[et_pb_section fb_built=”1″ _builder_version=”4.21.2″ _module_preset=”default” background_enable_color=”off” background_enable_image=”off” background_size=”custom” background_image_width=”26%” background_position=”bottom_left” background_horizontal_offset=”12%” background_vertical_offset=”0%” width=”100%” custom_padding=”0px||||false|false” global_colors_info=”{%22gcid-9b15d31e-2ee0-47f1-8284-e8f18d27ff83%22:%91%22background_mask_color%22,%22background_color%22%93}”][et_pb_row column_structure=”2_3,1_3″ _builder_version=”4.21.2″ _module_preset=”default” background_enable_image=”off” background_size=”custom” background_image_width=”70%” background_image_height=”0%” background_position=”bottom_left” background_horizontal_offset=”-10%” background_vertical_offset=”0%” background_blend=”overlay” global_colors_info=”{}”][et_pb_column type=”2_3″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][lwp_divi_breadcrumbs _builder_version=”4.21.2″ _module_preset=”default” custom_margin=”||||false|false” custom_padding=”||30px||false|false” global_colors_info=”{}”][\/lwp_divi_breadcrumbs][et_pb_text _builder_version=”4.21.2″ _module_preset=”default” custom_margin=”||1px|||” global_colors_info=”{}”]<\/p>\n
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The intended use and intended user of a product are central to a product\u2019s risk assessment. The required documentation and regulations differ depending on:<\/p>\n
Even products that are approved and well documented must be reapproved, if the intended use or user group for the device changes.<\/p>\n
[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”3px|||||” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_2″ _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
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Innoventa Medica wished to certify an existing product with a new intended purpose and target audience. The product had already been on the market for many years and had both been utilized for its original intended use, as well as in an off-label format.<\/p>\n
Considering that the new intended purpose and patient group were different and required different documentation and test data, the documentation had to be revised. In addition, while the original documentation was good, it was in a format that focused on the requirements of the outdated MDD, not the MDR.<\/p>\n
[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_cta _builder_version=”4.21.2″ _module_preset=”default” header_level=”h4″ header_text_color=”gcid-c217d30a-c3d7-447d-9a91-fed3df555541″ body_text_color=”gcid-c217d30a-c3d7-447d-9a91-fed3df555541″ background_color=”gcid-bbabc2e6-852b-4eea-ab3c-25adbf10ca69″ text_orientation=”left” background_layout=”light” max_width_tablet=”60%” max_width_phone=”90%” max_width_last_edited=”on|tablet” module_alignment_tablet=”center” module_alignment_phone=”center” module_alignment_last_edited=”on|desktop” global_colors_info=”{%22gcid-c217d30a-c3d7-447d-9a91-fed3df555541%22:%91%22header_text_color%22,%22body_text_color%22%93,%22gcid-bbabc2e6-852b-4eea-ab3c-25adbf10ca69%22:%91%22background_color%22%93}”]<\/p>\n
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[\/et_pb_cta][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|desktop” _builder_version=”4.21.2″ _module_preset=”default” background_color=”rgba(255,255,255,0.5)” background_image=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/05\/Hex-beige-650x750px.png” background_size=”custom” background_image_width=”45%” background_position=”top_right” background_horizontal_offset=”11%” background_vertical_offset=”0%” background_blend=”overlay” overflow-x=”visible” overflow-y=”visible” custom_margin=”-200px||||false|false” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”||||false|false” custom_margin_last_edited=”on|desktop” custom_padding=”200px||100px||false|false” custom_padding_tablet=”0px||0px||false|false” custom_padding_phone=”0px||0px||false|false” background_last_edited=”on|tablet” background_image_width_tablet=”70%” background_image_width_phone=”84%” background_horizontal_offset_tablet=”-20%” background_horizontal_offset_phone=”-70%” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n
[\/et_pb_text][et_pb_text ul_item_indent=”40px” ol_position=”outside” ol_item_indent=”20px” _builder_version=”4.21.2″ _module_preset=”default” custom_padding=”||||false|false” global_colors_info=”{}”]<\/p>\n
