RVer · Class I Medical Device
An immersive VR app — engineered to the bar of a Class I medical device. Registered with INFARMED under MDR (EU) 2017/745. A piece of code that legally counts as a regulated medical product.
Most VR apps ship when the team thinks they're good. A Class I medical device ships when its regulatory file says so — after a full technical dossier, risk-management file, clinical evaluation, post-market surveillance plan, and a label that a hospital can sign off on.
The build, when stripped back: make immersive VR that holds the engineering bar of a medical device, the user-experience bar of a consumer app, and the price bar of a software product.
Built for the regulator first.
The technical file pre-existed the gameplay. Risk-management matrix, intended-use statement, hazard analyses, software lifecycle (IEC 62304), usability validation (IEC 62366) — drafted before a single VR scene was committed. Every code change traces back to a documented requirement.
Engineered like an app, regulated like a device.
Native Unity build for Quest and Pico hardware, with the architecture splitting clinical logic (versioned, traceable, locked) from content (themes, environments, soundscapes — swappable per protocol). Updates roll out the way a Class I device must: deliberate, auditable, reversible.
Shipped, monitored, iterated.
Live in Portuguese hospitals and ambulatory clinics. Post-market surveillance feeds into the next minor version. The same codebase serves pain management, anxiety management, motor and cognitive rehabilitation settings — protocols layered on top of one engineering core.
A piece of software that legally is a medical product. Used in pain management, anxiety management and rehabilitation settings, in real clinics, on real patients. The codebase is now the platform — and the regulatory file is the moat.