![\"ORIKO](\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/07\/ORIKO-App-Icon-1.svg\"){kind=icon}
<\/a><\/h1>\nORIKO\u00ae – First DiGA for adults with ADHD<\/h1>\n
[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=”1″ next_background_color=”#ffffff” admin_label=”Feature” _builder_version=”4.16″ background_color=”#345168″ use_background_color_gradient=”on” background_color_gradient_stops=”#41B6E6 5%|#298FC2 100%” background_color_gradient_overlays_image=”on” background_color_gradient_start=”#41B6E6″ background_color_gradient_start_position=”5%” background_color_gradient_end=”#298FC2″ custom_padding=”1.8%||26px||false|false” top_divider_color=”#FFFFFF” bottom_divider_style=”slant2″ bottom_divider_flip=”horizontal” locked=”off” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.21.0″ custom_padding=”28px|0px|70px|0px|false|false” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/07\/ORIKO-Mockup-Desktop-Phone-scaled.webp” alt=”ORIKO Mockup Desktop + Phone” title_text=”ORIKO Mockup Desktop + Phone” show_in_lightbox=”on” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.21.0″ max_width=”100%” max_width_tablet=”60%” max_width_phone=”100%” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”||6px||false|false” custom_padding=”100px||0px||false|false” custom_padding_tablet=”0px||||false|false” custom_padding_phone=”0px||||false|false” custom_padding_last_edited=”on|desktop” animation_style=”zoom” global_colors_info=”{}”][\/et_pb_image][et_pb_image src=”https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Takeda-Logo-1.png” alt=”Takeda Logo 1″ title_text=”Takeda Logo 1″ url_new_window=”on” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.21.0″ max_width=”50%” max_width_tablet=”30%” max_width_phone=”80%” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”0px||0px||false|false” custom_padding=”1px||||false|false” global_colors_info=”{}”][\/et_pb_image][et_pb_image src=”https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/07\/Logo-Mindnet_white_background.webp” alt=”Logo Mindnet” title_text=”Logo Mindnet_white_background” url_new_window=”on” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.21.0″ max_width=”50%” max_width_tablet=”30%” max_width_phone=”80%” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”0px||0px||false|false” custom_padding=”0px||||false|false” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.21.0″ text_font=”||||||||” text_font_size=”18px” text_line_height=”1.8em” header_2_font=”Lato|700|||||||” header_2_font_size=”40px” header_2_letter_spacing=”2px” header_2_line_height=”1.5em” header_6_font=”Lato|700|||||||” header_6_font_size=”18px” header_6_letter_spacing=”1px” header_6_line_height=”1.8em” text_orientation=”right” background_layout=”dark” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” header_2_font_size_tablet=”” header_2_font_size_phone=”22px” header_2_font_size_last_edited=”on|phone” inline_fonts=”overpass-extralight,overpass-bold” global_colors_info=”{}”]<\/p>\n
Summary<\/h6>\nORIKO\u00ae<\/span><\/h2>\nORIKO\u00ae is a digital health application (DiGA)<\/strong> for adults with Attention Deficit Hyperactivity Disorder (ADHD).<\/strong><\/p>\nThe app offers a 12-week, guided therapy program<\/strong> that provides medically sound knowledge and supports those affected in their everyday lives – evidence-based, digital and close to the needs of the target group. The app combines scientifically proven content <\/strong>with interactive tools such as diary functions<\/strong>, skills training<\/strong> and medication management<\/strong>. The product was developed together with psychiatrists, therapists and those affected.<\/p>\nORIKO\u00ae has been listed in the BfArM’s DiGA directory since July 2025<\/strong>. The app has been clinically tested and with its inclusion in the BfArM’s DiGA directory, it can be prescribed by doctors and is reimbursable by statutory and most private health insurance companies.