{"id":31120,"date":"2025-03-02T22:10:46","date_gmt":"2025-03-02T21:10:46","guid":{"rendered":"https:\/\/avinent.com\/about-us\/health-legislation\/"},"modified":"2025-03-24T11:47:48","modified_gmt":"2025-03-24T10:47:48","slug":"health-legislation","status":"publish","type":"page","link":"https:\/\/avinent.com\/en\/about-us\/health-legislation\/","title":{"rendered":"Quality and regulatory"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"31120\" class=\"elementor elementor-31120 elementor-26357\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ecdbb7b e-flex e-con-boxed e-con e-parent\" data-id=\"ecdbb7b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-362e7f1 e-con-full e-flex e-con e-child\" data-id=\"362e7f1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d8e84e0 elementor-widget elementor-widget-heading\" data-id=\"d8e84e0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\"><strong>QUALITY AND<br>REGULATORY<\/strong><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-08495fc e-con-full sobre-nosotros-buttons e-flex e-con e-child\" data-id=\"08495fc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e85cd59 elementor-widget elementor-widget-text-editor\" data-id=\"e85cd59\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Avinent looks after every aspect regarding quality, from manufacturing processes, through product safety and functionality, to installations or specific regulations for each country. As such, when an Avinent product arrives at a clinic, laboratory, or hospital anywhere around the world, its quality is always assured. <\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7a437ca e-con-full e-flex e-con e-child\" data-id=\"7a437ca\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e6e4ec1 elementor-widget elementor-widget-spacer\" data-id=\"e6e4ec1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-98bcd2e e-flex e-con-boxed e-con e-parent\" data-id=\"98bcd2e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a118fa2 elementor-widget__width-inherit elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"a118fa2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><img fetchpriority=\"high\" decoding=\"async\" width=\"820\" height=\"820\" src=\"https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img01.png\" class=\"attachment-full size-full wp-image-26363\" alt=\"\" srcset=\"https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img01.png 820w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img01-300x300.png 300w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img01-150x150.png 150w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img01-768x768.png 768w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img01-180x180.png 180w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img01-360x360.png 360w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img01-640x640.png 640w\" sizes=\"(max-width: 820px) 100vw, 820px\" \/><\/figure><div class=\"elementor-image-box-content\"><h4 class=\"elementor-image-box-title\">THE MANUFACTURING PROCESS<\/h4><p class=\"elementor-image-box-description\">EN ISO 13485: 2016, the regulation for companies manufacturing health products. This quality certificate is renewed every 3 years through annual follow up audits, in our case, by the notifying body, T\u00dcV Rheinland. EN ISO 13485:2016 and the audits are essential aspects to enable manufacturing. The ISO covers the entire product manufacturing process, which includes the company\u2019s supplier evaluations, customer traceability management, and quality control during the production phase.   <\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-11840ff elementor-widget__width-inherit elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"11840ff\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><img decoding=\"async\" width=\"820\" height=\"820\" src=\"https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img02.png\" class=\"attachment-full size-full wp-image-29949\" alt=\"\" srcset=\"https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img02.png 820w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img02-300x300.png 300w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img02-150x150.png 150w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img02-768x768.png 768w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img02-180x180.png 180w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img02-360x360.png 360w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img02-640x640.png 640w\" sizes=\"(max-width: 820px) 100vw, 820px\" \/><\/figure><div class=\"elementor-image-box-content\"><p class=\"elementor-image-box-title\">PRODUCT SAFETY AND FUNCTIONALITY<\/p><p class=\"elementor-image-box-description\">Product safety and functionality is guaranteed by the CE mark. All Avinent medical devices comply with the current European Regulation MDR 2017\/745 (Medical Device Regulation). The CE mark is supported by a series of documentation and technical files which, in the case of Avinent, covers the different product lines of <strong>Avinent Implant System, Avinent CAD CAM, Avinent CMF and Avinent Orthodontics<\/strong>.  <\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ae71ceb e-flex e-con-boxed e-con e-parent\" data-id=\"ae71ceb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b690f3f elementor-widget__width-inherit elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"b690f3f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><img decoding=\"async\" width=\"820\" height=\"820\" src=\"https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img03.png\" class=\"attachment-full size-full wp-image-29954\" alt=\"\" srcset=\"https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img03.png 820w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img03-300x300.png 300w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img03-150x150.png 150w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img03-768x768.png 768w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img03-180x180.png 180w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img03-360x360.png 360w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img03-640x640.png 640w\" sizes=\"(max-width: 820px) 100vw, 820px\" \/><\/figure><div class=\"elementor-image-box-content\"><p class=\"elementor-image-box-title\">INSTALLATIONS<\/p><p class=\"elementor-image-box-description\">Avinent has a licence for each product line, meaning that they have a licence for the serialised product, <strong>Avinent Implant System <\/strong>(approved by the AEMPS), and for the personalised products, <strong>Avinent CAD CAM, Avinent CMF and Avinent Orthodontics, <\/strong>all approved by the Catalonia Autonomous Government\u2019s health authority.<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-39a4484 elementor-widget__width-inherit elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"39a4484\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><img loading=\"lazy\" decoding=\"async\" width=\"820\" height=\"820\" src=\"https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img04.png\" class=\"attachment-full size-full wp-image-29959\" alt=\"\" srcset=\"https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img04.png 820w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img04-300x300.png 300w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img04-150x150.png 150w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img04-768x768.png 768w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img04-180x180.png 180w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img04-360x360.png 360w, https:\/\/avinent.com\/wp-content\/uploads\/2025\/03\/ns-img04-640x640.png 640w\" sizes=\"(max-width: 820px) 100vw, 820px\" \/><\/figure><div class=\"elementor-image-box-content\"><p class=\"elementor-image-box-title\">INTERNATIONAL<\/p><p class=\"elementor-image-box-description\">Every country usually has specific requirements. For example, a technical document has to be presented to market a product in the United States of America. In this case the organisation, the Food &amp; Drug Administration, better known by its abbreviation, FDA, reviews the documentation and either approves or rejects the company starting their commercial activity. Avinent also has the certificates required to operate in other countries, such as Canada, Australia, Japan, Taiwan, Mexico, or Colombia.   <\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>QUALITY ANDREGULATORY Avinent looks after every aspect regarding quality, from manufacturing processes, through product safety and functionality, to installations or specific regulations for each country. As such, when an Avinent product arrives at a clinic, laboratory, or hospital anywhere around the world, its quality is always assured. THE MANUFACTURING PROCESS EN ISO 13485: 2016, the [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":26840,"parent":29226,"menu_order":181,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-31120","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical and dental health regulations | Avinent<\/title>\n<meta name=\"description\" content=\"Avinent takes care of all aspects of quality. 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