{"id":26809,"date":"2026-07-09T10:11:44","date_gmt":"2026-07-09T08:11:44","guid":{"rendered":"https:\/\/cluetec-audit.de\/?page_id=26809"},"modified":"2026-07-28T17:35:17","modified_gmt":"2026-07-28T15:35:17","slug":"audit-software-medical-technology","status":"publish","type":"page","link":"https:\/\/cluetec-audit.de\/en\/benefits\/audit-software-medical-technology\/","title":{"rendered":"Benefits Sector &#8211; Medical Technology"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row row_height_percent=&#8221;70&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;2&#8243; bottom_padding=&#8221;0&#8243; back_color=&#8221;color-146106&#8243; back_image=&#8221;25353&#8243; back_position=&#8221;center center&#8221; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; enable_bottom_divider=&#8221;custom&#8221; bottom_divider=&#8221;step_1_2&#8243; shape_bottom_custom=&#8221;21818&#8243; shape_bottom_h_use_pixel=&#8221;&#8221; shape_bottom_height=&#8221;46&#8243; shape_bottom_opacity=&#8221;100&#8243; shape_bottom_ratio=&#8221;yes&#8221; shape_bottom_index=&#8221;10&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;166916&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; style=&#8221;dark&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;10&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; uncode_shortcode_id=&#8221;212426&#8243;][vc_custom_heading heading_semantic=&#8221;h1&#8243; text_size=&#8221;fontsize-155944&#8243; uncode_shortcode_id=&#8221;423410&#8243;]Digital Audit Processes for <mark title=\"ISO 13485- and MDR-compliant quality management\">ISO 13485- and MDR-Compliant Quality Management<\/mark>[\/vc_custom_heading][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; position_horizontal=&#8221;right&#8221; position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;0&#8243; expand_height=&#8221;yes&#8221; back_image=&#8221;26930&#8243; back_position=&#8221;left center&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;1&#8243; align_medium=&#8221;align_right_tablet&#8221; medium_width=&#8221;0&#8243; mobile_visibility=&#8221;yes&#8221; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; uncode_shortcode_id=&#8221;117879&#8243; back_size=&#8221;cover&#8221; el_class=&#8221;branches-bg&#8221;][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;3&#8243; bottom_padding=&#8221;4&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; enable_top_divider=&#8221;custom&#8221; top_divider=&#8221;fan-opacity&#8221; shape_top_h_use_pixel=&#8221;&#8221; shape_top_height=&#8221;150&#8243; shape_top_opacity=&#8221;100&#8243; shape_top_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;223785&#8243;][vc_column column_width_percent=&#8221;70&#8243; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; style=&#8221;light&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;189132&#8243; css=&#8221;.vc_custom_1783588222154{padding-bottom: 24px !important;}&#8221;][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;134307&#8243;]<strong>Medical technology companies face significant regulatory pressure: audits must be documented in a traceable manner, \u201cCorrective and Preventive Action\u201d (CAPA) actions must be tracked comprehensively, and quality records must be available at all times. At the same time, requirements for traceability, validation, and compliance are constantly increasing. <\/strong>[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;4&#8243; bottom_padding=&#8221;4&#8243; back_color=&#8221;color-lxmt&#8221; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; enable_top_divider=&#8221;custom&#8221; shape_top_custom=&#8221;21698&#8243; shape_top_flip=&#8221;yes&#8221; shape_top_h_use_pixel=&#8221;&#8221; shape_top_height=&#8221;46&#8243; shape_top_opacity=&#8221;100&#8243; shape_top_ratio=&#8221;yes&#8221; shape_top_index=&#8221;0&#8243; enable_bottom_divider=&#8221;custom&#8221; shape_bottom_custom=&#8221;21698&#8243; shape_bottom_h_use_pixel=&#8221;&#8221; shape_bottom_height=&#8221;46&#8243; shape_bottom_opacity=&#8221;100&#8243; shape_bottom_ratio=&#8221;yes&#8221; shape_bottom_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;910491&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_column