{"id":1151,"date":"2026-05-29T08:17:35","date_gmt":"2026-05-29T08:17:35","guid":{"rendered":"https:\/\/www.qmserviceglobal.com\/?page_id=1151"},"modified":"2026-06-05T18:02:05","modified_gmt":"2026-06-05T18:02:05","slug":"ce-marking-service","status":"publish","type":"page","link":"https:\/\/www.qmserviceglobal.com\/?page_id=1151","title":{"rendered":"CE Marking Service"},"content":{"rendered":"<div class='clear'><\/div><div id='sub_menu1'  class='av-submenu-container av-mpwc034y-54b5fd076b0c44b270955a6f6f2637f4 socket_color  avia-builder-el-0  el_before_av_section  avia-builder-el-first  av-sticky-submenu container_wrap sidebar_right' style='z-index:301' ><div class='container av-menu-mobile-disabled av-submenu-pos-right'><ul id='av-custom-submenu-1' class='av-subnav-menu' role='menu'>\n<li class='menu-item av-yqa3jj-b073095c0ece1293df4405a8c81c8433 menu-item-top-level menu-item-top-level-1' role='menuitem'><a href='https:\/\/www.qmserviceglobal.com\/?page_id=1145'  ><span class='avia-bullet'><\/span><span class='avia-menu-text'>ISO<\/span><\/a><\/li>\n<li class='menu-item av-mpwc02nt-d8910cf2f97e70a263df608d91c00e51 menu-item-top-level av-menu-button av-menu-button-colored menu-item-top-level-2' role='menuitem'><a href='https:\/\/www.qmserviceglobal.com\/?page_id=1151'  ><span class='avia-bullet'><\/span><span class='avia-menu-text'>CE MARK<\/span><\/a><\/li>\n<li class='menu-item av-vzhff3-d3312adb08ec912c9e8e3e5e42558dbf menu-item-top-level menu-item-top-level-3' role='menuitem'><a href='https:\/\/www.qmserviceglobal.com\/?page_id=1153'  ><span class='avia-bullet'><\/span><span class='avia-menu-text'>EU REP<\/span><\/a><\/li>\n<li class='menu-item av-v5jjen-855bd9ecc4ceda6a530389536291b591 menu-item-top-level menu-item-top-level-4' role='menuitem'><a href='https:\/\/www.qmserviceglobal.com\/?page_id=1147'  ><span class='avia-bullet'><\/span><span class='avia-menu-text'>CDSCO<\/span><\/a><\/li>\n<li class='menu-item av-mpwbzyo0-6fd7a9fdd6da5c3d2ec5e5021e0e4b0e menu-item-top-level menu-item-top-level-5' role='menuitem'><a href='https:\/\/www.qmserviceglobal.com\/?page_id=1149'  ><span class='avia-bullet'><\/span><span class='avia-menu-text'>BIS<\/span><\/a><\/li>\n<li class='menu-item av-ssnzen-6cdebcda8129a6c4ea2c3eccb9f7383d menu-item-top-level menu-item-top-level-6' role='menuitem'><a href='https:\/\/www.qmserviceglobal.com\/?page_id=1155'  ><span class='avia-bullet'><\/span><span class='avia-menu-text'>SAHPRA<\/span><\/a><\/li>\n<li class='menu-item av-qxdkm7-43c474c4ee76f7ee287d2dae49780c10 menu-item-top-level menu-item-top-level-7' role='menuitem'><a href='https:\/\/www.qmserviceglobal.com\/?page_id=1158'  ><span class='avia-bullet'><\/span><span class='avia-menu-text'>SFDA<\/span><\/a><\/li>\n<li class='menu-item av-pv36pb-3647c74ca1cfcd6fce8889614743c0c2 menu-item-top-level menu-item-top-level-8' role='menuitem'><a href='https:\/\/www.fdahelp.us\/'  ><span class='avia-bullet'><\/span><span class='avia-menu-text'>US FDA<\/span><\/a><\/li>\n<\/ul><\/div><\/div><div class='sticky_placeholder'><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-njrklb-767e157956bec23790b0bb5cdd6d9874\">\n.avia-section.av-njrklb-767e157956bec23790b0bb5cdd6d9874{\nbackground-color:#5cb1db;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-njrklb-767e157956bec23790b0bb5cdd6d9874 main_color avia-section-small avia-no-border-styling  avia-builder-el-1  el_after_av_submenu  el_before_av_heading  avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-1151'><div class='entry-content-wrapper clearfix'>\n<div class='flex_column_table av-mtzptb-e2683e9ed3c91083f53498be2ef2d17a sc-av_one_fifth av-equal-height-column-flextable'><div  class='flex_column av-mtzptb-e2683e9ed3c91083f53498be2ef2d17a av_one_fifth  avia-builder-el-2  el_before_av_four_fifth  