{"id":26892,"date":"2026-06-17T14:26:07","date_gmt":"2026-06-17T14:26:07","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?page_id=26892"},"modified":"2026-06-18T10:57:21","modified_gmt":"2026-06-18T10:57:21","slug":"verification-validation-medical-device-software","status":"publish","type":"page","link":"https:\/\/quickbirdmedical.com\/en\/verification-validation-medical-device-software\/","title":{"rendered":"Verification and Validation of Medical Software"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; admin_label=&#8221;Sektion&#8221; _builder_version=&#8221;4.16&#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;Verification and Validation of Medical Software and AI Applications&#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;4.27.6&#8243; title_font=&#8221;overpass-extralight|200|||||||&#8221; title_text_align=&#8221;left&#8221; title_text_color=&#8221;#FFFFFF&#8221; title_font_size=&#8221;45px&#8221; title_line_height=&#8221;1.2em&#8221; content_font=&#8221;opensans-regular||||||||&#8221; content_text_color=&#8221;#FFFFFF&#8221; content_font_size=&#8221;18px&#8221; content_line_height=&#8221;1.8em&#8221; subhead_text_color=&#8221;#FFFFFF&#8221; background_enable_color=&#8221;off&#8221; background_color_gradient_direction=&#8221;36deg&#8221; background_color_gradient_start=&#8221;rgba(126,190,197,0.77)&#8221; background_color_gradient_end=&#8221;rgba(255,255,255,0)&#8221; background_image=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2026\/05\/Verifikation-und-Validierung-medizinischer-Software-durch-das-QuickBird-Medical-Team-1.webp&#8221; custom_button_one=&#8221;on&#8221; button_one_text_size=&#8221;14px&#8221; button_one_text_color=&#8221;#ffffff&#8221; button_one_bg_color=&#8221;#41B6E6&#8243; button_one_border_width=&#8221;8px&#8221; button_one_border_color=&#8221;#41b6e6&#8243; button_one_border_radius=&#8221;0px&#8221; button_one_letter_spacing=&#8221;1px&#8221; button_one_font=&#8221;overpass-bold|600|||||||&#8221; button_one_use_icon=&#8221;off&#8221; custom_button_two=&#8221;on&#8221; button_two_text_size=&#8221;14px&#8221; button_two_text_color=&#8221;#FFFFFF&#8221; button_two_bg_color=&#8221;rgba(255,255,255,0.17)&#8221; button_two_border_width=&#8221;8px&#8221; button_two_border_color=&#8221;rgba(255,255,255,0)&#8221; button_two_border_radius=&#8221;0px&#8221; button_two_letter_spacing=&#8221;1px&#8221; button_two_font=&#8221;|700|||||||&#8221; 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;||17.8%||false|false&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; title_font_size_tablet=&#8221;40px&#8221; title_font_size_phone=&#8221;33px&#8221; title_font_size_last_edited=&#8221;on|phone&#8221; content_font_size_tablet=&#8221;16px&#8221; content_font_size_phone=&#8221;&#8221; content_font_size_last_edited=&#8221;on|tablet&#8221; subhead_font_size_tablet=&#8221;&#8221; subhead_font_size_phone=&#8221;16px&#8221; subhead_font_size_last_edited=&#8221;on|phone&#8221; custom_css_button_1=&#8221; margin-left: 0px;||||||&#8221; button_one_letter_spacing_hover=&#8221;1px&#8221; button_two_letter_spacing_hover=&#8221;1px&#8221; locked=&#8221;off&#8221; inline_fonts=&#8221;overpass-extralight&#8221; global_colors_info=&#8221;{}&#8221; button_one_text_size__hover_enabled=&#8221;off&#8221; button_two_text_size__hover_enabled=&#8221;off&#8221; button_one_text_color__hover_enabled=&#8221;off&#8221; button_two_text_color__hover_enabled=&#8221;off&#8221; button_one_border_width__hover_enabled=&#8221;off&#8221; button_two_border_width__hover_enabled=&#8221;off&#8221; button_one_border_color__hover_enabled=&#8221;off&#8221; button_two_border_color__hover_enabled=&#8221;off&#8221; button_one_border_radius__hover_enabled=&#8221;off&#8221; button_two_border_radius__hover_enabled=&#8221;off&#8221; button_one_letter_spacing__hover_enabled=&#8221;on&#8221; button_one_letter_spacing__hover=&#8221;2px&#8221; button_two_letter_spacing__hover_enabled=&#8221;on&#8221; button_two_letter_spacing__hover=&#8221;1px&#8221; button_one_bg_color__hover_enabled=&#8221;off&#8221; button_two_bg_color__hover_enabled=&#8221;off&#8221;]<\/p>\n<p><span>We handle the complete verification and validation (V&#038;V) of your medical device software or Software as a Medical Device (SaMD): from <strong>software verification<\/strong> through <strong>clinical validation<\/strong> to <strong>security and AI validation<\/strong> in accordance with the <strong>MDR, IEC 62304, and ISO 13485<\/strong>. 