{"id":19103,"date":"2025-05-20T07:52:26","date_gmt":"2025-05-20T07:52:26","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?page_id=19103"},"modified":"2026-01-23T09:22:47","modified_gmt":"2026-01-23T09:22:47","slug":"ai-medicine-software-app-development","status":"publish","type":"page","link":"https:\/\/quickbirdmedical.com\/en\/ai-medicine-software-app-development\/","title":{"rendered":"Development of AI Software in Medicine \u2013 Landing page"},"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_style=&#8221;slide&#8221; animation_direction=&#8221;top&#8221; animation_intensity_slide=&#8221;2%&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_fullwidth_header title=&#8221;Development of Medical AI Systems in accordance with MDR &#038; AI Act&#8221; button_one_text=&#8221;CONTACT US&#8221; button_one_url=&#8221;https:\/\/quickbirdmedical.com\/en\/kontakt\/&#8221; 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; 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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; button_two_custom_margin_tablet=&#8221;&#8221; button_two_custom_margin_phone=&#8221;||30px|-15px|false|false&#8221; button_two_custom_margin_last_edited=&#8221;on|phone&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;||6%||false|false&#8221; custom_padding_tablet=&#8221;&#8221; custom_padding_phone=&#8221;||12%||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; background__hover_enabled=&#8221;off|desktop&#8221;]<\/p>\n<p class=\"p1\">We develop customized AI-based software solutions for companies in the healthcare industry\u2014certified <strong>according to ISO 13485 and ISO 27001<\/strong>.<\/p>\n<p>Our team in Munich has in-depth technical expertise in artificial intelligence \u2013 from classic <strong>machine learning methods<\/strong> to specialized <strong>LLMs<\/strong> and <strong>explainable AI<\/strong>.<\/p>\n<p>In doing so, we ensure <strong>regulatory<\/strong> compliance in accordance with <strong>MDR<\/strong>, <strong>GDPR<\/strong>, and the <strong>EU AI Act<\/strong>.<\/p>\n<p>[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|phone&#8221; disabled_on=&#8221;off|off|off&#8221; 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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; custom_padding_last_edited=&#8221;on|phone&#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%||6%||false|false&#8221; custom_padding_tablet=&#8221;||9%||false|false&#8221; custom_padding_phone=&#8221;||9%||false|false&#8221; 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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;||0px|||&#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 Services:<br \/>Technical Planning &amp; Implementation<\/h2>\n<p>[\/et_pb_text][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; text_orientation=&#8221;center&#8221; custom_margin=&#8221;||21px|||&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p>We implement AI solutions that are secure and reliable.<\/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; max_width=&#8221;1324px&#8221; custom_padding=&#8221;0|0px|3px|0px|false|false&#8221; use_custom_width=&#8221;on&#8221; custom_width_px=&#8221;1324px&#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_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/12\/Our-services-6.svg&#8221; alt=&#8221;Grafik Agilit\u00e4t&#8221; title_text=&#8221;Our services 6&#8243; align=&#8221;center&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.21.0&#8243; max_width=&#8221;65%&#8221; max_width_tablet=&#8221;40%&#8221; max_width_phone=&#8221;65%&#8221; max_width_last_edited=&#8221;on|tablet&#8221; custom_margin=&#8221;||-2px|||&#8221; custom_padding=&#8221;||8px|||&#8221; animation_style=&#8221;zoom&#8221; global_colors_info=&#8221;{}&#8221;]&nbsp;<\/p>\n<p style=\"text-align: center;\">[\/et_pb_image][et_pb_blurb title=&#8221;Database &#038; Data Management&#8221; icon_placement=&#8221;left&#8221; content_max_width=&#8221;1100px&#8221; _builder_version=&#8221;4.21.0&#8243; header_font=&#8221;overpass-bold|700||on|||||&#8221; header_text_align=&#8221;center&#8221; header_font_size=&#8221;24px&#8221; header_line_height=&#8221;1.4em&#8221; body_font=&#8221;opensans-regular||||||||&#8221; body_text_align=&#8221;center&#8221; body_font_size=&#8221;16px&#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; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>We ensure a structured and cleanly versioned database\u2014the foundation of every medical AI application. In doing so, we consistently pay attention to data quality, GDPR compliance, and transparency of data origin.