{"id":143091,"date":"2025-05-06T12:47:26","date_gmt":"2025-05-06T10:47:26","guid":{"rendered":"https:\/\/skrivanek.pl\/iso-13485\/"},"modified":"2026-03-24T16:24:19","modified_gmt":"2026-03-24T15:24:19","slug":"iso-13485","status":"publish","type":"page","link":"https:\/\/skrivanek.pl\/de\/iso-13485\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row css=&#8221;.vc_custom_1602755674326{margin-top: 50px !important;}&#8221;][vc_column]<div class=\"clearboth\"><\/div><style>#thegem-divider-69e47be6365fc {margin-top: 150px !important;}<\/style><div id=\"thegem-divider-69e47be6365fc\" class=\"gem-divider  \" style=\"\" ><\/div>[vc_column_text css=&#8221;&#8221;]<\/p>\n<h1><span style=\"color: #ff643b;\"><strong>ISO 13485:2016<\/strong><\/span><\/h1>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;true&#8221;][vc_column][vc_row_inner equal_height=&#8221;yes&#8221;][vc_column_inner width=&#8221;2\/3&#8243;][vc_column_text css=&#8221;&#8221;]<\/p>\n<h3>GARANTIE H\u00d6CHSTER STANDARDS BEI MEDIZINISCHEN \u00dcBERSETZUNGEN<\/h3>\n<p>Die Norm ISO 13485 legt die Anforderungen an ein Qualit\u00e4tsmanagementsystem (QMS) fest, das speziell f\u00fcr Unternehmen in der Medizintechnikbranche gilt. Ihr Hauptziel ist es, Konsistenz, Sicherheit und Qualit\u00e4t von Produkten und Dienstleistungen in allen Phasen sicherzustellen \u2013 von der Entwicklung und Produktion \u00fcber die Distribution bis hin zur Unterst\u00fctzung nach dem Inverkehrbringen.<\/p>\n<p>Bei Skrivanek verstehen wir die entscheidende Bedeutung von Pr\u00e4zision und regulatorischer Konformit\u00e4t im medizinischen Bereich. Aus diesem Grund haben wir ein Qualit\u00e4tsmanagementsystem implementiert und pflegen es, das der ISO 13485 entspricht. Diese Zertifizierung best\u00e4tigt unsere F\u00e4higkeit, Sprachdienstleistungen und \u00dcbersetzungen zu erbringen, die den h\u00f6chsten Anforderungen der Medizin- und Life-Sciences-Branche gerecht werden.<\/p>\n<p><strong>Was bedeutet ISO 13485 f\u00fcr unsere Kunden?<\/strong><\/p>\n<p>Die ISO 13485-Zertifizierung ist mehr als nur ein formaler Schritt \u2013 sie spiegelt unser Engagement f\u00fcr h\u00f6chste Qualit\u00e4t wider. F\u00fcr unsere Kunden bedeutet das:<\/p>\n<ul>\n<li>Medizinische und technische \u00dcbersetzungen werden mit h\u00f6chster Genauigkeit und unter Einhaltung aller relevanten Vorschriften und Richtlinien durchgef\u00fchrt.<\/li>\n<li>Wir gew\u00e4hrleisten vollst\u00e4ndige R\u00fcckverfolgbarkeit der Prozesse sowie strenge Qualit\u00e4tskontrollen in jeder Projektphase.<\/li>\n<li>Unsere Verfahren werden regelm\u00e4\u00dfig auditiert und kontinuierlich verbessert, wodurch das Fehlerrisiko minimiert und die Informationssicherheit gew\u00e4hrleistet wird.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;][vc_single_image image=&#8221;143071&#8243; img_size=&#8221;large&#8221; alignment=&#8221;center&#8221; onclick=&#8221;link_image&#8221; css=&#8221;&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row css=&#8221;.vc_custom_1602755674326{margin-top: 50px !important;}&#8221;][vc_column][vc_column_text css=&#8221;&#8221;] ISO 13485:2016 [\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;true&#8221;][vc_column][vc_row_inner equal_height=&#8221;yes&#8221;][vc_column_inner width=&#8221;2\/3&#8243;][vc_column_text css=&#8221;&#8221;] GARANTIE H\u00d6CHSTER STANDARDS BEI MEDIZINISCHEN \u00dcBERSETZUNGEN Die Norm&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":"","_wp_rev_ctl_limit":""},"class_list":["post-143091","page","type-page","status-publish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - 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