{"id":8354,"date":"2021-12-10T22:26:29","date_gmt":"2021-12-10T21:26:29","guid":{"rendered":"https:\/\/www.medicoforum.com\/risk-management\/"},"modified":"2024-05-17T15:40:33","modified_gmt":"2024-05-17T13:40:33","slug":"risk-management","status":"publish","type":"page","link":"https:\/\/www.medicoforum.com\/en\/risk-management\/","title":{"rendered":"Risk 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 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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-8354'><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-ldt40quh-24401f6123de5c69915dfa13061122c0 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h1><span class=\"clbold\">Risk management: <\/span>risk analysis, risk management plan and risk assessment according to MDR.<\/h1>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2duy89-ab6838a1838919156390d9d9b946234d\">\n#top .hr.av-2duy89-ab6838a1838919156390d9d9b946234d{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-2duy89-ab6838a1838919156390d9d9b946234d .hr-inner{\nwidth:50px;\nborder-color:#000000;\n}\n<\/style>\n<div  class='hr av-2duy89-ab6838a1838919156390d9d9b946234d 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-26e6ax-46f2de5a4d4cf26b32c7f7fd25fced96-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-26e6ax-46f2de5a4d4cf26b32c7f7fd25fced96\">\n#top #wrap_all .avia-button.av-26e6ax-46f2de5a4d4cf26b32c7f7fd25fced96{\nbackground-color:#edf5f9;\nborder-color:#edf5f9;\ncolor:#666666;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-26e6ax-46f2de5a4d4cf26b32c7f7fd25fced96 .avia-svg-icon svg:first-child{\nfill:#666666;\nstroke:#666666;\n}\n<\/style>\n<a href='#contactform'  class='avia-button av-26e6ax-46f2de5a4d4cf26b32c7f7fd25fced96 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-4wb7k7-5ae1a097f7d27e8ad88aa817415637c1\">\n#top .hr.av-4wb7k7-5ae1a097f7d27e8ad88aa817415637c1{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-4wb7k7-5ae1a097f7d27e8ad88aa817415637c1 .hr-inner{\nwidth:0px;\nborder-color:#000000;\n}\n<\/style>\n<div  class='hr av-4wb7k7-5ae1a097f7d27e8ad88aa817415637c1 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-fat'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-k7ooakmw-613eaad5cb9fbc26042fa1e57faaf447 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock strongblack'  itemprop=\"text\" ><h3>Medical devices must be safe<\/h3>\n<p>Efficient risk management is essential to ensure the safety of a medical device. As with drugs, medical devices must be safe!<\/p>\n<p>The risks to patients and users that may arise from the use of medical devices must be kept as low as possible, and must be outweighed by the benefits of the medical device, resulting in a positive risk-benefit ratio. Risks must be minimized as far as possible, especially with regard to the risk-benefit ratio.<\/p>\n<h3>Your obligations as a manufacturer<\/h3>\n<p>When placing their products on the market and making them available to patients and users, manufacturers of medical devices must ensure that they have been designed and manufactured in accordance with the requirements of the European Medical Device Regulation (MDR) 2017\/745. The MDR requires manufacturers to have a risk management process that continues throughout the life cycle of the product to ensure ongoing safety. This includes activities during production as well as downstream phases. Risk management is thus a key element in all phases of a medical device&#8217;s life.<\/p>\n<h3>Identifying and controlling risks through risk management<\/h3>\n<p>In addition to the identification and assessment of hazards, risk control measures play an important role in risk management.<\/p>\n<p>The internationally recognized standard for risk management, ISO 14971 &#8220;Medical devices &#8211; Application of risk management to medical devices&#8221;, provides a framework for developing risk management plans and supports manufacturers of medical devices in the implementation of these. This process must be implemented, documented in detail and filed in a risk management file.<\/p>\n<h3>Fulfill documentation requirements<\/h3>\n<div>The creation of a risk management file in accordance with the ISO 14971 standard enables the tracking of identified risks and includes:<\/div>\n<ul>\n<li>Risk analysis, risk control and risk assessment<\/li>\n<li>Risk Management Plan (EU RMP): Includes a description of the product, authorities and responsibilities, requirements for reviews, manufacturer&#8217;s premises for acceptance of risks, and further on data and information collected before and after commissioning, etc.<\/li>\n<li>Risk management report: A final report summarizing the results of the risk management process together with an assessment of the residual risk. It should reflect the effectiveness of the risk management plan and illustrate the acceptability of residual risk in relation to benefits of the device.<\/li>\n<\/ul>\n<h3>Keep knowledge up-to-date<\/h3>\n<p>We also offer qualified consulting and training on various risk management approaches such as FMEA (Failure Mode and Effects Analysis).<\/p>\n<h3>How Medicoforum supports you<\/h3>\n<p><strong>Benefit from our expertise in the area of efficient risk management for medical devices under MDR. We are happy to advise you at every stage of your product&#8217;s life cycle.<\/strong><\/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' av-medium-custom_margin='' 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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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