{"id":24173,"date":"2026-03-09T12:32:17","date_gmt":"2026-03-09T12:32:17","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?page_id=24173"},"modified":"2026-03-11T09:47:21","modified_gmt":"2026-03-11T09:47:21","slug":"ivdr-ivd-software-development-in-vitro","status":"publish","type":"page","link":"https:\/\/quickbirdmedical.com\/en\/ivdr-ivd-software-development-in-vitro\/","title":{"rendered":"Development IVDR Software"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; admin_label=&#8221;Sektion&#8221; _builder_version=&#8221;4.21.0&#8243; custom_padding=&#8221;0px|0px|0|0px|false|false&#8221; bottom_divider_style=&#8221;slant2&#8243; bottom_divider_color=&#8221;#FFFFFF&#8221; bottom_divider_flip=&#8221;horizontal&#8221; animation_direction=&#8221;top&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_fullwidth_header title=&#8221;Are you planning to develop an IVDR Software Product?&#8221; button_one_text=&#8221;CONTACT US&#8221; button_one_url=&#8221;https:\/\/quickbirdmedical.com\/en\/kontakt\/&#8221; button_two_url=&#8221;#1&#8243; background_overlay_color=&#8221;rgba(68,98,124,0.8)&#8221; content_max_width=&#8221;700px&#8221; admin_label=&#8221;Vollbreite Kopfzeile&#8221; _builder_version=&#8221;4.21.0&#8243; title_font=&#8221;overpass-extralight|200|||||||&#8221; title_text_align=&#8221;left&#8221; title_text_color=&#8221;#FFFFFF&#8221; title_font_size=&#8221;45px&#8221; title_line_height=&#8221;1.2em&#8221; content_font=&#8221;opensans-regular||||||||&#8221; content_text_color=&#8221;#FFFFFF&#8221; content_font_size=&#8221;18px&#8221; content_line_height=&#8221;1.8em&#8221; subhead_text_color=&#8221;#FFFFFF&#8221; background_enable_color=&#8221;off&#8221; background_color_gradient_direction=&#8221;36deg&#8221; background_color_gradient_start=&#8221;rgba(126,190,197,0.77)&#8221; background_color_gradient_end=&#8221;rgba(255,255,255,0)&#8221; background_image=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/12\/IVDR_Landingpage_software-e1765794938932.webp&#8221; background_position=&#8221;top_center&#8221; custom_button_one=&#8221;on&#8221; button_one_text_size=&#8221;14px&#8221; button_one_text_color=&#8221;#ffffff&#8221; button_one_bg_color=&#8221;#41B6E6&#8243; button_one_border_width=&#8221;8px&#8221; button_one_border_color=&#8221;#41b6e6&#8243; button_one_border_radius=&#8221;0px&#8221; button_one_letter_spacing=&#8221;1px&#8221; button_one_font=&#8221;overpass-bold|600|||||||&#8221; button_one_use_icon=&#8221;off&#8221; custom_button_two=&#8221;on&#8221; button_two_text_size=&#8221;14px&#8221; button_two_text_color=&#8221;#FFFFFF&#8221; button_two_bg_color=&#8221;rgba(255,255,255,0.17)&#8221; button_two_border_width=&#8221;8px&#8221; button_two_border_color=&#8221;rgba(255,255,255,0)&#8221; button_two_border_radius=&#8221;0px&#8221; button_two_letter_spacing=&#8221;1px&#8221; button_two_font=&#8221;|700|||||||&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;5%||5%||false|false&#8221; custom_padding_tablet=&#8221;&#8221; custom_padding_phone=&#8221;5%||15%||false|false&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; title_font_size_tablet=&#8221;40px&#8221; title_font_size_phone=&#8221;33px&#8221; title_font_size_last_edited=&#8221;on|phone&#8221; content_font_size_tablet=&#8221;16px&#8221; content_font_size_phone=&#8221;&#8221; content_font_size_last_edited=&#8221;on|tablet&#8221; subhead_font_size_tablet=&#8221;&#8221; subhead_font_size_phone=&#8221;16px&#8221; subhead_font_size_last_edited=&#8221;on|phone&#8221; custom_css_button_1=&#8221; margin-left: 0px;||||||&#8221; button_one_letter_spacing_hover=&#8221;1px&#8221; button_two_letter_spacing_hover=&#8221;1px&#8221; locked=&#8221;off&#8221; inline_fonts=&#8221;overpass-extralight&#8221; global_colors_info=&#8221;{}&#8221; button_one_text_size__hover_enabled=&#8221;off&#8221; button_two_text_size__hover_enabled=&#8221;off&#8221; button_one_text_color__hover_enabled=&#8221;off&#8221; button_two_text_color__hover_enabled=&#8221;off&#8221; button_one_border_width__hover_enabled=&#8221;off&#8221; button_two_border_width__hover_enabled=&#8221;off&#8221; button_one_border_color__hover_enabled=&#8221;off&#8221; button_two_border_color__hover_enabled=&#8221;off&#8221; button_one_border_radius__hover_enabled=&#8221;off&#8221; button_two_border_radius__hover_enabled=&#8221;off&#8221; button_one_letter_spacing__hover_enabled=&#8221;on&#8221; button_one_letter_spacing__hover=&#8221;2px&#8221; button_two_letter_spacing__hover_enabled=&#8221;on&#8221; button_two_letter_spacing__hover=&#8221;1px&#8221; button_one_bg_color__hover_enabled=&#8221;off&#8221; button_two_bg_color__hover_enabled=&#8221;off&#8221;]<\/p>\n<p class=\"md-end-block md-p md-focus\"><span class=\"md-plain md-expand\">We develop in vitro diagnostic software on a contract basis. 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data-group=\"wondercarousellightbox-4\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Charite.png\" alt=\"Logo Charite\u0301\" data-title=\"Logo Charite\u0301\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Biogen.png\" data-title=\"Logo Biogen\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Biogen.png\" class=\"wondercarousellightbox wondercarousellightbox-4\" data-group=\"wondercarousellightbox-4\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Biogen.png\" alt=\"Logo Biogen\" data-title=\"Logo Biogen\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Uniklinikum-Erlangen.png\" data-title=\"Logo Uniklinikum Erlangen\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Uniklinikum-Erlangen.png\" class=\"wondercarousellightbox wondercarousellightbox-4\" data-group=\"wondercarousellightbox-4\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Uniklinikum-Erlangen.png\" alt=\"Logo Uniklinikum Erlangen\" data-title=\"Logo Uniklinikum Erlangen\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div 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class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Sportsclinic-Cologne-1.png\" data-title=\"Logo Sportsclinic Cologne\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Sportsclinic-Cologne-1.png\" class=\"wondercarousellightbox wondercarousellightbox-4\" data-group=\"wondercarousellightbox-4\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Sportsclinic-Cologne-1.png\" alt=\"Logo Sportsclinic Cologne\" data-title=\"Logo Sportsclinic Cologne\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><\/ul><div class=\"amazingcarousel-prev\"><\/div><div class=\"amazingcarousel-next\"><\/div><\/div><div class=\"amazingcarousel-nav\"><\/div><\/div><\/div><script>jQuery(document).ready(function(){setTimeout(function(){jQuery(window).trigger(\"resize\");},5);});<\/script>[\/et_pb_code][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; next_background_color=&#8221;#ffffff&#8221; _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_stops=&#8221;#41b6e6 