_title' >Manufacturer Declaration<\/span><\/a><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-53avm-13-6ab6b7355ae0f26f450b115da7fc4c36\">\n.flex_column.av-53avm-13-6ab6b7355ae0f26f450b115da7fc4c36{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-53avm-13-6ab6b7355ae0f26f450b115da7fc4c36 av_one_fifth  avia-builder-el-21  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  '     ><div  class='avia-button-wrap av-k0f2tboy-12-6c1c098a57828de45ad002794200c706-wrap avia-button-center  avia-builder-el-22  avia-builder-el-no-sibling '><a href='https:\/\/www.rhein83.com\/wp-content\/uploads\/2026\/01\/0425-MDR-030107-02-RHEIN-83-S.R.L_.pdf'  class='avia-button av-k0f2tboy-12-6c1c098a57828de45ad002794200c706 av-link-btn avia-icon_select-yes-left-icon avia-size-large avia-position-center avia-color-light'   aria-label=\"CE - MDR\"><span class='avia_button_icon avia_button_icon_left avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue84b' data-av_iconfont='entypo-fontello' ><\/span><span class='avia_iconbox_title' >CE - MDR<\/span><\/a><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2xmd8oa-08bea7695733d4f4948086d3add3a2e1\">\n.flex_column.av-2xmd8oa-08bea7695733d4f4948086d3add3a2e1{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2xmd8oa-08bea7695733d4f4948086d3add3a2e1 av_one_fifth  avia-builder-el-23  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  '     ><div  class='avia-button-wrap av-2i11rje-eaaf38377066351b8100d1545f501b09-wrap avia-button-center  avia-builder-el-24  avia-builder-el-no-sibling '><a href='https:\/\/www.rhein83.com\/wp-content\/uploads\/2025\/01\/ICIM-9001-009520-04-RHEIN-83-S.R.L.pdf'  class='avia-button av-2i11rje-eaaf38377066351b8100d1545f501b09 av-link-btn avia-icon_select-yes-left-icon avia-size-large avia-position-center avia-color-light'   aria-label=\"ISO 9001:2015\"><span class='avia_button_icon avia_button_icon_left avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue84b' data-av_iconfont='entypo-fontello' ><\/span><span class='avia_iconbox_title' >ISO 9001:2015<\/span><\/a><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-53avm-11-1dd6901f64c32026cefee0e816f6c004\">\n.flex_column.av-53avm-11-1dd6901f64c32026cefee0e816f6c004{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-53avm-11-1dd6901f64c32026cefee0e816f6c004 av_one_fifth  avia-builder-el-25  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  '     ><div  class='avia-button-wrap av-k0f2tboy-10-3e303fb5f3576b823c5d5bb00879334b-wrap avia-button-center  avia-builder-el-26  avia-builder-el-no-sibling '><a href='https:\/\/www.rhein83.com\/wp-content\/uploads\/2024\/09\/ICIM-13485-009521-03-RHEIN-83-S.R.L.-.pdf'  class='avia-button av-k0f2tboy-10-3e303fb5f3576b823c5d5bb00879334b av-link-btn avia-icon_select-yes-left-icon avia-size-large avia-position-center avia-color-light'   aria-label=\"ISO 13485:2016\"><span class='avia_button_icon avia_button_icon_left avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue84b' data-av_iconfont='entypo-fontello' ><\/span><span class='avia_iconbox_title' >ISO 13485:2016<\/span><\/a><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-53avm-9-515c13ab69f1d67b8f6b27c4451ee4f3\">\n.flex_column.av-53avm-9-515c13ab69f1d67b8f6b27c4451ee4f3{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-53avm-9-515c13ab69f1d67b8f6b27c4451ee4f3 av_one_fifth  avia-builder-el-27  el_after_av_one_fifth  el_before_av_hr  flex_column_div av-zero-column-padding  '     ><div  class='avia-button-wrap av-k0f2tboy-8-3d79ae9f4d1e40afbb2a35792e5571ab-wrap avia-button-center  avia-builder-el-28  avia-builder-el-no-sibling '><a href='https:\/\/www.rhein83.com\/wp-content\/uploads\/2024\/11\/018.22-2-MDSAP_2024-11-11.pdf'  class='avia-button av-k0f2tboy-8-3d79ae9f4d1e40afbb2a35792e5571ab av-link-btn avia-icon_select-yes-left-icon avia-size-large avia-position-center avia-color-light'   aria-label=\"MDSAP\"><span class='avia_button_icon avia_button_icon_left avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue84b' data-av_iconfont='entypo-fontello' ><\/span><span class='avia_iconbox_title' >MDSAP<\/span><\/a><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-joo8ewa9-14-bfe1f5e7566eeae913c9b2af6a43f187\">\n#top .hr.hr-invisible.av-joo8ewa9-14-bfe1f5e7566eeae913c9b2af6a43f187{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-joo8ewa9-14-bfe1f5e7566eeae913c9b2af6a43f187 hr-invisible  avia-builder-el-29  el_after_av_one_fifth  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_2'  class='avia-section av-1wbdrey-ce6daaaf7300331e032740aedfdf73fe main_color avia-section-default avia-no-border-styling  avia-builder-el-30  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-17802'><div class='entry-content-wrapper clearfix'>\n<div  class='flex_column av-1q9aoiy-19b15b00783e083340f187cf413a554e av_one_full  avia-builder-el-31  avia-builder-el-no-sibling  first flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l88k9uq3-36f089b43f19907e19e09b6d699f9dcf\">\n#top 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