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align=&#8221;center&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.27.6&#8243; transform_scale=&#8221;200%|200%&#8221; max_width_tablet=&#8221;40%&#8221; max_width_phone=&#8221;65%&#8221; max_width_last_edited=&#8221;off|desktop&#8221; custom_margin=&#8221;50px||35px||false|false&#8221; custom_padding=&#8221;||0px|||&#8221; animation_style=&#8221;zoom&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\">[\/et_pb_image][et_pb_blurb title=&#8221;Prior to DiGA Listing&#8221; icon_placement=&#8221;left&#8221; content_max_width=&#8221;1100px&#8221; admin_label=&#8221;Informationstext&#8221; _builder_version=&#8221;4.27.6&#8243; header_font=&#8221;overpass-bold|700||on|||||&#8221; header_text_align=&#8221;center&#8221; header_font_size=&#8221;20px&#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|||&#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 style=\"text-align: center;\"><span>You are preparing the application for inclusion in the BfArM registry pursuant to Section 139e of SGB V and require clinical validation, a security assessment compliant with BSI TR-03161, and test documentation compliant with IEC 62304.<\/span><\/p>\n<p style=\"text-align: center;\">\n<p style=\"text-align: center;\">[\/et_pb_blurb][\/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|desktop&#8221; _builder_version=&#8221;4.27.6&#8243; custom_padding=&#8221;0|0px|75px|0px|false|false&#8221; custom_padding_tablet=&#8221;||90px||false|false&#8221; custom_padding_phone=&#8221;||90px||false|false&#8221; animation_style=&#8221;fade&#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\/2026\/05\/handshake_150dp_FFFFFF_FILL0_wght300_GRAD0_opsz48.svg&#8221; alt=&#8221;Unternehmen_U\u0308bernahme&#8221; title_text=&#8221;handshake_150dp_FFFFFF_FILL0_wght300_GRAD0_opsz48&#8243; align=&#8221;center&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.27.6&#8243; transform_scale=&#8221;200%|200%&#8221; max_width_tablet=&#8221;40%&#8221; max_width_phone=&#8221;65%&#8221; max_width_last_edited=&#8221;off|desktop&#8221; custom_margin=&#8221;50px||35px||false|false&#8221; custom_padding=&#8221;||0px|||&#8221; animation_style=&#8221;zoom&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\">[\/et_pb_image][et_pb_blurb title=&#8221;In Software Acquisitions and Due Diligence&#8221; icon_placement=&#8221;left&#8221; _builder_version=&#8221;4.27.6&#8243; header_font=&#8221;overpass-bold|700||on|||||&#8221; header_text_align=&#8221;center&#8221; header_font_size=&#8221;20px&#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|0px|0px|false|false&#8221; custom_padding=&#8221;0px|0px|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 style=\"text-align: center;\"><span>You are acquiring a software asset or medical device software and need an independent assessment of the depth of testing, the quality of documentation, and the compliance status.<\/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_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2026\/05\/rocket_launch_150dp_FFFFFF_FILL0_wght300_GRAD0_opsz48.svg&#8221; alt=&#8221;Unternehmen_U\u0308bernahme&#8221; title_text=&#8221;rocket_launch_150dp_FFFFFF_FILL0_wght300_GRAD0_opsz48&#8243; align=&#8221;center&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.27.6&#8243; transform_scale=&#8221;200%|200%&#8221; max_width_tablet=&#8221;40%&#8221; max_width_phone=&#8221;65%&#8221; max_width_last_edited=&#8221;off|desktop&#8221; custom_margin=&#8221;50px||35px||false|false&#8221; custom_padding=&#8221;||0px|||&#8221; animation_style=&#8221;zoom&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\">[\/et_pb_image][et_pb_blurb title=&#8221;For Major Releases&#8221; icon_placement=&#8221;left&#8221; content_max_width=&#8221;1100px&#8221; admin_label=&#8221;Informationstext&#8221; _builder_version=&#8221;4.27.6&#8243; header_font=&#8221;overpass-bold|700||on|||||&#8221; header_text_align=&#8221;center&#8221; header_font_size=&#8221;20px&#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; body_link_font=&#8221;|700|||||||&#8221; body_link_text_color=&#8221;#FFFFFF&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;-1px||0px|||&#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 style=\"text-align: center;\"><span>You are planning a major software update and need comprehensive regression testing, an updated risk analysis, and verification of the new functionality.