{"id":2664,"date":"2025-10-22T10:39:03","date_gmt":"2025-10-22T08:39:03","guid":{"rendered":"https:\/\/okuvision.de\/qualitaet\/"},"modified":"2026-05-21T13:47:56","modified_gmt":"2026-05-21T11:47:56","slug":"qualitaet","status":"publish","type":"page","link":"https:\/\/okuvision.de\/fr\/qualitaet\/","title":{"rendered":"Politique qualit\u00e9"},"content":{"rendered":"

[vc_row unlock_row_content=\u00a0\u00bbyes\u00a0\u00bb row_height_percent=\u00a0\u00bb0″ override_padding=\u00a0\u00bbyes\u00a0\u00bb h_padding=\u00a0\u00bb0″ top_padding=\u00a0\u00bb0″ bottom_padding=\u00a0\u00bb0″ back_color=\u00a0\u00bbcolor-206913″ overlay_alpha=\u00a0\u00bb50″ gutter_size=\u00a0\u00bb3″ column_width_percent=\u00a0\u00bb100″ shift_y=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ content_parallax=\u00a0\u00bb0″ uncode_shortcode_id=\u00a0\u00bb126459″ back_color_type=\u00a0\u00bbuncode-palette\u00a0\u00bb][vc_column width=\u00a0\u00bb1\/1″]\n

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\n Une qualit\u00e9 qui inspire confiance <\/h1>\n \n
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Comment nous garantissons une qualit\u00e9, une s\u00e9curit\u00e9 et des donn\u00e9es cliniques conformes au r\u00e8glement MDR \u2014 afin que la th\u00e9rapie TES puisse \u00eatre utilis\u00e9e de mani\u00e8re fiable au quotidien.<\/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=\u00a0\u00bb0″ override_padding=\u00a0\u00bbyes\u00a0\u00bb h_padding=\u00a0\u00bb2″ top_padding=\u00a0\u00bb3″ bottom_padding=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ gutter_size=\u00a0\u00bb3″ column_width_percent=\u00a0\u00bb100″ shift_y=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ content_parallax=\u00a0\u00bb0″ uncode_shortcode_id=\u00a0\u00bb137928″][vc_column width=\u00a0\u00bb1\/1″][vc_row_inner][vc_column_inner width=\u00a0\u00bb2\/3″][vc_custom_heading text_font=\u00a0\u00bbfont-714446″ text_size=\u00a0\u00bbfontsize-914237″ text_weight=\u00a0\u00bb300″ uncode_shortcode_id=\u00a0\u00bb772787″]Du d\u00e9veloppement aux essais cliniques, jusqu\u2019au quotidien[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=\u00a0\u00bb100″ gutter_size=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_visibility=\u00a0\u00bbyes\u00a0\u00bb medium_width=\u00a0\u00bb0″ mobile_visibility=\u00a0\u00bbyes\u00a0\u00bb mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/3″ uncode_shortcode_id=\u00a0\u00bb542260″][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner column_width_percent=\u00a0\u00bb100″ gutter_size=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_visibility=\u00a0\u00bbyes\u00a0\u00bb medium_width=\u00a0\u00bb0″ mobile_visibility=\u00a0\u00bbyes\u00a0\u00bb mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/3″ uncode_shortcode_id=\u00a0\u00bb163215″][\/vc_column_inner][vc_column_inner width=\u00a0\u00bb2\/3″][vc_column_text uncode_shortcode_id=\u00a0\u00bb672045″]Chez Okuvision, la qualit\u00e9 n\u2019est pas un simple label, mais un processus : du d\u00e9veloppement \u00e0 la prise en charge au quotidien, en passant par l\u2019\u00e9valuation clinique. \u00ab Nous testons nos produits conform\u00e9ment \u00e0 l\u2019ensemble des normes europ\u00e9ennes applicables \u2026 et r\u00e9alisons des \u00e9tudes cliniques afin de garantir que nos produits offrent les performances promises. \u00bb <\/p>\n

