[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”4.16″ _module_preset=”default” background_enable_color=”off” background_enable_image=”off” background_position=”center_right” background_blend=”multiply” global_colors_info=”{%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22background_color%22%93}”][et_pb_fullwidth_header title=”Welcome to RAQA” button_one_text=”Benefits for you” button_one_url=”#benefits” button_two_text=”About RAQA” button_two_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjcwIn19@” content_max_width=”60%” content_max_width_tablet=”60%” content_max_width_phone=”100%” content_max_width_last_edited=”on|phone” _builder_version=”4.21.0″ _dynamic_attributes=”button_two_url” _module_preset=”default” title_font=”Rubik||||||||” title_line_height=”1.2em” content_font_size=”16px” content_line_height=”1.8em” background_color=”#0084B5″ background_image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/11\/RAQA-banner_1920x1080.jpg” background_blend=”multiply” custom_button_one=”on” button_one_border_width=”1px” button_one_letter_spacing=”1px” button_one_custom_margin=”40px|30px|20px||false|false” button_one_custom_margin_tablet=”40px||0px||false|false” button_one_custom_margin_phone=”40px|0px|0px||false|false” button_one_custom_margin_last_edited=”on|tablet” button_one_custom_padding=”||||false|false” custom_button_two=”on” button_two_border_width=”1px” button_two_letter_spacing=”1px” button_two_custom_margin=”40px|30px|20px||false|false” button_two_custom_margin_tablet=”40px|30px|20px||false|false” button_two_custom_margin_phone=”40px|0px|0px||false|false” button_two_custom_margin_last_edited=”on|phone” button_two_custom_padding=”||||false|false” background_last_edited=”on|desktop” background_enable_image_phone=”off” global_colors_info=”{}”]<\/p>\n
Regulations for medical devices and health and welfare technologies are difficult to navigate and documentation must be kept up-to-date. You don\u2019t want to risk your investment or be denied market access by not having the correct documentation in place.<\/p>\n
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Finding a pragmatic consultant who can advise on all classes of device can be difficult, but that is exactly what we offer. Our consultants are ready to listen to your concerns and issues \u2013 and we help you solve them in a way that best fits your company’s practices and budget.<\/p>\n
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We are flexible and offer customer orientated solutions. Whether you want us to complete the work for you or create procedures and teach you how to complete the processes yourself, we are ready to help.<\/p>\n
[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” global_colors_info=”{}”]<\/p>\n
[\/et_pb_text][et_pb_text _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” max_width=”80%” module_alignment=”center” global_colors_info=”{}”]<\/p>\n
Let us help you scope a plan to solve your company’s challenges. We use different methods and approaches and are able to tailor-make a solution for your company which reflects your practices and approach.<\/p>\n
Often we start by simply answering your questions. Then we focus on the long term goals, including compliance of the necessary requirements.<\/strong><\/p>\n We help you understand, navigate and implement the necessary regulations and standards in the way best suited for your company, so that you can focus on what is important to you.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_2,1_2″ make_equal=”on” _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.16″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” global_colors_info=”{}”][et_pb_blurb title=”Regulatory Affairs” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/01\/Regulatory-Affairs-icon-blue.png” alt=”RAQA – Regulatory Affairs” image_icon_width=”85%” _builder_version=”4.21.0″ _module_preset=”default” header_text_align=”center” body_text_align=”left” body_ul_item_indent=”100px” custom_margin=”||-5px||false|false” custom_margin_tablet=”||-10px||false|false” custom_margin_phone=”||-10px||false|false” custom_margin_last_edited=”on|desktop” custom_padding=”||||false|false” body_ul_item_indent_tablet=”100px” body_ul_item_indent_phone=”20px” body_ul_item_indent_last_edited=”on|desktop” global_colors_info=”{}”]<\/p>\n [\/et_pb_blurb][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjE3MSJ9fQ==@” button_text=”Learn