<\/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_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2026\/05\/psychology_150dp_FFFFFF_FILL0_wght300_GRAD0_opsz48.svg&#8221; alt=&#8221;Unternehmen_U\u0308bernahme&#8221; title_text=&#8221;psychology_150dp_FFFFFF_FILL0_wght300_GRAD0_opsz48&#8243; align=&#8221;center&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.27.6&#8243; transform_scale=&#8221;200%|200%&#8221; max_width_tablet=&#8221;40%&#8221; max_width_phone=&#8221;65%&#8221; max_width_last_edited=&#8221;off|desktop&#8221; custom_margin=&#8221;50px||35px||false|false&#8221; custom_padding=&#8221;||0px|||&#8221; animation_style=&#8221;zoom&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\">[\/et_pb_image][et_pb_blurb title=&#8221;AI Model Validation&#8221; icon_placement=&#8221;left&#8221; content_max_width=&#8221;1100px&#8221; admin_label=&#8221;Informationstext&#8221; _builder_version=&#8221;4.27.6&#8243; header_font=&#8221;overpass-bold|700||on|||||&#8221; header_text_align=&#8221;center&#8221; header_font_size=&#8221;20px&#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|||&#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 style=\"text-align: center;\"><span>You are developing or updating an <span style=\"text-decoration: underline;\"><span style=\"color: #ffffff;\"><a href=\"https:\/\/quickbirdmedical.com\/en\/ai-medicine-software-app-development\/\" style=\"color: #ffffff; text-decoration: underline;\">AI or ML model<\/a><\/span><\/span> and want to validate its performance, robustness, fairness, and compliance with the MDR, FDA requirements, or the EU AI Act.<\/span><\/p>\n<p style=\"text-align: center;\">[\/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|tablet&#8221; admin_label=&#8221;Feature&#8221; _builder_version=&#8221;4.21.0&#8243; background_color=&#8221;#ffffff&#8221; custom_padding=&#8221;0||50px||false|false&#8221; custom_padding_tablet=&#8221;||50px||false|false&#8221; custom_padding_phone=&#8221;||50px||false|false&#8221; top_divider_color=&#8221;#FFFFFF&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row admin_label=&#8221;row&#8221; _builder_version=&#8221;4.21.0&#8243; custom_padding=&#8221;15px||15px||false|false&#8221; animation_style=&#8221;fade&#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;4.27.6&#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;\">An Overview of our V&#038;V Services<\/span><\/h2>\n<p style=\"text-align: center;\">[\/et_pb_text][et_pb_text _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#333333&#8243; text_font_size=&#8221;18px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\"><span>We cover all areas of medical software verification and validation, from the unit-test level to clinical trials, and from penetration testing to AI performance validation. You receive all services from a single source, complete with consistent documentation. <\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; custom_padding_last_edited=&#8221;on|tablet&#8221; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; custom_padding_tablet=&#8221;||0px||false|false&#8221; custom_padding_phone=&#8221;||0px||false|false&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;25px|45px|25px|45px|false|true&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/09\/IEC-62304-1.svg&#8221; title_text=&#8221;IEC 62304 (1)&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; width=&#8221;40%&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.27.6&#8243; text_font=&#8221;||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; header_2_font=&#8221;Lato|700|||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_3_font=&#8221;|700|||||||&#8221; header_3_text_align=&#8221;left&#8221; header_3_text_color=&#8221;#41b6e6&#8243; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#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;]<\/p>\n<h3 class=\"animate-in visible\" style=\"text-align: center;\"><strong><span md-inline=\"plain\" class=\"md-plain\">Software Verification according to IEC 62304<\/span><\/strong><\/h3>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.27.6&#8243; text_font=&#8221;||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; header_2_font=&#8221;Lato|700|||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_3_font=&#8221;|700|||||||&#8221; header_3_text_align=&#8221;left&#8221; header_3_text_color=&#8221;#41b6e6&#8243; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;||17px|||&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;22px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; inline_fonts=&#8221;overpass-extralight,overpass-bold&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p data-renderer-start-pos=\"449\" data-local-id=\"5e721483fb52\" style=\"text-align: center;\"><span>We verify your software against its requirements and specifications, from unit and integration tests to comprehensive system tests. We take into account the software safety classification (Class A, B, or C), ensure requirements traceability through a comprehensive test matrix, and provide you with test plans, test logs, and test reports in the format required for certification. <\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;25px|45px|25px|45px|false|true&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/09\/IEC-62366-1-1.svg&#8221; title_text=&#8221;IEC 