{"id":22329,"date":"2025-09-12T09:30:36","date_gmt":"2025-09-12T09:30:36","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?page_id=22329"},"modified":"2025-09-12T15:56:56","modified_gmt":"2025-09-12T15:56:56","slug":"mdr-fda-certification-standards-guidelines","status":"publish","type":"page","link":"https:\/\/quickbirdmedical.com\/en\/mdr-fda-certification-standards-guidelines\/","title":{"rendered":"Our Certifications & Standards"},"content":{"rendered":"

[et_pb_section fb_built=”1″ fullwidth=”on” admin_label=”Sektion” _builder_version=”4.21.0″ custom_padding=”0px|0px|0|0px|false|false” bottom_divider_style=”slant2″ bottom_divider_color=”#FFFFFF” bottom_divider_flip=”horizontal” animation_style=”slide” animation_direction=”top” animation_intensity_slide=”2%” global_colors_info=”{}”][et_pb_fullwidth_header title=”Our Certifications” button_one_text=”CONTACT US” button_one_url=”https:\/\/quickbirdmedical.com\/en\/kontakt\/” background_overlay_color=”rgba(68,98,124,0.85)” content_max_width=”700px” admin_label=”Vollbreite Kopfzeile” _builder_version=”4.21.0″ title_font=”overpass-extralight|200|||||||” title_text_align=”left” title_text_color=”#FFFFFF” title_font_size=”45px” title_line_height=”1.2em” content_font=”opensans-regular||||||||” content_text_color=”#FFFFFF” content_font_size=”18px” content_line_height=”1.8em” subhead_text_color=”#FFFFFF” background_enable_color=”off” background_color_gradient_direction=”36deg” background_color_gradient_start=”rgba(126,190,197,0.77)” background_color_gradient_end=”rgba(255,255,255,0)” background_image=”https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/09\/Header_Gesetze_Standards_Normen_MDR_FDA.webp” background_size=”custom” background_position=”bottom_center” background_vertical_offset=”40%” custom_button_one=”on” button_one_text_size=”14px” button_one_text_color=”#ffffff” button_one_bg_color=”#41B6E6″ button_one_border_width=”8px” button_one_border_color=”#41b6e6″ button_one_border_radius=”0px” button_one_letter_spacing=”1px” button_one_font=”overpass-bold|600|||||||” button_one_use_icon=”off” custom_button_two=”on” button_two_text_size=”14px” button_two_text_color=”#FFFFFF” button_two_bg_color=”rgba(255,255,255,0.17)” button_two_border_width=”8px” button_two_border_color=”rgba(255,255,255,0)” button_two_border_radius=”0px” button_two_letter_spacing=”1px” button_two_font=”|700|||||||” button_two_custom_margin_tablet=”” button_two_custom_margin_phone=”||30px|-15px|false|false” button_two_custom_margin_last_edited=”on|phone” custom_margin=”|||” custom_padding=”||6%||false|false” custom_padding_tablet=”” custom_padding_phone=”||12%||false|false” custom_padding_last_edited=”on|phone” title_font_size_tablet=”40px” title_font_size_phone=”33px” title_font_size_last_edited=”on|phone” content_font_size_tablet=”16px” content_font_size_phone=”” content_font_size_last_edited=”on|tablet” subhead_font_size_tablet=”” subhead_font_size_phone=”16px” subhead_font_size_last_edited=”on|phone” custom_css_button_1=” margin-left: 0px;||||||” button_one_letter_spacing_hover=”1px” button_two_letter_spacing_hover=”1px” locked=”off” inline_fonts=”overpass-extralight” global_colors_info=”{}” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_one_letter_spacing__hover_enabled=”on” button_one_letter_spacing__hover=”2px” button_two_letter_spacing__hover_enabled=”on” button_two_letter_spacing__hover=”1px” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off”]<\/p>\n

QuickBird Medical develops healthcare software<\/strong> in accordance with the leading international standards<\/strong> in Europe and the USA<\/strong>. An overview of our certifications<\/strong> and relevant standards<\/strong> and laws<\/strong> can be found here. <\/p>\n