<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][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_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/12\/Our-services-7.svg&#8221; alt=&#8221;Graphic know-how&#8221; title_text=&#8221;Our services 7&#8243; align=&#8221;center&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.21.0&#8243; max_width=&#8221;65%&#8221; max_width_tablet=&#8221;40%&#8221; max_width_phone=&#8221;65%&#8221; max_width_last_edited=&#8221;on|tablet&#8221; custom_margin=&#8221;||-2px|||&#8221; custom_padding=&#8221;||0px|||&#8221; animation_style=&#8221;zoom&#8221; global_colors_info=&#8221;{}&#8221;]&nbsp;<\/p>\n<p style=\"text-align: center;\">[\/et_pb_image][et_pb_blurb title=&#8221;Model Development &#038; training&#8221; icon_placement=&#8221;left&#8221; content_max_width=&#8221;1100px&#8221; admin_label=&#8221;Informationstext&#8221; _builder_version=&#8221;4.21.0&#8243; header_font=&#8221;overpass-bold|700||on|||||&#8221; header_text_align=&#8221;center&#8221; header_font_size=&#8221;24px&#8221; header_line_height=&#8221;1.4em&#8221; body_font=&#8221;opensans-regular||||||||&#8221; body_text_align=&#8221;center&#8221; body_font_size=&#8221;16px&#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; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>We select suitable model architectures and train them on medically valid data sets. Through targeted preprocessing and hyperparameter tuning, we achieve robust, powerful models. <\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][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_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/01\/QB-Med-Competencies-4.webp&#8221; alt=&#8221;Graphic Design&#8221; title_text=&#8221;QB Med Competencies 2&#8243; align=&#8221;center&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.21.0&#8243; max_width=&#8221;65%&#8221; max_width_tablet=&#8221;40%&#8221; max_width_phone=&#8221;65%&#8221; max_width_last_edited=&#8221;on|tablet&#8221; custom_margin=&#8221;||-2px|||&#8221; animation_style=&#8221;zoom&#8221; global_colors_info=&#8221;{}&#8221;]&nbsp;<\/p>\n<p style=\"text-align: center;\">[\/et_pb_image][et_pb_blurb title=&#8221;Validation &#038; Testing&#8221; icon_placement=&#8221;left&#8221; content_max_width=&#8221;1100px&#8221; admin_label=&#8221;Informationstext&#8221; _builder_version=&#8221;4.21.0&#8243; header_font=&#8221;overpass-bold|700||on|||||&#8221; header_text_align=&#8221;center&#8221; header_font_size=&#8221;24px&#8221; header_line_height=&#8221;1.4em&#8221; body_font=&#8221;opensans-regular||||||||&#8221; body_text_align=&#8221;center&#8221; body_font_size=&#8221;16px&#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; global_colors_info=&#8221;{}&#8221; content__hover_enabled=&#8221;off|desktop&#8221;]<\/p>\n<p data-start=\"740\" data-end=\"945\" class=\"\">Our models undergo a systematic testing process with clear performance metrics and robustness testing. We rely on established metrics as well as bias testing and cross-validation for clinical validation. <\/p>\n<p>[\/et_pb_blurb][\/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; max_width=&#8221;1324px&#8221; custom_padding=&#8221;0|0px|30px|0px|false|false&#8221; use_custom_width=&#8221;on&#8221; custom_width_px=&#8221;1324px&#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_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/12\/Our-services-5.svg&#8221; alt=&#8221;Grafik Agilit\u00e4t&#8221; title_text=&#8221;Our services 5&#8243; align=&#8221;center&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.21.0&#8243; max_width=&#8221;65%&#8221; max_width_tablet=&#8221;40%&#8221; max_width_phone=&#8221;65%&#8221; max_width_last_edited=&#8221;on|tablet&#8221; custom_margin=&#8221;||-2px|||&#8221; custom_padding=&#8221;||0px|||&#8221; animation_style=&#8221;zoom&#8221; global_colors_info=&#8221;{}&#8221;]&nbsp;<\/p>\n<p style=\"text-align: center;\">[\/et_pb_image][et_pb_blurb title=&#8221;Explainability &#038; Transparency&#8221; icon_placement=&#8221;left&#8221; content_max_width=&#8221;1100px&#8221; _builder_version=&#8221;4.21.0&#8243; header_font=&#8221;overpass-bold|700||on|||||&#8221; header_text_align=&#8221;center&#8221; header_font_size=&#8221;24px&#8221; header_line_height=&#8221;1.4em&#8221; body_font=&#8221;opensans-regular||||||||&#8221; body_text_align=&#8221;center&#8221; body_font_size=&#8221;16px&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;-11px||0px||false|false&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>We