{"id":171,"date":"2022-11-14T15:56:17","date_gmt":"2022-11-14T15:56:17","guid":{"rendered":"https:\/\/raqa.dk\/?page_id=171"},"modified":"2023-10-03T11:15:37","modified_gmt":"2023-10-03T11:15:37","slug":"regulatory-affairs","status":"publish","type":"page","link":"https:\/\/raqa.dk\/en\/regulatory-affairs\/","title":{"rendered":"Regulatory Affairs"},"content":{"rendered":"

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The medical device and welfare technology industries are subject to extensive rules and regulations. These regulations vary from country to country and are often wrought with excessive amounts of instructions, paperwork and forms.<\/p>\n

 <\/p>\n

The process can seem overwhelming, but it isn\u2019t as complicated as it seems. A viable solution doesn\u2019t need to be so different from your current systems \u2014 let RAQA show you how.<\/p>\n

[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=”1″ next_background_color=”#ffffff” _builder_version=”4.16″ _module_preset=”default” background_color=”gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f” custom_padding=”||130px|||” bottom_divider_style=”arrow” bottom_divider_height=”200px” bottom_divider_height_tablet=”120px” bottom_divider_height_phone=”120px” bottom_divider_height_last_edited=”on|phone” global_colors_info=”{%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22background_color%22%93}”][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” header_3_text_align=”center” header_3_text_color=”#FFFFFF” header_4_text_color=”gcid-9b15d31e-2ee0-47f1-8284-e8f18d27ff83″ global_colors_info=”{%22gcid-9b15d31e-2ee0-47f1-8284-e8f18d27ff83%22:%91%22header_4_text_color%22%93}”]<\/p>\n

Services – Regulatory Affairs<\/h3>\n

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header_font_size=”17px” text_orientation=”center” background_layout=”dark” global_colors_info=”{}” icon_color__hover=”#F9B13F” icon_color__hover_enabled=”on|hover” header_text_color__hover=”#F9B13F” header_text_color__hover_enabled=”on|desktop”][\/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 title=”Process implementation” url=”#process” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/Implementation-icon1-white.png” alt=”Process Implementation” image_icon_width=”55px” _builder_version=”4.21.2″ _module_preset=”default” header_font_size=”17px” text_orientation=”center” background_layout=”dark” global_colors_info=”{}” icon_color__hover=”#F9B13F” icon_color__hover_enabled=”on|hover” header_text_color__hover=”#F9B13F” header_text_color__hover_enabled=”on|desktop”][\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_6″ _builder_version=”4.16″ _module_preset=”default” 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_module_preset=”default” header_font_size=”17px” text_orientation=”center” background_layout=”dark” global_colors_info=”{}” icon_color__hover=”#F9B13F” icon_color__hover_enabled=”on|hover” header_text_color__hover=”#F9B13F” header_text_color__hover_enabled=”on|desktop”][\/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 title=”FAQ” url=”#faq” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/FAQ-icon1-white.png” alt=”Frequently Asked Questions” image_icon_width=”55px” _builder_version=”4.21.2″ _module_preset=”default” header_font_size=”17px” text_orientation=”center” background_layout=”dark” global_colors_info=”{}” icon_color__hover=”#F9B13F” icon_color__hover_enabled=”on|hover” header_text_color__hover=”#F9B13F” header_text_color__hover_enabled=”on|desktop”][\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Scoping & Planning” 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We help you determine which regulations and standards apply to your product based on which markets you would like to enter or are already in.<\/p>\n

From there we can determine the degree of assistance that you need. Our goal is to deliver the desired results while streamlining the process for you, so you can continue to successfully develop your products and business.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ specialty=”on” padding_top_bottom_link_2=”false” padding_left_right_link_2=”true” _builder_version=”4.22.1″ _module_preset=”default” background_color=”gcid-a9d165de-4653-4f96-8b6a-6956463a5090″ max_width=”1000px” max_width_tablet=”80%” max_width_phone=”80%” max_width_last_edited=”on|tablet” module_alignment=”center” custom_margin=”0px||80px||false|false” border_radii=”on|6px|6px|6px|6px” box_shadow_style=”preset1″ global_colors_info=”{%22gcid-a9d165de-4653-4f96-8b6a-6956463a5090%22:%91%22background_color%22%93}”][et_pb_column type=”2_3″ specialty_columns=”2″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_row_inner _builder_version=”4.22.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_column_inner saved_specialty_column_type=”2_3″ _builder_version=”4.22.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.22.2″ _module_preset=”default” custom_margin=”||15px||false|false” global_colors_info=”{}”]<\/p>\n

CE Approval Process (EU)<\/h3>\n

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The CE Approval Process for Medical Devices<\/strong> can be a bumpy road. There are so many requirements to consider, documents to get in order, decisions to get right \u2013 not to mention finding a Notified Body with the time and expertise to conduct the required certification process. And that is just to have your product certified for use in one<\/span> market (i.e. the EU). Other markets have other requirements and processes.<\/p>\n