avia-builder-el-first  first no_margin flex_column_table_cell av-equal-height-column av-align-top  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mpwbyxwo-6fc615ea4ceb492d4416d5cad40fbaf7\">\n@keyframes av_boxShadowEffect_av-mpwbyxwo-6fc615ea4ceb492d4416d5cad40fbaf7 {\n0%   { box-shadow:  0 0 0 0 ; opacity: 1; }\n100% { box-shadow:  0 0 10px 0 ; opacity: 1; }\n}\n.avia-image-container.av-mpwbyxwo-6fc615ea4ceb492d4416d5cad40fbaf7 img.avia_image{\nbox-shadow: 0 0 10px 0 ;\n}\n.avia-image-container.av-mpwbyxwo-6fc615ea4ceb492d4416d5cad40fbaf7 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-mpwbyxwo-6fc615ea4ceb492d4416d5cad40fbaf7 av-styling- avia-align-center  avia-builder-el-3  avia-builder-el-no-sibling  av-img-box-shadow av-box-shadow-not-animated'   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-1293 avia-img-lazy-loading-not-1293 avia_image shadow-not-animated' src=\"https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/05\/CE-Marking-2-80x80.png\" alt='' title='CE Marking'  height=\"80\" width=\"80\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/05\/CE-Marking-2-80x80.png 80w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/05\/CE-Marking-2-300x300.png 300w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/05\/CE-Marking-2-1030x1030.png 1030w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/05\/CE-Marking-2-768x768.png 768w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/05\/CE-Marking-2-36x36.png 36w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/05\/CE-Marking-2-180x180.png 180w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/05\/CE-Marking-2-705x705.png 705w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/05\/CE-Marking-2.png 1254w\" sizes=\"(max-width: 80px) 100vw, 80px\" \/><\/div><\/div><\/div><\/div><div  class='flex_column av-krbj4f-2adbdb2dca301b367f6e5d3e459d5843 av_four_fifth  avia-builder-el-4  el_after_av_one_fifth  avia-builder-el-last  no_margin flex_column_table_cell av-equal-height-column av-align-top  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mpwbzjoo-efbfea1d42122704042431f031246d9c\">\n#top .av_textblock_section.av-mpwbzjoo-efbfea1d42122704042431f031246d9c .avia_textblock{\npadding:0 20px 0 0;\n}\n<\/style>\n<section  class='av_textblock_section av-mpwbzjoo-efbfea1d42122704042431f031246d9c '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h1>CE Marking \u2013 EU MDR 2017<\/h1>\n<h1>EU Regulatory Consultancy Services<\/h1>\n<\/div><\/section><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_1'  class='main_color av_default_container_wrap container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-1151'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-fgr3tb-ec72161a7a193fad9d4546fb01234679\">\n#top .av-special-heading.av-fgr3tb-ec72161a7a193fad9d4546fb01234679{\npadding-bottom:10px;\ncolor:#5896c9;\n}\nbody .av-special-heading.av-fgr3tb-ec72161a7a193fad9d4546fb01234679 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-fgr3tb-ec72161a7a193fad9d4546fb01234679 .special-heading-inner-border{\nborder-color:#5896c9;\n}\n.av-special-heading.av-fgr3tb-ec72161a7a193fad9d4546fb01234679 .av-subheading{\nfont-size:15px;\ncolor:#000000;\n}\n<\/style>\n<div  class='av-special-heading av-fgr3tb-ec72161a7a193fad9d4546fb01234679 av-special-heading-h2 custom-color-heading blockquote modern-quote modern-centered  avia-builder-el-6  el_after_av_section  el_before_av_section  avia-builder-el-no-sibling '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Our EU Regulatory Consultancy <span class='special_amp'>&amp;<\/span> Certification Services<\/h2><div class='av_custom_color av-subheading av-subheading_below'><p>Comprehensive consultancy support for Indian and International Medical Device Manufacturers.