Our Approach

As a pure player of drug-specific digital solutions and drug-digital combinations,
Voluntis offers both a robust regulated technology platform and a unique expertise
to de-risk and accelerate the implementation of digital therapeutics.

Our expert and cross-functional teams support pharmaceutical partners at every stage of the DTx life cycle, implementing the industry’s best practices.  


We design our solutions in close collaboration with patients and healthcare professionals, implementing the best practices in usability and human factors engineering.

We leverage the best available science and evidence to design our solutions and the medical algorithms they embed to ensure alignment with standards of care.

Design phase of DTx project

We develop DTx based on our dedicated ​Theraxium platform, leveraging off-the-shelf modules addressing common needs of digital therapeutics out-of-the box.

Our platform accelerates and de-risks the development of digital solutions. It also facilitates custom developments to deliver unique features adapted to patients treated with specific drugs. Through an agile process, our expert teams of software engineers, clinicians, risk managers, graphic designers and human factors specialists, work hand in hand to develop solutions in accordance with standards and guidelines applicable to ​Software-as -Medical Devices.

Development of DTx projects

We verify and validate our solutions through robust processes, based on international standards for Software-as-a-Medical Device. Their validation often involves human factors studies to confirm usability by the intended population. When necessary, rigorous clinical studies such as randomized controlled trials are conducted to demonstrate the safety, efficacy, acceptance and technical performance of our solutions.

Validation pathway for DTx projects
Regulatory approval

The majority of the solutions we build are regulated as medical devices. Based on our successful track record of 14 regulatory approvals for DTx, we design and implement regulatory strategies to secure approval from relevant authorities.

Our platform and quality management system have supported DTx approvals in the US, EU and Canada. Through the MDSAP-certification, we can support our partners in additional geographies such as Japan, Australia, Brazil and more.

regulatory pathway for DTx projects
Deployment & Operations

As patients and healthcare professionals use our digital solutions in the real-world, we work in the background to ensure an optimal user experience. For our pharma partners, it means that we offer an end-to-end solution once the DTx is commercialized, covering secure hosting, device vigilance, customer support, software maintenance and data management and analytics.

deployment of DTx project

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