{"id":8337,"date":"2023-02-23T21:05:43","date_gmt":"2023-02-23T20:05:43","guid":{"rendered":"https:\/\/www.medicoforum.com\/quality-management\/"},"modified":"2024-08-07T21:16:13","modified_gmt":"2024-08-07T19:16:13","slug":"quality-management","status":"publish","type":"page","link":"https:\/\/www.medicoforum.com\/en\/quality-management\/","title":{"rendered":"Quality management"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bd796f-d0fb62a1ca4db618da335498cbc17266\">\n.avia-section.av-bd796f-d0fb62a1ca4db618da335498cbc17266{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.medicoforum.com\/wp-content\/uploads\/2020\/03\/layerformat_medicoforum_about_02.jpg);\nbackground-position:50% 0%;\nbackground-attachment:fixed;\nmargin-top:0px;\nmargin-bottom:60px;\n}\n.avia-section.av-bd796f-d0fb62a1ca4db618da335498cbc17266 .av-section-color-overlay{\nopacity:0.9;\n}\n#top .avia-section.av-bd796f-d0fb62a1ca4db618da335498cbc17266 .scroll-down-link{\ncolor:#0066bb;\n}\n#top .avia-section.av-bd796f-d0fb62a1ca4db618da335498cbc17266 .scroll-down-link.avia-svg-icon svg:first-child{\nstroke:#0066bb;\nfill:#0066bb;\n}\n.avia-section.av-bd796f-d0fb62a1ca4db618da335498cbc17266 .av-extra-border-element .av-extra-border-inner{\nbackground-color:#ffffff;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-bd796f-d0fb62a1ca4db618da335498cbc17266 main_color avia-section-default avia-shadow  avia-builder-el-0  el_before_av_postcontent  avia-builder-el-first  whiteright avia-full-stretch avia-bg-style-fixed av-section-color-overlay-active av-arrow-down-section av-minimum-height av-minimum-height-100 av-height-100  container_wrap sidebar_right'  data-section-bg-repeat='stretch' data-av_minimum_height_pc='100' data-av_min_height_opt='100'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><a href='#next-section' title='' class='scroll-down-link av-custom-scroll-down-color avia-svg-icon avia-font-svg_entypo-fontello' data-av_svg_icon='down-open-mini' data-av_iconset='svg_entypo-fontello'><svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"15\" height=\"32\" viewBox=\"0 0 15 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'>Scroll to next section<\/title>\n<desc id='av-svg-desc-1'>Scroll to next section<\/desc>\n<path d=\"M12.96 12.16q0.704-0.832 1.536 0 0.832 0.704 0 1.536l-6.272 6.144q-0.704 0.704-1.536 0l-6.272-6.144q-0.832-0.832 0-1.536 0.768-0.768 1.6 0l5.44 4.992z\"><\/path>\n<\/svg><\/a><div class='container av-section-cont-open' ><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-8337'><div class='entry-content-wrapper clearfix'>\n<div  class='flex_column av-9ew7w7-dc837895b7f19a8b868c8a2bb10e614d av_one_third  avia-builder-el-1  el_before_av_two_third  avia-builder-el-first  first flex_column_div  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-8tldev-7477fe854a43569da6a34da5169a9b8c\">\n.flex_column.av-8tldev-7477fe854a43569da6a34da5169a9b8c{\nborder-radius:0 21px 21px 21px;\npadding:34px 34px 34px 34px;\n}\n<\/style>\n<div  class='flex_column av-8tldev-7477fe854a43569da6a34da5169a9b8c av_two_third  avia-builder-el-2  el_after_av_one_third  avia-builder-el-last  whiteleft flex_column_div  '     ><section  class='av_textblock_section av-lehj7mxn-929d6ec71cb740f51d076352bef94182 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h1><span class=\"clbold\">Quality management for medical devices: <\/span>Our System for Success.<\/h1>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4wb7k7-6e210fbbd59127907a22efbb79467c19\">\n#top .hr.av-4wb7k7-6e210fbbd59127907a22efbb79467c19{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-4wb7k7-6e210fbbd59127907a22efbb79467c19 .hr-inner{\nwidth:50px;\nborder-color:#000000;\n}\n<\/style>\n<div  class='hr av-4wb7k7-6e210fbbd59127907a22efbb79467c19 hr-custom  avia-builder-el-4  el_after_av_textblock  el_before_av_button  hr-left hr-icon-no'><span class='hr-inner inner-border-av-border-fat'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='avia-button-wrap av-ld91m096-0815fddfa9d68fce07ee5ef111dee066-wrap avia-button-center  avia-builder-el-5  el_after_av_hr  el_before_av_hr  diamond'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ld91m096-0815fddfa9d68fce07ee5ef111dee066\">\n#top #wrap_all .avia-button.av-ld91m096-0815fddfa9d68fce07ee5ef111dee066{\nbackground-color:#edf5f9;\nborder-color:#edf5f9;\ncolor:#666666;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-ld91m096-0815fddfa9d68fce07ee5ef111dee066 .avia-svg-icon svg:first-child{\nfill:#666666;\nstroke:#666666;\n}\n<\/style>\n<a href='#contactform'  class='avia-button av-ld91m096-0815fddfa9d68fce07ee5ef111dee066 av-link-btn avia-icon_select-yes-left-icon avia-size-x-large avia-position-center'   aria-label=\"Get in touch now\"><span class='avia_button_icon avia_button_icon_left avia-iconfont avia-font-medicoforum_icon' data-av_icon='\ue900' data-av_iconfont='medicoforum_icon' ><\/span><span class='avia_iconbox_title' >Get in touch now<\/span><\/a><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ldukjjs5-f6249d5bb4e898ea3b0b82767254a852\">\n#top .hr.av-ldukjjs5-f6249d5bb4e898ea3b0b82767254a852{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-ldukjjs5-f6249d5bb4e898ea3b0b82767254a852 .hr-inner{\nwidth:50px;\nborder-color:#000000;\n}\n<\/style>\n<div  class='hr av-ldukjjs5-f6249d5bb4e898ea3b0b82767254a852 hr-custom  avia-builder-el-6  el_after_av_button  el_before_av_textblock  hr-left hr-icon-no'><span class='hr-inner inner-border-av-border-none'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-234fqe-00d7905a1480272a9811ed6139a4d999 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock strongblack'  itemprop=\"text\" ><p>Quality management systems (QMS) play a key role in the legal requirements for establishing a medical device on the market. An effective quality management system is not only a regulatory necessity, but also a strategic advantage. It ensures that your products meet the highest quality standards and at the same time minimizes various risks with regard to product quality and regulatory requirements. There are various normative and legal requirements, such as the MDR (Regulation EU 2017\/745), DIN EN ISO 13485 or FDA 21 CFR part 820, which are being continuously developed and adjusted. At Medicoforum, we offer comprehensive services for implementing and maintaining a QMS that meets the requirements of the MDR (EU 2017\/745) and DIN EN ISO 13485. Our expertise covers the entire range of QMS requirements. We advise, design and implement customized systems that are tailored to the specific needs of your company and your products. Implementing and maintaining a QMS requires not only technical knowledge, but also a deep understanding of the regulatory landscape and the specific requirements for medical devices. The continuous development of legal and normative requirements makes it difficult for companies to keep up to date at all times. This is where we provide you with targeted support: Our experts are always informed about the latest developments and can ensure that your QMS complies with current standards and is future-proof. We provide support where you need it &#8211; from checklists to accreditation with tailored information. We take care of the quality management of your products. <strong>We consult, design and implement systems for quality management according to the individual requirements of the respective product and the associated processes.<\/strong><\/p>\n<h2>What if you don&#8217;t have the capacities?<\/h2>\n<p> As we have our own QMS (quality management system), customers can implement their product in our system and thus delegate their obligation as a legal manufacturer. This means that you can concentrate on your core competencies while we take on the complex and time-consuming tasks of quality management.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kttrsoeq-f90a0d34935209dbb6c6aff98f9c0005\">\n#top .hr.hr-invisible.av-kttrsoeq-f90a0d34935209dbb6c6aff98f9c0005{\nheight:25px;\n}\n<\/style>\n<div  class='hr av-kttrsoeq-f90a0d34935209dbb6c6aff98f9c0005 hr-invisible  avia-builder-el-8  el_after_av_textblock  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div>[av_section min_height='percent' min_height_pc='77' min_height_px='500px' shadow='no-border-styling' bottom_border='border-extra-arrow-down' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' padding='large' margin='aviaTBmargin' custom_margin='0px,60px' av-desktop-custom_margin='' av-desktop-custom_margin_sync='true' 