[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n
[\/et_pb_text][et_pb_text _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”]Innoventa Medica had already started the process of redocumenting their product when they discovered that they needed additional resources to complete the task.<\/p>\n
RAQA was brought in to support the staff and draft the missing documents. Innoventa Medica was fully involved, maintaining full ownership of the process.<\/p>\n
We started by gathering and scanning or retyping all of the documentation and uploading it to an initial platform to create a complete overview. We discussed and agreed upon the level of the documentation needed to fulfil the regulations. Throughout the review process, we ensured that the focus of the documentation was on the new target group and new intended purpose of the product. The existing technical files were updated and new files were created to comply with the MDR.[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_cta disabled_on=”off|off|off” _builder_version=”4.21.2″ _module_preset=”default” header_level=”h5″ body_text_color=”#343434″ background_color=”gcid-ec226263-b31b-482e-8585-463d44f3e99c” text_orientation=”left” background_layout=”light” custom_padding=”40px||10px||false|false” border_radii=”on|2px|2px|2px|2px” global_colors_info=”{%22gcid-ec226263-b31b-482e-8585-463d44f3e99c%22:%91%22background_color%22,%22background_color%22%93,%22gcid-c217d30a-c3d7-447d-9a91-fed3df555541%22:%91%22body_text_color%22,%22header_text_color%22%93}”]<\/p>\n
– Niels Erik Holm (CEO), Innoventa Medica<\/p>\n
[\/et_pb_cta][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.21.2″ _module_preset=”default” custom_padding=”4px|||||” global_colors_info=”{}”][et_pb_row column_structure=”1_5,3_5,1_5″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_5″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.21.2″ _module_preset=”default” header_2_text_align=”center” global_colors_info=”{}”]<\/p>\n
[\/et_pb_text][et_pb_text _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”]The QMS system was updated according to the MDR and all of the new and revised documentation were entered into the QMS. The technical files were subsequently certified under the MDR by the Notified Body.<\/p>\n
The products have now been CE marked as per the MDR requirements where the new intended purpose and patient group are included. Now there is focus on maintenance, improvements, new products, as well as new markets.[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n
[\/et_pb_text][et_pb_text _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”]All post-market activities and ongoing updates are being performed in cooperation by Innoventa Medica and RAQA. Meanwhile, Innoventa Medica is busy exploring new ideas and investigating new products, with advisory services from RAQA as required.[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_cta disabled_on=”off|off|off” _builder_version=”4.21.2″ _module_preset=”default” header_level=”h5″ body_text_color=”#343434″ background_color=”gcid-ec226263-b31b-482e-8585-463d44f3e99c” text_orientation=”left” background_layout=”light” custom_margin=”||||false|false” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”0px||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”40px||10px||false|false” border_radii=”on|2px|2px|2px|2px” global_colors_info=”{%22gcid-ec226263-b31b-482e-8585-463d44f3e99c%22:%91%22background_color%22,%22background_color%22,%22background_color%22%93,%22gcid-c217d30a-c3d7-447d-9a91-fed3df555541%22:%91%22body_text_color%22,%22header_text_color%22%93}”]<\/p>\n
– Niels Erik Holm (CEO), Innoventa Medica[\/et_pb_cta][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ prev_background_color=”#ffffff” _builder_version=”4.14.8″ _module_preset=”default” background_color=”gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1″ module_alignment=”center” custom_padding=”||39px|||” top_divider_style=”arrow” top_divider_height=”200px” top_divider_flip=”vertical” bottom_divider_height=”200px” global_module=”465″ saved_tabs=”all” global_colors_info=”{%22gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1%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” text_orientation=”center” custom_margin=”40px||||false|false” global_colors_info=”{}”]<\/p>\n
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