column_width_percent=&#8221;100&#8243; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;132194&#8243;][vc_custom_heading heading_semantic=&#8221;h1&#8243; text_size=&#8221;h1&#8243; uncode_shortcode_id=&#8221;132403&#8243;]Smart Software for Digital Audits and Inspections in the Medical Technology Industry[\/vc_custom_heading][vc_empty_space empty_h=&#8221;2&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;190417&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;color-uydo&#8221; overlay_alpha=&#8221;50&#8243; radius=&#8221;lg&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/4&#8243; uncode_shortcode_id=&#8221;695568&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_icon icon_image=&#8221;5732&#8243; media_size=&#8221;20px&#8221; heading_semantic=&#8221;h2&#8243; uncode_shortcode_id=&#8221;194451&#8243; title=&#8221;Digitizing Audit Processes&#8221;]Digitize internal audits, supplier audits, and other audit processes in the medical technology industry on a central platform.[\/vc_icon][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;color-uydo&#8221; overlay_alpha=&#8221;50&#8243; radius=&#8221;lg&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/4&#8243; uncode_shortcode_id=&#8221;925650&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_icon icon_image=&#8221;5732&#8243; media_size=&#8221;20px&#8221; heading_semantic=&#8221;h2&#8243; uncode_shortcode_id=&#8221;147131&#8243; title=&#8221;Document in an audit-proof manner&#8221;]All audits are documented in a traceable, transparent, and audit-proof manner, from execution through approval.[\/vc_icon][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;color-uydo&#8221; overlay_alpha=&#8221;50&#8243; radius=&#8221;lg&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/4&#8243; uncode_shortcode_id=&#8221;181701&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_icon icon_image=&#8221;5732&#8243; media_size=&#8221;20px&#8221; heading_semantic=&#8221;h2&#8243; uncode_shortcode_id=&#8221;148092&#8243; title=&#8221;Manage CAPA Efficiently&#8221;]Track actions and corrective processes seamlessly and keep an eye on deadlines and responsibilities at all times.[\/vc_icon][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;color-uydo&#8221; overlay_alpha=&#8221;50&#8243; radius=&#8221;lg&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/4&#8243; uncode_shortcode_id=&#8221;549487&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_icon icon_image=&#8221;5732&#8243; media_size=&#8221;20px&#8221; heading_semantic=&#8221;h2&#8243; uncode_shortcode_id=&#8221;962765&#8243; title=&#8221;Ensure Compliance&#8221;]Support quality processes that require validation and establish a solid foundation for long-term compliance.[\/vc_icon][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;4&#8243; bottom_padding=&#8221;4&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;177626&#8243; back_color_type=&#8221;uncode-solid&#8221; back_color_solid=&#8221;#ffffff&#8221;][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; uncode_shortcode_id=&#8221;431934&#8243;][vc_single_image media=&#8221;26942&#8243; media_width_percent=&#8221;60&#8243; alignment=&#8221;center&#8221; uncode_shortcode_id=&#8221;928760&#8243;][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; uncode_shortcode_id=&#8221;377927&#8243;][vc_custom_heading