[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” _builder_version=”4.21.0″ _module_preset=”default” custom_padding=”0px||17px||false|false” custom_padding_tablet=”0px||24px||false|false” custom_padding_phone=”15px||19px||false|false” bottom_divider_style=”slant2″ bottom_divider_color=”#41b6e5″ bottom_divider_flip=”horizontal” global_colors_info=”{}”][et_pb_row _builder_version=”4.21.0″ _module_preset=”default” custom_padding=”15px||1px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.18.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.1″ text_font=”Lato||||||||” text_font_size=”18px” text_line_height=”1.8em” link_font=”||||||||” ul_font=”||||||||” ol_font=”||||||||” quote_font=”||||||||” header_font=”||||||||” header_2_font=”|700|||||||” header_2_font_size=”40px” header_2_letter_spacing=”2px” header_2_line_height=”1.5em” header_3_font=”||||||||” header_4_font=”||||||||” header_5_font=”||||||||” 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=”{}” header_2_text_color__hover_enabled=”on”]<\/p>\n

Certifications<\/span><\/h2>\n

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[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.21.0″ max_width=”1552px” custom_margin=”|||” custom_margin_tablet=”|||” custom_margin_phone=”|||” custom_margin_last_edited=”off|desktop” custom_padding=”0px|0px|75px|0px|false|false” use_custom_width=”on” custom_width_px=”1552px” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_blurb title=”ISO 13485 certified” image=”https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/ISO-13485-Siegel.webp” alt=”ISO 13485 Siegel” image_icon_width=”70%” image_icon_width_tablet=”70%” image_icon_width_phone=”85%” image_icon_width_last_edited=”on|phone” _builder_version=”4.21.0″ header_level=”h3″ header_font=”overpass-bold|700|||||||” header_text_align=”left” header_text_color=”#41b6e6″ header_font_size=”24px” header_line_height=”1.7em” body_text_color=”#333333″ body_font_size=”18px” body_line_height=”2em” image_icon_custom_margin=”||-25px||false|false” animation_style=”zoom” animation_intensity_zoom=”10%” animation=”off” header_text_align_tablet=”center” header_text_align_phone=”center” header_text_align_last_edited=”on|tablet” body_text_align_tablet=”center” body_text_align_phone=”center” body_text_align_last_edited=”on|tablet” inline_fonts=”overpass-extralightttf” global_colors_info=”{}”]<\/p>\n

Our quality management system is certified according to ISO 13485. This enables us to ensure the necessary quality of medical device software<\/strong> both under MDR<\/strong> and in accordance with the requirements of the FDA Quality System Regulation<\/strong> (21 CFR Part 820). <\/span><\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”ISO 27001 certified” image=”https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/03\/ISO-27001-Siegel.webp” alt=”ISO 27001 Siegel” image_icon_width=”70%” image_icon_width_tablet=”70%” image_icon_width_phone=”85%” image_icon_width_last_edited=”on|tablet” _builder_version=”4.21.0″ header_level=”h3″ header_font=”overpass-bold|700|||||||” header_text_align=”left” header_text_color=”#41b6e6″ header_font_size=”24px” header_line_height=”1.7em” body_text_color=”#333333″ body_font_size=”18px” body_line_height=”2em” image_icon_custom_margin=”||-25px||false|false” animation_style=”zoom” animation_intensity_zoom=”10%” animation=”off” header_text_align_tablet=”center” header_text_align_phone=”center” header_text_align_last_edited=”on|tablet” body_text_align_tablet=”center” body_text_align_phone=”center” body_text_align_last_edited=”on|tablet” inline_fonts=”overpass-extralightttf” global_colors_info=”{}”]<\/p>\n

QuickBird Medical is certified according to ISO\/IEC 27001 for information security<\/strong>. We are experts in the areas of cybersecurity<\/strong> and health data protection<\/strong>. This certification also enables us to assume the role of legal manufacturer for DiGA<\/a>, among other things.<\/span><\/p>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” admin_label=”Feature” _builder_version=”4.21.0″ 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″ background_enable_image=”off” custom_padding=”0%||7%||false|false” custom_padding_tablet=”||13%||false|false” custom_padding_phone=”||23%||false|false” bottom_divider_style=”slant2″ bottom_divider_color=”#FFFFFF” bottom_divider_flip=”horizontal” locked=”off” global_colors_info=”{}”][et_pb_row _builder_version=”4.21.0″ custom_padding=”15px||||false|false” 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=”4.21.0″ text_font=”opensans-regular||||||||” text_font_size=”16px” text_line_height=”1.8em” link_font=”||||||||” ul_font=”||||||||” ol_font=”||||||||” quote_font=”||||||||” header_font=”||||||||” header_2_font=”overpass-extralight|700|||||||” header_2_font_size=”40px” header_2_letter_spacing=”2px” header_2_line_height=”1.5em” header_3_font=”||||||||” header_4_font=”||||||||” header_5_font=”||||||||” 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=”||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” global_colors_info=”{}”]<\/p>\n