0%|#298fc2 100%&#8221; custom_padding=&#8221;3px||108px|||&#8221; bottom_divider_style=&#8221;slant2&#8243; bottom_divider_flip=&#8221;horizontal&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||2px|||&#8221; custom_css_main_element=&#8221;display: flex;||align-items: center;&#8221; global_colors_info=&#8221;{}&#8221; custom_css_main_element_last_edited=&#8221;on|tablet&#8221; custom_css_main_element_tablet=&#8221;display:block;&#8221; custom_css_main_element_phone=&#8221;display:block;&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text content_tablet=&#8221;<\/p>\n<h2>Development of Software Medical Devices (SaMD)<\/h2>\n<h4>We support you in all areas<\/h4>\n<p>&#8221; content_phone=&#8221;<\/p>\n<h2>Development of Software Medical Devices (SaMD)<\/h2>\n<h4>We support you in all areas<\/h4>\n<p>&#8221; content_last_edited=&#8221;on|tablet&#8221; _builder_version=&#8221;4.21.0&#8243; text_font=&#8221;opensans-regular||||||||&#8221; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;1.8em&#8221; header_2_font=&#8221;overpass-extralight|200|||||||&#8221; header_2_font_size=&#8221;34px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;||26px||false|false&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;22px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2 style=\"text-align: left;\">Development of IVD Software<\/h2>\n<h4 style=\"text-align: left;\">We support you in all areas<\/h4>\n<p>[\/et_pb_text][et_pb_text content_tablet=&#8221;<\/p>\n<p>Technical, as well as regulatory &#8211; our team has all the know-how necessary for the development of software medical products. Depending on your preference, we accompany you continuously or punctually and develop your medical device software in compliance with all legal requirements.<\/p>\n<p>&#8221; content_phone=&#8221;<\/p>\n<p>Technical, as well as regulatory &#8211; our team has all the know-how necessary for the development of software medical products. Depending on your preference, we accompany you continuously or punctually and develop your medical device software in compliance with all legal requirements.<\/p>\n<p>&#8221; content_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.21.0&#8243; text_font=&#8221;opensans-regular||||||||&#8221; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; link_font=&#8221;|700|||on||||&#8221; link_text_color=&#8221;#FFFFFF&#8221; header_2_font=&#8221;overpass-extralight|200|||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;22px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p class=\"md-end-block md-p md-focus\" style=\"text-align: left;\"><span class=\"md-plain md-expand\">Whether as an integral part of an in vitro diagnostic device, for controlling an analyzer, or as standalone software for IVD purposes, we develop customized software solutions in accordance with the entire IVDR. From <span style=\"text-decoration: underline;\"><a href=\"https:\/\/quickbirdmedical.com\/en\/embedded-software-medical-devices\/\">embedded systems<\/a><\/span> <\/span><span class=\"md-plain\"> to web and desktop applications to mobile applications, we implement powerful, secure, and standards-compliant software for modern diagnostic systems. <\/span><\/p>\n<p class=\"md-end-block md-p md-focus\" style=\"text-align: left;\"><span class=\"md-plain md-expand\">We combine technological expertise with in-depth regulatory know-how to ensure the compliance and quality of your IVD product. <\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/mood_16076_bearbeitet_crop-min-scaled-1.webp&#8221; alt=&#8221;Header Website&#8221; title_text=&#8221;mood_16076_bearbeitet_crop-min-scaled&#8221; align_tablet=&#8221;&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;||||false|false&#8221; custom_margin_tablet=&#8221;25px||||false|false&#8221; custom_margin_phone=&#8221;1px||||false|false&#8221; custom_margin_last_edited=&#8221;on|desktop&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;Feature&#8221; _builder_version=&#8221;4.21.0&#8243; background_color=&#8221;#ffffff&#8221; custom_padding=&#8221;0px||100px||false|false&#8221; top_divider_color=&#8221;#FFFFFF&#8221; bottom_divider_style=&#8221;slant2&#8243; bottom_divider_color=&#8221;#41b6e6&#8243; bottom_divider_flip=&#8221;horizontal&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; custom_padding_last_edited=&#8221;off|tablet&#8221; _builder_version=&#8221;4.21.0&#8243; custom_padding=&#8221;10px|0px|0px|0px|false|false&#8221; custom_padding_phone=&#8221;2px|0px|2px|0px|false|false&#8221; animation_style=&#8221;slide&#8221; custom_css_main_element=&#8221;display:flex;||align-items:center;&#8221; global_colors_info=&#8221;{}&#8221; custom_css_main_element_last_edited=&#8221;on|tablet&#8221; custom_css_main_element_tablet=&#8221;display:block;&#8221; custom_css_main_element_phone=&#8221;display:block;&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.21.0&#8243; custom_padding=&#8221;|||&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/12\/Entscheidungsbaum-IVDR-MDR-2.webp&#8221; alt=&#8221;Decision tree: Does my software fall under the IVDR or the MDR?&#8221; title_text=&#8221;Decision tree IVDR MDR (2)&#8221; show_in_lightbox=&#8221;on&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.21.0&#8243; width=&#8221;100%&#8221; module_alignment=&#8221;center&#8221; custom_margin=&#8221;||0px||false|false&#8221; animation_style=&#8221;zoom&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text content_tablet=&#8221;<\/p>\n<p>Decision tree: Does my software fall under the IVDR?<\/p>\n<p>&#8221; content_phone=&#8221;<\/p>\n<p>Decision tree: Does my software fall under the IVDR?<\/p>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.21.0&#8243; text_font=&#8221;||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; header_2_font=&#8221;Lato|700|||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;0px||||false|false&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;22px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; inline_fonts=&#8221;overpass-extralight,overpass-bold&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\">Decision tree: Does my software fall under the IVDR?