<\/p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Feature” _builder_version=”4.16″ background_color=”#ffffff” custom_padding=”2.6%||4%||false|false” top_divider_color=”#FFFFFF” bottom_divider_color=”#41B6E6″ bottom_divider_flip=”horizontal” locked=”off” global_colors_info=”{}”][et_pb_row column_structure=”1_3,1_3,1_3″ use_custom_gutter=”on” gutter_width=”4″ module_class=” et_pb_row_fullwidth” _builder_version=”4.16″ width=”86%” width_tablet=”80%” width_phone=”” width_last_edited=”on|desktop” max_width=”86%” max_width_tablet=”80%” max_width_phone=”” max_width_last_edited=”on|desktop” custom_padding=”27px|0px|27px|0|false|false” make_fullwidth=”on” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.21.0″ text_font=”opensans-regular||||||||” text_text_color=”#333333″ text_font_size=”18px” text_line_height=”1.8em” header_2_font=”|700|||||||” header_2_font_size=”40px” header_2_letter_spacing=”2px” header_2_line_height=”1.5em” header_6_font=”|700|||||||” header_6_font_size=”18px” header_6_letter_spacing=”1px” header_6_line_height=”1.8em” text_orientation=”right” background_layout=”dark” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” header_2_font_size_tablet=”” header_2_font_size_phone=”22px” header_2_font_size_last_edited=”on|phone” inline_fonts=”overpass-extralight,overpass-bold,overpass-extralightttf” global_colors_info=”{}”]<\/p>\n
Challenge<\/span><\/h2>\nQuickBird Medical was responsible for the technical, regulatory-compliant development of ORIKO\u00ae. QuickBird Medical was also significantly involved in the content and conceptual design of ORIKO\u00ae.<\/p>\n
In order to meet the requirements for a DiGA and be included in the DiGA directory<\/strong>, ORIKO\u00ae had to be developed as a medical device in accordance with the MDR and also fully meet the strict requirements of the BfArM. In addition to the regulatory obligations, the target group also posed a particular challenge: A digital solution for adults with ADHD must be low-threshold<\/strong> and motivating<\/strong> in order to encourage regular use in everyday life.<\/p>\nAchieving this balance of regulatory compliance, medical evidence, technical precision and user-centricity was the key to successful product development.<\/p>\n
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Process<\/span><\/h2>\nORIKO\u00ae was developed entirely within our ISO 13485-certified quality management system<\/strong> based on the IEC 62304<\/strong> standard for medical software. Every development step, from architecture to verification, was fully documented, tested and validated.<\/p>\nAt the same time, the extensive requirements of the BfArM<\/strong> for DiGA had to be met in full: These included the technical connection to the telematics infrastructure (GesundheitsID<\/strong>, ePA<\/strong>)<\/a> and the implementation of the extensive measures from BSI guideline TR-03161<\/strong>. In addition to the development within our certified information security management system in accordance with ISO 27001<\/strong>, ORIKO\u00ae also had to obtain an official security certificate in accordance with BSI TR-03161<\/a> in order to be listed as a DiGA.<\/p>\n[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.21.0″ text_font=”opensans-regular||||||||” text_text_color=”#333333″ text_font_size=”18px” text_line_height=”1.8em” header_2_font=”Lato|700|||||||” header_2_font_size=”40px” header_2_letter_spacing=”2px” header_2_line_height=”1.5em” header_6_font=”Lato|700|||||||” header_6_font_size=”18px” header_6_letter_spacing=”1px” header_6_line_height=”1.8em” text_orientation=”right” background_layout=”dark” custom_padding=”|||1px||” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” header_2_font_size_tablet=”” header_2_font_size_phone=”22px” header_2_font_size_last_edited=”on|phone” inline_fonts=”overpass-extralight,overpass-bold,overpass-extralightttf” global_colors_info=”{}”]<\/p>\n
