Quality & Regulatory
Focused on patient safety and driven by excellence,
we put quality at the heart of everything we do.
We work with methods driven by excellence and safety
Our Quality Assurance department 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.
Voluntis’ 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 and MDR 2017:745). Since 2010, our quality systems and processes are ISO:13485-certified, and in 2018 we obtained the MDSAP certification (USA & Canada) for medical device quality systems.
Patient safety is a fundamental element in our development process. 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 standard for medical device risk management. Our manufacturer processes follow the IEC:62304 standard for software development lifecycle management and the IEC:62366 standard for usability and human factors engineering of medical devices. Finally, all our validation engineers are certified by the ISTQB, the International Software Testing Qualifications Board. We also integrate the Agile methodology according to the AAMITIR45 guidelines in our software development process.
All our certifications and clearances are available here.
We are proven experts of regulatory processes for Softwares as Medical Devices
Our Regulatory Affairs team collaborates with you to define the best regulatory pathway for each digital solution we co-develop.
In particular, we offer support in :
- Pre-submissions meetings: Thanks to our significant experience in pre-submissions meetings in diverse therapeutic areas, we have succeeded in building a relationship of trust with the competent authorities who are already aware of our manufacturing and operational processes.
- Submissions and approvals: We have the in-house expertise to secure regulatory approvals in different jurisdictions (notably in the US, EU and Canada). In total, Voluntis has obtained 14 regulatory approvals and go-to-market authorizations for digital therapeutics based on our Quality Management System and technology platform.
- Legal manufacturing: We have the required capabilities to endorse the role of legal manufacturer – our infrastructure and expertise has been tested through years of operations of digital therapeutics in major global markets.