62366-1 (1)&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; width=&#8221;40%&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.27.6&#8243; text_font=&#8221;||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; header_2_font=&#8221;Lato|700|||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_3_font=&#8221;|700|||||||&#8221; header_3_text_align=&#8221;left&#8221; header_3_text_color=&#8221;#41b6e6&#8243; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#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;]<\/p>\n<h3 class=\"animate-in visible\" style=\"text-align: center;\"><strong><span md-inline=\"plain\" class=\"md-plain\">Usability Validation<\/span><\/strong><\/h3>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.27.6&#8243; text_font=&#8221;||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; header_2_font=&#8221;Lato|700|||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_3_font=&#8221;|700|||||||&#8221; header_3_text_align=&#8221;left&#8221; header_3_text_color=&#8221;#41b6e6&#8243; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;||17px|||&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;22px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; inline_fonts=&#8221;overpass-extralight,overpass-bold&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p data-renderer-start-pos=\"449\" data-local-id=\"5e721483fb52\" style=\"text-align: center;\"><span>We conduct formative and summative usability studies in accordance with IEC 62366 and identify usage errors before they become risks.<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; custom_padding_last_edited=&#8221;on|tablet&#8221; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; custom_padding_tablet=&#8221;||0px||false|false&#8221; custom_padding_phone=&#8221;||0px||false|false&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;25px|45px|25px|45px|false|true&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/09\/IEC-81001-5-1-1.svg&#8221; alt=&#8221;EU MDR (1)&#8221; title_text=&#8221;IEC 81001-5-1 (1)&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; width=&#8221;40%&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.27.6&#8243; text_font=&#8221;||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; header_2_font=&#8221;Lato|700|||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_3_font=&#8221;|700|||||||&#8221; header_3_text_align=&#8221;left&#8221; header_3_text_color=&#8221;#41b6e6&#8243; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#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;]<\/p>\n<h3 class=\"animate-in visible\" style=\"text-align: center;\"><strong><span md-inline=\"plain\" class=\"md-plain\">Security Validation<\/span><\/strong><\/h3>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.27.6&#8243; text_font=&#8221;||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; header_2_font=&#8221;Lato|700|||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_3_font=&#8221;|700|||||||&#8221; header_3_text_align=&#8221;left&#8221; header_3_text_color=&#8221;#41b6e6&#8243; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;||17px|||&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;22px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; inline_fonts=&#8221;overpass-extralight,overpass-bold&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p class=\"animate-in visible\" style=\"text-align: center;\"><span>In the area of cybersecurity, we offer penetration testing, vulnerability scans, threat modeling, SBOM creation, and compliance assessments against IEC 81001-5-1, FDA Cybersecurity Guidance, and BSI TR-03161 for DiGA.<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;25px|45px|25px|45px|false|true&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/\/2026\/06\/AI-Siegel.svg&#8221; alt=&#8221;AI Seal&#8221; title_text=&#8221;AI Seal&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; width=&#8221;40%&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.27.6&#8243; text_font=&#8221;||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; header_2_font=&#8221;Lato|700|||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_3_font=&#8221;|700|||||||&#8221; header_3_text_align=&#8221;left&#8221; header_3_text_color=&#8221;#41b6e6&#8243; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#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;]<\/p>\n<h3 class=\"animate-in visible\" style=\"text-align: center;\"><strong><span md-inline=\"plain\" class=\"md-plain\">AI