<\/p>\n<\/div><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/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-eimr4v-0746f3dc1d6275022462fefee1f2e497\">\n.avia-section.av-eimr4v-0746f3dc1d6275022462fefee1f2e497{\nbackground-color:#F4F9FF;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_2'  class='avia-section av-eimr4v-0746f3dc1d6275022462fefee1f2e497 custom avia-section-large avia-shadow  avia-builder-el-7  el_after_av_heading  el_before_av_section  avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-1151'><div class='entry-content-wrapper clearfix'>\n<div  class='flex_column av-1aa1qn-83b7d0f684e020b72d09d1de585403ed av_one_full  avia-builder-el-8  el_before_av_one_half  avia-builder-el-first  first flex_column_div  '     ><\/div><div  class='flex_column av-acfaxb-7e21439a7d8d26c8b9512d3a59fab772 av_one_half  avia-builder-el-9  el_after_av_one_full  el_before_av_one_half  first flex_column_div  column-top-margin'     ><section  class='av_textblock_section av-2ao6333-78a52f819bf8348af8258f67a9964c1d '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h2>What is CE Marking?<\/h2>\n<p>CE Marking indicates that a medical device complies with the requirements of the European Union Medical Device Regulation (EU MDR 2017\/745).<\/p>\n<p>The CE Mark demonstrates that the product has undergone the required conformity assessment procedures and meets all applicable European requirements relating to safety, performance, risk management, clinical evaluation, technical documentation, and post-market surveillance.<\/p>\n<p>CE Marking allows manufacturers to legally place their products throughout the European Economic Area (EEA) and access one of the world&#8217;s largest healthcare markets.<\/p>\n<\/div><\/section><\/div><div  class='flex_column av-9ervtb-454be0ba37c36c4b6aa258c50a9e6411 av_one_half  avia-builder-el-11  el_after_av_one_half  avia-builder-el-last  flex_column_div  column-top-margin'     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-263cven-4a2624229049728b32e0ef881a7165b4\">\n#top .avia-icon-list-container.av-263cven-4a2624229049728b32e0ef881a7165b4 .iconlist_icon{\ncolor:#ffffff;\nbackground-color:#7bb0e7;\n}\n#top .avia-icon-list-container.av-263cven-4a2624229049728b32e0ef881a7165b4 .iconlist_icon svg:first-child{\nstroke:#ffffff;\nfill:#ffffff;\n}\n#top #wrap_all .avia-icon-list-container.av-263cven-4a2624229049728b32e0ef881a7165b4 .av_iconlist_title{\ncolor:#000000;\n}\n.avia-icon-list-container.av-263cven-4a2624229049728b32e0ef881a7165b4 .iconlist_content{\ncolor:#000000;\n}\n<\/style>\n<div  class='avia-icon-list-container av-263cven-4a2624229049728b32e0ef881a7165b4  avia-builder-el-12  avia-builder-el-no-sibling '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-263cven-4a2624229049728b32e0ef881a7165b4 avia-iconlist-animate'>\n<li><div class='iconlist_icon av-24vn0gf-6639e93020a17695827df5c07e752468 avia-font-svg_entypo-fontello avia-svg-icon avia-font-svg_entypo-fontello'><span class='av-icon-char' data-av_svg_icon='check' data-av_iconset='svg_entypo-fontello'><svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"21\" height=\"32\" viewBox=\"0 0 21 32\" preserveAspectRatio=\"xMidYMid meet\" aria-labelledby='av-svg-title-1' aria-describedby='av-svg-desc-1' role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id='av-svg-title-1'>Check<\/title>\n<desc id='av-svg-desc-1'>Check<\/desc>\n<path d=\"M7.968 27.2q-1.088 0-1.792-0.896l-5.76-7.552q-0.512-0.768-0.384-1.664t0.832-1.472 1.632-0.448 1.504 0.896l3.776 4.928 9.472-15.168q0.512-0.768 1.376-0.96t1.696 0.256q0.768 0.512 0.96 1.376t-0.256 1.696l-11.2 17.92q-0.64 1.024-1.792 1.024z\"><\/path>\n<\/svg><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: EU MDR 2017\/745\"><h4 class='av_iconlist_title iconlist_title  av_inherit_color'  itemprop=\"headline\" >EU