Result<\/span><\/h2>\nORIKO\u00ae is the first prescription-only DiGA for adults with ADHD<\/strong>. The DiGA has been listed in the official BfArM directory<\/strong> since July 2025.<\/p>\nAnother huge success:<\/strong> ORIKO\u00ae is one of the first products on the entire DiGA market to receive an official BSI certificate for the new TR-03161 – proof of the extremely high standard of data security.<\/p>\nWe would like to thank MiNDNET<\/strong> and Takeda<\/strong> for the trust they have placed in us and the excellent cooperation in the technical and regulatory implementation of their product vision.<\/p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_4,3_4″ use_custom_gutter=”on” gutter_width=”4″ custom_padding_last_edited=”on|tablet” _builder_version=”4.21.0″ _module_preset=”default” background_color=”#f0f0f0″ width=”86%” width_tablet=”86%” width_phone=”80%” width_last_edited=”on|desktop” max_width=”86%” max_width_tablet=”80%” max_width_phone=”80%” max_width_last_edited=”on|desktop” custom_margin=”|auto|30px|auto|false|false” custom_padding=”0px|50px|0px|50px|false|true” custom_padding_tablet=”10px|25px|0px|25px|false|true” custom_padding_phone=”0px|25px|0px|25px|true|true” custom_css_main_element=”display: flex;||align-items: center;” locked=”off” global_colors_info=”{}” max_width__hover_enabled=”off|desktop” custom_css_main_element_tablet=”display: column;” custom_css_main_element_phone=”display: column;” custom_css_main_element_last_edited=”on|tablet”][et_pb_column type=”1_4″ _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Dr.-Andreas-Sprock.png” alt=”Dr. Andreas Sprock” title_text=”Dr. Andreas Sprock” align=”center” _builder_version=”4.21.0″ _module_preset=”default” transform_scale_tablet=”75%|75%” transform_scale_phone=”75%|75%” transform_scale_last_edited=”on|desktop” transform_translate_tablet=”” transform_translate_phone=”” transform_translate_last_edited=”on|desktop” transform_rotate_tablet=”” transform_rotate_phone=”” transform_rotate_last_edited=”on|desktop” transform_skew_tablet=”” transform_skew_phone=”” transform_skew_last_edited=”on|desktop” transform_origin_tablet=”” transform_origin_phone=”” transform_origin_last_edited=”on|desktop” transform_styles_last_edited=”on|desktop” max_width_tablet=”60%” max_width_phone=”60%” max_width_last_edited=”on|tablet” module_alignment=”center” custom_padding=”||0px||false|false” custom_padding_tablet=”||25px||false|false” custom_padding_phone=”||25px||false|false” custom_padding_last_edited=”on|desktop” transform_styles_tablet=”” transform_styles_phone=”” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_4″ _builder_version=”4.21.0″ _module_preset=”default” custom_padding=”25px||25px||false|false” global_colors_info=”{}”][et_pb_text _builder_version=”4.21.0″ _module_preset=”default” text_font_size=”18px” transform_scale_tablet=”” transform_scale_phone=”” transform_scale_last_edited=”on|tablet” transform_translate_tablet=”0px|-75px” transform_translate_phone=”0px|-75px” transform_translate_last_edited=”on|tablet” transform_translate_linked_tablet=”off” transform_rotate_tablet=”” transform_rotate_phone=”” transform_rotate_last_edited=”on|tablet” transform_skew_tablet=”” transform_skew_phone=”” transform_skew_last_edited=”on|tablet” transform_origin_tablet=”” transform_origin_phone=”” transform_origin_last_edited=”on|tablet” transform_styles_last_edited=”on|tablet” module_alignment=”center” transform_styles_tablet=”” transform_styles_phone=”” global_colors_info=”{}”]<\/p>\n
\u201cYou keep hearing about companies that develop their medical device software three times. The first time they simply do it themselves, the second time with a service provider who claims to be able to develop medical device software, and then the third time with a company that has already done it.
We were very fortunate to have come across QuickBird Medical. The team around Malte and Stefan knows what it takes to develop medical device software that meets all regulatory requirements and can also be approved as a DiGA.