\u00c0 propos du marquage CE, Fabian Kaiser (responsable management de la qualit\u00e9) explique : \u00ab Le marquage CE est comme une carte d\u2019identit\u00e9. Sans le marquage CE, il n\u2019est pas possible de commercialiser un produit en Europe. \u00bb
Et concernant l\u2019assurance qualit\u00e9 au quotidien : \u00ab Nous faisons l\u2019objet d\u2019audits chaque ann\u00e9e \u2026 et contr\u00f4lons tous les produits avant qu\u2019ils ne quittent nos locaux \u00bb ; \u00ab Ce n\u2019est qu\u2019apr\u00e8s la validation r\u00e9ussie de tous les contr\u00f4les qu\u2019un produit s\u00fbr et efficace quitte notre entreprise. \u00bb[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row unlock_row_content=\u00a0\u00bbyes\u00a0\u00bb row_height_percent=\u00a0\u00bb0″ override_padding=\u00a0\u00bbyes\u00a0\u00bb h_padding=\u00a0\u00bb0″ top_padding=\u00a0\u00bb0″ bottom_padding=\u00a0\u00bb4″ overlay_alpha=\u00a0\u00bb50″ equal_height=\u00a0\u00bbyes\u00a0\u00bb gutter_size=\u00a0\u00bb3″ column_width_percent=\u00a0\u00bb100″ shift_y=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ content_parallax=\u00a0\u00bb0″ cvc_maxwidth=\u00a0\u00bb1920″ uncode_shortcode_id=\u00a0\u00bb906550″][vc_column column_width_percent=\u00a0\u00bb100″ position_vertical=\u00a0\u00bbmiddle\u00a0\u00bb gutter_size=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_width=\u00a0\u00bb0″ mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb2\/3″ uncode_shortcode_id=\u00a0\u00bb586038″][vc_single_image media=\u00a0\u00bb2666″ media_width_percent=\u00a0\u00bb100″ media_ratio=\u00a0\u00bbsixteen-nine\u00a0\u00bb uncode_shortcode_id=\u00a0\u00bb113487″][\/vc_column][vc_column column_width_percent=\u00a0\u00bb70″ position_vertical=\u00a0\u00bbmiddle\u00a0\u00bb gutter_size=\u00a0\u00bb3″ override_padding=\u00a0\u00bbyes\u00a0\u00bb column_padding=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_width=\u00a0\u00bb0″ mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/3″ uncode_shortcode_id=\u00a0\u00bb196859″][vc_custom_heading uncode_shortcode_id=\u00a0\u00bb487703″]Conformit\u00e9 au MDR et marquage CE[\/vc_custom_heading][vc_column_text uncode_shortcode_id=\u00a0\u00bb101577″]<\/p>\n

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  • OkuStim\u00ae est un dispositif m\u00e9dical actif portant le marquage CE conform\u00e9ment au MDR (UE) 2017\/745 ; organisme notifi\u00e9 : T\u00dcV Rheinland (0197).<\/li>\n
  • La destination, l\u2019utilisation s\u00fbre et la maintenance sont d\u00e9crites dans le mode d\u2019emploi ; les param\u00e8tres de stimulation sont programm\u00e9s par un m\u00e9decin.<\/li>\n
  • La surveillance annuelle par l\u2019organisme de contr\u00f4le ainsi que des audits internes garantissent la conformit\u00e9 CE.<\/li>\n<\/ul>\n

    [\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=\u00a0\u00bb0″ override_padding=\u00a0\u00bbyes\u00a0\u00bb h_padding=\u00a0\u00bb2″ top_padding=\u00a0\u00bb3″ bottom_padding=\u00a0\u00bb3″ back_color=\u00a0\u00bbcolor-jevc\u00a0\u00bb overlay_alpha=\u00a0\u00bb50″ gutter_size=\u00a0\u00bb3″ column_width_percent=\u00a0\u00bb100″ shift_y=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ content_parallax=\u00a0\u00bb0″ uncode_shortcode_id=\u00a0\u00bb881306″ back_color_type=\u00a0\u00bbuncode-palette\u00a0\u00bb][vc_column column_width_percent=\u00a0\u00bb100″ gutter_size=\u00a0\u00bb3″ style=\u00a0\u00bbdark\u00a0\u00bb overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_width=\u00a0\u00bb0″ mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb2\/3″ uncode_shortcode_id=\u00a0\u00bb229691″][vc_custom_heading text_color=\u00a0\u00bbcolor-233806″ text_font=\u00a0\u00bbfont-714446″ text_size=\u00a0\u00bbfontsize-431854″ text_weight=\u00a0\u00bb300″ uncode_shortcode_id=\u00a0\u00bb148797″ text_color_type=\u00a0\u00bbuncode-palette\u00a0\u00bb]\u00ab C\u2019est la seule fa\u00e7on de nous assurer que nos produits r\u00e9pondent \u00e0 toutes les exigences, sont s\u00fbrs et efficaces. \u00bb[\/vc_custom_heading][vc_column_text text_lead=\u00a0\u00bbsmall\u00a0\u00bb uncode_shortcode_id=\u00a0\u00bb207923″]Fabian Kaiser, Management de la qualit\u00e9[\/vc_column_text][\/vc_column][vc_column column_width_percent=\u00a0\u00bb100″ gutter_size=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_visibility=\u00a0\u00bbyes\u00a0\u00bb medium_width=\u00a0\u00bb0″ mobile_visibility=\u00a0\u00bbyes\u00a0\u00bb mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/3″ uncode_shortcode_id=\u00a0\u00bb161376″][\/vc_column][\/vc_row][vc_row row_height_percent=\u00a0\u00bb0″ override_padding=\u00a0\u00bbyes\u00a0\u00bb h_padding=\u00a0\u00bb2″ top_padding=\u00a0\u00bb3″ bottom_padding=\u00a0\u00bb0″ overlay_alpha=\u00a0\u00bb50″ gutter_size=\u00a0\u00bb3″ column_width_percent=\u00a0\u00bb100″ shift_y=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ content_parallax=\u00a0\u00bb0″ uncode_shortcode_id=\u00a0\u00bb989922″][vc_column width=\u00a0\u00bb1\/1″][vc_row_inner][vc_column_inner width=\u00a0\u00bb2\/3″][vc_custom_heading text_font=\u00a0\u00bbfont-714446″ text_size=\u00a0\u00bbfontsize-914237″ text_weight=\u00a0\u00bb300″ uncode_shortcode_id=\u00a0\u00bb157496″]S\u00e9curit\u00e9 et preuves cliniques[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=\u00a0\u00bb100″ gutter_size=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_visibility=\u00a0\u00bbyes\u00a0\u00bb medium_width=\u00a0\u00bb0″ mobile_visibility=\u00a0\u00bbyes\u00a0\u00bb mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/3″ uncode_shortcode_id=\u00a0\u00bb542260″][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner column_width_percent=\u00a0\u00bb100″ gutter_size=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_visibility=\u00a0\u00bbyes\u00a0\u00bb medium_width=\u00a0\u00bb0″ mobile_visibility=\u00a0\u00bbyes\u00a0\u00bb mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/3″ uncode_shortcode_id=\u00a0\u00bb163215″][\/vc_column_inner][vc_column_inner width=\u00a0\u00bb2\/3″][vc_column_text uncode_shortcode_id=\u00a0\u00bb187401″]Dans les \u00e9tudes contr\u00f4l\u00e9es et les observations portant sur la TES avec OkuStim\u00ae, aucun \u00e9v\u00e9nement ind\u00e9sirable grave (EIG) li\u00e9 \u00e0 la th\u00e9rapie ou au dispositif n\u2019a \u00e9t\u00e9 rapport\u00e9 ; l\u2019effet ind\u00e9sirable le plus fr\u00e9quent est une s\u00e9cheresse oculaire temporaire, g\u00e9n\u00e9ralement bien trait\u00e9e par des substituts lacrymaux.<\/p>\n

    Des \u00e9tudes cliniques randomis\u00e9es et prospectives (notamment les s\u00e9ries EST et l\u2019\u00e9tude TESOLA) ont d\u00e9montr\u00e9 la s\u00e9curit\u00e9 de la m\u00e9thode ; des analyses exploratoires indiquent un ralentissement dose-d\u00e9pendant de la perte du champ visuel.<\/p>\n

