{"id":6955,"date":"2025-05-09T11:05:28","date_gmt":"2025-05-09T09:05:28","guid":{"rendered":"https:\/\/vysyo.homepagemeister.com\/mdr-compliance\/"},"modified":"2025-05-09T11:05:28","modified_gmt":"2025-05-09T09:05:28","slug":"mdr-compliance","status":"publish","type":"page","link":"https:\/\/vysyo.homepagemeister.com\/en\/mdr-compliance\/","title":{"rendered":"MDR Compliance"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; disabled_on=&#8221;off|off|on&#8221; admin_label=&#8221;Header 1&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_stops=&#8221;rgba(224,153,0,0) 0%|#00406b 100%&#8221; background_color_gradient_overlays_image=&#8221;on&#8221; background_image=&#8221;https:\/\/vysyo.homepagemeister.com\/uploads\/_vysyo\/2024\/12\/hans-reniers-lQGJCMY5qcM-unsplash-scaled-1.png&#8221; background_position=&#8221;top_center&#8221; min_height=&#8221;300px&#8221; min_height_tablet=&#8221;&#8221; min_height_phone=&#8221;&#8221; min_height_last_edited=&#8221;on|phone&#8221; height_tablet=&#8221;250px&#8221; height_phone=&#8221;200px&#8221; height_last_edited=&#8221;on|phone&#8221; filter_brightness=&#8221;105%&#8221; bottom_divider_color=&#8221;#aa926c&#8221; locked=&#8221;off&#8221; collapsed=&#8221;on&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; disabled_on=&#8221;off|off|off&#8221; admin_label=&#8221;Sektion 2.1&#8243; module_id=&#8221;training&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; height_last_edited=&#8221;off|desktop&#8221; custom_padding=&#8221;0px||||false|false&#8221; collapsed=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;1&#8243; disabled_on=&#8221;on|on|off&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;100%&#8221; max_width=&#8221;100%&#8221; min_height=&#8221;100vh&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_stops=&#8221;rgba(87,126,164,0.44) 0%|#00406b 100%&#8221; background_color_gradient_overlays_image=&#8221;on&#8221; background_color_gradient_start=&#8221;rgba(87,126,164,0.44)&#8221; background_color_gradient_end=&#8221;#00406b&#8221; background_image=&#8221;https:\/\/vysyo.homepagemeister.com\/uploads\/_vysyo\/2025\/03\/iStock-1335020215.jpg&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_divider show_divider=&#8221;off&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; height=&#8221;100vh&#8221; custom_margin=&#8221;0px||||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;10%||||false|false&#8221; custom_css_main_element=&#8221;margin-left: -10% !important;&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_blurb title=&#8221;MDR compliance &#8211; your path to safe and sustainable market authorisation&#8221; content_max_width=&#8221;100%&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; header_level=&#8221;h2&#8243; header_font=&#8221;|600||on|||||&#8221; header_text_align=&#8221;left&#8221; header_text_color=&#8221;#577ea4&#8243; header_font_size=&#8221;35px&#8221; body_text_color=&#8221;#577ea4&#8243; position_origin_a=&#8221;center_left&#8221; width=&#8221;100%&#8221; module_alignment=&#8221;left&#8221; custom_margin=&#8221;||||false|false&#8221; custom_margin_tablet=&#8221;&#8221; custom_margin_phone=&#8221;|0px|||false|false&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; custom_padding=&#8221;5%|5%|5%|5%|true|true&#8221; header_font_size_tablet=&#8221;35px&#8221; header_font_size_phone=&#8221;25px&#8221; header_font_size_last_edited=&#8221;on|phone&#8221; custom_css_main_element=&#8221; &#8221; border_radii=&#8221;on|10px|10px|10px|10px&#8221; box_shadow_style=&#8221;preset1&#8243; box_shadow_spread=&#8221;13px&#8221; box_shadow_color=&#8221;rgba(87,126,164,0.09)&#8221; global_colors_info=&#8221;{}&#8221; background_color=&#8221;#ffffff&#8221; header_line_height=&#8221;1.2em&#8221;]<\/p>\n<p>&nbsp;<\/p>\n<p>The EU&#8217;s Medical Device Directive (MDD) is a major challenge for manufacturers: It requires comprehensive evidence of the safety, performance and quality of medical devices.<\/p>\n<p>To help you fully comply with MDR requirements, our solutions are tailored to your business and support you at every stage: from design to implementation:<\/p>\n<ul style=\"list-style-type: disc;\">\n<li>Regulatory consulting: Detailed analysis of MDR requirements and development of customised implementation strategies.<\/li>\n<li>Quality Management: Establish and optimise a robust quality management system that integrates all relevant MDR requirements.<\/li>\n<li>Clinical evaluation: Helping you produce robust clinical evaluations and evidence on the safety and performance of your products.<\/li>\n<li>Post-market surveillance: Implementation of sustainable monitoring systems to ensure continued safety and compliance.<\/li>\n<\/ul>\n<p>With years of experience in the medical device industry, we can help you ensure MDR compliance &#8211; for a smooth, internationally recognised market entry and sustainable business success.