text_color=&#8221;color-xsdn&#8221; heading_semantic=&#8221;p&#8221; text_size=&#8221;h6&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-721605&#8243; badge_style=&#8221;yes&#8221; back_color=&#8221;color-185880&#8243; radius=&#8221;std&#8221; uncode_shortcode_id=&#8221;530176&#8243; text_color_type=&#8221;uncode-palette&#8221; back_color_type=&#8221;uncode-palette&#8221;]Challenge[\/vc_custom_heading][vc_custom_heading uncode_shortcode_id=&#8221;199709&#8243;]Regulatory Compliance in Complex Quality and Supply Chain Processes[\/vc_custom_heading][vc_column_text uncode_shortcode_id=&#8221;717076&#8243;]Medical technology companies must be able to demonstrate at all times that processes are controlled, risks are assessed, and deviations are effectively addressed. Internal audits, supplier audits, and CAPA processes generate large amounts of quality-related data that must be documented in an audit-proof manner and remain available over the long term.<\/p>\n<p>Without digital support, this often results in media breaks, a heavy administrative burden, and incomplete audit documentation. Actions are tracked on a decentralized basis, and audit reports are prepared manually. International supply chains further increase the demands on the availability of audit, approval, and quality documentation. [\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;5&#8243; bottom_padding=&#8221;5&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; enable_top_divider=&#8221;custom&#8221; shape_top_custom=&#8221;21698&#8243; shape_top_flip=&#8221;yes&#8221; shape_top_h_use_pixel=&#8221;&#8221; shape_top_height=&#8221;46&#8243; shape_top_opacity=&#8221;100&#8243; shape_top_ratio=&#8221;yes&#8221; shape_top_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;621742&#8243; back_color_type=&#8221;uncode-solid&#8221; back_color_solid=&#8221;#f2f2f2&#8243;][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; uncode_shortcode_id=&#8221;431934&#8243;][vc_single_image media=&#8221;26944&#8243; media_width_percent=&#8221;60&#8243; alignment=&#8221;center&#8221; uncode_shortcode_id=&#8221;107773&#8243;][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; uncode_shortcode_id=&#8221;377927&#8243;][vc_custom_heading text_color=&#8221;color-xsdn&#8221; heading_semantic=&#8221;p&#8221; text_size=&#8221;h6&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-721605&#8243; badge_style=&#8221;yes&#8221; back_color=&#8221;color-185880&#8243; radius=&#8221;std&#8221; uncode_shortcode_id=&#8221;277958&#8243; text_color_type=&#8221;uncode-palette&#8221; back_color_type=&#8221;uncode-palette&#8221;]Solution[\/vc_custom_heading][vc_custom_heading uncode_shortcode_id=&#8221;332283&#8243;]Audit Software for the Medical Technology Industry[\/vc_custom_heading][vc_column_text uncode_shortcode_id=&#8221;202700&#8243;]With cluetec Audit, you can plan, document, and track internal audits, process audits, and supplier audits digitally, centrally, and <a href=\"https:\/\/cluetec-audit.de\/audit-intelligence-ki-fuer-audits\/\">with AI support<\/a>. Mobile checklists, structured action management, and traceable documentation ensure transparent, timely audit processes.<\/p>\n<p>The platform supports regulatory requirements in accordance with ISO 13485 and the MDR, as well as risk-based quality, CAPA, and PDCA processes. Thanks to risk-based validation, cluetec Audit is also suitable for quality processes in the medical technology sector that require validation. [\/vc_column_text][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;186312&#8243; css=&#8221;.vc_custom_1783600778148{margin-bottom: -24px !important;}&#8221;]The Multi-Tool for Inspections and Checks in Medical Technology[\/vc_column_text][vc_row_inner row_inner_height_percent=&#8221;0&#8243; row_padding=&#8221;0&#8243; overlay_alpha=&#8221;0&#8243; radius=&#8221;lg&#8221; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;155615&#8243; css=&#8221;.vc_custom_1783600304204{padding-top: 