MDR 2017\/745<\/h4><\/header><div class='iconlist_content av_inherit_color'  itemprop=\"text\" ><p>Compliance with European Medical Device Regulation<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-23fw0jz-9122c5e1a09c680f8d6ce8e77b63c81f avia-font-svg_entypo-fontello avia-svg-icon avia-font-svg_entypo-fontello'><span class='av-icon-char' data-av_svg_icon='check' data-av_iconset='svg_entypo-fontello'><svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"21\" height=\"32\" viewBox=\"0 0 21 32\" preserveAspectRatio=\"xMidYMid meet\" aria-labelledby='av-svg-title-2' aria-describedby='av-svg-desc-2' role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id='av-svg-title-2'>Check<\/title>\n<desc id='av-svg-desc-2'>Check<\/desc>\n<path d=\"M7.968 27.2q-1.088 0-1.792-0.896l-5.76-7.552q-0.512-0.768-0.384-1.664t0.832-1.472 1.632-0.448 1.504 0.896l3.776 4.928 9.472-15.168q0.512-0.768 1.376-0.96t1.696 0.256q0.768 0.512 0.96 1.376t-0.256 1.696l-11.2 17.92q-0.64 1.024-1.792 1.024z\"><\/path>\n<\/svg><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Market Access\"><h4 class='av_iconlist_title iconlist_title  av_inherit_color'  itemprop=\"headline\" >Market Access<\/h4><\/header><div class='iconlist_content av_inherit_color'  itemprop=\"text\" ><p>Legal sale across European Economic Area<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-218q7yn-220bb8e3d4932afa52a4bf2be9b686df avia-font-svg_entypo-fontello avia-svg-icon avia-font-svg_entypo-fontello'><span class='av-icon-char' data-av_svg_icon='check' data-av_iconset='svg_entypo-fontello'><svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"21\" height=\"32\" viewBox=\"0 0 21 32\" preserveAspectRatio=\"xMidYMid meet\" aria-labelledby='av-svg-title-3' aria-describedby='av-svg-desc-3' role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id='av-svg-title-3'>Check<\/title>\n<desc id='av-svg-desc-3'>Check<\/desc>\n<path d=\"M7.968 27.2q-1.088 0-1.792-0.896l-5.76-7.552q-0.512-0.768-0.384-1.664t0.832-1.472 1.632-0.448 1.504 0.896l3.776 4.928 9.472-15.168q0.512-0.768 1.376-0.96t1.696 0.256q0.768 0.512 0.96 1.376t-0.256 1.696l-11.2 17.92q-0.64 1.024-1.792 1.024z\"><\/path>\n<\/svg><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Global Recognition\"><h4 class='av_iconlist_title iconlist_title  av_inherit_color'  itemprop=\"headline\" >Global Recognition<\/h4><\/header><div class='iconlist_content av_inherit_color'  itemprop=\"text\" ><p>Internationally recognized regulatory compliance<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-1ziwcsf-9e8b379558a3eeccb22b8002564645bb avia-font-svg_entypo-fontello avia-svg-icon avia-font-svg_entypo-fontello'><span class='av-icon-char' data-av_svg_icon='check' data-av_iconset='svg_entypo-fontello'><svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"21\" height=\"32\" viewBox=\"0 0 21 32\" preserveAspectRatio=\"xMidYMid meet\" aria-labelledby='av-svg-title-4' aria-describedby='av-svg-desc-4' role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id='av-svg-title-4'>Check<\/title>\n<desc id='av-svg-desc-4'>Check<\/desc>\n<path d=\"M7.968 27.2q-1.088 0-1.792-0.896l-5.76-7.552q-0.512-0.768-0.384-1.664t0.832-1.472 1.632-0.448 1.504 0.896l3.776 4.928 9.472-15.168q0.512-0.768 1.376-0.96t1.696 0.256q0.768 0.512 0.96 1.376t-0.256 1.696l-11.2 17.92q-0.64 1.024-1.792 1.024z\"><\/path>\n<\/svg><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Patient Safety\"><h4 class='av_iconlist_title iconlist_title  av_inherit_color'  itemprop=\"headline\" >Patient Safety<\/h4><\/header><div class='iconlist_content av_inherit_color'  itemprop=\"text\" ><p>Meeting European safety and performance standards<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_3'  class='avia-section av-m13jtr-f89b410d0989f393eb0f5f910c7a6044 