Validation<\/span><\/strong><\/h3>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.27.6&#8243; text_font=&#8221;||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; header_2_font=&#8221;Lato|700|||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_3_font=&#8221;|700|||||||&#8221; header_3_text_align=&#8221;left&#8221; header_3_text_color=&#8221;#41b6e6&#8243; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;||17px|||&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;22px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; inline_fonts=&#8221;overpass-extralight,overpass-bold&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p class=\"animate-in visible\" style=\"text-align: center;\"><span>We validate machine learning and AI models for clinical performance, robustness, fairness, and reproducibility. This includes subgroup analyses, distribution shift tests, bias and calibration checks, and the implementation of post-market drift monitoring. <\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; disabled_on=&#8221;on|on|off&#8221; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||||false|false&#8221; bottom_divider_color=&#8221;#1bb8ea&#8221; bottom_divider_flip=&#8221;horizontal&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||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 module_id=&#8221;2&#8243; _builder_version=&#8221;4.27.6&#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;\">Our Process: From a V&#038;V Engagement to Audit Assurance<\/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; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; custom_margin=&#8221;||35px||false|false&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#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_text _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; custom_padding=&#8221;1px||0px|||&#8221; animation_direction=&#8221;bottom&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3 style=\"text-align: center;\"><span style=\"font-weight: 400;\">1. Gap Analysis and Scoping<\/span><\/h3>\n<p style=\"text-align: center;\"><span>Together with you, we review the current status of your software, documentation, and tests. We identify gaps relative to the applicable standards (IEC 62304, ISO 14971, IEC 62366, IEC 81001-5-1) and the target regulatory approval (MDR, FDA, DiGA), and prioritize verification and validation (V&#038;V) activities based on risk class and audit relevance. <\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/Konzeption.webp&#8221; alt=&#8221;Grafik DiGA Konzeption&#8221; title_text=&#8221;Concept&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; custom_margin=&#8221;||35px||false|false&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#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\/App-Design.webp&#8221; alt=&#8221;Grafik User Interface&#8221; title_text=&#8221;App Design&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#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;4.27.6&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3 style=\"text-align: center;\"><span style=\"font-weight: 400;\">2. V&#038;V Planning<\/span><\/h3>\n<p style=\"text-align: center;\">We develop a comprehensive V&#038;V plan that includes a test strategy, test environment, traceability matrix, acceptance criteria, and deliverables. For clinical validation, this includes the Clinical Evaluation Plan; for AI applications, it includes the model validation plan, which covers performance metrics and dataset requirements. <\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; custom_margin=&#8221;||20px||false|false&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#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_text _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3 style=\"text-align: center;\"><span style=\"font-weight: 400;\">3. Implementation and Documentation<\/span><\/h3>\n<p style=\"text-align: center;\">We conduct the planned tests\u2014ranging from automated verification to clinical trials and penetration testing\u2014and document all results in an audit-ready format. You will receive test reports, risk-benefit analyses, clinical reports, and security assessments as part of your technical documentation. <\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/MDRkonform.webp&#8221; alt=&#8221;Grafik MDR konform&#8221; title_text=&#8221;MDR-compliant&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; custom_margin=&#8221;||20px||false|false&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#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\/Content-Produktion.webp&#8221; alt=&#8221;Graphic Content Production&#8221; title_text=&#8221;Content Production&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;52%&#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;4.27.6&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3 style=\"text-align: center;\"><span style=\"font-weight: 400;\">4. Audit Support and Post-Market<\/span><\/h3>\n<p style=\"text-align: center;\">We\u2019ll guide you through the Notified Body audit or the FDA submission, answer any technical or regulatory questions you may have, and, upon request, set up your post-market surveillance and drift monitoring programs.