EU: Standards & Laws for Medical Device Software<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.21.0″ _module_preset=”default” text_font=”||||||||” text_font_size=”18px” text_line_height=”1.8em” link_font=”|800|||on||||” link_text_color=”#FFFFFF” ul_font=”||||||||” ol_font=”||||||||” quote_font=”||||||||” text_orientation=”right” background_layout=”dark” global_colors_info=”{}”]<\/p>\n

QuickBird Medical operates in compliance with the following standards and laws for the development of software medical devices in the EU. <\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.21.0″ max_width=”1324px” custom_padding=”0|0px|50px|0px|false|false” use_custom_width=”on” custom_width_px=”1324px” 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\/09\/GuidelinesEU-MDR-NumberDefault.svg” alt=”EU MDR (1)” title_text=”Guidelines=EU MDR, Number=Default” align=”center” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.21.0″ transform_translate=”10px|0px” transform_translate_linked=”off” max_width=”40%” max_width_tablet=”25%” max_width_phone=”40%” max_width_last_edited=”on|tablet” custom_margin=”||20px||false|false” custom_margin_tablet=”||20px||false|false” custom_margin_phone=”||20px||false|false” custom_margin_last_edited=”on|desktop” custom_padding=”|0px|||false|false” animation_style=”zoom” global_colors_info=”{}”] <\/p>\n

[\/et_pb_image][et_pb_blurb title=”MDR” icon_placement=”left” content_max_width=”1100px” _builder_version=”4.21.0″ header_level=”h3″ header_font=”overpass-bold|700||on|||||” header_text_align=”center” header_font_size=”20px” header_line_height=”1.4em” body_font=”opensans-regular||||||||” body_text_align=”center” body_font_size=”18px” text_orientation=”center” background_layout=”dark” custom_margin=”0px||0px||false|false” custom_padding=”0px|0px|0px|0px|false|false” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” global_colors_info=”{}”]<\/p>\n

The Medical Device Regulation (MDR)<\/strong> is the legal basis for the approval of medical devices in the EU. We develop software in such a way that it complies with the strict requirements of the legislation. <\/p>\n

[\/et_pb_blurb][\/et_pb_column][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\/09\/ISO-14971-Icon.svg” alt=”Graphic know-how” title_text=”ISO 14971 Icon” align=”center” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.21.0″ transform_translate=”5px|0px” transform_translate_linked=”off” max_width=”40%” max_width_tablet=”25%” max_width_phone=”40%” max_width_last_edited=”on|tablet” custom_margin=”||20px||false|false” custom_margin_tablet=”||20px||false|false” custom_margin_phone=”||20px||false|false” custom_margin_last_edited=”on|desktop” custom_padding=”|0px|||false|false” animation_style=”zoom” global_colors_info=”{}”] <\/p>\n

[\/et_pb_image][et_pb_blurb title=” ISO 14971″ icon_placement=”left” content_max_width=”1100px” admin_label=”Informationstext” _builder_version=”4.21.0″ header_font=”overpass-bold|700||on|||||” header_text_align=”center” header_font_size=”20px” header_line_height=”1.4em” body_font=”opensans-regular||||||||” body_text_align=”center” body_font_size=”18px” background_layout=”dark” custom_margin=”0px||0px||false|false” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” global_colors_info=”{}”]<\/p>\n

This standard defines the process for risk management in medical devices<\/strong>. We systematically identify, evaluate, and minimize risks in order to develop safe software solutions. <\/p>\n

[\/et_pb_blurb][\/et_pb_column][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\/09\/GuidelinesIEC-Number62304.svg” alt=”Graphic Design” title_text=”Guidelines=IEC, Number=62304″ align=”center” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.21.0″ transform_translate=”5px|0px” transform_translate_linked=”off” max_width=”40%” max_width_tablet=”25%” max_width_phone=”40%” max_width_last_edited=”on|tablet” custom_margin=”||20px||false|false” custom_margin_tablet=”||20px||false|false” custom_margin_phone=”||20px||false|false” custom_margin_last_edited=”on|desktop” custom_padding=”|0px|||false|false” animation_style=”zoom” global_colors_info=”{}”] <\/p>\n

