{"id":1908,"date":"2025-10-22T10:39:03","date_gmt":"2025-10-22T08:39:03","guid":{"rendered":"https:\/\/okuvision.de\/quality-policy\/"},"modified":"2026-05-21T13:47:56","modified_gmt":"2026-05-21T11:47:56","slug":"quality","status":"publish","type":"page","link":"https:\/\/okuvision.de\/en\/quality\/","title":{"rendered":"Quality Policy"},"content":{"rendered":"

[vc_row unlock_row_content=”yes” row_height_percent=”0″ override_padding=”yes” h_padding=”0″ top_padding=”0″ bottom_padding=”0″ back_color=”color-206913″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ content_parallax=”0″ uncode_shortcode_id=”126459″ back_color_type=”uncode-palette”][vc_column width=”1\/1″]\n

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\n Quality that builds trust <\/h1>\n \n
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How we ensure MDR-compliant quality, safety, and clinical evidence \u2014 so TES therapy can be reliably integrated into everyday practice.<\/p>\n <\/div>\n \n <\/div>\n \n \n <\/div>\n \n \n

\n \"OkuStim\u00ae <\/div>\n <\/div>\n \n <\/div>\n \n<\/div>\n\n\n[\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”3″ bottom_padding=”3″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ content_parallax=”0″ uncode_shortcode_id=”137928″][vc_column width=”1\/1″][vc_row_inner][vc_column_inner width=”2\/3″][vc_custom_heading text_font=”font-714446″ text_size=”fontsize-914237″ text_weight=”300″ uncode_shortcode_id=”772787″]From Development and Clinical Evaluation to Everyday Use[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=”100″ gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_visibility=”yes” medium_width=”0″ mobile_visibility=”yes” mobile_width=”0″ width=”1\/3″ uncode_shortcode_id=”542260″][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner column_width_percent=”100″ gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_visibility=”yes” medium_width=”0″ mobile_visibility=”yes” mobile_width=”0″ width=”1\/3″ uncode_shortcode_id=”163215″][\/vc_column_inner][vc_column_inner width=”2\/3″][vc_column_text uncode_shortcode_id=”672045″]At Okuvision, quality is not a label, but a process\u2014from development and clinical evaluation through to everyday care. \u201cWe test our products in accordance with all applicable European standards \u2026 and conduct clinical studies to ensure that our products deliver the promised performance.\u201d <\/p>\n

On CE marking, Fabian Kaiser (QMB) explains: \u201cCE marking is like an ID card. Without the CE mark, a product cannot be placed on the market in Europe.\u201d And on quality assurance in practice: \u201cWe are audited every year \u2026 and test all products before they leave our facility.\u201d \u201cOnly when all tests have been successfully completed does a safe and effective product leave our facility.\u201d[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row unlock_row_content=”yes” row_height_percent=”0″ override_padding=”yes” h_padding=”0″ top_padding=”0″ bottom_padding=”4″ overlay_alpha=”50″ equal_height=”yes” gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ content_parallax=”0″ cvc_maxwidth=”1920″ uncode_shortcode_id=”906550″][vc_column column_width_percent=”100″ position_vertical=”middle” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”2\/3″ uncode_shortcode_id=”586038″][vc_single_image media=”1910″ media_width_percent=”100″ media_ratio=”sixteen-nine” uncode_shortcode_id=”113487″][\/vc_column][vc_column column_width_percent=”70″ position_vertical=”middle” gutter_size=”3″ override_padding=”yes” column_padding=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/3″ uncode_shortcode_id=”196859″][vc_custom_heading uncode_shortcode_id=”487703″]MDR Compliance & CE Marking[\/vc_custom_heading][vc_column_text uncode_shortcode_id=”101577″]<\/p>\n