<\/p>\n<p>&nbsp;<\/p>\n<p class=\"p1\"><a href=\"https:\/\/vysyo.homepagemeister.com\/kontakt\/\"><button class=\"kontaktbutton\">Contact us now<\/button><\/a><\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=&#8221;off|off|on&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; max_width=&#8221;100%&#8221; custom_padding=&#8221;||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_blurb title=&#8221;MDR compliance &#8211; your path to safe and sustainable market authorisation&#8221; content_max_width=&#8221;100%&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; header_level=&#8221;h2&#8243; header_font=&#8221;|600||on|||||&#8221; header_text_align=&#8221;left&#8221; header_text_color=&#8221;#577ea4&#8243; header_font_size=&#8221;35px&#8221; body_text_color=&#8221;#577ea4&#8243; background_color=&#8221;#ffffff&#8221; position_origin_a=&#8221;center_left&#8221; width=&#8221;100%&#8221; module_alignment=&#8221;left&#8221; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;5%|5%|5%|5%|true|true&#8221; hover_enabled=&#8221;0&#8243; header_font_size_tablet=&#8221;35px&#8221; header_font_size_phone=&#8221;25px&#8221; header_font_size_last_edited=&#8221;on|phone&#8221; border_radii=&#8221;on|10px|10px|10px|10px&#8221; box_shadow_style=&#8221;preset1&#8243; box_shadow_spread=&#8221;13px&#8221; box_shadow_color=&#8221;rgba(87,126,164,0.09)&#8221; global_colors_info=&#8221;{}&#8221; header_line_height=&#8221;1.2em&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p>&nbsp;<\/p>\n<p>The EU&#8217;s Medical Device Directive (MDD) is a major challenge for manufacturers: It requires comprehensive evidence of the safety, performance and quality of medical devices.<\/p>\n<p>To help you fully comply with MDR requirements, our solutions are tailored to your business and support you at every stage: from design to implementation:<\/p>\n<ul style=\"list-style-type: disc;\">\n<li>Regulatory consulting: Detailed analysis of MDR requirements and development of customised implementation strategies.<\/li>\n<li>Quality Management: Establish and optimise a robust quality management system that integrates all relevant MDR requirements.<\/li>\n<li>Clinical evaluation: Helping you produce robust clinical evaluations and evidence on the safety and performance of your products.<\/li>\n<li>Post-market surveillance: Implementation of sustainable monitoring systems to ensure continued safety and compliance.<\/li>\n<\/ul>\n<p>With years of experience in the medical device industry, we can help you ensure MDR compliance &#8211; for a smooth, internationally recognised market entry and sustainable business success.<\/p>\n<p>&nbsp;<\/p>\n<p class=\"p1\"><a href=\"https:\/\/vysyo.homepagemeister.com\/kontakt\/\"><button class=\"kontaktbutton\">Contact us now<\/button><\/a><\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; disabled_on=&#8221;off|off|off&#8221; admin_label=&#8221;Sektion 2.1&#8243; module_id=&#8221;ivdr&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||||false|false&#8221; collapsed=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;1&#8243; disabled_on=&#8221;on|on|off&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;100%&#8221; max_width=&#8221;100%&#8221; min_height=&#8221;100vh&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; z_index=&#8221;3&#8243; custom_padding=&#8221;10%||||false|false&#8221; custom_css_main_element=&#8221;margin-left: 10% !important;&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_blurb title=&#8221;IVDR Compliance &#8211; Your roadmap to safe and sustainable in-vitro diagnostics&#8221; content_max_width=&#8221;100%&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; header_level=&#8221;h2&#8243; header_font=&#8221;|600||on|||||&#8221; header_text_align=&#8221;left&#8221; header_text_color=&#8221;#577ea4&#8243; header_font_size=&#8221;35px&#8221; body_text_color=&#8221;#577ea4&#8243; background_color=&#8221;#ffffff&#8221; position_origin_a=&#8221;center_left&#8221; width=&#8221;100%&#8221; module_alignment=&#8221;left&#8221; custom_margin=&#8221;||||false|false&#8221; custom_margin_tablet=&#8221;&#8221; custom_margin_phone=&#8221;|0px|||false|false&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; custom_padding=&#8221;5%|5%|5%|5%|true|true&#8221; hover_enabled=&#8221;0&#8243; header_font_size_tablet=&#8221;35px&#8221; header_font_size_phone=&#8221;25px&#8221; header_font_size_last_edited=&#8221;on|desktop&#8221; custom_css_main_element=&#8221; &#8221; border_radii=&#8221;on|10px|10px|10px|10px&#8221; box_shadow_style=&#8221;preset1&#8243; box_shadow_spread=&#8221;13px&#8221; box_shadow_color=&#8221;rgba(87,126,164,0.09)&#8221; global_colors_info=&#8221;{}&#8221; header_line_height=&#8221;1.2em&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p>&nbsp;<\/p>\n<p>The new In Vitro Diagnostics Regulation (IVDR) presents significant challenges for manufacturers: In addition to adapting technical documentation, sound risk analyses, performance evaluations and a robust quality management system are essential.MDR compliance &#8211; your path to safe and sustainable market authorisation<\/p>\n<p>Many questions are new and unfamiliar. Our experienced experts will guide you from initial analysis to final market approval: <\/p>\n<ul style=\"list-style-type: disc;\">\n<li>Regulatory consulting: Analysis of the requirements of the IVDR and development of individual implementation strategies.