[\/et_pb_image][et_pb_blurb title=”IEC 62304″ icon_placement=”left” content_max_width=”1100px” admin_label=”Informationstext” _builder_version=”4.21.0″ header_font=”overpass-bold|700||on|||||” header_text_align=”center” header_font_size=”20px” header_line_height=”1.4em” body_font=”opensans-regular||||||||” body_text_align=”center” body_font_size=”18px” background_layout=”dark” custom_margin=”0px||0px||false|false” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” global_colors_info=”{}” content__hover_enabled=”off|desktop”]<\/p>\n

This standard specifies requirements for the entire development life cycle of medical device software<\/strong>. From planning to maintenance, we ensure the quality of software development. <\/p>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.21.0″ max_width=”1324px” custom_padding=”0|0px|0px|0px|false|false” use_custom_width=”on” custom_width_px=”1324px” 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\/09\/GuidelinesIEC-Number62366-1.svg” alt=”Grafik Agilit\u00e4t” title_text=”Guidelines=IEC, Number=62366-1″ align=”center” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.21.0″ transform_translate=”5px|0px” transform_translate_linked=”off” max_width=”40%” max_width_tablet=”25%” max_width_phone=”40%” max_width_last_edited=”on|tablet” custom_margin=”||20px||false|false” custom_margin_tablet=”||20px||false|false” custom_margin_phone=”||20px||false|false” custom_margin_last_edited=”on|desktop” custom_padding=”|0px|||false|false” animation_style=”zoom” global_colors_info=”{}”] <\/p>\n

[\/et_pb_image][et_pb_blurb title=” IEC 62366-1″ icon_placement=”left” content_max_width=”1100px” _builder_version=”4.21.0″ header_font=”overpass-bold|700||on|||||” header_text_align=”center” header_font_size=”20px” header_line_height=”1.4em” body_font=”opensans-regular||||||||” body_text_align=”center” body_font_size=”18px” background_layout=”dark” custom_margin=”0px||0px||false|false” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” global_colors_info=”{}”]<\/p>\n

IEC 62366-1 defines methods for ensuring the usability of medical devices<\/strong>. The standard establishes framework conditions for identifying and mitigating usability risks.<\/p>\n

[\/et_pb_blurb][\/et_pb_column][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\/09\/GuidelinesIEC-Number81001-5-1.svg” alt=”Graphic know-how” title_text=”Guidelines=IEC, Number=81001-5-1″ align=”center” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.21.0″ transform_translate=”5px|0px” transform_translate_linked=”off” max_width=”40%” max_width_tablet=”25%” max_width_phone=”40%” max_width_last_edited=”on|tablet” custom_margin=”||20px||false|false” custom_margin_tablet=”||20px||false|false” custom_margin_phone=”||20px||false|false” custom_margin_last_edited=”on|desktop” custom_padding=”|0px|||false|false” animation_style=”zoom” global_colors_info=”{}”] <\/p>\n

[\/et_pb_image][et_pb_blurb title=”IEC 81001-5-1″ icon_placement=”left” content_max_width=”1100px” admin_label=”Informationstext” _builder_version=”4.21.0″ header_font=”overpass-bold|700||on|||||” header_text_align=”center” header_font_size=”20px” header_line_height=”1.4em” body_font=”opensans-regular||||||||” body_text_align=”center” body_font_size=”18px” background_layout=”dark” custom_margin=”0px||0px||false|false” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” global_colors_info=”{}”]<\/p>\n

This standard addresses cybersecurity for healthcare software<\/strong> and is used by many notified bodies during testing. We work in compliance with the standard to meet the necessary data security standards for medical device software. <\/p>\n

[\/et_pb_blurb][\/et_pb_column][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\/09\/GuidelinesIEC-Number82304-1.svg” alt=”Graphic Design” title_text=”Guidelines=IEC, Number=82304-1″ align=”center” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.21.0″ transform_translate=”5px|0px” transform_translate_linked=”off” max_width=”40%” max_width_tablet=”25%” max_width_phone=”40%” max_width_last_edited=”on|tablet” custom_margin=”||20px||false|false” custom_margin_tablet=”||20px||false|false” custom_margin_phone=”||20px||false|false” custom_margin_last_edited=”on|desktop” custom_padding=”|0px|||false|false” animation_style=”zoom” global_colors_info=”{}”] <\/p>\n

