{"id":143078,"date":"2025-05-06T12:47:26","date_gmt":"2025-05-06T10:47:26","guid":{"rendered":"https:\/\/skrivanek.pl\/iso-13485\/"},"modified":"2026-02-05T12:31:42","modified_gmt":"2026-02-05T11:31:42","slug":"iso-13485","status":"publish","type":"page","link":"https:\/\/skrivanek.pl\/en\/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-69e15b2de3413 {margin-top: 100px !important;}<\/style><div id=\"thegem-divider-69e15b2de3413\" class=\"gem-divider  \" style=\"\" ><\/div>[vc_column_text css=&#8221;&#8221;]<\/p>\n<h1><span style=\"color: #ff6440;\"><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>Guaranteeing Top Standards in Medical Translations<\/h3>\n<p>The ISO 13485 standard defines the requirements for a quality management system (QMS) specific to companies involved in the medical device industry. Its main goal is to ensure consistency, safety, and quality in products and services throughout all stages \u2013 from design and production to distribution and post-market support.<\/p>\n<p>At Skrivanek, we understand the critical importance of precision and regulatory compliance in the medical field. That\u2019s why we have implemented and maintain a quality management system that complies with ISO 13485. This certification confirms our capability to deliver language services and translations that meet the highest standards required by the medical and life sciences sectors.<\/p>\n<p><strong>What does ISO 13485 mean for our clients?<\/strong><\/p>\n<p>Obtaining ISO 13485 certification is more than a formal step \u2013 it is a reflection of our commitment to excellence. For our clients, this means:<\/p>\n<ul>\n<li>Medical and technical translations are carried out with the utmost accuracy and in compliance with all relevant regulations and guidelines.<\/li>\n<li>We ensure full traceability of processes and rigorous quality control at every stage of a project.<\/li>\n<li>Our procedures are regularly audited and continuously improved, minimizing the risk of errors and ensuring information security.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;][vc_single_image image=&#8221;143070&#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;] Guaranteeing Top Standards in Medical Translations The ISO&#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-143078","page","type-page","status-publish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ISO 13485 - Skrivanek - agencja t\u0142umacze\u0144<\/title>\n<meta name=\"description\" content=\"Bei Skrivanek verstehen wir die entscheidende Bedeutung von Pr\u00e4zision und regulatorischer Konformit\u00e4t im medizinischen Bereich.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/skrivanek.pl\/en\/iso-13485\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 - Skrivanek - agencja t\u0142umacze\u0144\" \/>\n<meta property=\"og:description\" content=\"Bei Skrivanek verstehen wir die entscheidende Bedeutung von Pr\u00e4zision und regulatorischer Konformit\u00e4t im medizinischen Bereich.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/skrivanek.pl\/en\/iso-13485\/\" \/>\n<meta property=\"og:site_name\" content=\"Skrivanek - agencja t\u0142umacze\u0144\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/SkrivanekPolska\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-05T11:31:42+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/skrivanek.pl\/wp-content\/uploads\/2019\/11\/google-plus-2.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"426\" \/>\n\t<meta property=\"og:image:height\" content=\"240\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/skrivanek.pl\/en\/iso-13485\/\",\"url\":\"https:\/\/skrivanek.pl\/en\/iso-13485\/\",\"name\":\"ISO 13485 - Skrivanek - agencja t\u0142umacze\u0144\",\"isPartOf\":{\"@id\":\"https:\/\/skrivanek.pl\/#website\"},\"datePublished\":\"2025-05-06T10:47:26+00:00\",\"dateModified\":\"2026-02-05T11:31:42+00:00\",\"description\":\"Bei Skrivanek verstehen wir die entscheidende Bedeutung von Pr\u00e4zision und regulatorischer Konformit\u00e4t im medizinischen Bereich.