[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|||” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n
[\/et_pb_text][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=”{}”]Medical device regulations are constantly changing and being redefined. In this case, Microwarm ApS requested assistance updating their product documentation to transition compliance from the old Medical Device Directive (MDD) to the new Medical Device Regulation (MDR).[\/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=”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=”4.16″ _module_preset=”default” custom_margin=”||15px||false|false” global_colors_info=”{}”]<\/p>\n
[\/et_pb_text][et_pb_text _builder_version=”4.21.2″ _module_preset=”default” custom_margin=”||50px|||” global_colors_info=”{}”]Originally, Microwarm ApS had three different products, all Class I, in its product portfolio. The products originated from other companies and had varying levels of documentation which had been transferred to Microwarm. The was a good market history and well established manufacturing systems, though some information was lacking. Due to changes in regulations since the products had been designed and developed some updates were required.<\/p>\n
Much of the documentation was in hard copy and there was a desire to merge all of the documentation into a common structure and style. Early on in the collaboration, we discussed establishing an online QMS platform for the day-to-day business of the company and maintaining technical file documentation.[\/et_pb_text][et_pb_cta disabled_on=”off|off|off” _builder_version=”4.23″ _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” hover_enabled=”0″ border_radii=”on|3px|3px|3px|3px” 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}” sticky_enabled=”0″]<\/p>\n
-S\u00f8ren Badstue (Owner), Microwarm ApS<\/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=”{}”]We started by gathering and scanning or re-typing all of the available documentation and uploading it to an initial platform to create an overview.<\/p>\n
Agreeing on the level of documentation and detail that was required to fulfill the regulations, we then updated and created the missing technical files to comply with the MDR. As all three products were Class I, they didn\u2019t require a high level of documentation, but we wanted to ensure that it would be easy to understand and simple to keep updated.<\/p>\n
The documentation requirements and QMS expenses needed to suit Microwarm\u2019s products and resources. It was important that S\u00f8ren was involved in decisions and took ownership of the process, so he could continue to maintain it.[\/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=”4.23″ _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” hover_enabled=”0″ border_radii=”on|3px|3px|3px|3px” 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}” sticky_enabled=”0″]<\/p>\n
-S\u00f8ren Badstue (Owner), Microwarm ApS<\/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=”{}”]<\/p>\n
We identified a suitable QMS system which fitted Microwarm\u2019s budget and implemented it. S\u00f8ren was trained in the system and used it in cooperation with RAQA to maintain Microwarm\u2019s documentation. The monthly price was very affordable, though the initial start-up costs were higher, due to the need for customized templates and configurations. However, the customizations were very useful and improved the daily use of the system.<\/p>\n
All of the initial technical files were updated to the MDR and UK MDR and are now secured in the new QMS system.<\/p>\n
While this process was underway, S\u00f8ren developed a new product, and he used the QMS to manage all of the documentation.<\/p>\n
The Competent Authority inspection was successful with very few non-conformances.<\/p>\n
[\/et_pb_text][et_pb_cta disabled_on=”off|off|off” _builder_version=”4.23″ _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=”50px|||||” custom_padding=”40px||10px||false|false” hover_enabled=”0″ border_radii=”on|3px|3px|3px|3px” 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}” sticky_enabled=”0″]<\/p>\n
-S\u00f8ren Badstue (Owner), Microwarm ApS<\/p>\n
[\/et_pb_cta][\/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=”{}”]<\/p>\n
RAQA continues to collaborate with Microwarm to maintain documentation. The QMS system helps us track all ongoing tasks, like PMS reports and risk management, with email reminders.<\/p>\n
Besides document maintenance, RAQA assists and advises Microwarm with policy and procedural questions on an ad hoc basis. In addition, we continue to work together on issues such as questions from distributors, customer concerns, and entering new markets.<\/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 disabled_on=”off|off|off” _builder_version=”4.23″ _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” hover_enabled=”0″ border_radii=”on|3px|3px|3px|3px” 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}” sticky_enabled=”0″]<\/p>\n
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I have already recommended RAQA to several people in the industry, and expect to do so again in the future.\u201d<\/p>\n
-S\u00f8ren Badstue (Owner), Microwarm ApS<\/p>\n
[\/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
[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.16″ _module_preset=”default” width=”60%” 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” global_colors_info=”{}”]<\/p>\n
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We will get back to you as soon as possible.” _builder_version=”4.21.0″ _module_preset=”default” _unique_id=”0c5145c9-a4ab-4775-9b7b-0bb554c4d69e” custom_button=”on” button_text_size=”18px” button_text_color=”gcid-55beddab-172e-48fd-9da1-bb715d655a4d” button_bg_color=”gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f” button_border_width=”0px” button_letter_spacing=”1px” button_font=”|600|||||||” button_custom_margin=”10px||||false|false” button_custom_padding=”4px||4px||true|false” box_shadow_style_button=”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_enabled=”on|hover” button_border_radius__hover=”3px”][et_pb_contact_field field_id=”Name” field_title=”Name” _builder_version=”4.16″ global_colors_info=”{}” button_text_size__hover_enabled=”off” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_text_color__hover_enabled=”off” button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_border_width__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_border_color__hover_enabled=”off” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_border_radius__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_letter_spacing__hover_enabled=”off” button_one_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover_enabled=”off” button_bg_color__hover_enabled=”off” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off”][\/et_pb_contact_field][et_pb_contact_field field_id=”Email” field_title=”Email Address” field_type=”email” _builder_version=”4.16″ global_colors_info=”{}” button_text_size__hover_enabled=”off” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_text_color__hover_enabled=”off” button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_border_width__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_border_color__hover_enabled=”off” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_border_radius__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_letter_spacing__hover_enabled=”off” button_one_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover_enabled=”off” button_bg_color__hover_enabled=”off” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off”][\/et_pb_contact_field][et_pb_contact_field field_id=”Company” field_title=”Company \/ Organisation” fullwidth_field=”on” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_contact_field][et_pb_contact_field field_id=”Message” field_title=”Message” field_type=”text” fullwidth_field=”on” _builder_version=”4.16″ global_colors_info=”{}” button_text_size__hover_enabled=”off” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_text_color__hover_enabled=”off” button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_border_width__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_border_color__hover_enabled=”off” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_border_radius__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_letter_spacing__hover_enabled=”off” button_one_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover_enabled=”off” button_bg_color__hover_enabled=”off” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off”][\/et_pb_contact_field][\/et_pb_contact_form][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"