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; disabled_on=&#8221;off|off|on&#8221; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; bottom_divider_color=&#8221;#1bb8ea&#8221; bottom_divider_flip=&#8221;horizontal&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.18.1&#8243; _module_preset=&#8221;default&#8221; 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 module_id=&#8221;2&#8243; _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: #41b6e6; font-family: overpass-extralight;\">Our Acquisition Process<\/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; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; custom_margin=&#8221;||||false|false&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#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 DiGA Konzeption&#8221; title_text=&#8221;Concept&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width_tablet=&#8221;&#8221; width_phone=&#8221;&#8221; width_last_edited=&#8221;on|phone&#8221; max_width=&#8221;70%&#8221; max_width_tablet=&#8221;45%&#8221; max_width_phone=&#8221;70%&#8221; max_width_last_edited=&#8221;on|tablet&#8221; custom_margin=&#8221;||-10px||false|false&#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;4.27.6&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; custom_padding=&#8221;1px||0px|||&#8221; animation_direction=&#8221;bottom&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3 style=\"text-align: center;\"><span style=\"font-weight: 400;\">1. Gap Analysis and Scoping<\/span><\/h3>\n<p style=\"text-align: center;\"><span>Together with you, we review the current status of your software, documentation, and tests. We identify gaps relative to the applicable standards (IEC 62304, ISO 14971, IEC 62366, IEC 81001-5-1) and the target regulatory approval (MDR, FDA, DiGA), and prioritize verification and validation (V&#038;V) activities based on risk class and audit relevance. <\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; custom_margin=&#8221;||||false|false&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#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\/App-Design.webp&#8221; alt=&#8221;Grafik User Interface&#8221; title_text=&#8221;App Design&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; max_width=&#8221;70%&#8221; max_width_tablet=&#8221;45%&#8221; max_width_phone=&#8221;70%&#8221; max_width_last_edited=&#8221;on|phone&#8221; custom_margin=&#8221;||-10px||false|false&#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;4.27.6&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3 style=\"text-align: center;\"><span style=\"font-weight: 400;\">2. V&#038;V Planning<\/span><\/h3>\n<p style=\"text-align: center;\">We develop a comprehensive V&#038;V plan that includes a test strategy, test environment, traceability matrix, acceptance criteria, and deliverables. For clinical validation, this includes the Clinical Evaluation Plan; for AI applications, it includes the model validation plan, which covers performance metrics and dataset requirements. <\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; custom_margin=&#8221;||||false|false&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#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\/MDRkonform.webp&#8221; alt=&#8221;Grafik MDR konform&#8221; title_text=&#8221;MDR-compliant&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; max_width=&#8221;70%&#8221; max_width_tablet=&#8221;45%&#8221; max_width_phone=&#8221;70%&#8221; max_width_last_edited=&#8221;on|phone&#8221; module_alignment=&#8221;center&#8221; custom_margin=&#8221;||-10px||false|false&#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;4.27.6&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3 style=\"text-align: center;\"><span style=\"font-weight: 400;\">3. Implementation and Documentation<\/span><\/h3>\n<p style=\"text-align: center;\">We conduct the planned tests\u2014ranging from automated verification to clinical trials and penetration testing\u2014and document all results in an audit-ready format. You will receive test reports, risk-benefit analyses, clinical reports, and security assessments as part of your technical documentation. <\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; make_equal=&#8221;on&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; background_enable_image=&#8221;off&#8221; custom_margin=&#8221;||||false|false&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#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\/Content-Produktion.webp&#8221; title_text=&#8221;Content