    Dans l\u2019ensemble, les donn\u00e9es cliniques montrent qu\u2019une stimulation \u00e9lectrique r\u00e9guli\u00e8re de faible intensit\u00e9 peut ralentir la perte du champ visuel li\u00e9e \u00e0 la RP et ainsi contribuer \u00e0 pr\u00e9server plus longtemps la qualit\u00e9 de vie visuelle.<\/p>\n

    Ce que nous entendons par \u00ab s\u00e9curit\u00e9 \u00bb :<\/b><\/p>\n

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    • Aucun \u00e9v\u00e9nement ind\u00e9sirable grave (EIG) li\u00e9 au dispositif ou \u00e0 la th\u00e9rapie dans les \u00e9tudes de s\u00e9curit\u00e9 multicentriques.<\/li>\n
    • Indications d\u2019un effet dose-r\u00e9ponse sur le ralentissement de la perte du champ visuel.<\/li>\n
    • Th\u00e9rapie \u00e0 domicile avec des param\u00e8tres d\u00e9finis par le m\u00e9decin (30 min\/semaine).<\/li>\n<\/ul>\n

      [\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=\u00a0\u00bb0″ override_padding=\u00a0\u00bbyes\u00a0\u00bb h_padding=\u00a0\u00bb2″ top_padding=\u00a0\u00bb3″ bottom_padding=\u00a0\u00bb0″ overlay_alpha=\u00a0\u00bb50″ gutter_size=\u00a0\u00bb3″ column_width_percent=\u00a0\u00bb100″ shift_y=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ content_parallax=\u00a0\u00bb0″ uncode_shortcode_id=\u00a0\u00bb253652″][vc_column width=\u00a0\u00bb1\/1″][vc_row_inner][vc_column_inner width=\u00a0\u00bb2\/3″][vc_custom_heading text_font=\u00a0\u00bbfont-714446″ text_size=\u00a0\u00bbfontsize-914237″ text_weight=\u00a0\u00bb300″ uncode_shortcode_id=\u00a0\u00bb207844″]Utilisabilit\u00e9 et accessibilit\u00e9 au quotidien[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=\u00a0\u00bb100″ gutter_size=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_visibility=\u00a0\u00bbyes\u00a0\u00bb medium_width=\u00a0\u00bb0″ mobile_visibility=\u00a0\u00bbyes\u00a0\u00bb mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/3″ uncode_shortcode_id=\u00a0\u00bb542260″][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner column_width_percent=\u00a0\u00bb100″ gutter_size=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_visibility=\u00a0\u00bbyes\u00a0\u00bb medium_width=\u00a0\u00bb0″ mobile_visibility=\u00a0\u00bbyes\u00a0\u00bb mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/3″ uncode_shortcode_id=\u00a0\u00bb163215″][\/vc_column_inner][vc_column_inner width=\u00a0\u00bb2\/3″][vc_column_text uncode_shortcode_id=\u00a0\u00bb178997″]Le syst\u00e8me est con\u00e7u pour une utilisation autonome \u2013 avec une ergonomie claire, un retour LED et des messages syst\u00e8me sonores, qui apportent un soutien m\u00eame \u00e0 des stades avanc\u00e9s. Le mode d\u2019emploi couvre les \u00e9l\u00e9ments de commande, les signaux et la r\u00e9alisation s\u00fbre des s\u00e9ances.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=\u00a0\u00bb0″ override_padding=\u00a0\u00bbyes\u00a0\u00bb h_padding=\u00a0\u00bb2″ top_padding=\u00a0\u00bb3″ bottom_padding=\u00a0\u00bb0″ overlay_alpha=\u00a0\u00bb50″ gutter_size=\u00a0\u00bb3″ column_width_percent=\u00a0\u00bb100″ shift_y=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ content_parallax=\u00a0\u00bb0″ uncode_shortcode_id=\u00a0\u00bb253652″][vc_column width=\u00a0\u00bb1\/1″][vc_row_inner][vc_column_inner width=\u00a0\u00bb2\/3″][vc_custom_heading