{"id":890,"date":"2021-06-10T13:44:58","date_gmt":"2021-06-10T13:44:58","guid":{"rendered":"https:\/\/www.voluntis.com\/?post_type=crb_expertise&#038;p=890"},"modified":"2021-10-11T16:14:33","modified_gmt":"2021-10-11T14:14:33","slug":"engineering","status":"publish","type":"crb_expertise","link":"https:\/\/www.voluntis.com\/expertise\/engineering\/","title":{"rendered":"Engineering"},"content":{"rendered":"\n<div class=\"wp-block-group small\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<h2 class=\"wp-block-heading\"><\/h2>\n\n\n\n<div class=\"wp-block-group wp-block-group--small wp-block-group--title\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<figure class=\"wp-block-pullquote\"><blockquote><p>With over 40 solutions built and a versatile and modular <a href=\"https:\/\/www.voluntis.com\/solution\/theraxium-platform\/\">platform for DTx<\/a>, the Voluntis team has developed a unique expertise in developing Softwares-as-a-Medical Device.<\/p><\/blockquote><\/figure>\n<\/div><\/div>\n\n\n\n<p>Our design and development <a href=\"https:\/\/www.voluntis.com\/solution\/our-approach\/\">process<\/a> implements industry standard such as IEC 62304 \u2013 medical device software \u2013 software life cycle processes. We combine agility with regulatory compliance; our ISO-certified processes aim at delivering state-of-the-art products and solutions while following the Agile Manifesto, relying on an iterative approach that encourages:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Interaction<\/strong>: dialogue between functions is facilitated and project teams are inherently multidisciplinary.<\/li><li><strong>Task\u202f parallelization<\/strong>: the agile approach encourages tasks to be parallelized to constructively iterate on the solution.<\/li><li><strong>Responsiveness\u202f<\/strong>: SaMD development requires to respond to change swiftly and accurately, while enforcing robust version and configuration management policies.<\/li><li><strong>Customer\u202fcollaboration\u202f<\/strong>: customers are involved in each project from day 1 and follow the project through its entire life cycle.<\/li><\/ul>\n\n\n\n<p>Beyond being your main point of contact, your Voluntis project manager ensures that your project fully meets your expectations in terms of cost, time and quality throughout design, development,\u202fvalidation\u202fand delivery phases. In addition to traditional software project management, Voluntis project managers are able to coordinate all activities involved in medical device manufacturing (such as human factors engineering, product risk management or clinical evaluation), together with <a href=\"https:\/\/www.voluntis.com\/expertise\/\">our subject-matter experts<\/a>.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-group small\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<h2 class=\"wp-block-heading\">Our engineering team puts safety and connectivity at the heart of our projects<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>About risk management<\/strong>: our approach is based on ISO14971 and has been proven across multiple DTx project of moderate to high safety risks (e.g. class C per IEC 62304). Our <a href=\"https:\/\/www.voluntis.com\/expertise\/engineering\/\">engineering<\/a> approach is based on a systematic analysis of design elements and allows to:<ul><li>Cover all potential sources of risks, including software failure risks, cybersecurity risks or use-related risks.<\/li><li>Assess risks based on latest regulatory guidance and directives.<\/li><li>Optimize the work of subject-matter experts, such as clinicians, leveraging robust tools and processes.<\/li><\/ul><\/li><li><strong>About connectivity<\/strong>: the architecture of our <a href=\"https:\/\/www.voluntis.com\/solution\/theraxium-platform\/\">platform<\/a> and solutions is open in nature. We recognize that DTx must fit within a broader healthcare IT ecosystem in order to facilitate adoption and usage by end-users. This means integrating with medical devices (e.g., drug delivery systems, sensors and digital biomarkers), third-party software (e.g. ERPs, CRMs, SFAs) and EHRs\/EMRs. We design and <a href=\"https:\/\/www.voluntis.com\/expertise\/implementation\/\">implement strategies<\/a> to connect our DTx with this diverse ecosystem while maintaining compliance with applicable design controls and <a href=\"https:\/\/www.voluntis.com\/expertise\/privacy-security\/\">data privacy<\/a> regulations.<\/li><\/ul>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>With over 40 solutions built and a versatile and modular platform for DTx, the Voluntis team has developed a unique expertise in developing software medical devices.\u202f <\/p>\n","protected":false},"featured_media":2766,"menu_order":0,"template":"","class_list":["post-890","crb_expertise","type-crb_expertise","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Engineering - Voluntis<\/title>\n<meta name=\"description\" content=\"With our versatile DTx platform, our agile and collaborative engineering team places safety and connectivity at the heart of your projects.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.voluntis.com\/expertise\/engineering\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Engineering - 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