more” button_alignment=”center” _builder_version=”4.16″ _dynamic_attributes=”button_url” _module_preset=”default” custom_button=”on” button_text_size=”18px” button_bg_color=”#0084B5″ button_border_width=”0px” button_letter_spacing=”1px” button_font=”|600|||||||” background_layout=”dark” custom_margin=”15px||||false|false” custom_padding=”4px||4px||true|false” box_shadow_style=”preset6″ global_colors_info=”{%22gcid-55beddab-172e-48fd-9da1-bb715d655a4d%22:%91%22button_text_color%22%93,%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22button_bg_color%22%93}” button_border_radius__hover=”3px” button_border_radius__hover_enabled=”on|hover”][\/et_pb_button][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Quality Assurance” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/Regulatory-Affairs-icon-blue_1.png” alt=”RAQA – Quality Assurance” image_icon_width=”85%” _builder_version=”4.21.0″ _module_preset=”default” header_text_align=”center” body_text_align=”left” body_ul_item_indent=”100px” custom_margin=”||-5px||false|false” custom_margin_tablet=”50px||-10px||false|false” custom_margin_phone=”50px||-10px||false|false” custom_margin_last_edited=”on|desktop” body_ul_item_indent_tablet=”100px” body_ul_item_indent_phone=”20px” body_ul_item_indent_last_edited=”on|desktop” global_colors_info=”{}”]<\/p>\n [\/et_pb_blurb][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjQxMiJ9fQ==@” button_text=”Learn more” button_alignment=”center” _builder_version=”4.16″ _dynamic_attributes=”button_url” _module_preset=”default” custom_button=”on” button_text_size=”18px” button_bg_color=”#0084B5″ button_border_width=”0px” button_letter_spacing=”1px” button_font=”|600|||||||” background_layout=”dark” custom_margin=”15px||||false|false” custom_padding=”4px||4px||true|false” box_shadow_style=”preset6″ global_colors_info=”{%22gcid-55beddab-172e-48fd-9da1-bb715d655a4d%22:%91%22button_text_color%22%93,%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22button_bg_color%22%93}” button_border_radius__hover=”3px” button_border_radius__hover_enabled=”on|hover”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ _module_preset=”default” background_color=”gcid-a9d165de-4653-4f96-8b6a-6956463a5090″ global_colors_info=”{%22gcid-a9d165de-4653-4f96-8b6a-6956463a5090%22:%91%22background_color%22%93}”][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_padding=”||55px|||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” custom_margin=”||40px|||” global_colors_info=”{}”]<\/p>\n The registration and certification process for medical devices can be very extensive. There are many parts that are in the manufacturer’s control (gold boxes), while other parts rely on a notary body or regulatory authority (green boxes).<\/p>\n RAQA can help you navigate and streamline this process, so you save time and avoid unnecessary work and stress.<\/p>\n [\/et_pb_text][et_pb_button button_url=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/09\/RAQA-Certification-Process-Timeline.pdf” url_new_window=”on” button_text=”DOWNLOAD – Certification Process Timeline (PDF)” button_alignment=”center” _builder_version=”4.22.1″ _module_preset=”default” custom_button=”on” button_text_size=”18px” button_bg_color=”gcid-9b15d31e-2ee0-47f1-8284-e8f18d27ff83″ button_border_width=”0px” button_letter_spacing=”1px” button_font=”|600|||||||” background_layout=”dark” custom_margin=”15px||||false|false” custom_padding=”10px||10px||true|false” hover_enabled=”0″ box_shadow_style=”preset6″ 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_builder_version=”4.16″ _module_preset=”default” ul_line_height=”2em” text_orientation=”center” background_layout=”dark” max_width=”65%” max_width_tablet=”90%” max_width_phone=”90%” max_width_last_edited=”on|desktop” module_alignment=”center” custom_padding=”||||false|true” border_radii=”on|3px|3px|3px|3px” border_color_all=”gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f” global_colors_info=”{%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22border_color_all%22,%22box_shadow_color%22%93}”]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_6,1_6,1_6,1_6,1_6,1_6″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_6″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/Advisory-icon1-white-1.png” alt=”Personalized advising” image_icon_width=”65px” _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” background_layout=”dark” global_colors_info=”{}”]<\/p>\n Advice