Together with the highly motivated team, we were able to realize ORIKO in record time: an app of high visual, technical and medical quality that achieves measurable medical effects. I can therefore recommend QuickBird Medical with a clear conscience.\u201d<\/p>\n
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DR. ANDREAS SPROCK
<\/strong>CEO of MiNDNET E-Health AG<\/p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.16″ custom_padding=”||2px|||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.16″ text_font=”opensans-regular||||||||” text_text_color=”#999999″ text_font_size=”16px” text_line_height=”1.8em” header_2_font=”Lato|700|||||||” header_2_font_size=”40px” header_2_letter_spacing=”2px” header_2_line_height=”1.5em” header_6_font=”Lato|700|||||||” header_6_font_size=”18px” header_6_letter_spacing=”1px” header_6_line_height=”1.8em” text_orientation=”right” background_layout=”dark” custom_padding=”||0px|||” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” header_2_font_size_tablet=”” header_2_font_size_phone=”22px” header_2_font_size_last_edited=”on|phone” inline_fonts=”overpass-extralight,overpass-bold,overpass-extralightttf” global_colors_info=”{}”]<\/p>\n
Screenshots<\/span><\/h2>\n[\/et_pb_text][et_pb_text _builder_version=”4.21.0″ text_font=”opensans-regular||||||||” text_text_color=”#999999″ text_font_size=”16px” text_line_height=”1.8em” header_text_color=”#999999″ header_2_font=”|700|||||||” header_2_font_size=”40px” header_2_letter_spacing=”2px” header_2_line_height=”1.5em” header_3_text_color=”#999999″ header_6_font=”Lato|700|||||||” header_6_font_size=”18px” header_6_letter_spacing=”1px” header_6_line_height=”1.8em” text_orientation=”right” background_layout=”dark” custom_margin=”-35px|||||” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” header_2_font_size_tablet=”” header_2_font_size_phone=”22px” header_2_font_size_last_edited=”on|phone” inline_fonts=”overpass-extralight,overpass-bold,overpass-extralightttf” global_colors_info=”{}”]<\/p>\n
Mobile<\/h3>\n
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background_color=”RGBA(255,255,255,0)” max_width_tablet=”70%” max_width_phone=”70%” max_width_last_edited=”off|desktop” module_alignment=”center” animation_style=”zoom” global_colors_info=”{}”] [\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ use_custom_gutter=”on” custom_padding_last_edited=”on|phone” _builder_version=”4.27.6″ custom_padding=”2px|0px|27px|0px|false|false” custom_padding_tablet=”64px|0px|27px|0px|false|false” custom_padding_phone=”20px|0px|27px|0px|false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/ORIKO-Mockup-4.webp” alt=”ORIKO Mockup 4″ title_text=”ORIKO Mockup 4″ show_in_lightbox=”on” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.27.6″ max_width_tablet=”70%” max_width_phone=”70%” 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header_6_line_height=”1.8em” text_orientation=”right” background_layout=”dark” custom_margin=”0px||||false|false” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” header_2_font_size_tablet=”” header_2_font_size_phone=”22px” header_2_font_size_last_edited=”on|phone” inline_fonts=”overpass-extralight,overpass-bold,overpass-extralightttf” global_colors_info=”{}”]<\/p>\n
Desktop<\/h3>\n
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Future<\/span><\/h2>\nWith the provisional inclusion in the DiGA directory<\/strong>, an important milestone has been reached, but the journey continues. The next goal: permanent listing<\/strong> as a reimbursable DiGA.<\/p>\nAt the same time, the focus is now on reaching as many affected people as possible and giving them access to ORIKO\u00ae. We will continue to accompany this path – with technical developments, maintenance and regulatory expertise.<\/p>\n
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ORIKO\u00ae – First DiGA for adults with ADHD Summary ORIKO\u00ae ORIKO\u00ae is a digital health application (DiGA) for adults with Attention Deficit Hyperactivity Disorder (ADHD). The app offers a 12-week, guided therapy program that provides medically sound knowledge and supports those affected in their everyday lives – evidence-based, digital and close to the needs of […]<\/p>\n","protected":false},"author":22,"featured_media":20956,"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":""},"project_category":[],"project_tag":[],"class_list":["post-21415","project","type-project","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"\n