main_color avia-section-default avia-no-border-styling  avia-builder-el-13  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-1151'><div class='entry-content-wrapper clearfix'>\n<div  class='flex_column av-kjljen-54411ba6d5b0d9e9e26cf01555d0a16d av_two_fifth  avia-builder-el-14  el_before_av_three_fifth  avia-builder-el-first  first flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mpwf1cf3-998e2561c0d091a2ac9475a2bae7cfa1\">\n.avia-image-container.av-mpwf1cf3-998e2561c0d091a2ac9475a2bae7cfa1 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-mpwf1cf3-998e2561c0d091a2ac9475a2bae7cfa1 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-mpwf1cf3-998e2561c0d091a2ac9475a2bae7cfa1 av-styling- avia-align-center  avia-builder-el-15  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-1518 avia-img-lazy-loading-not-1518 avia_image ' src=\"https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-2-1030x1030.png\" alt='' title='CE-Img-2'  height=\"1030\" width=\"1030\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-2-1030x1030.png 1030w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-2-300x300.png 300w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-2-80x80.png 80w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-2-768x768.png 768w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-2-36x36.png 36w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-2-180x180.png 180w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-2-705x705.png 705w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-2.png 1254w\" sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><\/div><\/div><\/div><\/div><div  class='flex_column av-j17dkv-ad96379c5f46c3891aa7d8491822447f av_three_fifth  avia-builder-el-16  el_after_av_two_fifth  avia-builder-el-last  flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mpwf2zoe-8a87c6206e6da041ca3fa7b7eae759f4\">\n#top .av_textblock_section.av-mpwf2zoe-8a87c6206e6da041ca3fa7b7eae759f4 .avia_textblock{\nfont-size:18px;\n}\n<\/style>\n<section  class='av_textblock_section av-mpwf2zoe-8a87c6206e6da041ca3fa7b7eae759f4 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p><strong>What is CE Marking for Medical Devices<\/strong><\/p>\n<p>CE marking indicates that a medical device complies with the requirements of the European Union regulatory framework.<\/p>\n<p>Regulation (EU) 2017\/745 (EU MDR).<\/p>\n<p>The CE mark demonstrates that the device meets the applicable requirements relating to:<br \/>\n\u2022 Safety and performance<br \/>\n\u2022 Risk management<br \/>\n\u2022 Clinical evaluation<br \/>\n\u2022 Biocompatibility and technical documentation<br \/>\n\u2022 Quality Management System (typically ISO 13485 compliant)<br \/>\n\u2022 Post-Market Surveillance and Vigilance<\/p>\n<\/div><\/section><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_4'  class='avia-section av-h3ynxb-482265b331bd2994528bb1797469ce22 main_color avia-section-default avia-no-border-styling  avia-builder-el-18  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-1151'><div class='entry-content-wrapper clearfix'>\n<div  class='flex_column av-g628qn-61b6c0b7d6253c15dead830588dbbd9c av_three_fifth  avia-builder-el-19  el_before_av_two_fifth  avia-builder-el-first  first flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mpwg8qti-8e2a6fd52d7d774cf25bc4f04e0a5226\">\n#top .av_textblock_section.av-mpwg8qti-8e2a6fd52d7d774cf25bc4f04e0a5226 .avia_textblock{\nfont-size:18px;\ncolor:#af3636;\n}\n<\/style>\n<section  class='av_textblock_section av-mpwg8qti-8e2a6fd52d7d774cf25bc4f04e0a5226 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><h2><strong>Why CE Marking is Important<\/strong><\/h2>\n<p>_______________________________________________________________<\/p>\n<p>CE marking allows a medical device to be legally placed on the market within the European Economic Area (EEA). It confirms that:<\/p>\n<ul>\n<li>The device has undergone the appropriate conformity assessment procedure.