{"id":24114,"date":"2025-12-03T15:19:48","date_gmt":"2025-12-03T15:19:48","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?page_id=24114"},"modified":"2026-03-13T09:45:52","modified_gmt":"2026-03-13T09:45:52","slug":"fda-21-cfr-medical-devices-development","status":"publish","type":"page","link":"https:\/\/quickbirdmedical.com\/en\/fda-21-cfr-medical-devices-development\/","title":{"rendered":"Development of medical device software in accordance with FDA regulations"},"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;#41b6e6&#8243; bottom_divider_flip=&#8221;horizontal&#8221; animation_direction=&#8221;top&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_fullwidth_header title=&#8221;Development of Software as a Medical Device (SaMD) \u2013 FDA &#038; 21 CFR compliant &#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_font=&#8221;overpass-bold|700|||||||&#8221; subhead_text_align=&#8221;left&#8221; subhead_text_color=&#8221;#1bb8ea&#8221; subhead_font_size=&#8221;19px&#8221; subhead_line_height=&#8221;2.5em&#8221; background_enable_color=&#8221;off&#8221; background_color_gradient_direction=&#8221;36deg&#8221; 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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;]We develop your medical software or medical app in accordance with FDA requirements. We take care of design, software development, and 21 CFR compliance, and assist you with 510(k), De Novo, or PMA submissions.<br \/>\n[\/et_pb_fullwidth_header][\/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 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; animation_style=&#8221;zoom&#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; 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|phone&#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;36px&#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>Development of Software as a Medical Device (SaMD)<\/h2>\n<h4 style=\"text-align: right;\">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|phone&#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; 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;]Our team combines <strong>technical<\/strong> and <strong>regulatory<\/strong> expertise for the development of software medical devices in accordance with FDA regulations, including 21 CFR Part 820, 21 CFR Part 11, and relevant guidance documents.<br \/>\n[\/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; 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;SaMD Startbild&#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; 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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;\">Competencies<\/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_margin=&#8221;||50px||false|false&#8221; custom_margin_tablet=&#8221;0px||50px||false|false&#8221; custom_margin_phone=&#8221;-2px|auto|50px|auto|false|false&#8221; custom_margin_last_edited=&#8221;on|tablet&#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; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.18.1&#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; animation_style=&#8221;zoom&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><span style=\"font-weight: 400;\">Quality Management System Regulation (QMSR)<\/span><\/h3>\n<ul>\n<li><span style=\"font-weight: 400;\">Quality Management (ISO 13485) <\/span><\/li>\n<li><span style=\"font-weight: 400;\">Software Lifecycle Processes (IEC 62304)<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Risk Management (ISO 14971)<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Human Factors Engineering (IEC 62366)<\/span><\/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; 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; animation_style=&#8221;zoom&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><span style=\"font-weight: 400;\">Regulatory Consulting &amp; Preparation of<br \/>\nDHF, DMR, DHR <\/span><\/h3>\n<ul>\n<li><span style=\"font-weight: 400;\">Medical Device Approval<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Risk Classification of Medical Devices <\/span><\/li>\n<li><span style=\"font-weight: 400;\">Identification\/Implementation of FDA Requirements<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Takeover of the Manufacturer Role<\/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; 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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 content_tablet=&#8221;<\/p>\n<p>From the initial product idea to the final implementation and operation of your medical software, we accompany you through the entire development process. Our support covers all phases, from concept, design, and software development to FDA-compliant documentation and submission.<\/p>\n<p>&#8221; content_phone=&#8221;<\/p>\n<p>From the initial product idea to the final implementation and operation of your medical software, we accompany you through the entire development process. Our support covers all phases, from concept, design, and software development to FDA-compliant documentation and submission.<\/p>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; animation_style=&#8221;zoom&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\">From the initial product idea to the final implementation and operation of your medical software, we accompany you through the entire development process. Our support covers all phases, from concept, design, and software development to FDA-compliant documentation and submission.<\/p>\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; custom_css_main_element=&#8221;align-items: center;&#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; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/Konzeption.webp&#8221; alt=&#8221;Grafik Konzeption&#8221; title_text=&#8221;Concept&#8221; align=&#8221;center&#8221; align_tablet=&#8221;left&#8221; align_phone=&#8221;left&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#8221; width_tablet=&#8221;40%&#8221; width_phone=&#8221;50%&#8221; width_last_edited=&#8221;on|phone&#8221; module_alignment=&#8221;center&#8221; module_alignment_tablet=&#8221;left&#8221; module_alignment_phone=&#8221;center&#8221; module_alignment_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;1_2&#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; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3>1. Conception<\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Requirements analysis<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Definition