text_font=\u00a0\u00bbfont-714446″ text_size=\u00a0\u00bbfontsize-914237″ text_weight=\u00a0\u00bb300″ uncode_shortcode_id=\u00a0\u00bb112002″]Compatibilit\u00e9 \u00e9lectromagn\u00e9tique (CEM)[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=\u00a0\u00bb100″ gutter_size=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_visibility=\u00a0\u00bbyes\u00a0\u00bb medium_width=\u00a0\u00bb0″ mobile_visibility=\u00a0\u00bbyes\u00a0\u00bb mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/3″ uncode_shortcode_id=\u00a0\u00bb542260″][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner column_width_percent=\u00a0\u00bb100″ gutter_size=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_visibility=\u00a0\u00bbyes\u00a0\u00bb medium_width=\u00a0\u00bb0″ mobile_visibility=\u00a0\u00bbyes\u00a0\u00bb mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/3″ uncode_shortcode_id=\u00a0\u00bb163215″][\/vc_column_inner][vc_column_inner width=\u00a0\u00bb2\/3″][vc_column_text uncode_shortcode_id=\u00a0\u00bb190047″]Le dispositif est conforme aux exigences de compatibilit\u00e9 \u00e9lectromagn\u00e9tique (CEM) selon la norme CISPR 11, groupe 1, classe B \u2014 et convient \u00e0 une utilisation \u00e0 domicile, en cabinet m\u00e9dical et en clinique. Des consignes d\u2019utilisation permettent de limiter les interf\u00e9rences et de garantir des s\u00e9ances de th\u00e9rapie reproductibles.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=\u00a0\u00bb0″ override_padding=\u00a0\u00bbyes\u00a0\u00bb h_padding=\u00a0\u00bb2″ top_padding=\u00a0\u00bb3″ bottom_padding=\u00a0\u00bb0″ overlay_alpha=\u00a0\u00bb50″ gutter_size=\u00a0\u00bb3″ column_width_percent=\u00a0\u00bb100″ shift_y=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ content_parallax=\u00a0\u00bb0″ uncode_shortcode_id=\u00a0\u00bb394183″][vc_column width=\u00a0\u00bb1\/1″][vc_row_inner][vc_column_inner width=\u00a0\u00bb2\/3″][vc_custom_heading text_font=\u00a0\u00bbfont-714446″ text_size=\u00a0\u00bbfontsize-914237″ text_weight=\u00a0\u00bb300″ uncode_shortcode_id=\u00a0\u00bb953100″]Surveillance post-commercialisation et transparence[\/vc_custom_heading][\/vc_column_inner][vc_column_inner column_width_percent=\u00a0\u00bb100″ gutter_size=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_visibility=\u00a0\u00bbyes\u00a0\u00bb medium_width=\u00a0\u00bb0″ mobile_visibility=\u00a0\u00bbyes\u00a0\u00bb mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/3″ uncode_shortcode_id=\u00a0\u00bb542260″][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner column_width_percent=\u00a0\u00bb100″ gutter_size=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_visibility=\u00a0\u00bbyes\u00a0\u00bb medium_width=\u00a0\u00bb0″ mobile_visibility=\u00a0\u00bbyes\u00a0\u00bb mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/3″ uncode_shortcode_id=\u00a0\u00bb163215″][\/vc_column_inner][vc_column_inner width=\u00a0\u00bb2\/3″][vc_column_text uncode_shortcode_id=\u00a0\u00bb546250″]Nous suivons syst\u00e9matiquement la s\u00e9curit\u00e9, les performances et les retours des utilisateurs (\u00ab PMS \u00bb) et int\u00e9grons en continu les enseignements dans la maintenance du produit et l\u2019information des utilisateurs (p. ex. recommandation de larmes artificielles en cas de s\u00e9cheresse, consignes sur la manipulation des \u00e9lectrodes et le confort).