Production&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; max_width=&#8221;70%&#8221; max_width_tablet=&#8221;45%&#8221; max_width_phone=&#8221;70%&#8221; max_width_last_edited=&#8221;on|phone&#8221; custom_margin=&#8221;||-10px||false|false&#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;4.27.6&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;18px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3 style=\"text-align: center;\"><span style=\"font-weight: 400;\">4. Audit Support and Post-Market<\/span><\/h3>\n<p style=\"text-align: center;\">We\u2019ll guide you through the Notified Body audit or the FDA submission, answer any technical or regulatory questions you may have, and, upon request, set up your post-market surveillance and drift monitoring programs.<\/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|desktop&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||4%||false|false&#8221; custom_padding_tablet=&#8221;||50px||false|false&#8221; custom_padding_phone=&#8221;0px||100px||false|false&#8221; bottom_divider_style=&#8221;slant2&#8243; bottom_divider_color=&#8221;#1bb8ea&#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||0px||false|false&#8221; animation_style=&#8221;fade&#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; custom_padding=&#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;\">\n<span style=\"color: #41b6e6;\">What really sets us apart<\/span><\/h2>\n<p style=\"text-align: center;\">\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; _builder_version=&#8221;4.27.6&#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|51px|0px|false|false&#8221; animation_style=&#8221;fade&#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;4.27.6&#8243; header_level=&#8221;h3&#8243; header_font=&#8221;overpass-bold|700|||||||&#8221; header_text_align=&#8221;left&#8221; header_text_color=&#8221;#41b6e6&#8243; header_font_size=&#8221;20px&#8221; header_line_height=&#8221;1.7em&#8221; body_text_color=&#8221;#333333&#8243; body_font_size=&#8221;18px&#8221; body_line_height=&#8221;2em&#8221; image_icon_custom_margin=&#8221;||-25px||false|false&#8221; animation_style=&#8221;zoom&#8221; animation_intensity_zoom=&#8221;10%&#8221; animation=&#8221;off&#8221; inline_fonts=&#8221;overpass-extralightttf&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: left;\"><span>Our quality management system is certified in accordance with ISO 13485. This ensures that we conduct compliant verification and validation of software as a medical device and meet the requirements of the MDR and the FDA (21 CFR, QMSR) for quality management systems. <\/span><\/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; 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;4.27.6&#8243; header_level=&#8221;h3&#8243; header_font=&#8221;overpass-bold|700|||||||&#8221; header_text_align=&#8221;left&#8221; header_text_color=&#8221;#41b6e6&#8243; header_font_size=&#8221;20px&#8221; header_line_height=&#8221;1.7em&#8221; body_text_color=&#8221;#333333&#8243; body_font_size=&#8221;18px&#8221; body_line_height=&#8221;2em&#8221; image_icon_custom_margin=&#8221;||-25px||false|false&#8221; animation_style=&#8221;zoom&#8221; animation_intensity_zoom=&#8221;10%&#8221; animation=&#8221;off&#8221; inline_fonts=&#8221;overpass-extralightttf&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: left;\"><span>QuickBird Medical is ISO 27001 certified for information security. We are experts in cybersecurity and in handling sensitive health data in compliance with data protection regulations, whether through penetration tests, security audits, or the design of your security architecture. <\/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;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;4.27.6&#8243; header_level=&#8221;h3&#8243; header_font=&#8221;overpass-bold|700|||||||&#8221; header_text_align=&#8221;left&#8221; header_text_color=&#8221;#41b6e6&#8243; header_font_size=&#8221;20px&#8221; header_line_height=&#8221;1.7em&#8221; body_text_color=&#8221;#333333&#8243; body_font_size=&#8221;18px&#8221; body_line_height=&#8221;2em&#8221; image_icon_custom_margin=&#8221;||-25px||false|false&#8221; animation_style=&#8221;zoom&#8221; animation_intensity_zoom=&#8221;10%&#8221; animation=&#8221;off&#8221; inline_fonts=&#8221;overpass-extralightttf&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: left;\">If required, we can serve as the legal manufacturer for your medical device software. We will therefore assume legal responsibility for compliance with all regulatory requirements of the MDR or the FDA. 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