Detailed description of project  

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. 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. Furthermore, the project produces 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  

The SaFER project provides a compliance-by-design framework to make healthcare VR applications regulatory-ready. The scope of work involves: 

• 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 initiative co-funded by the Interregional Innovation Investments (I3) instrument under the European Regional Development Fund. This three-year project accelerates the adoption of VR/ AR technologies in healthcare by addressing market barriers in less developed regions. 

The initiative focuses on five flagship SMEs such as MEEVA (Italy), MedApp (Poland), Metaskills (Poland) MEEVA (Italy), .Lumen (Rumania) and Virtuleap (Portugal) that are driving advancement in medical diagnostics, therapies, surgeries, and healthcare training – while fostering knowledge transfer and creating funding opportunities to strengthen the European XR ecosystem.  The project is supported by a diverse network of healthcare units, research centres, universities, and industry leaders from Italy, Latvia, Hungary, Poland, Portugal, Spain, Belgium, and Germany. Instituto Pedro Nunes coordinates the initiative, which is co-ordinated by EIT Health InnoStars. 

For more information, visit vrhealthchampions.eu