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fold_btn_color='theme-color' fold_btn_bg_color='' fold_btn_font_color='' size-btn-text='' av-desktop-font-size-btn-text='' av-medium-font-size-btn-text='' av-small-font-size-btn-text='' av-mini-font-size-btn-text='' animation='' animation_duration='' animation_custom_bg_color='' animation_z_index_curtain='100' parallax_parallax='' parallax_parallax_speed='' av-desktop-parallax_parallax='' av-desktop-parallax_parallax_speed='' av-medium-parallax_parallax='' av-medium-parallax_parallax_speed='' av-small-parallax_parallax='' av-small-parallax_parallax_speed='' av-mini-parallax_parallax='' av-mini-parallax_parallax_speed='' fold_timer='' z_index_fold='' css_position='' css_position_location=',,,' css_position_z_index='' av-desktop-css_position='' av-desktop-css_position_location=',,,' av-desktop-css_position_z_index='' av-medium-css_position='' av-medium-css_position_location=',,,' av-medium-css_position_z_index='' av-small-css_position='' av-small-css_position_location=',,,' av-small-css_position_z_index='' av-mini-css_position='' av-mini-css_position_location=',,,' av-mini-css_position_z_index='' link='' linktarget='' link_hover='' title_attr='' alt_attr='' mobile_display='' mobile_col_pos='0' id='' custom_class='opak09 blockmargin border0 corner-top-left' template_class='' aria_label='' av_uid='av-g7cw4k' sc_version='1.0']\n\n[av_textblock textblock_styling_align='' textblock_styling='' textblock_styling_gap='' textblock_styling_mobile='' size='' av-desktop-font-size='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' font_color='' color='' id='' custom_class='' template_class='' av_uid='av-ldt3jz13' sc_version='1.0' admin_preview_bg='']\n<span class=\"h2optisch\">Medicoforum Factsheet<\/span>\n[\/av_textblock]\n\n[av_hr class='custom' height='50' shadow='no-shadow' position='left' custom_border='av-border-fat' custom_width='50px' custom_border_color='#000000' custom_margin_top='10px' custom_margin_bottom='10px' icon_select='no' custom_icon_color='' icon='ue808' font='entypo-fontello' av_uid='av-dvkk5w']\n\n[av_textblock textblock_styling_align='' textblock_styling='' textblock_styling_gap='' textblock_styling_mobile='' size='' av-desktop-font-size='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' font_color='' color='' id='' custom_class='hoehe_contact_bild' template_class='' av_uid='av-ktea9a10' sc_version='1.0' admin_preview_bg='']\n<img decoding=\"async\" class=\"wp-image-1191 alignleft\" src=\"https:\/\/www.medicoforum.com\/wp-content\/uploads\/2020\/04\/Medicoforum_building.jpg\" alt=\"Medicoforum Building Hannover\" width=\"490\" height=\"272\">\n[\/av_textblock]\n\n[av_hr class='custom' icon_select='no' icon='ue808' font='entypo-fontello' position='left' shadow='no-shadow' height='50' custom_border='av-border-none' custom_width='50px' custom_margin_top='15px' custom_margin_bottom='0px' custom_border_color='#000000' custom_icon_color='' id='' custom_class='' template_class='' av_uid='av-2tkxoc' sc_version='1.0' admin_preview_bg='']\n\n[av_textblock fold_type='' fold_height='' fold_more='Weiterlesen' fold_less='Read less' fold_text_style='' fold_btn_align='' textblock_styling_align='' textblock_styling='' textblock_styling_gap='' textblock_styling_mobile='' size='' av-desktop-font-size='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' font_color='' color='' fold_overlay_color='' fold_text_color='' fold_btn_color='theme-color' fold_btn_bg_color='' fold_btn_font_color='' size-btn-text='' av-desktop-font-size-btn-text='' av-medium-font-size-btn-text='' av-small-font-size-btn-text='' av-mini-font-size-btn-text='' fold_timer='' z_index_fold='' id='' custom_class='' template_class='' av_uid='av-ks0k1swi' sc_version='1.0' admin_preview_bg='']\n<span class=\"clbold\">Our focus:<\/span> MDR consulting and services for medical devices such as quality management, risk management, clinical data and studies or clinical evaluation. <span class=\"clbold\">Project overview:<\/span> 45+ medical device projects (from idea to product) 120+ dossiers 20+ patents <span class=\"clbold\">Competence status<\/span> Certified according to DIN EN ISO 13485:2016, Medical Device Regulation (MDR), Medical Device Law Implementation Act (MPDG), expert knowledge in GCP and GMP as well as ISO 14155 and always up-to-date specialist knowledge. <span class=\"clbold\">About the company:<\/span> Founded in 2003 10+ in-house specialists a large number of satisfied customers <span class=\"clbold\">Project partners:<\/span> Mediconomics GmbH (Europe\/USA\/Canada) DNV MedCert GmbH (Germany)\n[\/av_textblock]\n\n[\/av_one_half][av_one_half min_height='' vertical_alignment='av-align-top' space='' row_boxshadow_width='10' row_boxshadow_color='' margin='0px' margin_sync='true' av-desktop-margin='' av-desktop-margin_sync='true' av-medium-margin='' av-medium-margin_sync='true' av-small-margin='' av-small-margin_sync='true' av-mini-margin='' 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background_gradient_color2='' background_gradient_color3='' src='' attachment='' attachment_size='' background_position='top left' background_repeat='no-repeat' highlight_size='1.1' fold_overlay_color='' fold_text_color='' fold_btn_color='theme-color' fold_btn_bg_color='' fold_btn_font_color='' size-btn-text='' av-desktop-font-size-btn-text='' av-medium-font-size-btn-text='' av-small-font-size-btn-text='' av-mini-font-size-btn-text='' animation='' animation_duration='' animation_custom_bg_color='' animation_z_index_curtain='100' parallax_parallax='' parallax_parallax_speed='' av-desktop-parallax_parallax='' av-desktop-parallax_parallax_speed='' av-medium-parallax_parallax='' av-medium-parallax_parallax_speed='' av-small-parallax_parallax='' av-small-parallax_parallax_speed='' av-mini-parallax_parallax='' av-mini-parallax_parallax_speed='' fold_timer='' z_index_fold='' css_position='' css_position_location=',,,' css_position_z_index='' av-desktop-css_position='' av-desktop-css_position_location=',,,' av-desktop-css_position_z_index='' av-medium-css_position='' av-medium-css_position_location=',,,' av-medium-css_position_z_index='' av-small-css_position='' av-small-css_position_location=',,,' av-small-css_position_z_index='' av-mini-css_position='' av-mini-css_position_location=',,,' av-mini-css_position_z_index='' link='' linktarget='' link_hover='' title_attr='' alt_attr='' mobile_display='' mobile_col_pos='0' id='' custom_class='opak09 blockmargin' template_class='' aria_label='' av_uid='av-kuecw8es' sc_version='1.0']\n\n[av_textblock textblock_styling_align='' textblock_styling='' textblock_styling_gap='' textblock_styling_mobile='' size='' av-desktop-font-size='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' font_color='' color='' id='' custom_class='' template_class='' av_uid='av-ldt3k4ik' sc_version='1.0' admin_preview_bg='']\n<span class=\"h2optisch\">You\u2019re welcome<\/span>\n[\/av_textblock]\n\n[av_hr class='custom' height='50' shadow='no-shadow' position='left' custom_border='av-border-fat' custom_width='50px' custom_border_color='#000000' custom_margin_top='10px' custom_margin_bottom='10px' icon_select='no' custom_icon_color='' icon='ue808' font='entypo-fontello' av_uid='av-cv9bz8']\n\n[av_textblock fold_type='' fold_height='' fold_more='Weiterlesen' fold_less='Read less' fold_text_style='' fold_btn_align='' textblock_styling_align='left' textblock_styling='' textblock_styling_gap='' textblock_styling_mobile='767' size='' av-desktop-font-size='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' font_color='' color='' fold_overlay_color='' fold_text_color='' fold_btn_color='theme-color' fold_btn_bg_color='' fold_btn_font_color='' size-btn-text='' av-desktop-font-size-btn-text='' av-medium-font-size-btn-text='' av-small-font-size-btn-text='' av-mini-font-size-btn-text='' fold_timer='' z_index_fold='' id='' custom_class='hoehe_contact_bild' template_class='' av_uid='av-krh20xgb' sc_version='1.0' admin_preview_bg='']\n<div id=\"textbildblock\">\n<div class=\"textwidget\">\n<div class=\"textwidget\" data-wp-editing=\"1\"><img decoding=\"async\" class=\"wp-image-988 alignleft\" src=\"https:\/\/www.medicoforum.com\/wp-content\/uploads\/dr-uwe-albrecht_web.jpg\" alt=\"dr-uwe-albrecht\" width=\"200\" height=\"272\"><\/div>\n<br class=\"avia-permanent-lb\"><br class=\"avia-permanent-lb\"><br class=\"avia-permanent-lb\"><br class=\"avia-permanent-lb\"><strong>Managing Director:<\/strong><strong>Dr. (MD) Uwe Albrecht, <\/strong>FIBMS, FFPM (Dis.), FICR, CSci Phone: +49 (0) 511 5151 18 90 <a href=\"mailto:contact@medicoforum.com\">contact@medicoforum.com<\/a><\/div>\n<\/div>\n[\/av_textblock]\n\n[av_hr class='custom' icon_select='no' icon='ue808' font='entypo-fontello' position='left' shadow='no-shadow' height='50' custom_border='av-border-none' custom_width='50px' custom_margin_top='15px' custom_margin_bottom='0px' custom_border_color='#000000' 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