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  • OkuStim\u00ae is an active medical device with CE marking in accordance with MDR (EU) 2017\/745; notified body: T\u00dcV Rheinland (0197).<\/li>\n
  • The intended use, safe application, and maintenance are described in the instructions for use; the stimulation parameters are programmed by a physician.<\/li>\n
  • Annual audits by the notified body and internal audits ensure CE conformity.<\/li>\n<\/ul>\n

    [\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”3″ bottom_padding=”3″ back_color=”color-jevc” overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ content_parallax=”0″ uncode_shortcode_id=”881306″ back_color_type=”uncode-palette”][vc_column column_width_percent=”100″ gutter_size=”3″ style=”dark” overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”2\/3″ uncode_shortcode_id=”229691″][vc_custom_heading text_color=”color-233806″ text_font=”font-714446″ text_size=”fontsize-431854″ text_weight=”300″ uncode_shortcode_id=”148797″ text_color_type=”uncode-palette”]”This is the only way we can ensure that our products meet all requirements and are safe and effective.”[\/vc_custom_heading][vc_column_text text_lead=”small” uncode_shortcode_id=”207923″]Fabian Kaiser, Quality Management[\/vc_column_text][\/vc_column][vc_column column_width_percent=”100″ gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_visibility=”yes” medium_width=”0″ mobile_visibility=”yes” mobile_width=”0″ width=”1\/3″ uncode_shortcode_id=”161376″][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”3″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ content_parallax=”0″ uncode_shortcode_id=”989922″][vc_column width=”1\/1″][vc_row_inner][vc_column_inner width=”2\/3″][vc_custom_heading text_font=”font-714446″ text_size=”fontsize-914237″ text_weight=”300″ uncode_shortcode_id=”157496″]Safety & Clinical Evidence[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=”100″ gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_visibility=”yes” medium_width=”0″ mobile_visibility=”yes” mobile_width=”0″ width=”1\/3″ uncode_shortcode_id=”542260″][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner column_width_percent=”100″ gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_visibility=”yes” medium_width=”0″ mobile_visibility=”yes” mobile_width=”0″ width=”1\/3″ uncode_shortcode_id=”163215″][\/vc_column_inner][vc_column_inner width=”2\/3″][vc_column_text uncode_shortcode_id=”187401″]In controlled trials and observational data on TES with OkuStim\u00ae, no therapy- or device-related serious adverse events (SAEs) have been reported; the most common side effect is temporary eye dryness, which can be effectively managed with artificial tears.<\/p>\n

    Randomized and prospective clinical trials (e.g., EST series, TESOLA) demonstrate safety; exploratory analyses show a dose-dependent slowing of visual field loss.<\/p>\n

    In summary, the evidence shows that regular, low-intensity electrical stimulation can slow the loss of visual field in RP and thus preserve vision-related quality of life for longer.<\/p>\n

    What we mean by “safety”:<\/b><\/p>\n

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    • No device- or therapy- related serious adverse events (SAEs) in multicenter safety trials<\/li>\n
    • Dose-response evidence for slowing of visual field loss<\/li>\n
    • Home-based therapy with physician-prescribed parameters (30 min\/week)<\/li>\n<\/ul>\n