<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.21.0&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.21.0&#8243; text_font=&#8221;||||||||&#8221; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; header_2_font=&#8221;|700|||||||&#8221; header_2_font_size=&#8221;30px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.3em&#8221; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;||14px|||&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;22px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; inline_fonts=&#8221;overpass-extralight,overpass-bold&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h6 style=\"text-align: left;\"><span style=\"color: #41b6e6; font-family: overpass-bold;\">Guide<\/span><\/h6>\n<h2 style=\"text-align: left;\"><strong><span style=\"color: #41b6e6; font-family: overpass-extralight;\">IVDR Software: Qualification &amp; Classification<\/span><\/strong><\/h2>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.21.0&#8243; text_font=&#8221;||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; header_2_font=&#8221;Lato|700|||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;22px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; inline_fonts=&#8221;overpass-extralight,overpass-bold&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: left;\">In our guide <strong><a href=\"https:\/\/quickbirdmedical.com\/en\/ivdr-ivd-software-app-in-vitro\/\">IVDR Software \u2013 Qualification and Classification<\/a><\/strong>, we explain&#8230;<\/p>\n<ul>\n<li style=\"text-align: left;\">&#8230;when software falls under the <strong>In Vitro Diagnostic Regulation (IVDR)<\/strong><\/li>\n<li style=\"text-align: left;\">&#8230;how the <strong>qualification<\/strong> works<\/li>\n<li style=\"text-align: left;\">&#8230;and according to which criteria the <strong>risk classification<\/strong> is carried out.<\/li>\n<\/ul>\n<p>[\/et_pb_text][et_pb_button button_url=&#8221;https:\/\/quickbirdmedical.com\/en\/ivdr-ivd-software-app-in-vitro\/&#8221; button_text=&#8221;TO THE GUIDE&#8221; button_alignment=&#8221;left&#8221; module_id=&#8221;whitepaper-link&#8221; module_class=&#8221;digawhitepaperbutton&#8221; _builder_version=&#8221;4.21.0&#8243; custom_button=&#8221;on&#8221; button_text_size=&#8221;14px&#8221; button_text_color=&#8221;#ffffff&#8221; button_bg_color=&#8221;#41B6E6&#8243; button_border_width=&#8221;12px&#8221; button_border_color=&#8221;#41b6e6&#8243; button_border_radius=&#8221;0px&#8221; button_font=&#8221;|900||on|||||&#8221; button_use_icon=&#8221;off&#8221; custom_margin=&#8221;0px||||false|false&#8221; custom_margin_tablet=&#8221;|0px||&#8221; custom_margin_last_edited=&#8221;off|desktop&#8221; custom_padding=&#8221;|40px||40px||true&#8221; button_letter_spacing_tablet=&#8221;&#8221; button_letter_spacing_phone=&#8221;&#8221; button_letter_spacing_last_edited=&#8221;on|desktop&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; button_text_size__hover_enabled=&#8221;off&#8221; button_one_text_size__hover_enabled=&#8221;off&#8221; button_two_text_size__hover_enabled=&#8221;off&#8221; button_text_color__hover_enabled=&#8221;off&#8221; button_one_text_color__hover_enabled=&#8221;off&#8221; button_two_text_color__hover_enabled=&#8221;off&#8221; button_border_width__hover_enabled=&#8221;off&#8221; button_one_border_width__hover_enabled=&#8221;off&#8221; button_two_border_width__hover_enabled=&#8221;off&#8221; button_border_color__hover_enabled=&#8221;off&#8221; button_one_border_color__hover_enabled=&#8221;off&#8221; button_two_border_color__hover_enabled=&#8221;off&#8221; button_border_radius__hover_enabled=&#8221;off&#8221; button_one_border_radius__hover_enabled=&#8221;off&#8221; button_two_border_radius__hover_enabled=&#8221;off&#8221; button_letter_spacing__hover_enabled=&#8221;on&#8221; button_one_letter_spacing__hover_enabled=&#8221;off&#8221; button_two_letter_spacing__hover_enabled=&#8221;off&#8221; button_bg_color__hover_enabled=&#8221;off&#8221; button_one_bg_color__hover_enabled=&#8221;off&#8221; button_two_bg_color__hover_enabled=&#8221;off&#8221; button_letter_spacing__hover=&#8221;2px&#8221;][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; next_background_color=&#8221;#ffffff&#8221; _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_stops=&#8221;#41b6e6 0%|#298fc2 100%&#8221; custom_padding=&#8221;3px||42px|||&#8221; bottom_divider_style=&#8221;slant2&#8243; bottom_divider_flip=&#8221;horizontal&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.21.0&#8243; custom_padding=&#8221;||4px|||&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.21.0&#8243; text_font=&#8221;opensans-regular||||||||&#8221; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;1.8em&#8221; link_font=&#8221;||||||||&#8221; ul_font=&#8221;||||||||&#8221; ol_font=&#8221;||||||||&#8221; quote_font=&#8221;||||||||&#8221; header_font=&#8221;||||||||&#8221; header_2_font=&#8221;overpass-extralight|200|||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_3_font=&#8221;||||||||&#8221; header_4_font=&#8221;||||||||&#8221; header_5_font=&#8221;||||||||&#8221; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;22px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2 style=\"text-align: center;\">Our Expertise<\/h2>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||1px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#FFFFFF&#8221; text_font_size=&#8221;16px&#8221; link_text_color=&#8221;#FFFFFF&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_3_text_color=&#8221;#FFFFFF&#8221; background_color=&#8221;rgba(255,255,255,0.24)&#8221; custom_padding=&#8221;30px|30px|30px|30px|false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><span style=\"font-weight: 400;\">Software Development<\/span><\/h3>\n<ul>\n<li><span style=\"font-weight: 400;\">Mobile Apps<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Web Applications<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Desktop Applications<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Backend Components<\/span><\/li>\n<li><strong><span style=\"text-decoration: underline;\"><a href=\"https:\/\/quickbirdmedical.com\/en\/embedded-software-medical-devices\/\">Embedded Systems<\/a><\/span><\/strong><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#FFFFFF&#8221; text_font_size=&#8221;16px&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_3_text_color=&#8221;#FFFFFF&#8221; background_color=&#8221;rgba(255,255,255,0.24)&#8221; custom_padding=&#8221;30px|30px|30px|30px|false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><span style=\"font-weight: 400;\">Information Security<\/span><\/h3>\n<ul>\n<li>\n<p class=\"md-end-block md-p\"><span class=\"md-plain\">Certified Cyber Security according to ISO 27001, IEC 81001-5-1, MDCG 2019-16<\/span><\/p>\n<\/li>\n<li>\n<p class=\"md-end-block md-p\"><span class=\"md-plain\">Penetration Tests according to OWASP &amp; BSI TR-03161<\/span><\/p>\n<\/li>\n<li>\n<p class=\"md-end-block md-p\"><span class=\"md-plain\">Information Security Management<\/span><\/p>\n<\/li>\n<li>\n<p class=\"md-end-block md-p\"><span class=\"md-plain\">GDPR