{"id":3737,"date":"2021-08-19T16:21:58","date_gmt":"2021-08-19T16:21:58","guid":{"rendered":"https:\/\/www.voluntis.com\/?page_id=3737"},"modified":"2022-01-06T15:22:04","modified_gmt":"2022-01-06T13:22:04","slug":"certifications","status":"publish","type":"page","link":"https:\/\/www.voluntis.com\/certifications\/","title":{"rendered":"Certifications and clearances"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\">Certifications<\/h3>\n\n\n\n<div class=\"wp-block-group clearance\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<hr class=\"wp-block-separator\"\/>\n\n\n\r\n<div class=\"section__list-features\">\r\n\t<strong data-aos=\"fade-up\">\r\n\t\t\t<\/strong>\r\n\r\n\t<ul class=\"list-features\">\r\n\t\t\t\t\t<li>\r\n\t\t\t\t<p>\r\n\t\t\t\t\t<strong>\r\n\t\t\t\t\t\tISO\t\t\t\t\t<\/strong>\r\n\r\n\t\t\t\t\t\t\t\t\t\t\t<span>\r\n\t\t\t\t\t\t\t<small>\r\n\t\t\t\t\t\t\t\t13485\t\t\t\t\t\t\t<\/small>\r\n\t\t\t\t\t\t<\/span>\r\n\t\t\t\t\t\t\t\t\t<\/p>\r\n\t\t\t<\/li>\r\n\t\t\t<\/ul><!-- \/.list-features -->\r\n<\/div><!-- \/.section__list-features -->\r\n\n\n\n<p class=\"has-text-align-center\">Medical Device Quality Management System<\/p>\n\n\n\r\n\t<p class=\"link-icon\">\r\n\t\t<a href=\"https:\/\/www.voluntis.com\/wp-content\/uploads\/2022\/01\/19521-6-signe.pdf\" target=\"_blank\">\r\n\t\t\t<strong>\r\n\t\t\t\tView certificate\t\t\t<\/strong>\r\n\t\t<\/a>\r\n\t<\/p>\r\n\n\n\n<p><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<hr class=\"wp-block-separator\"\/>\n\n\n\r\n<div class=\"section__list-features\">\r\n\t<strong data-aos=\"fade-up\">\r\n\t\t\t<\/strong>\r\n\r\n\t<ul class=\"list-features\">\r\n\t\t\t\t\t<li>\r\n\t\t\t\t<p>\r\n\t\t\t\t\t<strong>\r\n\t\t\t\t\t\tMDSAP\t\t\t\t\t<\/strong>\r\n\r\n\t\t\t\t\t\t\t\t\t\t\t<span>\r\n\t\t\t\t\t\t\t<small>\r\n\t\t\t\t\t\t\t\tUS \/ Canada\t\t\t\t\t\t\t<\/small>\r\n\t\t\t\t\t\t<\/span>\r\n\t\t\t\t\t\t\t\t\t<\/p>\r\n\t\t\t<\/li>\r\n\t\t\t<\/ul><!-- \/.list-features -->\r\n<\/div><!-- \/.section__list-features -->\r\n\n\n\n<p>Regulatory audit for the requirements of the regulatory authorities in the U.S, Canada, Japan, Brazil and Australia<\/p>\n\n\n\r\n\t<p class=\"link-icon\">\r\n\t\t<a href=\"https:\/\/www.voluntis.com\/wp-content\/uploads\/2022\/01\/35069-1-signe.pdf\" target=\"_blank\">\r\n\t\t\t<strong>\r\n\t\t\t\tView Certificate\t\t\t<\/strong>\r\n\t\t<\/a>\r\n\t<\/p>\r\n\n\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<hr class=\"wp-block-separator\"\/>\n\n\n\r\n<div class=\"section__list-features\">\r\n\t<strong data-aos=\"fade-up\">\r\n\t\t\t<\/strong>\r\n\r\n\t<ul class=\"list-features\">\r\n\t\t\t\t\t<li>\r\n\t\t\t\t<p>\r\n\t\t\t\t\t<strong>\r\n\t\t\t\t\t\tIEC\t\t\t\t\t<\/strong>\r\n\r\n\t\t\t\t\t\t\t\t\t\t\t<span>\r\n\t\t\t\t\t\t\t<small>\r\n\t\t\t\t\t\t\t\t62304\t\t\t\t\t\t\t<\/small>\r\n\t\t\t\t\t\t<\/span>\r\n\t\t\t\t\t\t\t\t\t<\/p>\r\n\t\t\t<\/li>\r\n\t\t\t<\/ul><!