SaFER
Initiative to leverage virtual and augmented reality technologies to boost innovation in health
The SaFER project establishes a comprehensive compliance-by-design framework for the cogniclEar vR system to address the regulatory hurdles that often prevent healthcare VR solutions from moving beyond the pilot phase.
Detailed project description
Many innovative VR applications fail to achieve clinical deployment because they lack structured Verification & Validation (V&V) evidence, robust cybersecurity, or clear GDPR compliance.
To bridge this gap, SaFER implements a 16-week technical roadmap focused on delivering regulatory-ready documentation suitable for MDR technical file integration.
The methodology involves:
- validating the application according to EN ISO 62304 and
- performing ISO 81001-aligned cybersecurity assessments, which include threat modeling and penetration testing,
- a complete GDPR package containing DPIAs and consent flows tailored to the system’s specific data pathways.
A critical early milestone in this process is the approval of the SDP+CMP and the initial traceability structure.
By creating this repeatable “assurance pipeline,” SaFER enables faster, lower-cost compliance replication for future healthcare VR/AR solutions.
This framework ultimately builds the clinician and regulator trust required to integrate these technologies into broader digital health ecosystems and interregional value chains.
Type and scope of work provided
Το έργο SaFER παρέχει ένα πλαίσιο συμμόρφωσης για εφαρμογές VR στον τομέα της υγείας, με στόχο την ετοιμότητα για κανονιστική έγκριση.
Type and scope of work provided
- V&V Bundle (D1): Delivering a system-level report bundle containing SDP, software reviews, SOUP, and traceable test evidence.
- GDPR Package (D2): Providing complete documentation including ROPAs, DPIAs, consent flows, and privacy policies.
- Cybersecurity Report (D3): Conducting threat modeling, risk analysis, and penetration testing.
- Key Activities: Executing a 16-week roadmap involving baseline audits, documentation production, formal reviews, and testing execution
The project is funded by VR Health Champions.
About VR Health Champions
VR Health Champions is a 7.8 million euro initiative, co-funded by the Interregional Innovation Investments (I3) of the European Regional Development Fund.
The three-year project accelerates the adoption of VR/AR technologies in the healthcare sector by addressing market barriers in less developed regions.
The initiative focuses on five key SMEs:
• MEEVA (Italy)
• MedApp (Poland)
• Metaskills (Poland)
• Lumen (Romania)
• Virtuleap (Portugal)
which contribute to the development of applications for medical diagnosis, treatments, surgical procedures, and healthcare education.
The project is supported by a broad network of healthcare organizations, research centers, universities, and companies from countries such as Italy, Latvia, Hungary, Poland, Portugal, Spain, Belgium, and Germany.
The initiative is coordinated by the Instituto Pedro Nunes, while overall guidance is provided by EIT Health InnoStars.
Ημερομηνία:
January 2026