<\/li>\n<li>Documentation &amp; Risk Management: Creation and optimisation of technical documentation and implementation of systematic risk analysis.<\/li>\n<li>Clinical evaluation: Support in generating and documenting the required clinical evidence.<\/li>\n<li>Post-market surveillance: Establishing sustainable surveillance systems for continuous assessment of product safety.<\/li>\n<\/ul>\n<p>With customised solutions and many years of industry experience, we ensure a smooth path through the regulatory challenges &#8211; for a future-proof and successful market launch of your in-vitro diagnostics.<\/p>\n<p>&nbsp;<\/p>\n<p class=\"p1\"><a href=\"https:\/\/vysyo.homepagemeister.com\/kontakt\/\"><button class=\"kontaktbutton\">Contact us now<\/button><\/a><\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_stops=&#8221;rgba(87,126,164,0.44) 0%|#00406b 100%&#8221; background_color_gradient_overlays_image=&#8221;on&#8221; background_color_gradient_start=&#8221;rgba(87,126,164,0.44)&#8221; background_color_gradient_end=&#8221;#00406b&#8221; background_image=&#8221;https:\/\/vysyo.homepagemeister.com\/uploads\/_vysyo\/2021\/07\/hans-reniers-lQGJCMY5qcM-unsplash-scaled.jpg&#8221; custom_css_main_element=&#8221;position: absolute !important;||right: 0px;&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_divider show_divider=&#8221;off&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; height=&#8221;100vh&#8221; custom_margin=&#8221;0px||||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=&#8221;off|off|on&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; max_width=&#8221;100%&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_blurb title=&#8221;IVDR Compliance &#8211; Your roadmap to safe and sustainable in-vitro diagnostics&#8221; content_max_width=&#8221;100%&#8221; _builder_version=&#8221;4.24.0&#8243; _module_preset=&#8221;default&#8221; header_level=&#8221;h2&#8243; header_font=&#8221;|600||on|||||&#8221; header_text_align=&#8221;left&#8221; header_text_color=&#8221;#577ea4&#8243; header_font_size=&#8221;35px&#8221; body_text_color=&#8221;#577ea4&#8243; background_color=&#8221;#ffffff&#8221; position_origin_a=&#8221;center_left&#8221; width=&#8221;100%&#8221; module_alignment=&#8221;left&#8221; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;5%|5%|5%|5%|true|true&#8221; hover_enabled=&#8221;0&#8243; header_font_size_tablet=&#8221;35px&#8221; header_font_size_phone=&#8221;25px&#8221; header_font_size_last_edited=&#8221;on|phone&#8221; border_radii=&#8221;on|10px|10px|10px|10px&#8221; box_shadow_style=&#8221;preset1&#8243; box_shadow_spread=&#8221;13px&#8221; box_shadow_color=&#8221;rgba(87,126,164,0.09)&#8221; global_colors_info=&#8221;{}&#8221; header_line_height=&#8221;1.2em&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p>&nbsp;<\/p>\n<p>The new In Vitro Diagnostics Regulation (IVDR) presents significant challenges for manufacturers: In addition to adapting technical documentation, sound risk analyses, performance evaluations and a robust quality management system are essential.MDR compliance &#8211; your path to safe and sustainable market authorisation<\/p>\n<p>Many questions are new and unfamiliar. Our experienced experts will guide you from initial analysis to final market approval: <\/p>\n<ul style=\"list-style-type: disc;\">\n<li>Regulatory consulting: Analysis of the requirements of the IVDR and development of individual implementation strategies.<\/li>\n<li>Documentation &amp; Risk Management: Creation and optimisation of technical documentation and implementation of systematic risk analysis.<\/li>\n<li>Clinical evaluation: Support in generating and documenting the required clinical evidence.<\/li>\n<li>Post-market surveillance: Establishing sustainable surveillance systems for continuous assessment of product safety.<\/li>\n<\/ul>\n<p>With customised solutions and many years of industry experience, we ensure a smooth path through the regulatory challenges &#8211; for a future-proof and successful market launch of your in-vitro diagnostics.<\/p>\n<p>&nbsp;<\/p>\n<p class=\"p1\"><a href=\"https:\/\/vysyo.homepagemeister.com\/kontakt\/\"><button class=\"kontaktbutton\">Contact us now<\/button><\/a><\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; The EU&#8217;s Medical Device Directive (MDD) is a major challenge for manufacturers: It requires comprehensive evidence of the safety, performance and quality of medical devices. 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