-- \/.list-features -->\r\n<\/div><!-- \/.section__list-features -->\r\n\n\n\n<p>Software Development Lifecycle Management<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div style=\"height:37px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\r\n<div class=\"section__list-features\">\r\n\t<strong data-aos=\"fade-up\">\r\n\t\t\t<\/strong>\r\n\r\n\t<ul class=\"list-features\">\r\n\t\t\t\t\t<li>\r\n\t\t\t\t<p>\r\n\t\t\t\t\t<strong>\r\n\t\t\t\t\t\tISO\t\t\t\t\t<\/strong>\r\n\r\n\t\t\t\t\t\t\t\t\t\t\t<span>\r\n\t\t\t\t\t\t\t<small>\r\n\t\t\t\t\t\t\t\t14971\t\t\t\t\t\t\t<\/small>\r\n\t\t\t\t\t\t<\/span>\r\n\t\t\t\t\t\t\t\t\t<\/p>\r\n\t\t\t<\/li>\r\n\t\t\t<\/ul><!-- \/.list-features -->\r\n<\/div><!-- \/.section__list-features -->\r\n\n\n\n<p>Risk Management for Medical Device<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div style=\"height:37px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\r\n<div class=\"section__list-features\">\r\n\t<strong data-aos=\"fade-up\">\r\n\t\t\t<\/strong>\r\n\r\n\t<ul class=\"list-features\">\r\n\t\t\t\t\t<li>\r\n\t\t\t\t<p>\r\n\t\t\t\t\t<strong>\r\n\t\t\t\t\t\tIEC\t\t\t\t\t<\/strong>\r\n\r\n\t\t\t\t\t\t\t\t\t\t\t<span>\r\n\t\t\t\t\t\t\t<small>\r\n\t\t\t\t\t\t\t\t62366\t\t\t\t\t\t\t<\/small>\r\n\t\t\t\t\t\t<\/span>\r\n\t\t\t\t\t\t\t\t\t<\/p>\r\n\t\t\t<\/li>\r\n\t\t\t<\/ul><!-- \/.list-features -->\r\n<\/div><!-- \/.section__list-features -->\r\n\n\n\n<p>Usability &amp; Human Factors Engineering of Medical Device<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div style=\"height:37px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\r\n<div class=\"section__list-features\">\r\n\t<strong data-aos=\"fade-up\">\r\n\t\t\t<\/strong>\r\n\r\n\t<ul class=\"list-features\">\r\n\t\t\t\t\t<li>\r\n\t\t\t\t<p>\r\n\t\t\t\t\t<strong>\r\n\t\t\t\t\t\tISTQB\t\t\t\t\t<\/strong>\r\n\r\n\t\t\t\t\t\t\t\t\t<\/p>\r\n\t\t\t<\/li>\r\n\t\t\t<\/ul><!-- \/.list-features -->\r\n<\/div><!-- \/.section__list-features -->\r\n\n\n\n<p>International Software Testing Qualifications Board<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-group clearance\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<hr class=\"wp-block-separator\"\/>\n\n\n\r\n<div class=\"section__list-features\">\r\n\t<strong data-aos=\"fade-up\">\r\n\t\t\t<\/strong>\r\n\r\n\t<ul class=\"list-features\">\r\n\t\t\t\t\t<li>\r\n\t\t\t\t<p>\r\n\t\t\t\t\t<strong>\r\n\t\t\t\t\t\tHIPAA\t\t\t\t\t<\/strong>\r\n\r\n\t\t\t\t\t\t\t\t\t<\/p>\r\n\t\t\t<\/li>\r\n\t\t\t<\/ul><!-- \/.list-features -->\r\n<\/div><!-- \/.section__list-features -->\r\n\n\n\n<p>Health Insurance Portability and Accountability Act compliant<\/p>\n\n\n\n<p><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<hr class=\"wp-block-separator\"\/>\n\n\n\r\n<div class=\"section__list-features\">\r\n\t<strong data-aos=\"fade-up\">\r\n\t\t\t<\/strong>\r\n\r\n\t<ul class=\"list-features\">\r\n\t\t\t\t\t<li>\r\n\t\t\t\t<p>\r\n\t\t\t\t\t<strong>\r\n\t\t\t\t\t\tGDPR\t\t\t\t\t<\/strong>\r\n\r\n\t\t\t\t\t\t\t\t\t<\/p>\r\n\t\t\t<\/li>\r\n\t\t\t<\/ul><!