ORIKO\u00ae - DiGA for adults with ADHD - QuickBird Medical<\/title>\n<meta name=\"description\" content=\"ORIKO\u00ae - the first DiGA for adults with ADHD: digital, evidence-based, reimbursable & BfArM-listed since July 2025.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/quickbirdmedical.com\/en\/project\/oriko\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ORIKO\u00ae - DiGA for adults with ADHD - QuickBird Medical\" \/>\n<meta property=\"og:description\" content=\"ORIKO\u00ae - the first DiGA for adults with ADHD: digital, evidence-based, reimbursable & BfArM-listed since July 2025.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/quickbirdmedical.com\/en\/project\/oriko\/\" \/>\n<meta property=\"og:site_name\" content=\"QuickBird Medical\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-03T11:07:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/07\/ORIKO-Mockup-Desktop-Phone-1024x640.webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:image\" content=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/07\/ORIKO-Mockup-Desktop-Phone-1024x640.webp\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"8 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/project\\\/oriko\\\/\",\"url\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/project\\\/oriko\\\/\",\"name\":\"ORIKO\u00ae - 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ORIKO\u00ae is a digital health application (DiGA)<\/strong> for adults with Attention Deficit Hyperactivity Disorder (ADHD).<\/strong><\/p>\n The app offers a 12-week, guided therapy program<\/strong> that provides medically sound knowledge and supports those affected in their everyday lives – evidence-based, digital and close to the needs of the target group. The app combines scientifically proven content <\/strong>with interactive tools such as diary functions<\/strong>, skills training<\/strong> and medication management<\/strong>. The product was developed together with psychiatrists, therapists and those affected.<\/p>\n ORIKO\u00ae has been listed in the BfArM’s DiGA directory since July 2025<\/strong>. The app has been clinically tested and with its inclusion in the BfArM’s DiGA directory, it can be prescribed by doctors and is reimbursable by statutory and most private health insurance companies.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Feature” _builder_version=”4.16″ background_color=”#ffffff” custom_padding=”2.6%||4%||false|false” top_divider_color=”#FFFFFF” bottom_divider_color=”#41B6E6″ bottom_divider_flip=”horizontal” locked=”off” global_colors_info=”{}”][et_pb_row column_structure=”1_3,1_3,1_3″ use_custom_gutter=”on” gutter_width=”4″ module_class=” et_pb_row_fullwidth” _builder_version=”4.16″ width=”86%” width_tablet=”80%” width_phone=”” width_last_edited=”on|desktop” max_width=”86%” max_width_tablet=”80%” max_width_phone=”” max_width_last_edited=”on|desktop” custom_padding=”27px|0px|27px|0|false|false” make_fullwidth=”on” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.21.0″ text_font=”opensans-regular||||||||” text_text_color=”#333333″ text_font_size=”18px” text_line_height=”1.8em” header_2_font=”|700|||||||” header_2_font_size=”40px” header_2_letter_spacing=”2px” header_2_line_height=”1.5em” header_6_font=”|700|||||||” header_6_font_size=”18px” header_6_letter_spacing=”1px” header_6_line_height=”1.8em” text_orientation=”right” background_layout=”dark” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” header_2_font_size_tablet=”” header_2_font_size_phone=”22px” header_2_font_size_last_edited=”on|phone” inline_fonts=”overpass-extralight,overpass-bold,overpass-extralightttf” global_colors_info=”{}”]<\/p>\n QuickBird Medical was responsible for the technical, regulatory-compliant development of ORIKO\u00ae. QuickBird Medical was also significantly involved in the content and conceptual design of ORIKO\u00ae.<\/p>\n In order to meet the requirements for a DiGA and be included in the DiGA directory<\/strong>, ORIKO\u00ae had to be developed as a medical device in accordance with the MDR and also fully meet the strict requirements of the BfArM. In addition to the regulatory obligations, the target group also posed a particular challenge: A digital solution for adults with ADHD must be low-threshold<\/strong> and motivating<\/strong> in order to encourage regular use in everyday life.