specific to your company’s products, practices and approaches<\/p>\n [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_6″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb image=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/02\/Navigate-icon1-white.png” alt=”Navigate the system” image_icon_width=”65px” _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” background_layout=”dark” global_colors_info=”{}”]<\/p>\n Learn to navigate the system and understand the process<\/p>\n [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_6″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/Empower-icon1-white.png” alt=”Feel empowered” image_icon_width=”65px” _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” background_layout=”dark” global_colors_info=”{}”]<\/p>\n Feel empowered to continue the work on your own, or with the level of support you desire<\/p>\n [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_6″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb image=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/02\/Detect-oversigts-icon1-white.png” alt=”Detect oversights” image_icon_width=”65px” _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” background_layout=”dark” global_colors_info=”{}”]<\/p>\n Detect expensive and time consuming errors and oversights<\/p>\n [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_6″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb image=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/02\/Process-icon1-white.png” alt=”Implement processes” image_icon_width=”65px” _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” background_layout=”dark” global_colors_info=”{}”]<\/p>\n Implementation of suitable systems, processes and procedural frameworks<\/p>\n [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_6″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/Investment-icon1-white.png” alt=”Protect investment” image_icon_width=”65px” _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” background_layout=”dark” global_colors_info=”{}”]<\/p>\n Protect your investment<\/p>\n [\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_padding=”||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” custom_margin=”||15px||false|false” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” max_width=”80%” module_alignment=”center” global_colors_info=”{}”]<\/p>\n Protect your company by understanding and following the relevant regulations for your industry<\/strong>. We can help you select and navigate the necessary regulations, define the necessary procedures, and create a practical framework.<\/p>\n We assist Manufacturers \u2013 Distributors \u2013 Importers <\/strong>from the following sectors: [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ use_custom_gutter=”on” gutter_width=”1″ make_equal=”on” _builder_version=”4.16″ _module_preset=”default” custom_margin=”-30px||||false|false” custom_padding=”||||false|false” global_module=”965″ saved_tabs=”all” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” custom_padding=”|20px|20px|20px|false|true” global_colors_info=”{}”][et_pb_blurb title=”Medical Devices” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/01\/Sector_Medical-devices.jpg” alt=”Medical device sector” image_icon_width_tablet=”70%” image_icon_width_phone=”80%” image_icon_width_last_edited=”on|desktop” _builder_version=”4.16″ _module_preset=”default” header_text_color=”gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1″ text_orientation=”center” custom_margin=”20px||||false|false” global_colors_info=”{%22gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1%22:%91%22header_text_color%22,%22header_text_color%22,%22header_text_color%22,%22header_text_color%22%93}”]<\/p>\n Products or equipment intended for a medical purpose. These can range from simple tongue depressors to complex artificial organs, or even products like medical journal software.