Compliance<\/span><\/p>\n<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;||50px||false|false&#8221; custom_margin_tablet=&#8221;||50px||false|false&#8221; custom_margin_phone=&#8221;-2px|auto|50px|auto|false|false&#8221; custom_margin_last_edited=&#8221;on|tablet&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#FFFFFF&#8221; text_font_size=&#8221;16px&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_3_text_color=&#8221;#FFFFFF&#8221; background_color=&#8221;rgba(255,255,255,0.24)&#8221; custom_padding=&#8221;30px|30px|30px|30px|false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><span style=\"font-weight: 400;\">Technical Documentation according to IVDR<\/span><\/h3>\n<ul>\n<li>Quality Management (ISO 13485)<\/li>\n<li>Software Lifecycle Processes (IEC 62304)<\/li>\n<li>Risk Management (ISO 14971)<\/li>\n<li>Usability Engineering (IEC 62366)<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#FFFFFF&#8221; text_font_size=&#8221;16px&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_3_text_color=&#8221;#FFFFFF&#8221; background_color=&#8221;rgba(255,255,255,0.24)&#8221; custom_padding=&#8221;30px|30px|30px|30px|false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><span style=\"font-weight: 400;\">Regulatory Consulting<\/span><\/h3>\n<ul>\n<li>Approval as an in vitro diagnostic device according to IVDR<\/li>\n<li>Classification of in vitro diagnostic medical devices<\/li>\n<li>Identification and Implementation of IVDR Requirements<\/li>\n<li>Validation of IVD Products<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; custom_padding=&#8221;3px||100px|||&#8221; bottom_divider_style=&#8221;slant2&#8243; bottom_divider_color=&#8221;#41b6e6&#8243; bottom_divider_flip=&#8221;horizontal&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||0px||false|false&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.16&#8243; text_font=&#8221;Lato||||||||&#8221; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; link_font=&#8221;||||||||&#8221; ul_font=&#8221;||||||||&#8221; ol_font=&#8221;||||||||&#8221; quote_font=&#8221;||||||||&#8221; header_font=&#8221;||||||||&#8221; header_2_font=&#8221;|700|||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_3_font=&#8221;||||||||&#8221; header_4_font=&#8221;||||||||&#8221; header_5_font=&#8221;||||||||&#8221; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;||2px|||&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;22px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; inline_fonts=&#8221;overpass-extralight,overpass-bold&#8221; global_colors_info=&#8221;{}&#8221; header_2_text_color__hover_enabled=&#8221;on&#8221;]<\/p>\n<h2 style=\"text-align: center;\"><span style=\"color: #41b6e6; font-family: overpass-extralight;\">Our Process<\/span><\/h2>\n<p style=\"text-align: center;\">[\/et_pb_text][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; global_colors_info=&#8221;{}&#8221;]We are at your side from the initial concept design to the operation of your IVD software. We flexibly adapt our services to the respective stage of your project in order to provide exactly the services you need.<br \/>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;1&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;60%&#8221; width_tablet=&#8221;80%&#8221; width_phone=&#8221;80%&#8221; width_last_edited=&#8221;on|tablet&#8221; custom_padding=&#8221;|0px|0px|0px|false|false&#8221; animation_style=&#8221;zoom&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|25px|||false|false&#8221; custom_padding_tablet=&#8221;|0px|||false|false&#8221; custom_padding_phone=&#8221;|0px|||false|false&#8221; custom_padding_last_edited=&#8221;on|desktop&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/Konzeption.webp&#8221; alt=&#8221;Graphic Concept&#8221; title_text=&#8221;Concept&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#8221; width_tablet=&#8221;50%&#8221; width_phone=&#8221;80%&#8221; width_last_edited=&#8221;on|tablet&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; custom_padding=&#8221;|15px|||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3>1. Conception<\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Requirements Analysis<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Definition of the Intended Purpose<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Planning of the System Architecture<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Selection of suitable Technologies<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Determination of Regulatory Strategy<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|||25px|false|false&#8221; custom_padding_tablet=&#8221;|||0px|false|false&#8221; custom_padding_phone=&#8221;|||0px|false|false&#8221; custom_padding_last_edited=&#8221;on|desktop&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/2-Planning.webp&#8221; alt=&#8221;Grafik Planning&#8221; title_text=&#8221;2-Planning&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#8221; width_tablet=&#8221;50%&#8221; width_phone=&#8221;80%&#8221; width_last_edited=&#8221;on|tablet&#8221; custom_margin=&#8221;|||0px|false|false&#8221; custom_padding=&#8221;|||0px|false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><span style=\"font-weight: 400;\">2. Planning<\/span><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Project Planning<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Definition of the Project Team<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clarification of Responsibilities<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identification of Requirements (technical and regulatory)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Prioritization of Functions<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Risk Analysis &amp; Planning of Control Measures (IT security and patient safety)<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;1&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;60%&#8221; width_tablet=&#8221;80%&#8221; width_phone=&#8221;80%&#8221; width_last_edited=&#8221;on|tablet&#8221; custom_padding=&#8221;||0px|||&#8221; animation_style=&#8221;zoom&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|25px|||false|false&#8221; custom_padding_tablet=&#8221;|0px|||false|false&#8221; custom_padding_phone=&#8221;|0px|||false|false&#8221; custom_padding_last_edited=&#8221;on|desktop&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/3-Development-and-Documentation.webp&#8221; alt=&#8221;Graphic Development and Documentation&#8221; title_text=&#8221;3-Development-and-Documentation&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#8221; width_tablet=&#8221;50%&#8221; width_phone=&#8221;80%&#8221; width_last_edited=&#8221;on|tablet&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; custom_padding=&#8221;|15px|||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><span