Our Approach

Through robust and proven processes and proprietary design tools adapted to Software-as-a-Medical Device, we collaborate with you to design digital solutions and algorithms adapted to your therapy. Our goal is to help deliver personalized education and real-time recommendations aligned with clinical best practices and validated guidelines. We work closely with key opinion leaders (such as members of our international Medical Advisory Board) to implement decision-support functions that align with routine clinical practice.

While building our solution, we implement the industry’s best practices to offer an optimal user experience, accessible, easy to use and adapted to each culture. Our design and labeling teams a work hard to deliver user-friendly solutions for every kind of users, across ages, languages and social determinants of health.

We use agile methods to develop our devices. Our functional experts are embedded in our development teams and work directly with our Android, iOS and web developers to create solutions that are ready for the real-world.

From quality assurance to data privacy and cybersecurity, from human factors engineering to medical affairs, all our experts are directly involved in the development of our solutions.

Each product we build follows strict requirements for performance and safety. Once the product is developed, our Verification & Validation team conduct thorough test campaigns to confirm that it meets its specification. Its final validation is subject to extensive risk management and human factors analyses and, when needed, a dedicated clinical evaluation is performed to generate the appropriate evidence.

The road to successful regulatory approval of DTx solutions starts on day 1, through appropriate planning and documentation of all activities required to develop Software-as-a-Medical-Device. Our platform, tools, processes and methods have proven their ability to secure market authorizations for DTx such 510(k) clearances and CE marks.

Voluntis can act as legal manufacturer of the solutions co-develop with pharma partners and can lead regulatory activities such as pre-submission meetings, submission and maintenance of the regulatory dossier throughout the life cycle of the solutions once commercialized.

Our work does not stop with the validation and approval of the DTx. We support our partners across the life cycle of the digital solution. Once the product is in market, we take care of technical operations such as hosting in our secure cloud infrastructure, app publishing on stores and technical support.

As legal manufacturer of the majority of the DTx we co-develop with pharma partners, we are in charge of device vigilance and contribute to pharmacovigilance activities. We also process data in accordance with applicable data privacy regulations.

Finally, we provide maintenance services to ensure that the digital solution is compatible with new phone models, browsers and operating systems as they become available on the market. Through post-market surveillance and post-market clinical follow-up, we monitor changes in clinical evidence and best practices to adapt our solutions accordingly.