<\/p>\n [\/et_pb_blurb][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjI5NCJ9fQ==@” url_new_window=”on” button_text=”See how we can help” button_alignment=”center” _builder_version=”4.16″ _dynamic_attributes=”button_url” _module_preset=”default” custom_button=”on” button_text_size=”18px” button_bg_color=”gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1″ button_border_width=”0px” button_letter_spacing=”1px” button_font=”|600|||||||” background_layout=”dark” custom_margin=”15px||||false|false” custom_padding=”4px||4px||true|false” box_shadow_style=”preset6″ global_colors_info=”{%22gcid-55beddab-172e-48fd-9da1-bb715d655a4d%22:%91%22button_text_color%22%93,%22gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1%22:%91%22button_bg_color%22%93}” button_border_radius__hover=”3px” button_border_radius__hover_enabled=”on|hover”][\/et_pb_button][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” custom_padding=”|20px|20px|20px|false|true” global_colors_info=”{}”][et_pb_blurb title=”Health and Welfare Technology” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/01\/Sector_Welfare-technology2.jpg” alt=”Welfare technology sector” image_icon_width_tablet=”70%” image_icon_width_phone=”80%” image_icon_width_last_edited=”on|tablet” _builder_version=”4.16″ _module_preset=”default” header_text_color=”gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1″ text_orientation=”center” custom_margin=”20px||||false|false” global_colors_info=”{%22gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1%22:%91%22header_text_color%22,%22header_text_color%22,%22header_text_color%22,%22header_text_color%22,%22header_text_color%22,%22header_text_color%22,%22header_text_color%22,%22header_text_color%22,%22header_text_color%22,%22header_text_color%22,%22header_text_color%22,%22header_text_color%22%93}”]<\/p>\n A sub-category of medical devices designed to improve the life and quality-of-care for patients \u2013 often by increasing security, activity, participation or independence.<\/p>\n [\/et_pb_blurb][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjMwMSJ9fQ==@” url_new_window=”on” button_text=”See how we can help” button_alignment=”center” _builder_version=”4.16″ _dynamic_attributes=”button_url” _module_preset=”default” custom_button=”on” button_text_size=”18px” button_bg_color=”gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1″ button_border_width=”0px” button_letter_spacing=”1px” button_font=”|600|||||||” background_layout=”dark” custom_margin=”15px||||false|false” custom_padding=”4px||4px||true|false” box_shadow_style=”preset6″ global_colors_info=”{%22gcid-55beddab-172e-48fd-9da1-bb715d655a4d%22:%91%22button_text_color%22,%22button_text_color%22,%22button_text_color%22%93,%22gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1%22:%91%22button_bg_color%22,%22button_bg_color%22,%22button_bg_color%22%93}” button_border_radius__hover=”3px” button_border_radius__hover_enabled=”on|hover”][\/et_pb_button][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” custom_padding=”|20px|20px|20px|false|true” border_radii=”on|3px|3px|3px|3px” global_colors_info=”{}”][et_pb_blurb title=”Local Councils and Hospitals” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/01\/Sector_Local-councils-hospitals3.jpg” alt=”Municipalities and hospital sector” image_icon_width_tablet=”70%” image_icon_width_phone=”80%” image_icon_width_last_edited=”on|desktop” _builder_version=”4.16″ _module_preset=”default” header_text_color=”gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1″ text_orientation=”center” custom_margin=”20px||||false|false” global_colors_info=”{%22gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1%22:%91%22header_text_color%22,%22header_text_color%22,%22header_text_color%22,%22header_text_color%22,%22header_text_color%22,%22header_text_color%22%93}”]<\/p>\n Did you know that you become a ‘medical device manufacturer’ if you alter, adapt or use medical devices in a way other than intended?<\/p>\n See more details in the box below.<\/em><\/p>\n [\/et_pb_blurb][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjMwNyJ9fQ==@” url_new_window=”on” button_text=”See how we can help” button_alignment=”center” _builder_version=”4.16″ _dynamic_attributes=”button_url” _module_preset=”default” custom_button=”on” button_text_size=”18px” button_bg_color=”gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1″ button_border_width=”0px” button_letter_spacing=”1px” button_font=”|600|||||||” background_layout=”dark” custom_margin=”15px||||false|false” custom_padding=”4px||4px||true|false” box_shadow_style=”preset6″ global_colors_info=”{%22gcid-55beddab-172e-48fd-9da1-bb715d655a4d%22:%91%22button_text_color%22,%22button_text_color%22,%22button_text_color%22%93,%22gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1%22:%91%22button_bg_color%22,%22button_bg_color%22,%22button_bg_color%22%93}” button_border_radius__hover=”3px” button_border_radius__hover_enabled=”on|hover”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_4,3_4″ _builder_version=”4.16″ _module_preset=”default” background_color=”gcid-a9d165de-4653-4f96-8b6a-6956463a5090″ width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width=”900px” custom_margin=”50px||40px||false|false” custom_padding=”40px|40px|40px|40px|true|true” border_radii=”on|3px|3px|3px|3px” border_color_all=”gcid-9b15d31e-2ee0-47f1-8284-e8f18d27ff83″ box_shadow_style=”preset1″ global_colors_info=”{%22gcid-9b15d31e-2ee0-47f1-8284-e8f18d27ff83%22:%91%22border_color_all%22%93,%22gcid-a9d165de-4653-4f96-8b6a-6956463a5090%22:%91%22background_color%22%93}”][et_pb_column type=”1_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/11\/Did-you-know_icon.png” alt=”RAQA – Did you know? icon” title_text=”Did-you-know_icon” align_tablet=”right” align_phone=”center” align_last_edited=”on|phone” _builder_version=”4.16″ _module_preset=”default” max_width_tablet=”30%” max_width_phone=”70%” max_width_last_edited=”on|tablet” custom_margin_tablet=”||-50px||false|false” custom_margin_phone=”||0px||false|false” custom_margin_last_edited=”on|phone” custom_padding=”||||false|false” custom_padding_tablet=”||||false|false” custom_padding_phone=”||||false|false” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.16″ _module_preset=”default” custom_margin=”||15px||false|false” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.21.0″ _module_preset=”default” text_text_color=”gcid-c217d30a-c3d7-447d-9a91-fed3df555541″ global_colors_info=”{%22gcid-c217d30a-c3d7-447d-9a91-fed3df555541%22:%91%22text_text_color%22%93}”]<\/p>\n Changing and altering devices can be dangerous<\/b> The change can be as simple as using a different mattress on a hospital bed or adding a headrest to a wheelchair, but can have important consequences with regards to responsibility and even more daunting, liability.<\/p>\n [\/et_pb_text][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjQyMyJ9fQ==@” 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_module_preset=”default” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n Your content goes here. Edit or remove this text inline or in the module Content settings. You can also style every aspect of this content in the module Design settings and even apply custom CSS to this text in the module Advanced settings.<\/p>\n [\/et_pb_text][et_pb_button url_new_window=”on” button_text=”Read more” button_alignment=”left” _builder_version=”4.16″ _module_preset=”default” custom_button=”on” button_text_size=”18px” button_bg_color=”#0084B5″ button_border_width=”0px” button_letter_spacing=”1px” button_font=”|600|||||||” background_layout=”dark” custom_margin=”15px||||false|false” custom_padding=”4px||4px||true|false” box_shadow_style=”preset6″ global_colors_info=”{%22gcid-55beddab-172e-48fd-9da1-bb715d655a4d%22:%91%22button_text_color%22,%22button_text_color%22%93,%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22button_bg_color%22,%22button_bg_color%22%93}” button_border_radius__hover=”3px” button_border_radius__hover_enabled=”on|hover”][\/et_pb_button][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”data:image\/svg+xml;base64,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” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ disabled_on=”off|off|off” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”data:image\/svg+xml;base64,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” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n Your content goes here. Edit or remove this text inline or in the module Content settings. 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She uses the right approach and offers competent, well thought-out solutions and insights into the future that you can trust.<\/p>\n It frees up some time for me, and it gives me a sense of security when I work with RAQA. I am sure that everything that is being done is in order.