style=\"font-weight: 400;\">3. Development &amp; Documentation<\/span><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Technical Implementation of Requirements<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Agile Development of IVD Software<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Compliance with IVDR Requirements<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Regulatory Compliance of Documentation<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Product Labeling<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|||25px|false|false&#8221; custom_padding_tablet=&#8221;|||0px|false|false&#8221; custom_padding_phone=&#8221;|||0px|false|false&#8221; custom_padding_last_edited=&#8221;on|desktop&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/4-Verification.webp&#8221; alt=&#8221;Icon Verification&#8221; title_text=&#8221;4-Verification&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#8221; width_tablet=&#8221;50%&#8221; width_phone=&#8221;80%&#8221; width_last_edited=&#8221;on|tablet&#8221; custom_margin=&#8221;|||0px|false|false&#8221; custom_padding=&#8221;|||0px|false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><span style=\"font-weight: 400;\">4. Verification &amp; Validation<\/span><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Software Tests<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Clinical Evaluation and Testing<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Penetration Testing<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Safety Inspections<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;1&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;60%&#8221; width_tablet=&#8221;80%&#8221; width_phone=&#8221;80%&#8221; width_last_edited=&#8221;on|tablet&#8221; custom_padding=&#8221;||0px|||&#8221; animation_style=&#8221;zoom&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|25px|||false|false&#8221; custom_padding_tablet=&#8221;|0px|||false|false&#8221; custom_padding_phone=&#8221;|0px|||false|false&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/5-Medical-Software.webp&#8221; alt=&#8221;Graphic Medical Software&#8221; title_text=&#8221;5-Medical-Software&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#8221; width_tablet=&#8221;50%&#8221; width_phone=&#8221;80%&#8221; width_last_edited=&#8221;on|tablet&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; custom_padding=&#8221;|15px|||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><span style=\"font-weight: 400;\">5. Approval as an In Vitro Diagnostic Device<\/span><\/h3>\n<ul>\n<li class=\"md-end-block md-p md-focus\"><span class=\"md-plain md-expand\">CE Certification<\/span><\/li>\n<li class=\"md-end-block md-p md-focus\"><span class=\"md-plain\">Generation of a UDI Number<\/span><\/li>\n<li class=\"md-end-block md-p md-focus\"><span class=\"md-plain\">Product Registration (EUDAMED)<\/span><\/li>\n<li class=\"md-end-block md-p md-focus\"><span class=\"md-plain\">Support for the Audit by Notified Bodies <\/span><\/li>\n<li class=\"md-end-block md-p md-focus\"><span class=\"md-plain md-expand\">Support for Monitoring by Supervisory Authorities<\/span><\/li>\n<li style=\"list-style-type: none;\"><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;|||25px|false|false&#8221; custom_padding_tablet=&#8221;|||0px|false|false&#8221; custom_padding_phone=&#8221;|||0px|false|false&#8221; custom_padding_last_edited=&#8221;on|desktop&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2023\/02\/7-Maintanance.png&#8221; alt=&#8221;Icon Verification&#8221; title_text=&#8221;7-Maintanance&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#8221; width_tablet=&#8221;50%&#8221; width_phone=&#8221;80%&#8221; width_last_edited=&#8221;on|tablet&#8221; custom_margin=&#8221;|||0px|false|false&#8221; custom_padding=&#8221;|||0px|false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><span style=\"font-weight: 400;\">6. After Approval<\/span><\/h3>\n<ul>\n<li class=\"md-end-block md-p md-focus\"><span class=\"md-plain md-expand\">Technical Development and Change Management<\/span><\/li>\n<li class=\"md-end-block md-p md-focus\"><span class=\"md-plain\">User Support<\/span><\/li>\n<li class=\"md-end-block md-p md-focus\"><span class=\"md-plain\">Maintenance of the IVD Software<\/span><\/li>\n<li class=\"md-end-block md-p md-focus\"><span class=\"md-plain\">Post-market Surveillance (PMS)<\/span><\/li>\n<li class=\"md-end-block md-p md-focus\"><span class=\"md-plain\">Post-market Clinical Follow-up (PMCF)<\/span><\/li>\n<li class=\"md-end-block md-p md-focus\"><span class=\"md-plain md-expand\">Incident Reporting (Vigilance)<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|desktop&#8221; disabled_on=&#8221;off|off|off&#8221; admin_label=&#8221;Feature&#8221; _builder_version=&#8221;4.21.0&#8243; background_color=&#8221;#345168&#8243; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_stops=&#8221;#41B6E6 5%|#298FC2 100%&#8221; background_color_gradient_overlays_image=&#8221;on&#8221; background_color_gradient_start=&#8221;#41B6E6&#8243; background_color_gradient_start_position=&#8221;5%&#8221; background_color_gradient_end=&#8221;#298FC2&#8243; background_enable_image=&#8221;off&#8221; custom_padding=&#8221;0%||7%||false|false&#8221; custom_padding_tablet=&#8221;||12%||false|false&#8221; custom_padding_phone=&#8221;||18%||false|false&#8221; top_divider_color=&#8221;#FFFFFF&#8221; bottom_divider_style=&#8221;slant2&#8243; bottom_divider_color=&#8221;#ffffff&#8221; bottom_divider_flip=&#8221;horizontal&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||0px|||&#8221; animation_style=&#8221;slide&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text content_tablet=&#8221;<\/p>\n<h2 style=%22text-align: center;%22>IVD Software Types<\/h2>\n<p>&#8221; content_phone=&#8221;<\/p>\n<h2 style=%22text-align: center;%22>IVD Software Types<\/h2>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#FFFFFF&#8221; text_font_size=&#8221;18px&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_2_text_color=&#8221;#FFFFFF&#8221; header_2_font_size=&#8221;40px&#8221; custom_margin=&#8221;||3px|||&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h2 style=\"text-align: center;\">IVD Software Types<\/h2>\n<p>[\/et_pb_text][et_pb_text content_tablet=&#8221;<\/p>\n<p>We develop various types of software solutions for in vitro diagnostic medical devices (IVDR) that are tailored to your specific requirements and area of application. Whether you need <strong>standalone software<\/strong>, <strong>embedded software <\/strong>or <strong>control software for devices<\/strong>, we offer customized solutions that guarantee the highest quality and compliance.