<\/li>\n<li>The product complies with applicable EU regulatory requirements.<\/li>\n<li>The manufacturer has prepared and maintains technical documentation.<\/li>\n<li>The device is registered in EUDAMED (where applicable).<\/li>\n<\/ul>\n<p>For higher-risk devices (Class Is, Im, Ir, IIa, IIb, III), the conformity assessment is carried out by a designated Notified Body. For certain low-risk Class I devices, manufacturers may self-declare conformity.<\/p>\n<\/div><\/section><\/div><div  class='flex_column av-dz1dm7-4d9f145f8d6228696c23bda5e05ddb75 av_two_fifth  avia-builder-el-21  el_after_av_three_fifth  avia-builder-el-last  flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mpwh22v5-888224fcd5c6871f21a0947d82ec433f\">\n.avia-image-container.av-mpwh22v5-888224fcd5c6871f21a0947d82ec433f img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-mpwh22v5-888224fcd5c6871f21a0947d82ec433f .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-mpwh22v5-888224fcd5c6871f21a0947d82ec433f av-styling- avia-align-center  avia-builder-el-22  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-1534 avia-img-lazy-loading-not-1534 avia_image ' src=\"https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-3-1030x1030.png\" alt='' title='CE-Img-3'  height=\"1030\" width=\"1030\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-3-1030x1030.png 1030w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-3-300x300.png 300w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-3-80x80.png 80w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-3-768x768.png 768w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-3-36x36.png 36w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-3-180x180.png 180w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-3-705x705.png 705w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/06\/CE-Img-3.png 1254w\" sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><\/div><\/div><\/div><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_5'  class='avia-section av-19n44f-58fee73269131dd3b59af0884c9b468b main_color avia-section-default avia-no-border-styling  avia-builder-el-23  el_after_av_section  el_before_av_textblock  avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-1151'><div class='entry-content-wrapper clearfix'>\n<div  class='flex_column av-aznunz-143b744139d47c48aeb5a481518a2c5f av_one_full  avia-builder-el-24  avia-builder-el-no-sibling  first flex_column_div  '     ><section  class='av_textblock_section av-mpwhe39g-836593a2632789da9f42af5ef55f2eec '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h2><strong>What CE Marking Represents<\/strong><\/h2>\n<ul>\n<li>The CE mark is not a quality award or certification label \u2014 it is a regulatory conformity marking that demonstrates compliance with European legislation and enables free circulation of medical devices within the EU market.<\/li>\n<li>CE Marking Consultancy Services for Medical Devices<\/li>\n<li>CE marking is mandatory for placing medical devices on the European market in accordance with Regulation (EU) 2017\/745 (EU MDR). It confirms that a device meets the applicable requirements for safety, performance, risk management, clinical evaluation, and post-market surveillance.<\/li>\n<li>Navigating the EU MDR framework can be complex due to stringent documentation, classification rules, UDI requirements, EUDAMED registration, and Notified Body involvement for higher-risk devices. Our expert team provides end-to-end regulatory support to help manufacturers achieve CE marking efficiently and in full compliance.