When scoping a product certification project, it is important to consider and plan for all of the necessary steps and requirements. This is the only way to ensure that everything is accounted for and create a realistic timeline for the project.<\/p>\n

We have created this process chart to help you visualize and understand the the many facets of the certification process \u2013 download this free PDF for a closer look.<\/p>\n

[\/et_pb_text][\/et_pb_column_inner][\/et_pb_row_inner][et_pb_row_inner column_structure=”1_2,1_2″ _builder_version=”4.22.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_column_inner type=”1_2″ saved_specialty_column_type=”2_3″ _builder_version=”4.22.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjQyMyJ9fQ==@” button_text=”Contact us” button_alignment=”left” button_alignment_tablet=”center” button_alignment_phone=”center” button_alignment_last_edited=”on|phone” _builder_version=”4.22.1″ _dynamic_attributes=”button_url” _module_preset=”default” custom_button=”on” button_bg_color=”#F9B13F” button_border_width=”1px” button_letter_spacing=”1px” background_layout=”dark” custom_margin=”||||false|false” global_colors_info=”{}” button_custom_margin_tablet=”40px||0px||false|false” button_custom_margin_phone=”40px|0px|0px||false|false” button_custom_margin_last_edited=”on|tablet”][\/et_pb_button][\/et_pb_column_inner][et_pb_column_inner type=”1_2″ saved_specialty_column_type=”2_3″ _builder_version=”4.22.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/09\/RAQA-CE-Approval-Process-for-Medical-Devices-EU.pdf” url_new_window=”on” button_text=”Download PDF” button_alignment=”left” button_alignment_tablet=”center” button_alignment_phone=”center” button_alignment_last_edited=”on|tablet” _builder_version=”4.22.1″ _module_preset=”default” custom_button=”on” button_bg_color=”#0084B5″ button_border_width=”1px” button_letter_spacing=”1px” background_layout=”dark” custom_margin=”||||false|false” global_colors_info=”{}” button_custom_margin_tablet=”40px||0px||false|false” button_custom_margin_phone=”40px|0px|0px||false|false” button_custom_margin_last_edited=”on|tablet”][\/et_pb_button][\/et_pb_column_inner][\/et_pb_row_inner][\/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:\/\/raqa.dk\/wp-content\/uploads\/2023\/10\/RAQA-CE-Approval-Process.jpg” alt=”RAQA CE Approval Process thumbnail” title_text=”RAQA – CE Approval Process” url=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/10\/RAQA-CE-Approval-Process-for-Medical-Devices-EU.pdf” url_new_window=”on” _builder_version=”4.22.2″ _module_preset=”default” max_width_tablet=”60%” max_width_phone=”80%” max_width_last_edited=”on|phone” module_alignment_tablet=”center” module_alignment_phone=”center” module_alignment_last_edited=”on|tablet” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Advising” module_id=”advising” _builder_version=”4.16″ _module_preset=”default” background_color=”gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f” custom_margin=”||||false|false” custom_padding=”||0px||false|false” top_divider_height=”200px” top_divider_flip=”vertical” bottom_divider_style=”arrow” bottom_divider_color=”#FFFFFF” bottom_divider_height=”200px” bottom_divider_height_tablet=”120px” bottom_divider_height_phone=”120px” bottom_divider_height_last_edited=”on|tablet” global_colors_info=”{%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22background_color%22%93}”][et_pb_row column_structure=”3_5,2_5″ _builder_version=”4.16″ _module_preset=”default” custom_margin=”||||false|false” custom_padding=”||50px||false|false” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Advising” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/Advisory-icon1-white-1.png” alt=”Personalized advising” icon_placement=”left” _builder_version=”4.16″ _module_preset=”default” header_level=”h2″ image_icon_custom_margin=”-10px|||-30px|false|false” background_layout=”dark” custom_margin=”||||false|false” custom_padding=”||||false|false” global_colors_info=”{}”][\/et_pb_blurb][et_pb_text _builder_version=”4.16″ _module_preset=”default” background_layout=”dark” max_width=”100%” module_alignment=”center” global_colors_info=”{}”]<\/p>\n

We are available to advise you on regulations and procedures, guiding you through the process from start to finish.<\/p>\n

Don\u2019t let high ambitions, good intentions and ingenuity become a hindrance \u2014 the regulatory process doesn\u2019t need to be complicated. Together we will create a model that meets the level of assistance you require.<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/11\/RAQA-Advising.jpg” alt=”RAQA Advising” title_text=”RAQA-Advising” align=”center” _builder_version=”4.16″ _module_preset=”default” max_width=”300px” custom_padding=”|||0px||” module_alignment_tablet=”center” module_alignment_phone=”center” module_alignment_last_edited=”on|phone” global_colors_info=”{}”][\/et_pb_image][\/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