develop explainable AI solutions that make medical decisions transparent. Interpretability, user comprehensibility, and audit trails are our focus. <\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][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_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/01\/QB-Med-Competencies-1.webp&#8221; alt=&#8221;Graphic know-how&#8221; title_text=&#8221;QB Med Competencies 1&#8243; align=&#8221;center&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.21.0&#8243; max_width=&#8221;65%&#8221; max_width_tablet=&#8221;40%&#8221; max_width_phone=&#8221;65%&#8221; max_width_last_edited=&#8221;on|tablet&#8221; custom_margin=&#8221;||-2px|||&#8221; custom_padding=&#8221;||0px|||&#8221; animation_style=&#8221;zoom&#8221; global_colors_info=&#8221;{}&#8221;]&nbsp;<\/p>\n<p style=\"text-align: center;\">[\/et_pb_image][et_pb_blurb title=&#8221;Operations &#038; MLOps&#8221; icon_placement=&#8221;left&#8221; content_max_width=&#8221;1100px&#8221; admin_label=&#8221;Informationstext&#8221; _builder_version=&#8221;4.21.0&#8243; header_font=&#8221;overpass-bold|700||on|||||&#8221; header_text_align=&#8221;center&#8221; header_font_size=&#8221;24px&#8221; header_line_height=&#8221;1.4em&#8221; body_font=&#8221;opensans-regular||||||||&#8221; body_text_align=&#8221;center&#8221; body_font_size=&#8221;16px&#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; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Our infrastructure enables continuous monitoring, automatic retraining, and drift detection. This ensures that the AI application remains stable, secure, and up to date in the long term. <\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][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_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/\/2025\/06\/Icon-Cyber-Security.svg&#8221; alt=&#8221;Icon-Cyber Security&#8221; title_text=&#8221;Icon-Cyber Security&#8221; align=&#8221;center&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.21.0&#8243; max_width=&#8221;65%&#8221; max_width_tablet=&#8221;40%&#8221; max_width_phone=&#8221;65%&#8221; max_width_last_edited=&#8221;on|tablet&#8221; custom_margin=&#8221;||-2px|||&#8221; animation_style=&#8221;zoom&#8221; global_colors_info=&#8221;{}&#8221;]&nbsp;<\/p>\n<p style=\"text-align: center;\">[\/et_pb_image][et_pb_blurb title=&#8221;Cyber Security&#8221; icon_placement=&#8221;left&#8221; content_max_width=&#8221;1100px&#8221; admin_label=&#8221;Informationstext&#8221; _builder_version=&#8221;4.21.0&#8243; header_font=&#8221;overpass-bold|700||on|||||&#8221; header_text_align=&#8221;center&#8221; header_font_size=&#8221;24px&#8221; header_line_height=&#8221;1.4em&#8221; body_font=&#8221;opensans-regular||||||||&#8221; body_text_align=&#8221;center&#8221; body_font_size=&#8221;16px&#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; global_colors_info=&#8221;{}&#8221; content__hover_enabled=&#8221;off|desktop&#8221;]<\/p>\n<p data-start=\"1430\" data-end=\"1619\" class=\"\">We integrate protection mechanisms against attacks such as data poisoning, model inversion, and extraction. We view security as an integral part of the development process. <\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.21.0&#8243; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;15px||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;4.16&#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|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;||-3px||false|false&#8221; custom_padding=&#8221;||5px|||&#8221; animation_direction=&#8221;bottom&#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 Service:<br \/>Regulatory Compliance<\/h2>\n<p>[\/et_pb_text][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; text_orientation=&#8221;center&#8221; custom_margin=&#8221;||21px|||&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p>We ensure regulatory compliance of the AI solution in all relevant aspects. This includes, among other things:<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_4,3_4&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; min_height_tablet=&#8221;&#8221; min_height_phone=&#8221;&#8221; min_height_last_edited=&#8221;on|tablet&#8221; custom_padding=&#8221;3px|||||&#8221; animation_style=&#8221;slide&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_4&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; background_position=&#8221;top_center&#8221; background_vertical_offset=&#8221;0%&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/\/2025\/05\/MDR.svg&#8221; alt=&#8221;MDR