[fusion_builder_container admin_label=”Your products” hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”no” status=”published” publish_date=”” class=”” id=”” background_color=”#f6f6f6″ background_image=”” background_position=”left top” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_size=”0px” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”40px” padding_right=”” padding_bottom=”50px” padding_left=””][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”no” hover_type=”none” link=”” min_height=”none” hide_on_mobile=”no” class=”” id=”” background_color=”” background_image=”” background_position=”left top” undefined=”” background_repeat=”no-repeat” border_size=”” border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”0px” margin_bottom=”50px” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”true” first=”true”][fusion_title hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”center” size=”2″ font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”#214d72″ style_type=”default” sep_color=””]
CE certification
[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]
Our team will be here to help you place your Medical Device on the EU market by being your guide on this journey.
As we are experts on Quality and Regulatory Affairs, we know that these areas cannot be separated. This is why we offer a full service to keep your business compliant.
[/fusion_text][fusion_separator style_type=”single solid” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”#ed6063″ top_margin=”” bottom_margin=”” border_size=”7″ icon=”” icon_circle=”” icon_circle_color=”” width=”200″ alignment=”center” /][/fusion_builder_column][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” background_color=”#f6f6f6″ background_image=”” background_position=”left top” background_repeat=”no-repeat” hover_type=”none” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_left=”” border_radius_bottom_right=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”true” first=”true”][fusion_title hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”center” size=”2″ font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”#214d72″ style_type=”default” sep_color=””]
CE Marking of your products
[/fusion_title][fusion_content_boxes layout=”clean-horizontal” columns=”5″ heading_size=”2″ title_color=”#ffffff” body_color=”#ffffff” iconspin=”no” circlecolor=”#ffffff” hover_accent_color=”#ffffff” icon_align=”left” animation_direction=”left” animation_speed=”0.3″ hide_on_mobile=”small-visibility,medium-visibility,large-visibility”][fusion_content_box title=”We offer you support to define your Regulatory Compliance strategy” backgroundcolor=”#2e7795″ icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][fusion_content_box title=”Our experts will perform a full compliance check on your products and your Quality System” backgroundcolor=”#50bfc3″ icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][fusion_content_box title=”We will guide you on the building of your Technical Documentation and the Conformity Assessment Process” backgroundcolor=”#2e7795″ icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][fusion_content_box title=”Our Medical Writers will help you create or update your Clinical Evaluation Reports (CER) or Post-marketing Clinical Follow-up (PMCF)” backgroundcolor=”#50bfc3″ icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][fusion_content_box title=”We can help you select the most appropriate Notified Body and organise a Technical Documentation Review with them prior to the final submission” backgroundcolor=”#2e7795″ icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][/fusion_content_boxes][fusion_separator style_type=”single solid” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”#ed6063″ top_margin=”” bottom_margin=”” border_size=”7″ icon=”” icon_circle=”” icon_circle_color=”” width=”200″ alignment=”center” /][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container admin_label=”Quality Management System” hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”no” status=”published” publish_date=”” class=”” id=”” background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_size=”0px” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”20px” padding_right=”” padding_bottom=”70px” padding_left=””][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_image_id=”” background_position=”left top” background_repeat=”no-repeat” hover_type=”none” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” border_radius=”” box_shadow=”no” dimension_box_shadow=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”true” first=”true”][fusion_title hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”center” size=”2″ font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”#214d72″ style_type=”default” sep_color=””]
Quality Management System
[/fusion_title][fusion_content_boxes layout=”clean-horizontal” columns=”4″ heading_size=”2″ title_color=”#ffffff” body_color=”#ffffff” iconspin=”no” circlecolor=”#ffffff” hover_accent_color=”#ffffff” icon_align=”left” animation_direction=”left” animation_speed=”0.3″ hide_on_mobile=”small-visibility,medium-visibility,large-visibility”][fusion_content_box title=”We can build your Quality Management System so it is compliant with ISO 13485″ backgroundcolor=”#2e7795″ icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][fusion_content_box title=”We can prepare your team and provide support during your third-party audits” backgroundcolor=”#50bfc3″ icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][fusion_content_box title=”In case of any vigilance reporting, we can help you evaluate the risks and define the actions required to remain compliant” backgroundcolor=”#2e7795″ icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][fusion_content_box title=”During your Product Development phase, we can provide Quality and Regulatory Affairs support to help ensure that you are including the right data for your design file” backgroundcolor=”#50bfc3″ icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][/fusion_content_boxes][fusion_separator style_type=”single solid” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”#ed6063″ top_margin=”” bottom_margin=”” border_size=”7″ icon=”” icon_circle=”” icon_circle_color=”” width=”200″ alignment=”center” /][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” background_color=”” background_image=”https://rapportss.com/wp-content/uploads/2019/09/blue-min-2-1024×309.jpg” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”fixed” enable_mobile=”no” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_size=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”100″ padding_right=”” padding_bottom=”100″ padding_left=””][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_image_id=”” background_position=”left top” background_repeat=”no-repeat” hover_type=”none” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” border_radius=”” box_shadow=”no” dimension_box_shadow=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”true” element_content=”” first=”true”][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container admin_label=”Other services” hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”no” status=”published” publish_date=”” class=”” id=”” background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_size=”0px” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”50px” padding_right=”” padding_bottom=”0px” padding_left=””][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_image_id=”” background_position=”left top” background_repeat=”no-repeat” hover_type=”none” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” border_radius=”” box_shadow=”no” dimension_box_shadow=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”true” first=”true”][fusion_title hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”center” size=”2″ font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”#214d72″ style_type=”default” sep_color=””]
Other Services
[/fusion_title][fusion_content_boxes layout=”clean-horizontal” columns=”4″ heading_size=”2″ title_color=”#ffffff” body_color=”#ffffff” iconspin=”no” circlecolor=”#ffffff” hover_accent_color=”#ffffff” icon_align=”left” animation_direction=”left” animation_speed=”0.3″ hide_on_mobile=”small-visibility,medium-visibility,large-visibility”][fusion_content_box title=”We can support your conversion to Digitalisation ” backgroundcolor=”#2e7795″ icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][fusion_content_box title=”If you need a Person Responsible for Regulatory Compliance, we can offer you our support” backgroundcolor=”#50bfc3″ icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][fusion_content_box title=”In Due Diligence, our experts can help you determine whether the Quality and Regulatory Affairs processes of the company are compliant or provide support in the acquisition of a new product” backgroundcolor=”#2e7795″ icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][fusion_content_box title=”Training and Mentoring your team” backgroundcolor=”#50bfc3″ icon=”” iconflip=”” iconrotate=”” iconspin=”” iconcolor=”” circlecolor=”” circlebordersize=”” circlebordercolor=”” outercirclebordersize=”” outercirclebordercolor=”” image=”” image_id=”” image_max_width=”” link=”” linktext=”Read More” link_target=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” /][/fusion_content_boxes][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_size=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”50″ padding_left=””][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_image_id=”” background_position=”left top” background_repeat=”no-repeat” hover_type=”none” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” border_radius=”” box_shadow=”no” dimension_box_shadow=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”true” element_content=”” first=”true”][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]