      \nParall\u00e8lement, des donn\u00e9es cliniques \u00e0 long terme sont recueillies dans le cadre de programmes multicentriques ; l\u2019\u00e9tude allemande d\u2019\u00e9valuation du G-BA (TES-RP) analyse des crit\u00e8res d\u2019\u00e9valuation pertinents pour les patients sur plusieurs ann\u00e9es.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=\u00a0\u00bb0″ override_padding=\u00a0\u00bbyes\u00a0\u00bb h_padding=\u00a0\u00bb2″ top_padding=\u00a0\u00bb3″ bottom_padding=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ gutter_size=\u00a0\u00bb3″ column_width_percent=\u00a0\u00bb100″ shift_y=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ content_parallax=\u00a0\u00bb0″ uncode_shortcode_id=\u00a0\u00bb418228″][vc_column width=\u00a0\u00bb1\/1″][vc_custom_heading heading_semantic=\u00a0\u00bbh3″ text_font=\u00a0\u00bbfont-714446″ text_size=\u00a0\u00bbh1″ text_weight=\u00a0\u00bb300″ uncode_shortcode_id=\u00a0\u00bb453385″]Comment notre PMS agit en pratique[\/vc_custom_heading][vc_accordion typography=\u00a0\u00bbadvanced\u00a0\u00bb sign=\u00a0\u00bbplus\u00a0\u00bb gutter_simple=\u00a0\u00bb0″ heading_semantic=\u00a0\u00bbh3″ titles_size=\u00a0\u00bbh4″ cvc_color_scheme=\u00a0\u00bbviolet\u00a0\u00bb cvc_background_color=\u00a0\u00bblight-gray\u00a0\u00bb uncode_shortcode_id=\u00a0\u00bb108876″ active_tab=\u00a0\u00bb999″][vc_accordion_tab gutter_size=\u00a0\u00bb2″ column_padding=\u00a0\u00bb2″ title=\u00a0\u00bbGestion des risques et vigilance\u00a0\u00bb tab_id=\u00a0\u00bb1758294612-1-917646061286981764773716040″][vc_row_inner row_inner_height_percent=\u00a0\u00bb0″ overlay_alpha=\u00a0\u00bb50″ gutter_size=\u00a0\u00bb3″ shift_y=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ uncode_shortcode_id=\u00a0\u00bb561844″][vc_column_inner column_width_percent=\u00a0\u00bb100″ gutter_size=\u00a0\u00bb2″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_width=\u00a0\u00bb0″ mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/1″ uncode_shortcode_id=\u00a0\u00bb746443″][vc_column_text uncode_shortcode_id=\u00a0\u00bb674030″]\u00e9valuation continue des signalements, analyses de tendances, mesures correctives.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_accordion_tab][vc_accordion_tab gutter_size=\u00a0\u00bb2″ column_padding=\u00a0\u00bb2″ title=\u00a0\u00bbSuivi clinique apr\u00e8s commercialisation (PMCF)\u00a0\u00bb tab_id=\u00a0\u00bb1758294612-2-4517646061286981764773716040″][vc_row_inner][vc_column_inner column_width_percent=\u00a0\u00bb100″ gutter_size=\u00a0\u00bb2″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_width=\u00a0\u00bb0″ mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/1″ uncode_shortcode_id=\u00a0\u00bb164952″][vc_column_text uncode_shortcode_id=\u00a0\u00bb189975″]Int\u00e9gration de donn\u00e9es d\u2019utilisation r\u00e9elles issues des cliniques\/de la prise en charge.