{"id":857,"date":"2019-09-19T14:46:14","date_gmt":"2019-09-19T12:46:14","guid":{"rendered":"https:\/\/www.velixx.com\/?p=857"},"modified":"2019-09-25T10:55:38","modified_gmt":"2019-09-25T08:55:38","slug":"iso-13485","status":"publish","type":"post","link":"https:\/\/www.velixx.com\/en\/2019\/09\/iso-13485\/","title":{"rendered":"ISO 13485:2016"},"content":{"rendered":"\n<p>Since August 2019 our quality management system is certified according to the latest ISO standard for medical device development. <br>The mdc medical device certification GmbH confirms, that the QM-System from velixX corresponds to ISO 13485:2016 standard in all points.<\/p>\n\n\n\n<p> <\/p>\n\n\n\n<figure class=\"wp-block-image\"><img loading=\"lazy\" decoding=\"async\" width=\"786\" height=\"757\" src=\"https:\/\/www.velixx.com\/wp-content\/uploads\/2019\/09\/mdc_plakette_13485_e1.jpg\" alt=\"\" class=\"wp-image-788\" srcset=\"https:\/\/www.velixx.com\/wp-content\/uploads\/2019\/09\/mdc_plakette_13485_e1.jpg 786w, https:\/\/www.velixx.com\/wp-content\/uploads\/2019\/09\/mdc_plakette_13485_e1-300x289.jpg 300w, https:\/\/www.velixx.com\/wp-content\/uploads\/2019\/09\/mdc_plakette_13485_e1-768x740.jpg 768w\" sizes=\"(max-width: 786px) 100vw, 786px\" \/><figcaption><a href=\"https:\/\/www.velixx.com\/wp-content\/uploads\/2019\/09\/D1448400001_D.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"ISO 13485 Certificate (\u00f6ffnet in neuem Tab)\">ISO 13485 Certificate<\/a><\/figcaption><\/figure>\n\n\n\n<p>Just in time before the 9th anniversary of the company&#8217;s foundation, the\nquality management system of velixX GmbH was certified according to ISO\n13485:2016.<\/p>\n\n\n\n<p>During the certification audit carried out on 22\/23 July 2019, the velixX\nQM system was certified to meet all requirements of the standard. The audit\nreport certified that all processes fully comply with the requirements of the\nstandard without any deviation.<\/p>\n\n\n\n<p>Based on this, the certification committee of mdc medical device\ncertification GmbH issued the certificate to velixX GmbH.<\/p>\n\n\n\n<p>velixX is very proud to be able to show that quality management does not\ndepend on the size of the company and that the company has thus also been\nformally certified to work with medical technology-compliant processes.<\/p>\n\n\n\n<p>The organization and management of modern development processes do not\ncontradict good quality management.<\/p>\n\n\n\n<p>For the customers of velixX, this is a further proof of the reliability and\nhigh result quality of the services offered.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Since August 2019 our quality management system is certified according [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":789,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[48],"_links":{"self":[{"href":"https:\/\/www.velixx.com\/en\/wp-json\/wp\/v2\/posts\/857"}],"collection":[{"href":"https:\/\/www.velixx.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.velixx.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.velixx.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.velixx.com\/en\/wp-json\/wp\/v2\/comments?post=857"}],"version-history":[{"count":6,"href":"https:\/\/www.velixx.com\/en\/wp-json\/wp\/v2\/posts\/857\/revisions"}],"predecessor-version":[{"id":1109,"href":"https:\/\/www.velixx.com\/en\/wp-json\/wp\/v2\/posts\/857\/revisions\/1109"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.velixx.com\/en\/wp-json\/wp\/v2\/media\/789"}],"wp:attachment":[{"href":"https:\/\/www.velixx.com\/en\/wp-json\/wp\/v2\/media?parent=857"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.velixx.com\/en\/wp-json\/wp\/v2\/categories?post=857"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.velixx.com\/en\/wp-json\/wp\/v2\/tags?post=857"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}