08-05-2026
News
Virtuleap is a Portugal-based start-up developing immersive solutions for health and education, focused on addressing the growing impact of cognitive disorders. Its flagship product, Enhance VR, supports cognitive training and monitoring, while its latest solution, Cogniclear VR, is designed as a short, VR-based cognitive assessment tool. Within the VR Health Champions project, Virtuleap partnered with Critical Catalyst to accelerate the testing, validation and regulatory readiness of Cogniclear VR.
Company context
Together with Metaskills, dotLumen, MEEVA and MedApp, Virtuleap was selected as one of five flagship SMEs in the VR Health Champions project, developing innovative XR solutions for healthcare. The key challenge for Virtuleap was to prepare Cogniclear VR for regulatory compliance as a Software as a Medical Device (SaMD), while continuing product development and validation. To address this, Virtuleap defined a dedicated regulatory challenge through the VR Health Champions Open Call 2025. Critical Catalyst (Portugal) was selected as the winner. The company specialises in supporting medical technology organisations in navigating MDR and IVDR requirements, with strong expertise in SaMD pathways, risk management and quality systems.
Problem and challenge
Bringing XR-based cognitive solutions into the healthcare market requires compliance with strict regulatory frameworks. For Virtuleap, the key challenge was to move from an innovative product concept to a solution aligned with medical device requirements.
“Our main goal was to build a solid foundation for the technical documentation of our solution, Cogniclear VR. Rather than focusing on isolated tasks, we worked on establishing a complete framework covering areas like safety, clinical evaluation and post-market monitoring.” – Amir Bozorgzadeh, Co-founder & CEO, Virtuleap
Critical Catalyst perspective
Cogniclear VR presented an interesting problem. Virtuleap had done serious product development work, but the regulatory dimension had not kept pace. Our starting point was not a blank page, but the translation into MDR-compliant documentation had not yet happened. Virtuleap understood their technology and their target users well. What we brought was the ability to take that product knowledge and convert it into a structured compliance framework: qualification rationale, classification analysis under Rule 11, technical documentation mapping against MDR Annex II, risk management grounded in ISO 14971, and a clinical evaluation strategy suited to a cognitive assessment tool with no direct clinical precedent in VR.
The regulatory challenges specific to VR are not trivial. Unlike conventional software medical devices, VR introduces hazard categories that most existing guidance simply does not address directly: cybersickness, spatial disorientation, the cognitive load of immersive interfaces, and hardware dependencies that affect how the software behaves in practice. MDR does not disappear because the technology is novel. If anything, the absence of established precedent makes the documentation burden heavier, because you cannot rely on predicate devices or well-worn interpretations. Every classification argument, every GSPR applicability decision, every clinical equivalence claim had to be built from first principles and defended on its own merits.
“Working with Virtuleap confirmed something we see repeatedly: the regulatory complexity of VR medical devices is consistently underestimated. Not because manufacturers are careless, but because the guidance landscape genuinely has gaps. Cogniclear VR forced us to develop positions on questions that had no ready-made answers, and that is precisely the kind of work that makes the output durable.” – Emanuel Valpacos, Chief Medical Officer, CRITICAL CATALYST
What was done
Virtuleap worked closely with CRITICAL CATALYST to build a structured regulatory framework for Cogniclear VR.
The collaboration focused on:
- Developing a comprehensive technical documentation framework
- Establishing processes for clinical evaluation and risk management
- Interpreting and applying MDR requirements to an Vr-based solution
- Aligning development with Software as a Medical Device (SaMD) pathways
“Critical Catalyst helped us interpret regulatory requirements and translate them into clear, actionable steps. This ensured we stayed aligned with expectations while continuing product development.”- Amir
The work also involved identifying VR-specific risks and integrating quality and risk management processes early in the development cycle. For a product like Cogniclear VR, where cognitive assessment outcomes feed directly into clinical decision-making, getting risk management right from the outset is not optional. Retrofitting an ISO 14971-compliant risk management file after development is complete is both harder and less defensible than building it in parallel with product decisions. The several dedicated working sessions the teams held on topics from probability estimation to clinical benefit and claims were a direct consequence of that approach. Regulatory rigour became the norm while product decisions were still being made.
Results
The collaboration delivered a clear and structured approach to regulatory readiness.
Key outcomes included:
- A robust technical documentation framework
- Defined processes for clinical evaluation and risk management
- Improved understanding of MDR requirements for VR solutions
- A clearer pathway towards CE certification
“We realised how complex risk management can be for XR. Virtual reality introduces unique considerations, such as immersion, user interaction and potential side effects like discomfort or disorientation.” – Amir
By the end of the project, Virtuleap had moved from a pre-regulatory state to a position where the core compliance architecture for Cogniclear VR was in place. The device was qualified as SaMD, classified as Class IIa under MDR Rule 11. A documented framework to achieve CE marking was developed and supported by a technical documentation mapping, aligned with MDR Annex II. Risk management templates were built around the specific hazard profile of a VR cognitive assessment tool. The post-market surveillance package, initially limited in scoped, expanded as the clinical and real-world monitoring requirements became clearer through the process.
That kind of scope growth is not unusual; it reflects genuine engagement with the requirements rather than a box-ticking exercise. From our perspective, Virtuleap ended the project with a foundation that is credible, defensible, and built to support the Class IIa submission when they are ready to make it.
Conclusions
The collaboration with Critical Catalyst enabled Virtuleap to strengthen both the regulatory and clinical positioning of Cogniclear VR.
“This collaboration helped us understand what evidence is needed, what we already have, and how to plan for market entry. It made our path to becoming market-ready much more achievable.” – Amir
Critical Catalyst perspective
Regulatory work done well is only partly about documents. The other part is about the conversations that happen while those documents are being built, particularly the ones where a team grapples with what their product actually does, who it does it for, and what could go wrong. That process, done seriously, changes how a company thinks about its product. Virtuleap arrived at the end of this project with something more useful than a set of compliant templates: a clearer picture of the evidence their clinical evaluation will need, the risks that require ongoing monitoring, and the technical arguments they will have to make to a Notified Body.
That kind of regulatory literacy does not come from reading guidance documents. It comes from working through the problems, case by case, with people who have done it before. With a structured compliance foundation now in place, Virtuleap is better positioned than most first-time SaMD applicants to move towards certification and broader market deployment.