Did you know?<\/h3>\n

[\/et_pb_text][et_pb_text _builder_version=”4.16″ _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

Some products are covered by several different regulations and directives<\/b><\/p>\n

This can make global registrations a little more complicated. You will need to monitor more sets of regulations, but it isn’t unmanageable. You just need to be aware and be organized.<\/p>\n

Two categories of products which are regulated by more than one directive are height-adjustable hospital beds and any product with incorporated software.<\/p>\n

[\/et_pb_text][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjQyMyJ9fQ==@” button_text=”Contact us” button_alignment=”left” _builder_version=”4.16″ _dynamic_attributes=”button_url” _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=”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-9b15d31e-2ee0-47f1-8284-e8f18d27ff83%22:%91%22button_bg_color%22%93}” button_border_radius__hover=”3px” button_border_radius__hover_enabled=”on|hover”][\/et_pb_button][et_pb_text _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We can answer your questions and help you navigate the system, finding the best solution for your organisation and your clients.<\/h6>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Process Implementation” module_id=”process” _builder_version=”4.16″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” module_alignment=”center” top_divider_height=”200px” top_divider_flip=”vertical” bottom_divider_height=”200px” global_colors_info=”{}” custom_padding__hover_enabled=”on|desktop”][et_pb_row column_structure=”2_5,3_5″ _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_column][et_pb_column type=”3_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Process Implementation” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/Implementation-icon1-color.png” alt=”Process Implementation” icon_placement=”left” _builder_version=”4.16″ _module_preset=”default” header_level=”h2″ image_icon_custom_margin=”-10px|||-30px|false|false” custom_margin=”||||false|false” custom_padding=”||||false|false” global_colors_info=”{}”][\/et_pb_blurb][et_pb_text _builder_version=”4.16″ _module_preset=”default” max_width=”100%” module_alignment=”center” global_colors_info=”{}”]<\/p>\n

By defining and implementing procedures and processes, we can help build a solid foundation for your future work. We can create guideline documents and procedures that are easy to follow, so you minimize the amount of time and energy you spend on regulatory approvals.<\/p>\n

This can be done in your existing quality management system (QMS), or alternatively, we can find and set-up one of the many useful and affordable online QMS resources.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Project Management” module_id=”advising” _builder_version=”4.16″ _module_preset=”default” background_color=”gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f” custom_margin=”||||false|false” custom_padding=”||0px||false|false” top_divider_color=”#FFFFFF” top_divider_height=”150px” top_divider_flip=”vertical” bottom_divider_style=”arrow” bottom_divider_color=”#FFFFFF” bottom_divider_height=”200px” bottom_divider_height_tablet=”120px” bottom_divider_height_phone=”120px” bottom_divider_height_last_edited=”on|tablet” global_colors_info=”{%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22background_color%22,%22background_color%22,%22background_color%22%93}”][et_pb_row column_structure=”1_5,3_5,1_5″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”||0px||false|false” global_colors_info=”{}”][et_pb_column type=”1_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Project Management” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/Project-Management-icon1-white.png” alt=”Project Management” icon_placement=”left” _builder_version=”4.16″ _module_preset=”default” header_level=”h2″ image_icon_custom_margin=”-10px|||-30px|false|false” background_layout=”dark” custom_margin=”||||false|false” custom_padding=”||||false|false” global_colors_info=”{}”][\/et_pb_blurb][et_pb_text _builder_version=”4.16″ _module_preset=”default” background_layout=”dark” max_width=”100%” module_alignment=”center” global_colors_info=”{}”]<\/p>\n

If managing the regulatory process for your products is outside of your scope and current resources, we can help manage the entire process for you. We will ensure the process is completed professionally and efficiently.<\/p>\n

We can assist in communication with Notified Bodies and other authorities regarding certification requirements and compile the information required by the authority.<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/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

Did you know?<\/h3>\n

[\/et_pb_text][et_pb_text _builder_version=”4.16″ _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

Regulations differ around the world
<\/b><\/p>\n

The process<\/strong> to register medical devices, the time<\/strong> required for processing, and the price<\/strong> of submissions vary around the world.<\/p>\n

The primary regulating bodies are located in Europe (EU), USA, Canada, Brazil, Latin America and China. However, your products need to be registered in any market you wish to sell them in.<\/p>\n

[\/et_pb_text][et_pb_button button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjQyMyJ9fQ==@” button_text=”Contact us” button_alignment=”left” _builder_version=”4.16″ _dynamic_attributes=”button_url” _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=”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-9b15d31e-2ee0-47f1-8284-e8f18d27ff83%22:%91%22button_bg_color%22%93}” button_border_radius__hover=”3px” button_border_radius__hover_enabled=”on|hover”][\/et_pb_button][et_pb_text _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

