{"id":11233,"date":"2024-03-06T10:20:46","date_gmt":"2024-03-06T09:20:46","guid":{"rendered":"https:\/\/gemino.de\/?p=11233"},"modified":"2024-03-06T10:20:46","modified_gmt":"2024-03-06T09:20:46","slug":"gemino-certified-according-to-iso-13485","status":"publish","type":"post","link":"https:\/\/gemino.de\/en\/gemino-certified-according-to-iso-13485\/","title":{"rendered":"Gemino certified according to ISO 13485"},"content":{"rendered":"<p><em><span style=\"color: #00ccff;\">Gemino\u2019s ISO 13485 compliance complements our ISO 17100 and ISO 9001 certification, ensuring optimized processes and the highest quality with regard to MDR\/IVDR requirements.<\/span><\/em><\/p>\n<p>Companies with medical technology products need to know that their multilingual content and translation processes comply with regulatory requirements. Gemino can ensure this thanks to its ISO 13485 certification.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Regulatory requirements are understood<\/strong><\/p>\n<p>Companies can rest assured that Gemino understands the MDR\/IVDR requirements for labeling translations and takes them into account when designing and adapting processes.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Security &amp; risk management<\/strong><\/p>\n<p>Our ISO 13485 certification confirms that, as a language service provider, we work according to standards that meet the requirements of medical device manufacturers for outsourced processes.<\/p>\n<p>Gemino always takes a risk-based approach, especially when unexpected changes occur.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Simple verification<\/strong><\/p>\n<p>Even if notified bodies cannot require language service providers to adhere to ISO\u00a013485 (yet): With Gemino as a certified language service provider, the obligations for managing and monitoring outsourced translation processes can be verified quickly and easily.<\/p>\n<p>&nbsp;<\/p>\n<p>Thanks to our combination of ISO 17100, ISO 13485 and ISO 9001 certifications, we optimize your processes and provide the highest quality with regard to MDR\/IVDR requirements.<\/p>\n<p>Further information on our <a href=\"https:\/\/gemino.de\/en\/quality-standards\/\">quality standards<\/a> and especially about <a href=\"https:\/\/gemino.de\/en\/iso13485\/\">ISO 13485<\/a> can be found on our <a href=\"https:\/\/gemino.de\/en\/iso13485\/\">website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gemino\u2019s ISO 13485 compliance complements our ISO 17100 and ISO 9001 certification, ensuring optimized processes and the highest quality with regard to MDR\/IVDR requirements. Companies with medical technology products need to know that their multilingual content and translation processes comply with regulatory requirements. Gemino can ensure this thanks to its ISO 13485 certification. &nbsp; Regulatory&#8230; <\/p>\n<div class=\"clear\"><\/div>\n<p><a href=\"https:\/\/gemino.de\/en\/gemino-certified-according-to-iso-13485\/\" class=\"gdlr-button with-border excerpt-read-more\">Read More<\/a><\/p>\n","protected":false},"author":4,"featured_media":7480,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[90],"tags":[],"class_list":["post-11233","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gemino-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>Gemino certified according to ISO 13485 - Gemino, Language Services &amp; Solutions<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/gemino.de\/en\/gemino-certified-according-to-iso-13485\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"Gemino certified according to ISO 13485 - Gemino, Language Services &amp; Solutions\" \/>\r\n<meta property=\"og:description\" content=\"Gemino\u2019s ISO 13485 compliance complements our ISO 17100 and ISO 9001 certification, ensuring optimized processes and the highest quality with regard to MDR\/IVDR requirements. 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