-- \/.list-features -->\r\n<\/div><!-- \/.section__list-features -->\r\n\n\n\n<p>General Data Protection Regulation compliant in the European Union<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">Clearances <\/h3>\n\n\n\n<div class=\"wp-block-group clearance\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<hr class=\"wp-block-separator\"\/>\n\n\n\r\n<div class=\"section__list-features\">\r\n\t<strong data-aos=\"fade-up\">\r\n\t\t\t<\/strong>\r\n\r\n\t<ul class=\"list-features\">\r\n\t\t\t\t\t<li>\r\n\t\t\t\t<p>\r\n\t\t\t\t\t<strong>\r\n\t\t\t\t\t\t510 (K)\t\t\t\t\t<\/strong>\r\n\r\n\t\t\t\t\t\t\t\t\t<\/p>\r\n\t\t\t<\/li>\r\n\t\t\t<\/ul><!-- \/.list-features -->\r\n<\/div><!-- \/.section__list-features -->\r\n\n\n\n<p>5 clearances obtained for our Medical Devices in the US in oncology and diabetes <\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<hr class=\"wp-block-separator\"\/>\n\n\n\r\n<div class=\"section__list-features\">\r\n\t<strong data-aos=\"fade-up\">\r\n\t\t\t<\/strong>\r\n\r\n\t<ul class=\"list-features\">\r\n\t\t\t\t\t<li>\r\n\t\t\t\t<p>\r\n\t\t\t\t\t<strong>\r\n\t\t\t\t\t\tCE Mark\t\t\t\t\t<\/strong>\r\n\r\n\t\t\t\t\t\t\t\t\t<\/p>\r\n\t\t\t<\/li>\r\n\t\t\t<\/ul><!-- \/.list-features -->\r\n<\/div><!-- \/.section__list-features -->\r\n\n\n\n<p>8 clearances obtained for our Medical Devices in the European Union in oncology and diabetes <\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<hr class=\"wp-block-separator\"\/>\n\n\n\r\n<div class=\"section__list-features\">\r\n\t<strong data-aos=\"fade-up\">\r\n\t\t\t<\/strong>\r\n\r\n\t<ul class=\"list-features\">\r\n\t\t\t\t\t<li>\r\n\t\t\t\t<p>\r\n\t\t\t\t\t<strong>\r\n\t\t\t\t\t\tHealth Canada\t\t\t\t\t<\/strong>\r\n\r\n\t\t\t\t\t\t\t\t\t<\/p>\r\n\t\t\t<\/li>\r\n\t\t\t<\/ul><!-- \/.list-features -->\r\n<\/div><!-- \/.section__list-features -->\r\n\n\n\n<p>1 clearance obtained for one of our Medical Devices in Canada in diabetes<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Certifications Medical Device Quality Management System Regulatory audit for the requirements of the regulatory authorities in the U.S, Canada, Japan, Brazil and Australia Software Development Lifecycle Management Risk Management for Medical Device Usability &amp; Human Factors Engineering of Medical Device International Software Testing Qualifications Board Health Insurance Portability and Accountability Act compliant General Data Protection&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":66,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"om_disable_all_campaigns":false,"footnotes":""},"class_list":["post-3737","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ 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