<\/p>\n<p>&#8221; content_phone=&#8221;<\/p>\n<p>We develop various types of software solutions for in vitro diagnostic medical devices (IVDR) that are tailored to your specific requirements and area of application. Whether you need <strong>standalone software<\/strong>, <strong>embedded software <\/strong>or <strong>control software for devices<\/strong>, we offer customized solutions that guarantee the highest quality and compliance.<\/p>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#FFFFFF&#8221; text_font_size=&#8221;18px&#8221; header_text_color=&#8221;#FFFFFF&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p>We develop various types of software solutions for in vitro diagnostic medical devices (IVDR) that are tailored to your specific requirements and area of application. Whether you need <strong>standalone software<\/strong>, <strong>embedded software <\/strong>or <strong>control software for devices<\/strong>, we offer customized solutions that guarantee the highest quality and compliance.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,1_3,1_3&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/12\/IVDR_Standalone-Software-1.webp&#8221; alt=&#8221;IVDR Standalone Software&#8221; title_text=&#8221;IVDR_Standalone Software&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;||30px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; header_3_text_color=&#8221;#FFFFFF&#8221; header_3_font_size=&#8221;24px&#8221; custom_margin=&#8221;||1px|||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3 style=\"text-align: left;\"><strong>Standalone Software<\/strong><\/h3>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.21.0&#8243; text_text_color=&#8221;#FFFFFF&#8221; text_font_size=&#8221;18px&#8221; header_text_color=&#8221;#FFFFFF&#8221; inline_fonts=&#8221;overpass-extralight,overpass-bold&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: left;\">Standalone software solutions are independent applications that operate independently of other systems. This type of software is often used in clinical environments to support diagnoses or enable analysis processes. We ensure that this software is not only user-friendly and reliable, but also meets all regulatory requirements of the IVDR.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/12\/IVDR_Embedded-Software.webp&#8221; alt=&#8221;IVDR Embedded Software&#8221; title_text=&#8221;IVDR_Embedded Software&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; header_3_text_color=&#8221;#FFFFFF&#8221; header_3_font_size=&#8221;24px&#8221; custom_margin=&#8221;||1px|||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3 style=\"text-align: left;\"><strong>Embedded Software<\/strong><\/h3>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.21.0&#8243; text_text_color=&#8221;#FFFFFF&#8221; text_font_size=&#8221;18px&#8221; link_text_color=&#8221;#FFFFFF&#8221; header_text_color=&#8221;#FFFFFF&#8221; inline_fonts=&#8221;overpass-extralight,overpass-bold&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: left;\">For IVDR devices that work with integrated software, we offer customized embedded solutions. This software is integrated as part of an in vitro diagnostic device and implements the core functionality. For more information about our embedded software services, please visit our <span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/quickbirdmedical.com\/en\/embedded-software-medical-devices\/\">Embedded Software Service page.<\/a><\/strong><\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/12\/IVDR-Software-Steuerung-fuer-Geraete.webp&#8221; alt=&#8221;IVDR Control Software for Devices&#8221; title_text=&#8221;IVDR Control Software for Devices&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; header_3_text_color=&#8221;#FFFFFF&#8221; header_3_font_size=&#8221;24px&#8221; custom_margin=&#8221;||1px|||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3 style=\"text-align: left;\"><strong>Control Software for Devices<\/strong><\/h3>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.21.0&#8243; text_text_color=&#8221;#FFFFFF&#8221; text_font_size=&#8221;18px&#8221; header_text_color=&#8221;#FFFFFF&#8221; inline_fonts=&#8221;overpass-extralight,overpass-bold&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: left;\">Control software is responsible for the direct control and operation of IVD devices. It ensures that the device works reliably and that all diagnostic processes are carried out correctly. We guarantee full compliance with IVDR requirements so that your devices can be used safely and efficiently.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; custom_padding=&#8221;3px|||||&#8221; bottom_divider_style=&#8221;slant2&#8243; bottom_divider_color=&#8221;#41b6e6&#8243; bottom_divider_flip=&#8221;horizontal&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;4px||4px|||&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.21.0&#8243; text_font=&#8221;Lato||||||||&#8221; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; link_font=&#8221;||||||||&#8221; ul_font=&#8221;||||||||&#8221; ol_font=&#8221;||||||||&#8221; quote_font=&#8221;||||||||&#8221; header_font=&#8221;||||||||&#8221; header_2_font=&#8221;Lato|700|||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_3_font=&#8221;||||||||&#8221; header_4_font=&#8221;||||||||&#8221; header_5_font=&#8221;||||||||&#8221; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; custom_padding=&#8221;21px|||||&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;22px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; inline_fonts=&#8221;overpass-extralight,overpass-bold&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2 style=\"text-align: center;\"><span style=\"color: #41b6e6; font-family: overpass-extralight;\">What makes us special <\/span><\/h2>\n<p style=\"text-align: center;\">[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,1_3,1_3&#8243; custom_padding_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.21.0&#8243; custom_margin=&#8221;|||&#8221; custom_margin_tablet=&#8221;|||&#8221; custom_margin_phone=&#8221;|||&#8221; custom_margin_last_edited=&#8221;off|desktop&#8221; custom_padding=&#8221;1px|0px|50px|0px|false|false&#8221; custom_padding_tablet=&#8221;27px|0px|50px|0px|false|false&#8221; custom_padding_phone=&#8221;3px|0px|50px|0px|false|false&#8221; animation_style=&#8221;slide&#8221; use_custom_width=&#8221;on&#8221; custom_width_px=&#8221;1552px&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_blurb title=&#8221;ISO 13485 certified&#8221; image=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/ISO-13485-Siegel.webp&#8221; alt=&#8221;ISO 13485 Siegel&#8221; image_icon_width=&#8221;100%&#8221; _builder_version=&#8221;4.21.0&#8243; header_level=&#8221;h3&#8243; header_font=&#8221;overpass-bold|700|||||||&#8221; header_text_align=&#8221;left&#8221; header_text_color=&#8221;#41b6e6&#8243; header_font_size=&#8221;20px&#8221; header_line_height=&#8221;1.7em&#8221; body_text_color=&#8221;#333333&#8243; body_font_size=&#8221;18px&#8221; body_line_height=&#8221;2em&#8221; image_icon_custom_margin=&#8221;||-25px||false|false&#8221; animation_style=&#8221;zoom&#8221; animation_intensity_zoom=&#8221;10%&#8221; animation=&#8221;off&#8221; inline_fonts=&#8221;overpass-extralightttf&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Our quality management system is certified according to ISO 13485. This ensures that we develop software for in vitro diagnostics in compliance with regulations and meet the requirements of the IVDR for quality management systems.