      [\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”3″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ content_parallax=”0″ uncode_shortcode_id=”253652″][vc_column width=”1\/1″][vc_row_inner][vc_column_inner width=”2\/3″][vc_custom_heading text_font=”font-714446″ text_size=”fontsize-914237″ text_weight=”300″ uncode_shortcode_id=”207844″]Usability & Accessibility in Everyday Use[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=”100″ gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_visibility=”yes” medium_width=”0″ mobile_visibility=”yes” mobile_width=”0″ width=”1\/3″ uncode_shortcode_id=”542260″][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner column_width_percent=”100″ gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_visibility=”yes” medium_width=”0″ mobile_visibility=”yes” mobile_width=”0″ width=”1\/3″ uncode_shortcode_id=”163215″][\/vc_column_inner][vc_column_inner width=”2\/3″][vc_column_text uncode_shortcode_id=”178997″]The system is designed for independent use \u2013 with clear tactile feedback, LED indicators, and acoustic system notifications that provide support even in advanced stages. The instructions for use cover controls, signals, and the safe conduct of sessions.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”3″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ content_parallax=”0″ uncode_shortcode_id=”253652″][vc_column width=”1\/1″][vc_row_inner][vc_column_inner width=”2\/3″][vc_custom_heading text_font=”font-714446″ text_size=”fontsize-914237″ text_weight=”300″ uncode_shortcode_id=”112002″]Electromagnetic Compatibility (EMC)[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=”100″ gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_visibility=”yes” medium_width=”0″ mobile_visibility=”yes” mobile_width=”0″ width=”1\/3″ uncode_shortcode_id=”542260″][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner column_width_percent=”100″ gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_visibility=”yes” medium_width=”0″ mobile_visibility=”yes” mobile_width=”0″ width=”1\/3″ uncode_shortcode_id=”163215″][\/vc_column_inner][vc_column_inner width=”2\/3″][vc_column_text uncode_shortcode_id=”190047″]The device meets EMC requirements in accordance with CISPR 11, Group 1, Class B \u2013 suitable for home environments, medical practices, and clinics. Usage instructions minimize interference and ensure reproducible therapy sessions.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”3″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ content_parallax=”0″ uncode_shortcode_id=”394183″][vc_column width=”1\/1″][vc_row_inner][vc_column_inner width=”2\/3″][vc_custom_heading text_font=”font-714446″ text_size=”fontsize-914237″ text_weight=”300″ uncode_shortcode_id=”953100″]Post-Market Surveillance and Transparency[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=”100″ gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_visibility=”yes” medium_width=”0″ mobile_visibility=”yes” mobile_width=”0″ width=”1\/3″ uncode_shortcode_id=”542260″][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner column_width_percent=”100″ gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_visibility=”yes” medium_width=”0″ mobile_visibility=”yes” mobile_width=”0″ width=”1\/3″ uncode_shortcode_id=”163215″][\/vc_column_inner][vc_column_inner width=”2\/3″][vc_column_text uncode_shortcode_id=”546250″]We systematically monitor safety, performance, and user feedback (“PMS”) and continuously feed findings back into product maintenance and user information (e.g., recommendation of artificial tears for dryness, guidance on electrode handling and comfort).
      \nIn parallel, long-term clinical data are collected in multicenter programs; the German G-BA trial study (TES-RP) investigates patient-relevant endpoints over several years.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”3″ bottom_padding=”3″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ content_parallax=”0″ uncode_shortcode_id=”418228″][vc_column width=”1\/1″][vc_custom_heading heading_semantic=”h3″ text_font=”font-714446″ text_size=”h1″ text_weight=”300″ uncode_shortcode_id=”453385″]How our PMS works in practice[\/vc_custom_heading][vc_accordion typography=”advanced” sign=”plus” gutter_simple=”0″ heading_semantic=”h3″ titles_size=”h4″ cvc_color_scheme=”violet” cvc_background_color=”light-gray” uncode_shortcode_id=”108876″ active_tab=”999″][vc_accordion_tab gutter_size=”2″ column_padding=”2″ title=”Risk Management & Vigilance” tab_id=”1758294612-1-917646061286981764773716040″][vc_row_inner row_inner_height_percent=”0″ overlay_alpha=”50″ gutter_size=”3″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”561844″][vc_column_inner column_width_percent=”100″ gutter_size=”2″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”746443″][vc_column_text uncode_shortcode_id=”674030″]continuous evaluation of reports, trend analyses, corrective actions.