{"id":2445,"date":"2021-06-23T14:12:42","date_gmt":"2021-06-23T14:12:42","guid":{"rendered":"https:\/\/www.voluntis.com\/?post_type=crb_expertise&p=2445"},"modified":"2022-01-12T15:56:46","modified_gmt":"2022-01-12T13:56:46","slug":"quality-regulatory","status":"publish","type":"crb_expertise","link":"https:\/\/www.voluntis.com\/expertise\/quality-regulatory\/","title":{"rendered":"Quality & Regulatory"},"content":{"rendered":"\n
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We work with methods driven by excellence and safety<\/strong><\/h2>\n\n\n\n

Our Quality Assurance department<\/strong> ensures compliance with regulations and standards, trains employees to our quality processes and manages regulatory approvals and registrations. All our methods are driven by excellence and safety.<\/p>\n\n\n\n

Voluntis\u2019 Quality Management System has been tailored to develop Softwares-as-Medical-Devices and complies with requirements from global regulatory standards, with a particular emphasis on US and EU regulations (FDA 21 CFR part 820, EU 93\/42\/EEC <\/strong>and MDR 2017:745<\/strong>). Since 2010, our quality systems and processes are ISO:13485-certified<\/strong>, and in 2018 we obtained the MDSAP <\/strong>certification (USA & Canada) for medical device quality systems. <\/p>\n\n\n\n

Patient safety is a fundamental element in our development process<\/a><\/strong>. By combining our design, clinical, engineering and quality assurance capabilities, our risk management team can implement robust processes to monitor and manage product risks during design, development and operation. In addition, we apply the ISO:14971<\/strong> standard for medical device risk management. Our manufacturer processes follow the IEC:62304<\/strong> standard for software development lifecycle management and the IEC:62366<\/strong> standard for usability and human factors engineering<\/a> of medical devices. Finally, all our validation engineers are certified by the ISTQB<\/strong>, the International Software Testing Qualifications Board. We also integrate the Agile methodology according to the AAMITIR45 guidelines in our software development<\/a> process.<\/p>\n\n\n\n

All our certifications and clearances are available here<\/a>.<\/p>\n<\/div><\/div>\n\n\n\n

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\"Excellence<\/figure>\n<\/div>\n\n\n\n
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We are proven experts of regulatory processes for Softwares as Medical Devices<\/strong><\/h2>\n\n\n\n

Our Regulatory Affairs team collaborates with you to define the best regulatory pathway for each digital solution we co-develop.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n

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In particular, we offer support in :  <\/strong><\/h4>\n\n\n\n