<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_blurb title=&#8221;External placing on the market&#8221; image=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/legal-manufacturer-badge.png&#8221; alt=&#8221;Legal Manufacturer Siegel&#8221; image_icon_width=&#8221;100%&#8221; _builder_version=&#8221;4.21.0&#8243; header_level=&#8221;h3&#8243; header_font=&#8221;overpass-bold|700|||||||&#8221; header_text_align=&#8221;left&#8221; header_text_color=&#8221;#41b6e6&#8243; header_font_size=&#8221;20px&#8221; header_line_height=&#8221;1.7em&#8221; body_text_color=&#8221;#333333&#8243; body_font_size=&#8221;18px&#8221; body_line_height=&#8221;2em&#8221; image_icon_custom_margin=&#8221;||-25px||false|false&#8221; animation_style=&#8221;zoom&#8221; animation_intensity_zoom=&#8221;10%&#8221; animation=&#8221;off&#8221; inline_fonts=&#8221;overpass-extralightttf&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Upon request, we can assume the role of legal manufacturer for your IVDR software product. We bear legal responsibility for compliance with all regulatory requirements of the IVDR, allowing you to concentrate on your core competencies such as sales and marketing.<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_blurb title=&#8221;ISO 27001 certified&#8221; image=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/ISO-27001-Siegel.webp&#8221; alt=&#8221;ISO 27001 Siegel&#8221; image_icon_width=&#8221;100%&#8221; _builder_version=&#8221;4.21.0&#8243; header_level=&#8221;h3&#8243; header_font=&#8221;overpass-bold|700|||||||&#8221; header_text_align=&#8221;left&#8221; header_text_color=&#8221;#41b6e6&#8243; header_font_size=&#8221;20px&#8221; header_line_height=&#8221;1.7em&#8221; body_text_color=&#8221;#333333&#8243; body_font_size=&#8221;18px&#8221; body_line_height=&#8221;2em&#8221; image_icon_custom_margin=&#8221;||-25px||false|false&#8221; animation_style=&#8221;zoom&#8221; animation_intensity_zoom=&#8221;10%&#8221; animation=&#8221;off&#8221; inline_fonts=&#8221;overpass-extralightttf&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>QuickBird Medical is ISO 27001 certified for information security. 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data-navheight=\"16\" data-navspacing=\"8\" data-hoveroverlayimage=\"\" data-lightboxthumbwidth=\"90\" data-lightboxthumbheight=\"60\" data-lightboxthumbtopmargin=\"12\" data-lightboxthumbbottommargin=\"4\" data-lightboxbarheight=\"64\" data-lightboxtitlebottomcss=\"{color:#333; font-size:14px; font-family:Armata,sans-serif,Arial; overflow:hidden; text-align:left;}\" data-lightboxdescriptionbottomcss=\"{color:#333; font-size:12px; font-family:Arial,Helvetica,sans-serif; overflow:hidden; text-align:left; margin:4px 0px 0px; padding: 0px;}\" data-continuousduration=\"5000\" data-autoplaydir=\"left\" data-scrollmode=\"item\" data-interval=\"3000\" data-transitionduration=\"1000\" data-lightboxtitlestyle=\"bottom\" data-lightboximagepercentage=\"75\" data-lightboxdefaultvideovolume=\"1\" data-lightboxoverlaybgcolor=\"#000\" data-lightboxoverlayopacity=\"0.9\" data-lightboxbgcolor=\"#fff\" data-lightboxtitleprefix=\"%NUM \/ %TOTAL\" data-lightboxtitleinsidecss=\"color:#fff; font-size:16px; font-family:Arial,Helvetica,sans-serif; overflow:hidden; text-align:left;\" data-lightboxdescriptioninsidecss=\"color:#fff; font-size:12px; font-family:Arial,Helvetica,sans-serif; overflow:hidden; text-align:left; margin:4px 0px 0px; padding: 0px;\" data-playvideoimage=\"playvideo-64-64-0.png\" data-playvideoimagepos=\"center\" data-imgtitle=\"title\" data-circularlimit=\"3\" data-deferloadingdelay=\"0\" data-firstlasthalfsmallscreen=\"640\" data-hidebulletssmallscreensize=\"480\" data-movemode=\"carousel\" data-moveduration=\"500\" data-ga4account=\"\" data-googleanalyticsaccount=\"\" data-cookiehours=\"24\" data-lightboxsocialposition=\"position:absolute;top:100%;right:0;\" data-lightboxsocialpositionsmallscreen=\"position:absolute;top:100%;right:0;left:0;\" data-lightboxsocialdirection=\"horizontal\" data-lightboxsocialbuttonsize=\"32\" data-lightboxsocialbuttonfontsize=\"18\" data-sameheightmediumscreen=\"769\" data-sameheightmediumheight=\"125\" data-sameheightsmallscreen=\"415\" data-sameheightsmallheight=\"100\" data-triggerresizedelay=\"5\" data-lightboxslideinterval=\"5000\" data-lightboxtimerposition=\"bottom\" data-lightboxtimercolor=\"#dc572e\" data-lightboxtimeropacity=\"1\" data-lightboxbordersize=\"8\" data-lightboxborderradius=\"0\" data-screenquery='{ \"tablet\": { \"screenwidth\": 800, \"visibleitems\": 4 }, \"mobile\": { \"screenwidth\": 480, \"visibleitems\": 4 } }' data-jsfolder=\"https:\/\/quickbirdmedical.com\/wp-content\/plugins\/wonderplugin-carousel\/engine\/\" style=\"display:none;position:relative;margin:0 auto;width:100%;max-width:450px;\" ><div class=\"amazingcarousel-list-container\" style=\"overflow:hidden;\"><ul class=\"amazingcarousel-list\"><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Barmer.png\" alt=\"Logo Barmer\" data-title=\"Logo Barmer\" data-description=\"\" \/><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-DAK.png\" data-title=\"Logo DAK\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-DAK.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-DAK.png\" alt=\"Logo DAK\" data-title=\"Logo DAK\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Novartis.png\" data-title=\"Logo Novartis\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Novartis.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Novartis.png\" alt=\"Logo Novartis\" data-title=\"Logo Novartis\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Hyundai.png\" data-title=\"Logo Hyundai\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Hyundai.