of the intended purpose<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-size: 18px;\">Architectural concept according to FDA Design Controls<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-size: 18px;\">Definition of regulatory strategy<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Definition of responsibilities<\/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; background_enable_image=&#8221;off&#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; custom_css_main_element=&#8221;align-items: center;&#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; 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; align=&#8221;center&#8221; align_tablet=&#8221;left&#8221; align_phone=&#8221;left&#8221; align_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; width=&#8221;50%&#8221; width_tablet=&#8221;40%&#8221; width_phone=&#8221;50%&#8221; width_last_edited=&#8221;on|phone&#8221; module_alignment=&#8221;center&#8221; module_alignment_tablet=&#8221;left&#8221; module_alignment_phone=&#8221;center&#8221; module_alignment_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;1_2&#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; _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-size: 18px;\">Kickoff for agile design sprints<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-size: 18px;\">Technical specification<\/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\">Risk analysis and planning of control measures according to 21 CFR 820.30<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Regulatory planning<\/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;||3px|||&#8221; animation_style=&#8221;zoom&#8221; custom_css_main_element=&#8221;align-items: center;&#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; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/3-Development-and-Documentation.webp&#8221; title_text=&#8221;3-Development-and-Documentation&#8221; align=&#8221;center&#8221; align_tablet=&#8221;left&#8221; align_phone=&#8221;left&#8221; align_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#8221; width_tablet=&#8221;40%&#8221; width_phone=&#8221;50%&#8221; width_last_edited=&#8221;on|phone&#8221; module_alignment_tablet=&#8221;left&#8221; module_alignment_phone=&#8221;center&#8221; module_alignment_last_edited=&#8221;on|tablet&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;1_2&#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; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><span style=\"font-weight: 400;\">3. Software Development and Documentation<\/span><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Technical implementation of requirements<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Agile development of the software medical product<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Continuous delivery<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Prototyping<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">User tests<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Product labeling<\/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; background_enable_image=&#8221;off&#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||false|false&#8221; animation_style=&#8221;zoom&#8221; custom_css_main_element=&#8221;align-items: center;&#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; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/4-Verification.webp&#8221; title_text=&#8221;4-Verification&#8221; align=&#8221;center&#8221; align_tablet=&#8221;left&#8221; align_phone=&#8221;left&#8221; align_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#8221; width_tablet=&#8221;40%&#8221; width_phone=&#8221;50%&#8221; width_last_edited=&#8221;on|phone&#8221; module_alignment_tablet=&#8221;left&#8221; module_alignment_phone=&#8221;center&#8221; module_alignment_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;1_2&#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; _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 and Validation<\/span><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Software testing<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clinical evaluation &amp; investigation<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Penetration testing<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Security audits<\/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; background_image=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2022\/02\/hexagon-background-web.png&#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; background_last_edited=&#8221;on|desktop&#8221; background_enable_image_tablet=&#8221;off&#8221; custom_css_main_element=&#8221;align-items: center;&#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; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/11\/FDA_Logo_Icon.webp&#8221; alt=&#8221;FDA Logo Icon&#8221; title_text=&#8221;FDA_Logo_Icon&#8221; align=&#8221;center&#8221; align_tablet=&#8221;left&#8221; align_phone=&#8221;left&#8221; align_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; background_enable_color=&#8221;off&#8221; background_enable_image=&#8221;off&#8221; width=&#8221;50%&#8221; width_tablet=&#8221;40%&#8221; width_phone=&#8221;50%&#8221; width_last_edited=&#8221;on|phone&#8221; module_alignment_tablet=&#8221;left&#8221; module_alignment_phone=&#8221;center&#8221; module_alignment_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;1_2&#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; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><span style=\"font-weight: 400;\">5. Approval as Medical Device<\/span><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-size: 18px;\">FDA-Submission &#8211; 510(k), De Novo, PMA<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-size: 18px;\">Generation of a UDI number<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Supporting the FDA review process<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Q-submission (pre-sub) for early FDA feedback, if applicable<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Submission via the FDA CDRH portal (eSTAR)<\/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; custom_css_main_element=&#8221;align-items: center;&#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; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2023\/02\/7-Maintanance.png&#8221; title_text=&#8221;7-Maintanance&#8221; align=&#8221;center&#8221; align_tablet=&#8221;left&#8221; align_phone=&#8221;left&#8221; align_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#8221; width_tablet=&#8221;40%&#8221; width_phone=&#8221;50%&#8221; width_last_edited=&#8221;on|phone&#8221; module_alignment_tablet=&#8221;left&#8221; module_alignment_phone=&#8221;center&#8221; module_alignment_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;1_2&#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; _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 style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Further development and change management<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">User support<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-size: 18px;\">Maintenance of the software medical device<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\">Post-market surveillance (PMS) according to FDA requirements<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Incident reporting (vigilance)<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; animation_style=&#8221;zoom&#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;20px||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;]<\/p>\n<h6 style=\"text-align: center;\"><\/h6>\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;0px|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; 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; image_icon_width_tablet=&#8221;70%&#8221; image_icon_width_phone=&#8221;70%&#8221; image_icon_width_last_edited=&#8221;on|tablet&#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;]<span style=\"font-weight: 400;\">Our quality management system is certified according to ISO 13485. This enables us to ensure the compliant development of software as a medical device and to meet the requirements of the FDA &amp; Quality Management Systems Regulation (QMSR) for quality management systems.<\/span><br \/>\n[\/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; image_icon_width_tablet=&#8221;70%&#8221; image_icon_width_phone=&#8221;70%&#8221; image_icon_width_last_edited=&#8221;on|tablet&#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;]<span style=\"font-weight: 400;\">If required, we can take over the role of the legal manufacturer for your medical device software. We therefore bear legal responsibility for compliance with all FDA regulatory requirements. This allows you to focus on your core competencies such as sales &amp; marketing.<\/span><br \/>\n[\/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; image_icon_width_tablet=&#8221;70%&#8221; image_icon_width_phone=&#8221;70%&#8221; image_icon_width_last_edited=&#8221;on|tablet&#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;]QuickBird Medical is certified according to ISO 27001 for information security management. Our team has extensive expertise in cybersecurity and in handling sensitive health data in compliance with data protection regulations.<br \/>\n[\/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|desktop&#8221; next_background_color=&#8221;#ffffff&#8221; _builder_version=&#8221;4.21.0&#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;30px||80px|||&#8221; custom_padding_tablet=&#8221;&#8221; custom_padding_phone=&#8221;24px||18%||false|false&#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;6px|||||&#8221; animation_style=&#8221;zoom&#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: column;||align-items: center;&#8221; custom_css_main_element_phone=&#8221;display: block;||align-items: center;&#8221;][et_pb_column type=&#8221;1_2&#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<h1>QuickBird Medical as manufacturer<\/h1>\n<p>&#8221; content_phone=&#8221;<\/p>\n<h1>QuickBird Medical as manufacturer<\/h1>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; 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; custom_margin=&#8221;||1px|||&#8221; animation_direction=&#8221;bottom&#8221; header_2_font_size_tablet=&#8221;40px&#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;\">About QuickBird Medical<\/h2>\n<p>[\/et_pb_text][et_pb_text content_tablet=&#8221;<\/p>\n<p>Through our internal quality management system (certified according to ISO 13485), we are also able to take over the manufacturer role for your product. In doing so, we take over communication with authorities and any regulatory responsibility for the product.<\/p>\n<p>This allows you to fully focus on your core competencies &#8211; sales and conceptual development of the product. This service is particularly interesting for companies that do not (yet) have a quality management system themselves.<\/p>\n<p>Sounds interesting? Then contact us.<\/p>\n<p>&#8221; content_phone=&#8221;<\/p>\n<p>Through our internal quality management system (certified according to ISO 13485), we are also able to take over the manufacturer role for your product. In doing so, we take over communication with authorities and any regulatory responsibility for the product.<\/p>\n<p>This allows you to fully focus on your core competencies &#8211; sales and conceptual development of the product. This service is particularly interesting for companies that do not (yet) have a quality management system themselves.<\/p>\n<p>Sounds interesting? Then contact us.<\/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; global_colors_info=&#8221;{}&#8221;]QuickBird Medical is a Munich-based company <strong>specializing in the development of medical software<\/strong>. Our <strong>30-strong team<\/strong> of <strong>developers<\/strong>, <strong>regulatory experts<\/strong> and <strong>UX designers<\/strong> work closely together on digital solutions that make medicine more effective, safer and more efficient.<\/p>\n<p>We support our customers in <strong>implementing certified medical software<\/strong>: from <strong>certified digital therapeutics<\/strong> to complex <strong>web platforms for clinics<\/strong>. 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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; hover_enabled=&#8221;0&#8243; 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; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h2 style=\"text-align: center;\"><span style=\"color: #41b6e6; font-family: overpass-extralight;\">Our Medical Software and DTx <\/span><span style=\"color: #41b6e6; font-family: overpass-extralight;\">Customers<\/span><\/h2>\n<p style=\"text-align: center;\">[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row disabled_on=&#8221;off|off|off&#8221; _builder_version=&#8221;4.21.0&#8243; 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