{"id":294,"date":"2022-11-22T15:39:14","date_gmt":"2022-11-22T15:39:14","guid":{"rendered":"https:\/\/raqa.dk\/?page_id=294"},"modified":"2023-08-11T10:21:00","modified_gmt":"2023-08-11T10:21:00","slug":"medical-device-sector","status":"publish","type":"page","link":"https:\/\/raqa.dk\/en\/sectors\/medical-device-sector\/","title":{"rendered":"Medical Device Sector"},"content":{"rendered":"

[et_pb_section fb_built=”1″ _builder_version=”4.21.0″ _module_preset=”default” background_color=”gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1″ custom_margin=”||||false|false” custom_padding=”0px||0px||true|false” global_colors_info=”{%22gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1%22:%91%22background_color%22%93}”][et_pb_row _builder_version=”4.21.0″ _module_preset=”default” custom_margin=”||-20px||false|false” custom_padding=”||0px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][lwp_divi_breadcrumbs _builder_version=”4.21.0″ _module_preset=”default” global_colors_info=”{}”][\/lwp_divi_breadcrumbs][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”4.16″ _module_preset=”default” custom_margin=”||||false|false” custom_padding=”||||false|false” bottom_divider_style=”arrow” bottom_divider_color=”#FFFFFF” global_colors_info=”{}”][et_pb_fullwidth_header title=”Medical Devices” text_orientation=”center” button_one_text=”Our Services” button_one_url=”#services” button_two_text=”Contact us” button_two_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjQyMyJ9fQ==@” content_max_width=”60%” content_max_width_tablet=”60%” content_max_width_phone=”100%” content_max_width_last_edited=”on|phone” _builder_version=”4.16″ _dynamic_attributes=”button_two_url” _module_preset=”default” title_line_height=”1.2em” content_font_size=”16px” content_line_height=”1.8em” background_color=”#93CFC8″ background_enable_image=”off” background_blend=”multiply” custom_button_one=”on” button_one_text_color=”#FFFFFF” button_one_bg_color=”#0084B5″ 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_text_color=”#FFFFFF” button_two_bg_color=”#F9B13F” 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_layout=”light” child_mix_blend_mode=”screen” title_font_size_tablet=”” title_font_size_phone=”45px” title_font_size_last_edited=”on|phone” background_last_edited=”on|desktop” background_enable_image_phone=”off” global_colors_info=”{}”][\/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 column_structure=”2_3,1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”2_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.21.0″ _module_preset=”default” text_orientation=”center” custom_margin=”||15px||false|false” global_colors_info=”{}”]<\/p>\n

How we work<\/h2>\n

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RAQA helps small and medium sized medical device companies<\/strong> achieve regulatory compliance for their products – compliance that is necessary for products to be sold on the market. For some companies, we create the entire technical documentation package, while for others we assist with specific tasks, like setting up processes, post-marketing activities in the Quality Management System or writing reports.<\/p>\n

Our specialty is the regulatory process for Class I and Class IIa and IIb products<\/strong>.<\/p>\n

We create value for companies by giving them a strategic and planned process of how to approach and secure market access in their chosen markets.<\/p>\n