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Hyundai.png\" alt=\"Logo Hyundai\" data-title=\"Logo Hyundai\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-TK.png\" data-title=\"Logo TK\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-TK.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-TK.png\" alt=\"Logo TK\" data-title=\"Logo TK\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Takeda.png\" data-title=\"Logo Takeda\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Takeda.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Takeda.png\" alt=\"Logo Takeda\" data-title=\"Logo Takeda\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/09\/Logo-sidekick-health-2.svg\" data-title=\"Logo sidekick health\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/09\/Logo-sidekick-health-2.svg\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/09\/Logo-sidekick-health-2.svg\" alt=\"Logo sidekick health\" data-title=\"Logo sidekick health\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/11\/Logo-Dexcom.svg\" data-title=\"Logo Dexcom\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/11\/Logo-Dexcom.svg\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/11\/Logo-Dexcom.svg\" alt=\"Logo Dexcom\" data-title=\"Logo Dexcom\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Lufthansa.png\" data-title=\"Logo Lufthansa\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Lufthansa.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Lufthansa.png\" alt=\"Logo Lufthansa\" data-title=\"Logo Lufthansa\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-AOP.png\" data-title=\"Logo AOP\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-AOP.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-AOP.png\" alt=\"Logo AOP\" data-title=\"Logo AOP\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-LMU-Klinikum-1.png\" data-title=\"Logo LMU Klinikum\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-LMU-Klinikum-1.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-LMU-Klinikum-1.png\" alt=\"Logo LMU Klinikum\" data-title=\"Logo LMU Klinikum\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-TUM-Universitaetsklinikum-1.png\" data-title=\"Logo TUM Universita\u0308tsklinikum\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-TUM-Universitaetsklinikum-1.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-TUM-Universitaetsklinikum-1.png\" alt=\"Logo TUM Universita\u0308tsklinikum\" data-title=\"Logo TUM Universita\u0308tsklinikum\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Charite.png\" data-title=\"Logo Charite\u0301\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Charite.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Charite.png\" alt=\"Logo Charite\u0301\" data-title=\"Logo Charite\u0301\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Biogen.png\" data-title=\"Logo Biogen\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Biogen.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Biogen.png\" alt=\"Logo Biogen\" data-title=\"Logo Biogen\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Uniklinikum-Erlangen.png\" data-title=\"Logo Uniklinikum Erlangen\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Uniklinikum-Erlangen.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Uniklinikum-Erlangen.png\" alt=\"Logo Uniklinikum Erlangen\" data-title=\"Logo Uniklinikum Erlangen\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Indivior.png\" data-title=\"Logo Indivior\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Indivior.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Indivior.png\" alt=\"Logo Indivior\" data-title=\"Logo Indivior\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Max-Planck-Gesellschaft-1.png\" data-title=\"Logo Max-Planck-Gesellschaft\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Max-Planck-Gesellschaft-1.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Max-Planck-Gesellschaft-1.png\" alt=\"Logo Max-Planck-Gesellschaft\" data-title=\"Logo Max-Planck-Gesellschaft\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-vdek-1.png\" data-title=\"Logo vdek\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-vdek-1.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-vdek-1.png\" alt=\"Logo vdek\" data-title=\"Logo vdek\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Labor-Becker-1.png\" data-title=\"Logo Labor Becker\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Labor-Becker-1.png\" class=\"wondercarousellightbox wondercarousellightbox-1\" data-group=\"wondercarousellightbox-1\" data-mediatype=0><img decoding=\"async\" class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Labor-Becker-1.png\" alt=\"Logo Labor Becker\" data-title=\"Logo Labor Becker\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><li class=\"amazingcarousel-item\"><div class=\"amazingcarousel-item-container\"><div class=\"amazingcarousel-flipout\">\n\t<div class=\"amazingcarousel-image\"><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Universitaet-Witten-Herdecke-1.png\" data-title=\"Logo Universita\u0308t Witten-Herdecke\" data-thumbnail=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Universitaet-Witten-Herdecke-1.png\" class=\"wondercarousellightbox 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class=\"amazingcarousel-image-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Logo-Sportsclinic-Cologne-1.png\" alt=\"Logo Sportsclinic Cologne\" data-title=\"Logo Sportsclinic Cologne\" data-description=\"\" \/><\/a><\/div>\n<\/div><\/div><\/li><\/ul><div class=\"amazingcarousel-prev\"><\/div><div class=\"amazingcarousel-next\"><\/div><\/div><div class=\"amazingcarousel-nav\"><\/div><\/div><\/div><script>jQuery(document).ready(function(){setTimeout(function(){jQuery(window).trigger(\"resize\");},5);});<\/script><div class=\"wondercarousellightbox_options\" data-skinsfoldername=\"\"  data-jsfolder=\"https:\/\/quickbirdmedical.com\/wp-content\/plugins\/wonderplugin-carousel\/engine\/\" style=\"display:none;\"><\/div>\r\n<style>#wonderplugincarousel-4 .amazingcarousel-image {\t \tposition: relative;         pointer-events: none; }  #wonderplugincarousel-4 .amazingcarousel-image img { \tdisplay: block; \twidth: 100%; \tmax-width: 100%; \tborder: 0; \tmargin: 0; 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[&hellip;]<\/p>\n","protected":false},"author":22,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"class_list":["post-24173","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Development of Software for In Vitro Diagnostic Medical Devices (IVDR)<\/title>\n<meta name=\"description\" content=\"We offer specialized software development for IVDR products and ensure compliance and the highest quality in all development phases.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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