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_accordion_tab][vc_accordion_tab gutter_size=”2″ column_padding=”2″ title=”Post-Market Clinical Follow-up (PMCF)” tab_id=”1758294612-2-4517646061286981764773716040″][vc_row_inner][vc_column_inner column_width_percent=”100″ gutter_size=”2″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”164952″][vc_column_text uncode_shortcode_id=”189975″]Integration of real-world application data from clinics\/care settings.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_accordion_tab][vc_accordion_tab gutter_size=”2″ column_padding=”2″ title=”Usability Feedback” tab_id=”1759218552822-2-617646061286981764773716040″][vc_row_inner][vc_column_inner width=”1\/1″][vc_column_text uncode_shortcode_id=”127086″]Integration of user feedback into IFU supplements and training materials.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_accordion_tab][\/vc_accordion][\/vc_column][\/vc_row][vc_row unlock_row_content=”yes” row_height_percent=”0″ override_padding=”yes” h_padding=”0″ top_padding=”3″ bottom_padding=”3″ overlay_alpha=”50″ equal_height=”yes” gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ content_parallax=”0″ cvc_maxwidth=”1920″ uncode_shortcode_id=”490954″][vc_column column_width_percent=”70″ position_vertical=”middle” gutter_size=”3″ override_padding=”yes” column_padding=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”126108″][vc_custom_heading text_font=”font-714446″ text_size=”fontsize-914237″ text_weight=”300″ uncode_shortcode_id=”197986″]Certificates[\/vc_custom_heading][vc_button button_color=”color-312440″ size=”link” btn_link_hover=”btn-hover-accent” custom_typo=”yes” font_family=”font-153386″ font_weight=”700″ button_color_type=”uncode-palette” icon=”fa fa-arrow-down2″ uncode_shortcode_id=”600883″ link=”url:https%3A%2F%2Fokuvision.de%2Fwp-content%2Fuploads%2F2026%2F01%2FQMH-00-03_03.pdf|target:_blank”]ISO 13485:2016 Certificate[\/vc_button][vc_button button_color=”color-312440″ size=”link” btn_link_hover=”btn-hover-accent” custom_typo=”yes” font_family=”font-153386″ font_weight=”700″ button_color_type=”uncode-palette” icon=”fa fa-arrow-down2″ uncode_shortcode_id=”165535″ link=”url:https%3A%2F%2Fokuvision.de%2Fwp-content%2Fuploads%2F2025%2F12%2FQMH-00-05.pdf|target:_blank”]Quality Management System REGULATION (EU) 2017\/745 on Medical Devices Annex IX Chapter I, Section 2 and 3 and Chapter III[\/vc_button][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”3″ bottom_padding=”3″ back_color=”color-206913″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ content_parallax=”0″ uncode_shortcode_id=”118356″ back_color_type=”uncode-palette”][vc_column column_width_percent=”100″ align_horizontal=”align_center” gutter_size=”4″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”152446″][vc_custom_heading text_font=”font-714446″ text_size=”fontsize-914237″ text_weight=”300″ uncode_shortcode_id=”109998″]Insights into Therapy,
      \nResearch & Company[\/vc_custom_heading][vc_row_inner][vc_column_inner width=”1\/1″][uncode_index el_id=”index-974899″ index_type=”carousel” loop=”size:3|order_by:date|post_type:post|categories:88|taxonomy_count:10″ carousel_lg=”3″ carousel_md=”2″ carousel_sm=”1″ thumb_size=”sixteen-nine” gutter_size=”3″ post_items=”media|featured|onpost|original,date,title|-,text|excerpt|200,category|colorbg|relative|display-icon” carousel_height=”equal” carousel_interval=”3000″ carousel_navspeed=”400″ advanced_nav=”yes” el_id1=”index-974899″ stage_padding=”0″ single_back_color=”color-942029″ single_overlay_opacity=”50″ single_padding=”2″ single_title_dimension=”h4″ single_border=”yes” uncode_shortcode_id=”198467″][uncode_carousel_nav padding=”0″ h_align=”center” hide_arrows=”yes” dots_style=”lines” hide_counter=”yes” uncode_shortcode_id=”207978″ target=”index-974899″ dot_single_width=”12″ dot_single_active=”24″ dot_single_height=”12″ dot_single_radius=”999″][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

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