RVer · Class I Medical Device · amplified creations

ALL WORK

Client: In-house
Sector: Healthcare
Year: 2024
Product: RVer
Live: rver.pt

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.

Brief

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.

Approach

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.

Result

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 — 50,000+ sessions delivered across hospitals, clinics, continuing-care units and senior residences. The codebase is now the platform — and the regulatory file is the moat.

In the press

More work in 3D / Virtual Reality

— Further reading

Journal · 4 Jul 2026 · 8 min How much does it cost to build a VR therapy app? A 2026 breakdown A simple VR therapy pilot can start in the low tens of thousands; a regulated Class I medical VR product runs well into six figures. Here is what actually drives the cost — content, platform, and regulation — and how to spend less without cutting the parts that matter. Journal · 29 Jun 2026 · 6 min Does VR actually reduce pain and anxiety? What the evidence says Yes — for many people, immersive VR measurably reduces acute pain and anxiety, and it's used in hospitals today. But it works as an adjunct to care, not a cure. Here's how, and where the limits are. Journal · 24 Jun 2026 · 4 min Medicine you can wear A Class I medical device that happens to look like a headset. Of everything we build, this is the work we're proudest of — because the metric isn't engagement. It's relief.

— Next steps

Tell us what was only ever described.

or write to info@amplifiedcreations.com · a senior member of the team answers