RAQA can also act as the ‘Person Responsible for Regulatory Compliance’, in accordance with Article 15.<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/08\/Quote-icon2-color.png” _builder_version=”4.21.2″ _module_preset=”default” title_text=”Quote-icon2-color” hover_enabled=”0″ sticky_enabled=”0″ align=”center” custom_margin=”||-35px||false|false” width=”70px” z_index=”1″ width_last_edited=”on|desktop” width_tablet=”70px” width_phone=”69px” global_module=”1006″ saved_tabs=”all”][\/et_pb_image][et_pb_testimonial author=”Niels Erik Holm” quote_icon_color=”gcid-88bd245e-faae-493b-9828-50690d0703ad” font_icon=”||divi||400″ use_icon_font_size=”on” icon_font_size=”50px” disabled_on=”off|off|off” _builder_version=”4.21.2″ _module_preset=”default” position_font=”||||||||” company_font=”||||||||” custom_padding=”40px||||false|false” hover_enabled=”0″ global_colors_info=”{%22gcid-88bd245e-faae-493b-9828-50690d0703ad%22:%91%22quote_icon_color%22%93,%22gcid-ec226263-b31b-482e-8585-463d44f3e99c%22:%91%22background_color%22%93}” job_title=”CEO” company_name=”Innoventa Medica” background_color=”gcid-ec226263-b31b-482e-8585-463d44f3e99c” quote_icon=”off” sticky_enabled=”0″ text_orientation_last_edited=”on|tablet” text_orientation_tablet=”center” text_orientation_phone=”center”]<\/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. She 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″ prev_background_color=”#ffffff” next_background_color=”#ffffff” _builder_version=”4.16″ _module_preset=”default” background_color=”gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1″ custom_padding=”150px||150px||true|false” top_divider_style=”arrow” top_divider_height=”150px” top_divider_flip=”vertical” bottom_divider_style=”arrow” bottom_divider_height=”150px” global_colors_info=”{%22gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1%22:%91%22background_color%22%93}”][et_pb_row column_structure=”1_3,2_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/01\/Sector_Medical-devices.jpg” alt=”Medical device sector” title_text=”Sector_Medical-devices” align_tablet=”center” align_phone=”center” align_last_edited=”on|tablet” _builder_version=”4.16″ _module_preset=”default” max_width_tablet=”300px” max_width_phone=”300px” max_width_last_edited=”on|tablet” global_colors_info=”{}”][\/et_pb_image][et_pb_cta disabled_on=”on|on|off” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

“We are true believers in that anyone can do regulatory work, given the right approach and understanding of the field
\u2013 a little guidance and a few examples can go a long way!”<\/h5>\n

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We hear your concerns<\/h2>\n

Regulatory processes are difficult to understand and thereby difficult to implement.<\/h6>\n

Many of the companies we work with are small and this means that there can be very diverse educational and work experience profiles behind the different tasks.<\/p>\n

We are true believers that anyone can do regulatory work, given the right approach and understanding of the field \u2013 a little guidance and a few examples can go a long way!<\/p>\n

The language and terms used in the regulations are not easy to understand.<\/h6>\n

We can help you understand the terms and thoughts behind the regulations. By using examples specific to your company’s approach to your products and customers, we make it relevant and understandable.<\/p>\n

The consequences of specific actions (or inaction) are unclear.
<\/strong><\/h6>\n

In 99% of cases, we experience that employees pride themselves on making a safe and proper functioning devices or product for users.<\/p>\n

We can teach you how to identify and talk about the potential risks of your product in a company-relevant way, so you understand the relevance and expectations of the regulatory process.<\/p>\n

Resources in the regulatory field are difficult to come by.<\/h6>\n

It is difficult to know if you have the right person or skill set in-house or in a consultant.<\/p>\n

We help companies help themselves by guiding them through the requirements, based on a prioritized list of what they feel they need. We offer input and can help with operational tasks to move the process forward. This is, in many ways, part of our one-on-one training of employees.\u00a0<\/p>\n

By sharing information and creating company-specific procedures, we help build your employees’ skillsets and confidence.<\/p>\n

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“Getting help to make the first steps often makes it easier to establish a methodology and healthy approach so that you also can plan your Regulatory tasks in and around the other tasks at hand”<\/h5>\n

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Services we commonly provide<\/h2>\n

[\/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=”2″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_3″ _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” image_icon_width=”75%” icon_placement_tablet=”top” icon_placement_phone=”top” icon_placement_last_edited=”on|phone” icon_alignment_tablet=”left” icon_alignment_phone=”center” icon_alignment_last_edited=”on|phone” _builder_version=”4.16″ _module_preset=”default” background_color=”#0084B5″ image_icon_custom_padding=”20px|20px|0px|20px|false|true” background_layout=”dark” custom_padding=”15px|20px|10px|20px|false|true” border_radii_image=”on|3px|3px|3px|3px” border_color_all_image=”gcid-55beddab-172e-48fd-9da1-bb715d655a4d” global_colors_info=”{%22gcid-55beddab-172e-48fd-9da1-bb715d655a4d%22:%91%22border_color_all_image%22,%22border_color_all_image%22%93}”]<\/p>\n