[\/et_pb_image][et_pb_blurb title=”IEC 82304-1″ icon_placement=”left” content_max_width=”1100px” admin_label=”Informationstext” _builder_version=”4.21.0″ header_font=”overpass-bold|700||on|||||” header_text_align=”center” header_font_size=”20px” header_line_height=”1.4em” body_font=”opensans-regular||||||||” body_text_align=”center” body_font_size=”18px” background_layout=”dark” custom_margin=”0px||0px||false|false” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” global_colors_info=”{}” content__hover_enabled=”off|desktop”]<\/p>\n

IEC 82304-1 specifies safety requirements <\/strong>specifically for health software. It fits into our software development life cycle according to IEC 62304. <\/p>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” admin_label=”Feature” _builder_version=”4.21.0″ background_color=”#ffffff” custom_padding=”0||2%||false|false” custom_padding_tablet=”0||2%||false|false” custom_padding_phone=”0||2%||false|false” top_divider_color=”#FFFFFF” bottom_divider_color=”#41b6e5″ bottom_divider_flip=”horizontal” locked=”off” global_colors_info=”{}”][et_pb_row admin_label=”row” _builder_version=”4.21.0″ custom_padding=”15px||15px||false|false” 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=”4.21.0″ text_font=”Lato||||||||” text_font_size=”18px” text_line_height=”1.8em” link_font=”||||||||” ul_font=”||||||||” ol_font=”||||||||” quote_font=”||||||||” header_font=”||||||||” header_2_font=”|700|||||||” header_2_font_size=”40px” header_2_letter_spacing=”2px” header_2_line_height=”1.5em” header_3_font=”||||||||” header_4_font=”||||||||” header_5_font=”||||||||” 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=”||-2px|||” 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=”{}” header_2_text_color__hover_enabled=”on”]<\/p>\n

USA: Norms & Standards for Medical Device Software
<\/span><\/h2>\n

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QuickBird Medical operates in compliance with the following standards for the development of software medical devices in the United States. The FDA guidelines<\/strong> form the basis for our development processes.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.21.0″ max_width=”1324px” custom_padding=”0|0px|0px|0px|false|false” use_custom_width=”on” custom_width_px=”1324px” 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\/09\/SOC-2.svg” alt=”Grafik Agilit\u00e4t” title_text=”SOC (2)” align=”center” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.21.0″ transform_translate=”15px|0px” transform_translate_linked=”off” max_width=”40%” max_width_tablet=”40%” max_width_phone=”55%” max_width_last_edited=”on|tablet” custom_margin=”||0px|||” animation_style=”zoom” global_colors_info=”{}”] <\/p>\n

[\/et_pb_image][et_pb_blurb title=”SOC 2 Compliance” icon_placement=”left” content_max_width=”1100px” _builder_version=”4.21.0″ header_font=”overpass-extralight||||||||” header_text_align=”center” header_text_color=”#41b6e6″ header_font_size=”27px” body_text_align=”left” body_text_color=”#333333″ body_font_size=”18px” background_layout=”dark” custom_margin=”0px||0px||false|false” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” header_text_align_tablet=”center” header_text_align_phone=”center” header_text_align_last_edited=”on|tablet” body_text_align_tablet=”center” body_text_align_phone=”center” body_text_align_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

SOC 2 is a standard for data management based on Trust Service Principles<\/strong>. We develop software according to these principles for security, availability, and confidentiality. <\/p>\n

[\/et_pb_blurb][\/et_pb_column][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\/09\/HIPPA-2.svg” alt=”HIPPA” title_text=”HIPPA (2)” align=”center” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.21.0″ max_width=”40%” max_width_tablet=”40%” max_width_phone=”55%” max_width_last_edited=”on|tablet” custom_margin=”||0px|||” custom_padding=”||0px|||” animation_style=”zoom” global_colors_info=”{}”] <\/p>\n

[\/et_pb_image][et_pb_blurb title=”HIPAA & HITECH Compliance” icon_placement=”left” content_max_width=”1100px” admin_label=”Informationstext” _builder_version=”4.21.0″ header_font=”overpass-extralight||||||||” header_text_align=”center” header_text_color=”#41b6e6″ header_font_size=”27px” body_text_align=”left” body_text_color=”#333333″ body_font_size=”18px” background_layout=”dark” custom_margin=”0px||0px||false|false” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” header_text_align_tablet=”center” header_text_align_phone=”center” header_text_align_last_edited=”on|tablet” body_text_align_tablet=”center” body_text_align_phone=”center” body_text_align_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