Icon&#8221; title_text=&#8221;MDR&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;center&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_css_main_element=&#8221;height: 100%;||object-fit: cover;&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;3_4&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_css_main_element=&#8221;display: flex;||align-items: center;||&#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; hover_enabled=&#8221;0&#8243; custom_css_main_element=&#8221;ul li {||  margin-bottom: 10px;||}&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<ul>\n<li><strong>Data protection in accordance with the GDPR<\/strong><br \/><span>(data protection impact assessment, privacy by design, data minimization, data subject rights, etc.)<\/span><\/li>\n<li><strong>Medical device regulations according to MDR<\/strong><br \/><span>(AI development taking into account ISO 13485, IEC 62304, ISO 14971, clinical evaluation according to MDR, PMS, etc.)<\/span><\/li>\n<li><strong>DiGA regulations according to DiGAV &amp; SGB V<\/strong><br \/><span>(evidence requirements, quality of medical content, patient safety, etc.)<\/span><\/li>\n<li><strong>AI Act<\/strong><br \/><span>(Risk classification, transparency requirements, data quality, human oversight, etc.)<\/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; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||89px||false|false&#8221; bottom_divider_style=&#8221;slant2&#8243; bottom_divider_color=&#8221;#1bb8ea&#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; 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;4.18.1&#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; 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;\">What really sets us apart<\/span><\/h2>\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;4.16&#8243; max_width=&#8221;1552px&#8221; 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;0px|0px|29px|0px|false|false&#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;24px&#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 as a medical device in compliance with regulations and meet the requirements of the MDR and FDA (21 CFR) 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;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;24px&#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><span style=\"font-weight: 400;\">QuickBird Medical is ISO 27001 certified for information security. We are experts in the areas of cybersecurity and health data protection.<\/span><\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][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;Legal Manufacturer for your Medical Device&#8221; image=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2023\/10\/manufacturer-final.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;24px&#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><span style=\"font-weight: 400;\">If required, we can take on the role of legal manufacturer for your medical device software. We therefore bear legal responsibility for compliance with all regulatory requirements of the MDR. This allows you to focus on your core competencies such as sales &amp; marketing.<\/span><\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#1bb8ea&#8221; 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;5%||11%||false|false&#8221; custom_padding_phone=&#8221;0.9%||25%||false|false&#8221; bottom_divider_style=&#8221;slant2&#8243; bottom_divider_color=&#8221;#FFFFFF&#8221; 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;15px||15px||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;4.21.0&#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;|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; 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: #ffffff;\">About QuickBird Medical<\/span><\/h2>\n<p style=\"text-align: center;\">[\/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; max_width=&#8221;1552px&#8221; 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;0px|0px|0px|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_2&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/02\/QuickBird-Medical_Geschaeftsfuehrer_Malte-Bucksch-und-Stefan-Kofler.webp&#8221; alt=&#8221;QuickBird Medical Managing Directors Malte Bucksch and Stefan Kofler&#8221; title_text=&#8221;QuickBird Medical_Gescha\u0308ftsfu\u0308hrer_Malte Bucksch und Stefan Kofler&#8221; align=&#8221;right&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][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; content_font_size_tablet=&#8221;16px&#8221; content_font_size_last_edited=&#8221;on|tablet&#8221; content_font_size_phone=&#8221;16px&#8221;]<\/p>\n<p data-start=\"155\" data-end=\"335\" class=\"\"><span style=\"color: #ffffff;\">In the heart of Munich, we develop <strong data-start=\"192\" data-end=\"250\">software solutions for pharmaceutical and medtech companies, clinics, and digital health startups<\/strong>\u2014customized, regulatory compliant, and certified according to <strong>ISO 13485<\/strong> and <strong>ISO 27001<\/strong>.