\",\"breadcrumb\":{\"@id\":\"https:\/\/skrivanek.pl\/en\/iso-13485\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/skrivanek.pl\/en\/iso-13485\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/skrivanek.pl\/en\/iso-13485\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Strona g\u0142\u00f3wna\",\"item\":\"https:\/\/skrivanek.pl\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"ISO 13485\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/skrivanek.pl\/#website\",\"url\":\"https:\/\/skrivanek.pl\/\",\"name\":\"Skrivanek - agencja t\u0142umacze\u0144\",\"description\":\"Skrivanek - t\u0142umaczenia\",\"publisher\":{\"@id\":\"https:\/\/skrivanek.pl\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/skrivanek.pl\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/skrivanek.pl\/#organization\",\"name\":\"Skrivanek agencja t\u0142umacze\u0144 i szko\u0142a j\u0119zykowa\",\"url\":\"https:\/\/skrivanek.pl\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/skrivanek.pl\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/skrivanek.pl\/wp-content\/uploads\/2020\/12\/logo-skrivanek-black.png\",\"contentUrl\":\"https:\/\/skrivanek.pl\/wp-content\/uploads\/2020\/12\/logo-skrivanek-black.png\",\"width\":441,\"height\":116,\"caption\":\"Skrivanek agencja t\u0142umacze\u0144 i szko\u0142a j\u0119zykowa\"},\"image\":{\"@id\":\"https:\/\/skrivanek.pl\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/SkrivanekPolska\",\"https:\/\/www.instagram.com\/skrivanek_official\/\",\"https:\/\/www.linkedin.com\/company\/skrivanek-poland\/\",\"https:\/\/www.youtube.com\/c\/SkrivanekPl\/\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"ISO 13485 - Skrivanek - agencja t\u0142umacze\u0144","description":"Bei Skrivanek verstehen wir die entscheidende Bedeutung von Pr\u00e4zision und regulatorischer Konformit\u00e4t im medizinischen Bereich.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/skrivanek.pl\/en\/iso-13485\/","og_locale":"en_US","og_type":"article","og_title":"ISO 13485 - Skrivanek - agencja t\u0142umacze\u0144","og_description":"Bei Skrivanek verstehen wir die entscheidende Bedeutung von Pr\u00e4zision und regulatorischer Konformit\u00e4t im medizinischen Bereich.","og_url":"https:\/\/skrivanek.pl\/en\/iso-13485\/","og_site_name":"Skrivanek - agencja t\u0142umacze\u0144","article_publisher":"https:\/\/www.facebook.com\/SkrivanekPolska","article_modified_time":"2026-02-05T11:31:42+00:00","og_image":[{"width":426,"height":240,"url":"https:\/\/skrivanek.pl\/wp-content\/uploads\/2019\/11\/google-plus-2.jpg","type":"image\/jpeg"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/skrivanek.pl\/en\/iso-13485\/","url":"https:\/\/skrivanek.pl\/en\/iso-13485\/","name":"ISO 13485 - Skrivanek - agencja t\u0142umacze\u0144","isPartOf":{"@id":"https:\/\/skrivanek.pl\/#website"},"datePublished":"2025-05-06T10:47:26+00:00","dateModified":"2026-02-05T11:31:42+00:00","description":"Bei Skrivanek verstehen wir die entscheidende Bedeutung von Pr\u00e4zision und regulatorischer Konformit\u00e4t im medizinischen Bereich.","breadcrumb":{"@id":"https:\/\/skrivanek.pl\/en\/iso-13485\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/skrivanek.pl\/en\/iso-13485\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/skrivanek.pl\/en\/iso-13485\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Strona g\u0142\u00f3wna","item":"https:\/\/skrivanek.pl\/en\/"},{"@type":"ListItem","position":2,"name":"ISO 13485"}]},{"@type":"WebSite","@id":"https:\/\/skrivanek.pl\/#website","url":"https:\/\/skrivanek.pl\/","name":"Skrivanek - agencja t\u0142umacze\u0144","description":"Skrivanek - t\u0142umaczenia","publisher":{"@id":"https:\/\/skrivanek.pl\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/skrivanek.pl\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/skrivanek.pl\/#organization","name":"Skrivanek agencja t\u0142umacze\u0144 i szko\u0142a j\u0119zykowa","url":"https:\/\/skrivanek.pl\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/skrivanek.pl\/#\/schema\/logo\/image\/","url":"https:\/\/skrivanek.pl\/wp-content\/uploads\/2020\/12\/logo-skrivanek-black.png","contentUrl":"https:\/\/skrivanek.pl\/wp-content\/uploads\/2020\/12\/logo-skrivanek-black.png","width":441,"height":116,"caption":"Skrivanek agencja t\u0142umacze\u0144 i szko\u0142a j\u0119zykowa"},"image":{"@id":"https:\/\/skrivanek.pl\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/SkrivanekPolska","https:\/\/www.instagram.com\/skrivanek_official\/","https:\/\/www.linkedin.com\/company\/skrivanek-poland\/","https:\/\/www.youtube.com\/c\/SkrivanekPl\/"]}]}},"_links":{"self":[{"href":"https:\/\/skrivanek.pl\/en\/wp-json\/wp\/v2\/pages\/143078","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/skrivanek.pl\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/skrivanek.pl\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/skrivanek.pl\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/skrivanek.pl\/en\/wp-json\/wp\/v2\/comments?post=143078"}],"version-history":[{"count":3,"href":"https:\/\/skrivanek.pl\/en\/wp-json\/wp\/v2\/pages\/143078\/revisions"}],"predecessor-version":[{"id":150242,"href":"https:\/\/skrivanek.pl\/en\/wp-json\/wp\/v2\/pages\/143078\/revisions\/150242"}],"wp:attachment":[{"href":"https:\/\/skrivanek.pl\/en\/wp-json\/wp\/v2\/media?parent=143078"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}