1.5em !important;}&#8221;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; uncode_shortcode_id=&#8221;434542&#8243;][uncode_list icon=&#8221;fa fa-plus-circle&#8221; uncode_shortcode_id=&#8221;432430&#8243;]<\/p>\n<ul>\n<li>ISO 13485 Audits<\/li>\n<li>MDR Requirements<\/li>\n<li>Supplier Qualifications<\/li>\n<\/ul>\n<p>[\/uncode_list][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][uncode_list icon=&#8221;fa fa-plus-circle&#8221; uncode_shortcode_id=&#8221;213216&#8243;]<\/p>\n<ul>\n<li>CAPA Processes<\/li>\n<li>Risk-Based Quality Assessments<\/li>\n<\/ul>\n<p>[\/uncode_list][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;4&#8243; bottom_padding=&#8221;4&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; enable_top_divider=&#8221;custom&#8221; shape_top_custom=&#8221;21756&#8243; shape_top_flip=&#8221;yes&#8221; shape_top_h_use_pixel=&#8221;&#8221; shape_top_height=&#8221;46&#8243; shape_top_opacity=&#8221;100&#8243; shape_top_ratio=&#8221;yes&#8221; shape_top_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;158589&#8243;][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; uncode_shortcode_id=&#8221;431934&#8243;][vc_single_image media=&#8221;26948&#8243; media_width_percent=&#8221;60&#8243; alignment=&#8221;center&#8221; uncode_shortcode_id=&#8221;116779&#8243;][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/2&#8243; uncode_shortcode_id=&#8221;377927&#8243;][vc_custom_heading text_color=&#8221;color-xsdn&#8221; heading_semantic=&#8221;p&#8221; text_size=&#8221;h6&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-721605&#8243; badge_style=&#8221;yes&#8221; back_color=&#8221;color-185880&#8243; radius=&#8221;std&#8221; uncode_shortcode_id=&#8221;706818&#8243; text_color_type=&#8221;uncode-palette&#8221; back_color_type=&#8221;uncode-palette&#8221;]Benefits[\/vc_custom_heading][vc_custom_heading uncode_shortcode_id=&#8221;113446&#8243;]Greater transparency for audits, CAPA, and compliance[\/vc_custom_heading][vc_column_text uncode_shortcode_id=&#8221;254398&#8243;]cluetec Audit significantly reduces the effort required for <a href=\"https:\/\/cluetec-audit.de\/webinare-events\/webinar-auditprogrammplanung\/\">audit planning<\/a>, documentation, and action tracking. Audits are planned centrally, findings are documented in a structured manner, and actions are tracked automatically.<\/p>\n<p>This results in transparent and auditable quality processes across locations and suppliers. At the same time, it creates a central database for quality and compliance documentation\u2014such as for CAPA processes, supplier qualifications, MDR documentation, or regulatory inspections. [\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;4&#8243; bottom_padding=&#8221;2&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; enable_top_divider=&#8221;custom&#8221; shape_top_flip=&#8221;yes&#8221; shape_top_h_use_pixel=&#8221;&#8221; shape_top_height=&#8221;46&#8243; shape_top_opacity=&#8221;100&#8243; shape_top_ratio=&#8221;yes&#8221; shape_top_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;548966&#8243;][vc_column column_width_percent=&#8221;100&#8243; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; overlay_alpha=&#8221;50&#8243; radius=&#8221;lg&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;157589&#8243; back_color_type=&#8221;uncode-gradient&#8221; back_color_gradient=&#8221;{&#8220;css&#8220;:&#8220;background: radial-gradient(circle at left top , rgb(246, 247, 220) 32% , rgb(223, 228, 231) 81%);&#8220;,&#8220;sliders&#8220;:`{`{&#8220;color&#8220;:&#8220;rgb(246, 247, 220)&#8220;,&#8220;position&#8220;:32},{&#8220;color&#8220;:&#8220;rgb(223, 228, 231)&#8220;,&#8220;position&#8220;:81}`}`,&#8220;type&#8220;:&#8220;circle&#8220;,&#8220;direction&#8220;:&#8220;left