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_accordion_tab][vc_accordion_tab gutter_size=\u00a0\u00bb2″ column_padding=\u00a0\u00bb2″ title=\u00a0\u00bbRetours sur l\u2019utilisabilit\u00e9\u00a0\u00bb tab_id=\u00a0\u00bb1759218552822-2-617646061286981764773716040″][vc_row_inner][vc_column_inner width=\u00a0\u00bb1\/1″][vc_column_text uncode_shortcode_id=\u00a0\u00bb127086″]Int\u00e9gration des retours des utilisateurs dans les compl\u00e9ments de l\u2019IFU et les supports de formation.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_accordion_tab][\/vc_accordion][\/vc_column][\/vc_row][vc_row unlock_row_content=\u00a0\u00bbyes\u00a0\u00bb row_height_percent=\u00a0\u00bb0″ override_padding=\u00a0\u00bbyes\u00a0\u00bb h_padding=\u00a0\u00bb0″ top_padding=\u00a0\u00bb3″ bottom_padding=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ equal_height=\u00a0\u00bbyes\u00a0\u00bb gutter_size=\u00a0\u00bb3″ column_width_percent=\u00a0\u00bb100″ shift_y=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ content_parallax=\u00a0\u00bb0″ cvc_maxwidth=\u00a0\u00bb1920″ uncode_shortcode_id=\u00a0\u00bb490954″][vc_column column_width_percent=\u00a0\u00bb70″ position_vertical=\u00a0\u00bbmiddle\u00a0\u00bb gutter_size=\u00a0\u00bb3″ override_padding=\u00a0\u00bbyes\u00a0\u00bb column_padding=\u00a0\u00bb3″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_width=\u00a0\u00bb0″ mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/1″ uncode_shortcode_id=\u00a0\u00bb126108″][vc_custom_heading text_font=\u00a0\u00bbfont-714446″ text_size=\u00a0\u00bbfontsize-914237″ text_weight=\u00a0\u00bb300″ uncode_shortcode_id=\u00a0\u00bb197986″]Certificats[\/vc_custom_heading][vc_button button_color=\u00a0\u00bbcolor-312440″ size=\u00a0\u00bblink\u00a0\u00bb btn_link_hover=\u00a0\u00bbbtn-hover-accent\u00a0\u00bb custom_typo=\u00a0\u00bbyes\u00a0\u00bb font_family=\u00a0\u00bbfont-153386″ font_weight=\u00a0\u00bb700″ button_color_type=\u00a0\u00bbuncode-palette\u00a0\u00bb icon=\u00a0\u00bbfa fa-arrow-down2″ uncode_shortcode_id=\u00a0\u00bb600883″ link=\u00a0\u00bburl:https%3A%2F%2Fokuvision.de%2Fwp-content%2Fuploads%2F2026%2F01%2FQMH-00-03_03.pdf|target:_blank\u00a0\u00bb]Certificat ISO 13485:2016[\/vc_button][vc_button button_color=\u00a0\u00bbcolor-312440″ size=\u00a0\u00bblink\u00a0\u00bb btn_link_hover=\u00a0\u00bbbtn-hover-accent\u00a0\u00bb custom_typo=\u00a0\u00bbyes\u00a0\u00bb font_family=\u00a0\u00bbfont-153386″ font_weight=\u00a0\u00bb700″ button_color_type=\u00a0\u00bbuncode-palette\u00a0\u00bb icon=\u00a0\u00bbfa fa-arrow-down2″ uncode_shortcode_id=\u00a0\u00bb165535″ link=\u00a0\u00bburl:https%3A%2F%2Fokuvision.de%2Fwp-content%2Fuploads%2F2025%2F12%2FQMH-00-05.pdf|target:_blank\u00a0\u00bb]Syst\u00e8me de management de la qualit\u00e9 R\u00c8GLEMENT (UE) 2017\/745 relatif aux dispositifs m\u00e9dicaux, annexe IX, chapitre I, sections 2 et 3, et chapitre III[\/vc_button][\/vc_column][\/vc_row][vc_row row_height_percent=\u00a0\u00bb0″ override_padding=\u00a0\u00bbyes\u00a0\u00bb h_padding=\u00a0\u00bb2″ top_padding=\u00a0\u00bb3″ bottom_padding=\u00a0\u00bb3″ back_color=\u00a0\u00bbcolor-206913″ overlay_alpha=\u00a0\u00bb50″ gutter_size=\u00a0\u00bb3″ column_width_percent=\u00a0\u00bb100″ shift_y=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ content_parallax=\u00a0\u00bb0″ uncode_shortcode_id=\u00a0\u00bb118356″ back_color_type=\u00a0\u00bbuncode-palette\u00a0\u00bb][vc_column column_width_percent=\u00a0\u00bb100″ align_horizontal=\u00a0\u00bbalign_center\u00a0\u00bb gutter_size=\u00a0\u00bb4″ overlay_alpha=\u00a0\u00bb50″ shift_x=\u00a0\u00bb0″ shift_y=\u00a0\u00bb0″ shift_y_down=\u00a0\u00bb0″ z_index=\u00a0\u00bb0″ medium_width=\u00a0\u00bb0″ mobile_width=\u00a0\u00bb0″ width=\u00a0\u00bb1\/1″ uncode_shortcode_id=\u00a0\u00bb152446″][vc_custom_heading text_font=\u00a0\u00bbfont-714446″ text_size=\u00a0\u00bbfontsize-914237″ text_weight=\u00a0\u00bb300″ uncode_shortcode_id=\u00a0\u00bb109998″]Tout savoir sur la th\u00e9rapie,
      \nla recherche clinique et Okuvision[\/vc_custom_heading][vc_row_inner][vc_column_inner width=\u00a0\u00bb1\/1″][uncode_index el_id=\u00a0\u00bbindex-974899″ index_type=\u00a0\u00bbcarousel\u00a0\u00bb loop=\u00a0\u00bbsize:3|order_by:date|post_type:post|categories:88|taxonomy_count:10″ carousel_lg=\u00a0\u00bb3″ carousel_md=\u00a0\u00bb2″ carousel_sm=\u00a0\u00bb1″ thumb_size=\u00a0\u00bbsixteen-nine\u00a0\u00bb gutter_size=\u00a0\u00bb3″ post_items=\u00a0\u00bbmedia|featured|onpost|original,date,title|-,text|excerpt|200,category|colorbg|relative|display-icon\u00a0\u00bb carousel_height=\u00a0\u00bbequal\u00a0\u00bb carousel_interval=\u00a0\u00bb3000″ carousel_navspeed=\u00a0\u00bb400″ advanced_nav=\u00a0\u00bbyes\u00a0\u00bb el_id1=\u00a0\u00bbindex-974899″ stage_padding=\u00a0\u00bb0″ single_back_color=\u00a0\u00bbcolor-942029″ single_overlay_opacity=\u00a0\u00bb50″ single_padding=\u00a0\u00bb2″ single_title_dimension=\u00a0\u00bbh4″ single_border=\u00a0\u00bbyes\u00a0\u00bb uncode_shortcode_id=\u00a0\u00bb198467″][uncode_carousel_nav padding=\u00a0\u00bb0″ h_align=\u00a0\u00bbcenter\u00a0\u00bb hide_arrows=\u00a0\u00bbyes\u00a0\u00bb dots_style=\u00a0\u00bblines\u00a0\u00bb hide_counter=\u00a0\u00bbyes\u00a0\u00bb uncode_shortcode_id=\u00a0\u00bb207978″ target=\u00a0\u00bbindex-974899″ dot_single_width=\u00a0\u00bb12″ dot_single_active=\u00a0\u00bb24″ dot_single_height=\u00a0\u00bb12″ dot_single_radius=\u00a0\u00bb999″][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

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s\u00fbre, fond\u00e9e sur des preuves, conforme au MDR<\/title>\n<meta name=\"description\" content=\"Comment nous mesurons la qualit\u00e9 : conformit\u00e9 au MDR, CE (0197), preuves cliniques, utilisabilit\u00e9 & s\u00e9curit\u00e9 \u2013 pour une th\u00e9rapie TES fiable.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/okuvision.de\/fr\/qualitaet\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Politique qualit\u00e9\" \/>\n<meta property=\"og:description\" content=\"Comment nous mesurons la qualit\u00e9 : conformit\u00e9 au MDR, CE (0197), preuves cliniques, utilisabilit\u00e9 & s\u00e9curit\u00e9 \u2013 pour une th\u00e9rapie TES fiable.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/okuvision.de\/fr\/qualitaet\/\" \/>\n<meta property=\"og:site_name\" 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