\u201d<\/p>\n [\/et_pb_testimonial][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/01\/Innoventa-Medica_logo.jpg” alt=”Customer logo Innoventa Medica” title_text=”Innoventa-Medica_logo” align=”center” _builder_version=”4.21.2″ _module_preset=”default” height=”60px” custom_margin=”||||false|false” custom_padding=”||||false|false” global_colors_info=”{}”][\/et_pb_image][et_pb_testimonial author=”Niels Erik Holm” job_title=”CEO” company_name=”Innoventa Medica” quote_icon=”off” quote_icon_color=”gcid-9b15d31e-2ee0-47f1-8284-e8f18d27ff83″ quote_icon_background_color=”RGBA(255,255,255,0)” portrait_width=”113px” portrait_height=”50px” use_icon_font_size=”on” _builder_version=”4.21.2″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” background_layout=”dark” custom_padding=”0px|10px||10px|false|true” border_radii_portrait=”on|0px|0px|0px|0px” border_style_all_portrait=”none” global_colors_info=”{%22gcid-9b15d31e-2ee0-47f1-8284-e8f18d27ff83%22:%91%22quote_icon_color%22%93}”]<\/p>\n \u201cWe have been working with RAQA since 2021, and Laura has been a major contributor in helping us obtain MDR approval of our Class IIb implant products.<\/p>\n Laura has been helping us both with regards to establishment of the technical files and certification of our QMS system to meet the MDR standard. She has a good relationship with our customers and is trusted to participate in meetings with them and staff from our company.<\/p>\n Laura is a trustworthy person who seeks to simplify issues, and she takes a pragmatic view when needed.\u201d<\/p>\n [\/et_pb_testimonial][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ _module_preset=”default” global_module=”967″ saved_tabs=”all” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_padding=”4px|||||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” 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_module_preset=”default” global_colors_info=”{}”]<\/p>\n We are here to help<\/strong><\/p>\n Please send us a message and we will get back to you within 24 hours.<\/span><\/p>\n [\/et_pb_text][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjMifX0=@” url_new_window=”on” button_text=”Read our Privacy Policy” button_alignment=”left” _builder_version=”4.16″ _dynamic_attributes=”button_url” _module_preset=”default” custom_button=”on” button_text_size=”15px” button_bg_color=”gcid-88bd245e-faae-493b-9828-50690d0703ad” button_border_width=”0px” button_letter_spacing=”1px” button_font=”|600|||||||” background_layout=”dark” custom_margin=”15px||||false|false” custom_padding=”4px||4px||true|false” box_shadow_style=”preset6″ locked=”off” global_colors_info=”{%22gcid-55beddab-172e-48fd-9da1-bb715d655a4d%22:%91%22button_text_color%22%93,%22gcid-88bd245e-faae-493b-9828-50690d0703ad%22:%91%22button_bg_color%22%93}” 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You don\u2019t want to risk your investment or be denied market access by not having the correct documentation in place. Finding a pragmatic consultant who can advise on all classes of device can be difficult, […]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","iawp_total_views":64684,"footnotes":""},"class_list":["post-14","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/raqa.dk\/da\/wp-json\/wp\/v2\/pages\/14","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/raqa.dk\/da\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/raqa.dk\/da\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/raqa.dk\/da\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/raqa.dk\/da\/wp-json\/wp\/v2\/comments?post=14"}],"version-history":[{"count":74,"href":"https:\/\/raqa.dk\/da\/wp-json\/wp\/v2\/pages\/14\/revisions"}],"predecessor-version":[{"id":1024,"href":"https:\/\/raqa.dk\/da\/wp-json\/wp\/v2\/pages\/14\/revisions\/1024"}],"wp:attachment":[{"href":"https:\/\/raqa.dk\/da\/wp-json\/wp\/v2\/media?parent=14"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
\n
Certification process<\/h3>\n
DEFINE<\/h4>\n
\n <\/p>\n1-2 meetings<\/h6>\n
DETERMINE<\/h4>\n
\n <\/p>\n1-2 meetings per country \/ region<\/h6>\n
SCOPE \/ PLAN<\/h4>\n
2-3 days<\/h6>\n
CREATE Technical File<\/h4>\n
4-6 months<\/h6>\n
ESTABLISH QMS<\/h4>\n
2-3 months<\/h6>\n
INITIATE Certification Process<\/h4>\n
~6 months<\/h6>\n
Certification Process<\/h4>\n
12-18 months<\/h6>\n
Approval<\/h4>\n
Post Market Activities<\/h4>\n
Benefits of working with RAQA<\/h3>\n
Sectors<\/h2>\n
<\/strong><\/p>\nDid you know?<\/h3>\n
If you update or change a medical device with a custom attachment or alternative part than specified, you are then defined as a medical device manufacturer. It will need to be documented in your Quality Management System and assessed for potential impacts and risks.<\/p>\nWe can answer your questions and help you navigate the system, finding the best solution for your organisation and your clients.<\/h6>\n
Case Studies<\/h2>\n
Title 1<\/h4>\n
Title 2<\/h4>\n
Testimonials<\/h2>\n
Trusted by<\/h2>\n
Get in Touch<\/h1>\n