top&#8220;}&#8221;][vc_custom_heading heading_semantic=&#8221;h1&#8243; text_size=&#8221;h1&#8243; uncode_shortcode_id=&#8221;175745&#8243;]cluetec Audit \u2013 Audit Software for the Medical Technology Industry[\/vc_custom_heading][vc_empty_space empty_h=&#8221;2&#8243;][vc_tabs history=&#8221;yes&#8221; target=&#8221;row&#8221; tab_no_fade=&#8221;yes&#8221; tab_switch=&#8221;yes&#8221; animation_active=&#8221;yes&#8221; typography=&#8221;advanced&#8221; accordion_bp=&#8221;yes&#8221; titles_size=&#8221;h5&#8243; titles_weight=&#8221;600&#8243; gutter_simple=&#8221;0&#8243; uncode_shortcode_id=&#8221;958850&#8243;][vc_tab gutter_size=&#8221;2&#8243; column_padding=&#8221;3&#8243; title=&#8221;Implementing Compliance&#8221; tab_id=&#8221;1671548483489-0-916728314047851672833104030fcf8-38d417701354999471784021508362&#8243; slug=&#8221;Zusammenfassungen&#8221;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;206415&#8243; limit_content=&#8221;&#8221;][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;5\/12&#8243; uncode_shortcode_id=&#8221;157925&#8243;][vc_single_image media=&#8221;9918&#8243; media_width_percent=&#8221;100&#8243; alignment=&#8221;center&#8221; uncode_shortcode_id=&#8221;841717&#8243;][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;7\/12&#8243; uncode_shortcode_id=&#8221;165671&#8243;][vc_custom_heading text_height=&#8221;fontheight-357766&#8243; uncode_shortcode_id=&#8221;159259&#8243;]Ensuring Effective Compliance[\/vc_custom_heading][vc_column_text uncode_shortcode_id=&#8221;175795&#8243;]ISO 13485 and the MDR significantly increase the requirements for transparency, documentation, and traceability. Thanks to cluetec Audit, companies can establish structured processes. All audit and quality data are documented centrally and are available and traceable at all times.[\/vc_column_text][uncode_list icon=&#8221;fa fa-plus-circle&#8221; uncode_shortcode_id=&#8221;107284&#8243;]<\/p>\n<ul>\n<li>Internal and External Audits<\/li>\n<li>Supplier Audits<\/li>\n<li>CAPA Processes<\/li>\n<li>Action Management<\/li>\n<li>Quality Records<\/li>\n<li>Audit Trails<\/li>\n<li>Digital Approvals<\/li>\n<\/ul>\n<p>[\/uncode_list][\/vc_column_inner][\/vc_row_inner][\/vc_tab][vc_tab gutter_size=&#8221;3&#8243; column_padding=&#8221;3&#8243; title=&#8221;Increase Efficiency&#8221; tab_id=&#8221;1671548483266-0-316728314047851672833104030fcf8-38d417701354999471784021508362&#8243; slug=&#8221;Bildanalyse&#8221;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;963721&#8243; limit_content=&#8221;&#8221;][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;5\/12&#8243; uncode_shortcode_id=&#8221;157925&#8243;][vc_single_image media=&#8221;9415&#8243; media_width_percent=&#8221;100&#8243; alignment=&#8221;center&#8221; uncode_shortcode_id=&#8221;647057&#8243;][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;7\/12&#8243; uncode_shortcode_id=&#8221;165671&#8243;][vc_custom_heading text_height=&#8221;fontheight-357766&#8243; uncode_shortcode_id=&#8221;185724&#8243;]Increase Efficiency, Make Optimal Use of Resources[\/vc_custom_heading][vc_column_text uncode_shortcode_id=&#8221;143438&#8243;]Complex documentation requirements and increasing compliance demands significantly increase the workload involved in audit processes. With cluetec Audit, companies can significantly reduce the effort required for audit preparation, action item management, and evidence tracking.