HIPAA & HITECH define strict requirements for the protection of patient data in the USA<\/strong>. We ensure that our software solutions meet these security and data protection requirements. <\/p>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.21.0″ max_width=”1324px” custom_padding=”0|0px|0px|0px|false|false” use_custom_width=”on” custom_width_px=”1324px” 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\/09\/FDA11-1.svg” alt=”Grafik Agilit\u00e4t” title_text=”FDA11 (1)” align=”center” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.21.0″ max_width=”40%” max_width_tablet=”40%” max_width_phone=”55%” max_width_last_edited=”on|tablet” custom_margin=”||0px|||” animation_style=”zoom” global_colors_info=”{}”] <\/p>\n

[\/et_pb_image][et_pb_blurb title=”FDA 21 CFR Part 11″ icon_placement=”left” content_max_width=”1100px” _builder_version=”4.21.0″ header_font=”overpass-extralight||||||||” header_text_align=”center” header_text_color=”#41b6e6″ header_font_size=”27px” body_text_align=”left” body_text_color=”#333333″ body_font_size=”18px” background_layout=”dark” custom_margin=”0px||0px||false|false” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” header_text_align_tablet=”center” header_text_align_phone=”center” header_text_align_last_edited=”on|tablet” body_text_align_tablet=”center” body_text_align_phone=”center” body_text_align_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

This regulation governs how electronic records and signatures are used in a legally compliant manner<\/strong>. Our systems meet these requirements, thereby guaranteeing integrity and security. <\/p>\n

[\/et_pb_blurb][\/et_pb_column][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\/09\/FDA820-1.svg” alt=”Graphic know-how” title_text=”FDA820 (1)” align=”center” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.21.0″ max_width=”40%” max_width_tablet=”40%” max_width_phone=”55%” max_width_last_edited=”on|tablet” custom_margin=”||0px|||” animation_style=”zoom” global_colors_info=”{}”] <\/p>\n

[\/et_pb_image][et_pb_blurb title=”FDA 21 CFR Part 820 (QMSR)” icon_placement=”left” content_max_width=”1100px” admin_label=”Informationstext” _builder_version=”4.21.0″ header_font=”overpass-extralight||||||||” header_text_align=”center” header_text_color=”#41b6e6″ header_font_size=”27px” body_text_align=”left” body_text_color=”#333333″ body_font_size=”18px” background_layout=”dark” custom_margin=”0px||0px||false|false” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” header_text_align_tablet=”center” header_text_align_phone=”center” header_text_align_last_edited=”on|tablet” body_text_align_tablet=”center” body_text_align_phone=”center” body_text_align_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

Part 820 is the FDA’s Quality Management System Regulation (QMSR). It defines requirements for the quality management system for the manufacture of medical devices<\/strong>. <\/p>\n

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Are you planning to implement medical software
or DiGA?<\/h2>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.16″ custom_padding=”5%|6%|10%|6%” custom_padding_tablet=”||150px|” custom_padding_phone=”” custom_padding_last_edited=”on|desktop” global_colors_info=”{}” padding_tablet=”||150px|” padding_last_edited=”on|desktop” custom_padding__hover=”|||” padding_phone=”||150px|”][et_pb_text _builder_version=”4.21.0″ text_font=”Lato||||||||” text_font_size=”18px” text_line_height=”1.8em” background_layout=”dark” max_width=”600px” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” text_font_size_tablet=”” text_font_size_phone=”” text_font_size_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

Contact us for a free initial consultation. We will give you an estimate of the effort and timeframe required to implement your project. We will also examine the regulatory and strategic framework conditions for your product. <\/p>\n

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QuickBird Medical develops healthcare software in accordance with the leading international standards in Europe and the USA. An overview of our certifications and relevant standards and laws can be found here. Certifications Our quality management system is certified according to ISO 13485. This enables us to ensure the necessary quality of medical device software both […]<\/p>\n","protected":false},"author":22,"featured_media":22355,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"class_list":["post-22329","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"\nMDR, FDA, ISO & IEC: Our Certifications & Standards<\/title>\n<meta name=\"description\" content=\"Our certifications, standards, and regulations: ISO, MDR, FDA, and more \u2013 for secure and compliant healthcare software.\" \/>\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\/mdr-fda-certification-standards-guidelines\/\" \/>\n<meta property=\"og:locale\" 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