We can answer your questions, help you make an overview, and plan the required submissions. You are in good hands with RAQA.<\/h6>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Mentoring” module_id=”mentoring” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_row column_structure=”3_5,2_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Mentoring” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/Mentoring-icon1-color.png” alt=”Mentoring” icon_placement=”left” _builder_version=”4.16″ _module_preset=”default” header_level=”h2″ image_icon_custom_margin=”-10px|||-30px|false|false” custom_margin=”||||false|false” custom_padding=”||||false|false” global_colors_info=”{}”][\/et_pb_blurb][et_pb_text _builder_version=”4.16″ _module_preset=”default” max_width=”100%” module_alignment=”center” global_colors_info=”{}”]<\/p>\n

Let us demystify the Regulatory Process for you.<\/p>\n

We are ready to teach you how to navigate the rules and understand the procedures. When you are ready to try it on your own, we are only a phone call away with support, encouragement and good advice.<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/Mentoring_300px.jpg” alt=”Mentoring” title_text=”Mentoring_300px” align=”center” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ next_background_color=”#ffffff” admin_label=”FAQ-RA” module_id=”faq” _builder_version=”4.16″ _module_preset=”default” background_color=”gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1″ background_color_gradient_start=”gcid-a9d165de-4653-4f96-8b6a-6956463a5090″ background_color_gradient_end=”gcid-55beddab-172e-48fd-9da1-bb715d655a4d” custom_margin=”||||false|false” custom_padding=”||130px||false|false” top_divider_height=”200px” top_divider_flip=”vertical” bottom_divider_style=”arrow” bottom_divider_height=”200px” global_colors_info=”{%22gcid-a9d165de-4653-4f96-8b6a-6956463a5090%22:%91%22top_divider_color%22,%22colorStart%22%93,%22gcid-55beddab-172e-48fd-9da1-bb715d655a4d%22:%91%22colorEnd%22%93,%22gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1%22:%91%22background_color%22%93}”][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_margin=”||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”FAQ” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/FAQ-icon1-color.png” alt=”Mentoring” icon_placement=”left” image_icon_width=”80px” content_max_width=”1020px” icon_placement_tablet=”left” icon_placement_phone=”left” icon_placement_last_edited=”on|phone” content_max_width_tablet=”” content_max_width_phone=”” content_max_width_last_edited=”on|phone” _builder_version=”4.16″ _module_preset=”default” header_level=”h2″ image_icon_custom_margin=”-10px|||-30px|false|false” image_icon_custom_margin_tablet=”|||0px|false|false” image_icon_custom_margin_phone=”|||0px|false|false” image_icon_custom_margin_last_edited=”on|desktop” module_alignment=”left” custom_margin=”||||false|false” custom_padding=”||||false|false” header_text_align_tablet=”” header_text_align_phone=”” header_text_align_last_edited=”on|tablet” text_orientation_tablet=”center” text_orientation_phone=”center” text_orientation_last_edited=”on|tablet” module_alignment_tablet=”right” module_alignment_phone=”right” module_alignment_last_edited=”on|tablet” global_colors_info=”{}”]<\/p>\n

Frequently asked questions about Regulatory Affairs<\/h5>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”FAQ-RA” _builder_version=”4.14.8″ _module_preset=”default” global_module=”241″ saved_tabs=”all” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_accordion open_toggle_text_color=”gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f” open_toggle_background_color=”gcid-55beddab-172e-48fd-9da1-bb715d655a4d” closed_toggle_text_color=”gcid-55beddab-172e-48fd-9da1-bb715d655a4d” closed_toggle_background_color=”gcid-88bd245e-faae-493b-9828-50690d0703ad” icon_color=”gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1″ use_icon_font_size=”on” icon_font_size=”22px” _builder_version=”4.22.2″ _module_preset=”default” body_ul_item_indent=”40px” hover_enabled=”0″ border_color_all=”gcid-88bd245e-faae-493b-9828-50690d0703ad” global_colors_info=”{%22gcid-88bd245e-faae-493b-9828-50690d0703ad%22:%91%22closed_toggle_background_color%22,%22border_color_all%22%93,%22gcid-55beddab-172e-48fd-9da1-bb715d655a4d%22:%91%22open_toggle_background_color%22,%22closed_toggle_text_color%22%93,%22gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1%22:%91%22icon_color%22%93,%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22open_toggle_text_color%22%93}” sticky_enabled=”0″][et_pb_accordion_item title=”What is Regulatory Affairs? ” open=”on” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

Regulatory Affairs<\/strong> is a profession within regulated industries, such as medical devices, pharmaceuticals or the financial sector.<\/p>\n

Regulatory Affairs Professionals in the medical device industry are often responsible for:<\/p>\n