<\/p>\n Achieving this balance of regulatory compliance, medical evidence, technical precision and user-centricity was the key to successful product development.<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.21.0″ text_font=”opensans-regular||||||||” text_text_color=”#333333″ text_font_size=”18px” text_line_height=”1.8em” header_2_font=”Lato|700|||||||” header_2_font_size=”40px” header_2_letter_spacing=”2px” header_2_line_height=”1.5em” header_6_font=”Lato|700|||||||” header_6_font_size=”18px” header_6_letter_spacing=”1px” header_6_line_height=”1.8em” text_orientation=”right” background_layout=”dark” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” header_2_font_size_tablet=”” header_2_font_size_phone=”22px” header_2_font_size_last_edited=”on|phone” inline_fonts=”overpass-extralight,overpass-bold,overpass-extralightttf” global_colors_info=”{}”]<\/p>\n ORIKO\u00ae was developed entirely within our ISO 13485-certified quality management system<\/strong> based on the IEC 62304<\/strong> standard for medical software. Every development step, from architecture to verification, was fully documented, tested and validated.<\/p>\n At the same time, the extensive requirements of the BfArM<\/strong> for DiGA had to be met in full: These included the technical connection to the telematics infrastructure (GesundheitsID<\/strong>, ePA<\/strong>)<\/a> and the implementation of the extensive measures from BSI guideline TR-03161<\/strong>. In addition to the development within our certified information security management system in accordance with ISO 27001<\/strong>, ORIKO\u00ae also had to obtain an official security certificate in accordance with BSI TR-03161<\/a> in order to be listed as a DiGA.<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.21.0″ text_font=”opensans-regular||||||||” text_text_color=”#333333″ text_font_size=”18px” text_line_height=”1.8em” header_2_font=”Lato|700|||||||” header_2_font_size=”40px” header_2_letter_spacing=”2px” header_2_line_height=”1.5em” header_6_font=”Lato|700|||||||” header_6_font_size=”18px” header_6_letter_spacing=”1px” header_6_line_height=”1.8em” text_orientation=”right” background_layout=”dark” custom_padding=”|||1px||” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” header_2_font_size_tablet=”” header_2_font_size_phone=”22px” header_2_font_size_last_edited=”on|phone” inline_fonts=”overpass-extralight,overpass-bold,overpass-extralightttf” global_colors_info=”{}”]<\/p>\n ORIKO\u00ae is the first prescription-only DiGA for adults with ADHD<\/strong>. The DiGA has been listed in the official BfArM directory<\/strong> since July 2025.<\/p>\n Another huge success:<\/strong> ORIKO\u00ae is one of the first products on the entire DiGA market to receive an official BSI certificate for the new TR-03161 – proof of the extremely high standard of data security.<\/p>\n We would like to thank MiNDNET<\/strong> and Takeda<\/strong> for the trust they have placed in us and the excellent cooperation in the technical and regulatory implementation of their product vision.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_4,3_4″ use_custom_gutter=”on” gutter_width=”4″ custom_padding_last_edited=”on|tablet” _builder_version=”4.21.0″ _module_preset=”default” background_color=”#f0f0f0″ width=”86%” width_tablet=”86%” width_phone=”80%” width_last_edited=”on|desktop” max_width=”86%” max_width_tablet=”80%” max_width_phone=”80%” max_width_last_edited=”on|desktop” custom_margin=”|auto|30px|auto|false|false” custom_padding=”0px|50px|0px|50px|false|true” custom_padding_tablet=”10px|25px|0px|25px|false|true” custom_padding_phone=”0px|25px|0px|25px|true|true” custom_css_main_element=”display: flex;||align-items: center;” locked=”off” global_colors_info=”{}” max_width__hover_enabled=”off|desktop” custom_css_main_element_tablet=”display: column;” custom_css_main_element_phone=”display: column;” custom_css_main_element_last_edited=”on|tablet”][et_pb_column type=”1_4″ _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Dr.