<\/span><\/p>\n<p data-start=\"337\" data-end=\"509\" class=\"\"><span style=\"color: #ffffff;\">Our team of 30 has built up in-depth expertise in the development of medical AI systems over many years. We have developed and trained AI models for decision support systems and integrated specialized LLMs into patient apps, for example. <\/span><\/p>\n<p data-start=\"511\" data-end=\"736\" class=\"\"><span style=\"color: #ffffff;\">Thanks to our 10 years of experience in developing medical device software, we are also familiar with the regulatory requirements that must be met when <strong data-start=\"625\" data-end=\"656\">developing AI software for the medical industry<\/strong>, and we can help you implement these requirements safely and efficiently.<\/span><\/p>\n<p data-start=\"511\" data-end=\"736\" class=\"\"><span style=\"color: #ffffff;\"><img decoding=\"async\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/02\/SVG_ISO13485.svg\" width=\"75\" height=\"75\" alt=\"\" class=\"wp-image-18422 alignnone size-medium\"> <img decoding=\"async\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/02\/SVG_ISO27001.svg\" width=\"75\" height=\"75\" alt=\"\" class=\"wp-image-18420 alignnone size-medium\"><\/span><\/p>\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|phone&#8221; admin_label=&#8221;Feature&#8221; _builder_version=&#8221;4.21.0&#8243; custom_padding=&#8221;0px||100px||false|false&#8221; custom_padding_tablet=&#8221;0px||50px||false|false&#8221; custom_padding_phone=&#8221;15px||65px||false|false&#8221; bottom_divider_style=&#8221;slant2&#8243; bottom_divider_color=&#8221;#1bb8ea&#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; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;15px||15px||false|false&#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;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;||0px|||&#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;\">Our Guidelines on AI as a Medical Device<\/span><\/h2>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,2_3&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; link_option_url=&#8221;https:\/\/quickbirdmedical.com\/en\/ai-act-medizinprodukt-mdr\/&#8221; global_colors_info=&#8221;{}&#8221; transform_styles__hover_enabled=&#8221;on|hover&#8221; transform_scale__hover_enabled=&#8221;on|hover&#8221; transform_translate__hover_enabled=&#8221;on|desktop&#8221; transform_rotate__hover_enabled=&#8221;on|desktop&#8221; transform_skew__hover_enabled=&#8221;on|desktop&#8221; transform_origin__hover_enabled=&#8221;on|desktop&#8221; transform_scale__hover=&#8221;110%|110%&#8221;][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_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/08\/QBM-Blogartikel-Social-26.png&#8221; alt=&#8221;Social cover image for blog: AI Act: Guide for medical device manufacturers according to MDR&#8221; title_text=&#8221;EU AI Act_A guide for medical device manufacturers under the MDR_Social Header&#8221; url=&#8221;https:\/\/quickbirdmedical.com\/en\/ai-act-medizinprodukt-mdr\/&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; transform_styles__hover_enabled=&#8221;on|hover&#8221; transform_scale__hover_enabled=&#8221;on|hover&#8221; transform_translate__hover_enabled=&#8221;on|desktop&#8221; transform_rotate__hover_enabled=&#8221;on|desktop&#8221; transform_skew__hover_enabled=&#8221;on|desktop&#8221; transform_origin__hover_enabled=&#8221;on|desktop&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; transform_styles__hover_enabled=&#8221;on|hover&#8221; transform_scale__hover_enabled=&#8221;on|hover&#8221; transform_translate__hover_enabled=&#8221;on|desktop&#8221; transform_rotate__hover_enabled=&#8221;on|desktop&#8221; transform_skew__hover_enabled=&#8221;on|desktop&#8221; transform_origin__hover_enabled=&#8221;on|desktop&#8221;][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; header_3_font_size=&#8221;24px&#8221; custom_margin=&#8221;||-1px|||&#8221; link_option_url=&#8221;https:\/\/quickbirdmedical.com\/en\/ai-act-medizinprodukt-mdr\/&#8221; global_colors_info=&#8221;{}&#8221; transform_styles__hover_enabled=&#8221;on|hover&#8221; transform_scale__hover_enabled=&#8221;on|hover&#8221; transform_translate__hover_enabled=&#8221;on|desktop&#8221; transform_rotate__hover_enabled=&#8221;on|desktop&#8221; transform_skew__hover_enabled=&#8221;on|desktop&#8221; transform_origin__hover_enabled=&#8221;on|desktop&#8221;]<\/p>\n<h3><strong>AI