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We support you in implementing the requirements as per<\/p>\n
Gap analysis (MDD\/MDR, FDA), preparation\/review of technical documentation, monitoring during approval processes, transition from MDD to MDR<\/p>\nRead more<\/a>[\/vc_hoverbox][\/vc_column][vc_column text_align=”center” width=”1\/3″][vc_hoverbox image=”16413″ primary_title=”Risk Management & Usability Engineering” primary_title_font_container=”color:%23365e73″ primary_title_use_theme_fonts=”yes” hover_title=” ” shape=”square” use_custom_fonts_primary_title=”true” css=”.vc_custom_1552494081247{background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” primary_title_el_class=”kompetenz-block”]Our Services:<\/p>\n Gap analysis for risk management and usability engineering, preparation\/implementation of risk management and usability engineering process, execution of risk analysis<\/p>\nRead more<\/a>[\/vc_hoverbox][\/vc_column][\/vc_row][vc_row bg_color=”#405d79″][vc_column text_align=”center” width=”1\/1″] Do you have any ideas about new devices?<\/p>\n We are your well-versed partner in feasibility studies and implementation of your ideas<\/p>\nRead more<\/a>[\/vc_hoverbox][\/vc_column][vc_column text_align=”center” width=”1\/3″][vc_hoverbox image=”16409″ primary_title=”Project Management & Project Documentation” primary_title_font_container=”color:%23365e73″ primary_title_use_theme_fonts=”yes” hover_title=” ” shape=”square” use_custom_fonts_primary_title=”true” primary_title_el_class=”kompetenz-block”]Our Services:<\/p>\n Support for your project team, assuming project responsibility (project management), project documentation according to your specifications<\/p>\nRead more<\/a>[\/vc_hoverbox][\/vc_column][vc_column text_align=”center” width=”1\/3″][vc_hoverbox image=”16405″ primary_title=”Medical Device Reporting & Medical Device Safety Officer” primary_title_font_container=”color:%23365e73″ primary_title_use_theme_fonts=”yes” hover_title=”” shape=”square” use_custom_fonts_primary_title=”true” primary_title_el_class=”kompetenz-block”]Our Services:<\/p>\n Development\/implementation of an individual MDR process Assuming the task of medical device reporting, also as an external Medical Device Safety Officer (Section 30 of the Medical Devices Act \u2013 MPG)<\/p>\nRead more<\/a>[\/vc_hoverbox][\/vc_column][\/vc_row][vc_row bg_color=”#405d79″][vc_column text_align=”center” width=”1\/1″] Gap analysis for clinical evaluation according to MEDDEV 2.7\/1 rev. 4, preparation of clinical evaluation plans (CEP) and clinical evaluation reports (CER), execution of literature research and clinical trials<\/p>\nRead more<\/a>[\/vc_hoverbox][\/vc_column][vc_column text_align=”center” width=”1\/3″][vc_hoverbox image=”16399″ primary_title=”Audit Preparation & Audit Support” primary_title_font_container=”color:%23365e73″ primary_title_use_theme_fonts=”yes” hover_title=” ” shape=”square” use_custom_fonts_primary_title=”true” css=”.vc_custom_1552494133337{background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” primary_title_el_class=”kompetenz-block”]Our Services:<\/p>\n Gap analysis, preparation of specifications and verification documents, back office organization, internal system audits, supplier audits<\/p>\nRead more<\/a>[\/vc_hoverbox][\/vc_column][vc_column text_align=”center” width=”1\/3″][vc_hoverbox image=”16403″ primary_title=”Interim Management & Restructuring” primary_title_font_container=”color:%23365e73″ primary_title_use_theme_fonts=”yes” hover_title=” ” shape=”square” use_custom_fonts_primary_title=”true” primary_title_el_class=”kompetenz-block”]Our Services:<\/p>\n