-Andreas-Sprock.png” alt=”Dr. Andreas Sprock” title_text=”Dr. Andreas Sprock” align=”center” _builder_version=”4.21.0″ _module_preset=”default” transform_scale_tablet=”75%|75%” transform_scale_phone=”75%|75%” transform_scale_last_edited=”on|desktop” transform_translate_tablet=”” transform_translate_phone=”” transform_translate_last_edited=”on|desktop” transform_rotate_tablet=”” transform_rotate_phone=”” transform_rotate_last_edited=”on|desktop” transform_skew_tablet=”” transform_skew_phone=”” transform_skew_last_edited=”on|desktop” transform_origin_tablet=”” transform_origin_phone=”” transform_origin_last_edited=”on|desktop” transform_styles_last_edited=”on|desktop” max_width_tablet=”60%” max_width_phone=”60%” max_width_last_edited=”on|tablet” module_alignment=”center” custom_padding=”||0px||false|false” custom_padding_tablet=”||25px||false|false” custom_padding_phone=”||25px||false|false” custom_padding_last_edited=”on|desktop” transform_styles_tablet=”” transform_styles_phone=”” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_4″ _builder_version=”4.21.0″ _module_preset=”default” custom_padding=”25px||25px||false|false” global_colors_info=”{}”][et_pb_text _builder_version=”4.21.0″ _module_preset=”default” text_font_size=”18px” transform_scale_tablet=”” transform_scale_phone=”” transform_scale_last_edited=”on|tablet” transform_translate_tablet=”0px|-75px” transform_translate_phone=”0px|-75px” transform_translate_last_edited=”on|tablet” transform_translate_linked_tablet=”off” transform_rotate_tablet=”” transform_rotate_phone=”” transform_rotate_last_edited=”on|tablet” transform_skew_tablet=”” transform_skew_phone=”” transform_skew_last_edited=”on|tablet” transform_origin_tablet=”” transform_origin_phone=”” transform_origin_last_edited=”on|tablet” transform_styles_last_edited=”on|tablet” module_alignment=”center” transform_styles_tablet=”” transform_styles_phone=”” global_colors_info=”{}”]<\/p>\n \u201cYou keep hearing about companies that develop their medical device software three times. The first time they simply do it themselves, the second time with a service provider who claims to be able to develop medical device software, and then the third time with a company that has already done it. [\/et_pb_text][et_pb_text _builder_version=”4.21.0″ _module_preset=”default” text_text_color=”#41b6e6″ text_font_size=”18px” transform_scale_tablet=”” transform_scale_phone=”” transform_scale_last_edited=”on|tablet” transform_translate_tablet=”0px|-75px” transform_translate_phone=”0px|-75px” transform_translate_last_edited=”on|tablet” transform_translate_linked_tablet=”off” transform_rotate_tablet=”” transform_rotate_phone=”” transform_rotate_last_edited=”on|tablet” transform_skew_tablet=”” transform_skew_phone=”” transform_skew_last_edited=”on|tablet” transform_origin_tablet=”” transform_origin_phone=”” transform_origin_last_edited=”on|tablet” custom_margin=”-20px||0px||false|false” custom_margin_tablet=”-80px||0px||false|false” custom_margin_phone=”-80px||0px||false|false” custom_margin_last_edited=”on|phone” custom_padding=”||0px||false|false” custom_padding_tablet=”||0px||false|false” custom_padding_phone=”||0px||false|false” custom_padding_last_edited=”on|desktop” global_colors_info=”{}”]<\/p>\n DR. 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The app offers a 12-week, guided therapy program that provides medically sound knowledge and supports those affected in their everyday lives – evidence-based, digital and close to the needs of […]<\/p>\n","protected":false},"author":22,"featured_media":20956,"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":""},"project_category":[],"project_tag":[],"class_list":["post-21415","project","type-project","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"\nChallenge<\/span><\/h2>\n
Process<\/span><\/h2>\n
Result<\/span><\/h2>\n
We were very fortunate to have come across QuickBird Medical. The team around Malte and Stefan knows what it takes to develop medical device software that meets all regulatory requirements and can also be approved as a DiGA.
Together with the highly motivated team, we were able to realize ORIKO in record time: an app of high visual, technical and medical quality that achieves measurable medical effects. I can therefore recommend QuickBird Medical with a clear conscience.\u201d<\/p>\n
<\/strong>CEO of MiNDNET E-Health AG<\/p>\nScreenshots<\/span><\/h2>\n
Mobile<\/h3>\n
Desktop<\/h3>\n
Future<\/span><\/h2>\n
Further Case Studies<\/span><\/h2>\n