<\/li>\n<\/ul>\n<\/div><\/section><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_5'  class='main_color av_default_container_wrap container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-1151'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mpwi6af0-645932bcf24e885ac031a5f7af8266f9\">\n.av_textblock_section.av-mpwi6af0-645932bcf24e885ac031a5f7af8266f9{\nbackground-color:#4e938e;\n}\n#top .av_textblock_section.av-mpwi6af0-645932bcf24e885ac031a5f7af8266f9 .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-mpwi6af0-645932bcf24e885ac031a5f7af8266f9 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><h1 style=\"text-align: center;\">Our Services &amp; What we offer<\/h1>\n<\/div><\/section>\n<div  class='flex_column av-9gblzj-a7df92c88b71a3b45680bec868199bb1 av_one_half  avia-builder-el-27  el_after_av_textblock  el_before_av_one_half  first flex_column_div  column-top-margin'     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mpwhfbqy-a148b7c1549e97dedc8516bfa2e5f2ee\">\n#top .av_textblock_section.av-mpwhfbqy-a148b7c1549e97dedc8516bfa2e5f2ee .avia_textblock{\nfont-size:20px;\ncolor:#6c387c;\ntext-align:left;\n}\n\n@media only screen and (min-width: 990px){ \n#top .av_textblock_section.av-mpwhfbqy-a148b7c1549e97dedc8516bfa2e5f2ee .avia_textblock{\npadding:5px 5px 5px 5px;\n}\n}\n<\/style>\n<section  class='av_textblock_section av-mpwhfbqy-a148b7c1549e97dedc8516bfa2e5f2ee '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><ul>\n<li>Device classification as per EU MDR<\/li>\n<li>Gap analysis against EU MDR requirements<\/li>\n<li>Preparation and review of Technical Documentation (Annex II &#038; III)<\/li>\n<li>Clinical Evaluation Report (CER) support \u2022 Risk Management File preparation (ISO 14971 aligned)<\/li>\n<\/ul>\n<\/div><\/section><\/div>\n<div  class='flex_column av-9h8u7-8c2cc456a7015c82643183f9f39a2249 av_one_half  avia-builder-el-29  el_after_av_one_half  el_before_av_section  avia-builder-el-last  flex_column_div  column-top-margin'     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mq0jv69b-1cd5ef936029597ef6bdef0530788ed2\">\n#top .av_textblock_section.av-mq0jv69b-1cd5ef936029597ef6bdef0530788ed2 .avia_textblock{\nfont-size:20px;\ncolor:#6c387c;\ntext-align:left;\n}\n\n@media only screen and (min-width: 990px){ \n#top .av_textblock_section.av-mq0jv69b-1cd5ef936029597ef6bdef0530788ed2 .avia_textblock{\npadding:5px 5px 5px 5px;\n}\n}\n<\/style>\n<section  class='av_textblock_section av-mq0jv69b-1cd5ef936029597ef6bdef0530788ed2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><ul>\n<li>ISO 13485 Quality Management System implementation and documentation<\/li>\n<li>UDI assignment and EUDAMED registration support<\/li>\n<li>Coordination with EU Authorized Representatives<\/li>\n<li>Notified Body submission guidance and audit preparation<\/li>\n<li>Post-Market Surveillance (PMS) and Vigilance system setup<\/li>\n<\/ul>\n<\/div><\/section><\/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-7h0yan-776056444002ed1211cafdc9936607ea\">\n.avia-section.av-7h0yan-776056444002ed1211cafdc9936607ea{\nbackground-color:#5cb1db;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_6'  class='avia-section av-7h0yan-776056444002ed1211cafdc9936607ea header_color avia-section-large avia-no-border-styling  avia-builder-el-31  el_after_av_one_half  avia-builder-el-last  avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-1151'><div class='entry-content-wrapper clearfix'>\n<div  class='flex_column av-5gqpqn-43948d3d2b1aa1c50075f4cdacebb676 av_two_fifth  avia-builder-el-32  el_before_av_one_half  avia-builder-el-first  first flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mpwbvyl5-56ece059d1104f8c80d9777ea960c4e0\">\n#top .av_textblock_section.av-mpwbvyl5-56ece059d1104f8c80d9777ea960c4e0 .