[\/vc_column_text][uncode_list icon=&#8221;fa fa-plus-circle&#8221; uncode_shortcode_id=&#8221;329730&#8243;]<\/p>\n<ul>\n<li>Reduced documentation workload<\/li>\n<li>Faster audit preparation<\/li>\n<li>Greater transparency<\/li>\n<li>Structured tracking of corrective actions<\/li>\n<li>Improved CAPA tracking<\/li>\n<li>Faster response times to nonconformities<\/li>\n<li>Centrally available audit information<\/li>\n<\/ul>\n<p>[\/uncode_list][\/vc_column_inner][\/vc_row_inner][\/vc_tab][vc_tab gutter_size=&#8221;2&#8243; column_padding=&#8221;3&#8243; title=&#8221;Monitor suppliers&#8221; tab_id=&#8221;1671548483061-0-516728314047851672833104030fcf8-38d417701354999471784021508362&#8243; slug=&#8221;Chat&#8221;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;144778&#8243; limit_content=&#8221;&#8221;][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;5\/12&#8243; uncode_shortcode_id=&#8221;157925&#8243;][vc_single_image media=&#8221;3556&#8243; media_width_percent=&#8221;100&#8243; alignment=&#8221;center&#8221; uncode_shortcode_id=&#8221;152225&#8243;][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;7\/12&#8243; uncode_shortcode_id=&#8221;165671&#8243;][vc_custom_heading text_height=&#8221;fontheight-357766&#8243; uncode_shortcode_id=&#8221;528915&#8243;]Monitor suppliers[\/vc_custom_heading][vc_column_text uncode_shortcode_id=&#8221;165250&#8243;]Supplier quality is a key component of regulatory requirements in the medical technology industry. With cluetec Audit, you can manage audits digitally and maintain a clear audit trail across the entire supply chain.[\/vc_column_text][uncode_list icon=&#8221;fa fa-plus-circle&#8221; uncode_shortcode_id=&#8221;126131&#8243;]<\/p>\n<ul>\n<li>Digital Supplier Audits<\/li>\n<li>Structured Qualification Processes<\/li>\n<li>Centralized Audit Planning<\/li>\n<li>Action Tracking<\/li>\n<li>Escalation Management<\/li>\n<li>Audit-Compliant Documentation<\/li>\n<\/ul>\n<p>[\/uncode_list][\/vc_column_inner][\/vc_row_inner][\/vc_tab][\/vc_tabs][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;4&#8243; bottom_padding=&#8221;4&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;125149&#8243;][vc_column column_width_percent=&#8221;100&#8243; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;132194&#8243;][vc_row_inner][vc_column_inner column_width_percent=&#8221;60&#8243; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;4&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;166549&#8243;][vc_custom_heading heading_semantic=&#8221;h1&#8243; text_size=&#8221;h1&#8243; uncode_shortcode_id=&#8221;107037&#8243;]Greater Efficiency with Medical Technology Audit Software[\/vc_custom_heading][vc_empty_space empty_h=&#8221;2&#8243;][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;190417&#8243;][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;color-uydo&#8221; overlay_alpha=&#8221;50&#8243; radius=&#8221;lg&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/3&#8243; uncode_shortcode_id=&#8221;766489&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_icon icon_image=&#8221;5732&#8243; media_size=&#8221;20px&#8221; heading_semantic=&#8221;h2&#8243; uncode_shortcode_id=&#8221;513550&#8243; title=&#8221;Ensuring Quality Over the Long Term&#8221;]With cluetec Audit, companies can digitize their audit and quality processes in a centralized and traceable manner.[\/vc_icon][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;color-uydo&#8221; overlay_alpha=&#8221;50&#8243; radius=&#8221;lg&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/3&#8243; uncode_shortcode_id=&#8221;169903&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_icon icon_image=&#8221;5732&#8243; media_size=&#8221;20px&#8221; heading_semantic=&#8221;h2&#8243; uncode_shortcode_id=&#8221;146120&#8243; title=&#8221;Comply with Regulatory Requirements&#8221;]Support ISO 13485- and MDR-compliant quality management systems with structured audit and documentation processes.[\/vc_icon][\/vc_column_inner][vc_column_inner column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;color-uydo&#8221; overlay_alpha=&#8221;50&#8243; radius=&#8221;lg&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; 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