Act: Guide for Medical Device Manufacturers according to MDR<\/strong><\/h3>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;16px&#8221; link_option_url=&#8221;https:\/\/quickbirdmedical.com\/en\/ai-act-medizinprodukt-mdr\/&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>With the EU AI Act, the EU is now also regulating the use of artificial intelligence (AI). This also affects manufacturers of software medical devices who integrate AI into their MDR medical devices. The AI Act ensures that AI systems are designed in such a way that the safety and fundamental rights of individuals are protected. Find out here what manufacturers of software medical devices need to bear in mind<a href=\"https:\/\/quickbirdmedical.com\/en\/ai-act-medical-devices-mdr\/\">.<\/a>   <\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,2_3&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; link_option_url=&#8221;https:\/\/quickbirdmedical.com\/en\/ai-medical-device-regulation-mdr\/&#8221; global_colors_info=&#8221;{}&#8221; transform_styles__hover_enabled=&#8221;on|hover&#8221; transform_scale__hover_enabled=&#8221;on|hover&#8221; transform_translate__hover_enabled=&#8221;on|desktop&#8221; transform_rotate__hover_enabled=&#8221;on|desktop&#8221; transform_skew__hover_enabled=&#8221;on|desktop&#8221; transform_origin__hover_enabled=&#8221;on|desktop&#8221; transform_scale__hover=&#8221;110%|110%&#8221;][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_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/QBM-Blogartikel-Social-7.png&#8221; alt=&#8221;Social cover image for blog: Artificial intelligence in medical devices according to MDR&#8221; title_text=&#8221;QBM Blog Social 4&#8243; url=&#8221;https:\/\/quickbirdmedical.com\/en\/ai-medical-device-regulation-mdr\/&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; transform_styles__hover_enabled=&#8221;on|hover&#8221; transform_scale__hover_enabled=&#8221;on|hover&#8221; transform_translate__hover_enabled=&#8221;on|desktop&#8221; transform_rotate__hover_enabled=&#8221;on|desktop&#8221; transform_skew__hover_enabled=&#8221;on|desktop&#8221; transform_origin__hover_enabled=&#8221;on|desktop&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; transform_styles__hover_enabled=&#8221;on|hover&#8221; transform_scale__hover_enabled=&#8221;on|hover&#8221; transform_translate__hover_enabled=&#8221;on|hover&#8221; transform_rotate__hover_enabled=&#8221;on|desktop&#8221; transform_skew__hover_enabled=&#8221;on|desktop&#8221; transform_origin__hover_enabled=&#8221;on|desktop&#8221;][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; header_3_font_size=&#8221;24px&#8221; custom_margin=&#8221;||-1px|||&#8221; link_option_url=&#8221;https:\/\/quickbirdmedical.com\/en\/ai-medical-device-regulation-mdr\/&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><strong>Artificial Intelligence in Medical Devices \u2013 MDR Guide<\/strong><\/h3>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;16px&#8221; link_option_url=&#8221;https:\/\/quickbirdmedical.com\/en\/ai-medical-device-regulation-mdr\/&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"font-weight: 400;\">With ChatGPT at the latest, artificial intelligence (AI) has become the topic of our time &#8211; also in the field of software medical products. Many manufacturers are unsure about the extent to which AI can be used in medical devices at all. For this reason, in this article we want to look at the use of artificial intelligence, in particular machine learning (ML), in regulated medical devices. In this guide, we focus on the implications of the Medical Device Regulation (MDR) for AI-based medical devices.<\/p>\n<p>[\/et_pb_text][\/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;#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_image=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2019\/01\/header_test1.jpg&#8221; custom_padding=&#8221;0%||70px||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; 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