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-mpwbvyl5-56ece059d1104f8c80d9777ea960c4e0 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p><strong>Why Choose Us?<\/strong><\/p>\n<ul>\n<li>Strong regulatory expertise in EU MDR compliance<\/li>\n<li>Practical, audit-ready documentation approach<\/li>\n<li>Structured project timelines for faster market access<\/li>\n<li>Ongoing regulatory lifecycle support<\/li>\n<\/ul>\n<p>We work closely with manufacturers to simplify the CE marking process, minimize regulatory delays, and ensure smooth entry into the European market.<\/p>\n<p>For expert guidance on CE marking for your medical devices, contact our regulatory team today.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-hutbj-9b0e6a516aae84768ad751cbbd8e24ec\">\n.flex_column.av-hutbj-9b0e6a516aae84768ad751cbbd8e24ec{\nbackground-color:#ffffff;\n}\n<\/style>\n<div  class='flex_column av-hutbj-9b0e6a516aae84768ad751cbbd8e24ec av_one_half  avia-builder-el-34  el_after_av_two_fifth  avia-builder-el-last  flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2qien3-432c678be97ca7ecc10fe2be6ac678e1\">\n#top .av_textblock_section.av-2qien3-432c678be97ca7ecc10fe2be6ac678e1 .avia_textblock{\npadding:20px 20px 20px 20px;\ntext-align:center;\n}\n<\/style>\n<section  class='av_textblock_section av-2qien3-432c678be97ca7ecc10fe2be6ac678e1 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-1198 aligncenter\" src=\"https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/05\/qm-srv-lo-300x138.jpg\" alt=\"\" width=\"300\" height=\"138\" srcset=\"https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/05\/qm-srv-lo-300x138.jpg 300w, https:\/\/www.qmserviceglobal.com\/wp-content\/uploads\/2026\/05\/qm-srv-lo.jpg 340w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p style=\"text-align: center;\">Puthiyaveetil, Parampuzha, Kottayam, Kerala \u2013 686004, INDIA<\/p>\n<p style=\"text-align: center;\"><a href=\"mailto:qmserviceindia@gmail.com\">qmserviceindia@gmail.com<\/a>\u00a0 |\u00a0 <a href=\"mailto:ceo@qmserviceindia.com\">ceo@qmserviceindia.com<\/a><\/p>\n<p style=\"text-align: center;\"><a href=\"http:\/\/www.qmserviceindia.com\">www.qmserviceindia.com<\/a><\/p>\n<p style=\"text-align: center;\">GSTIN: 32ARTPS8732P2ZP | PAN: ARTPS8732P<\/p>\n<p style=\"text-align: center;\">Benadict Boby Sebastian\u00a0 |\u00a0 CEO<\/p>\n<p style=\"text-align: center;\">91-9061033526, 91-9349208199, 91-8075108926<\/p>\n<p><a href=\"mailto:ceo@qmserviceindia.com\">info@qmserviceglobal.com<\/a>\u00a0 \u00a0|\u00a0 \u00a0<a href=\"https:\/\/www.qmserviceglobal.com\/\">www.qmserviceglobal.com<\/a><\/p>\n<\/div><\/section><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_6'  class='main_color av_default_container_wrap container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-1151'><div class='entry-content-wrapper clearfix'>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1151","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.qmserviceglobal.com\/index.php?rest_route=\/wp\/v2\/pages\/1151","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.qmserviceglobal.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.qmserviceglobal.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.qmserviceglobal.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.qmserviceglobal.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1151"}],"version-history":[{"count":5,"href":"https:\/\/www.qmserviceglobal.com\/index.php?rest_route=\/wp\/v2\/pages\/1151\/revisions"}],"predecessor-version":[{"id":1641,"href":"https:\/\/www.qmserviceglobal.com\/index.php?rest_route=\/wp\/v2\/pages\/1151\/revisions\/1641"}],"wp:attachment":[{"href":"https:\/\/www.qmserviceglobal.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1151"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}