Summary
- Profile Type
- Research & Development Request
- POD Reference
- RDRTR20260807027
- Term of Validity
- 7 August 2026 - 7 August 2027
- Company's Country
- Türkiye
- Type of partnership
- Research and development cooperation agreement
- Targeted Countries
- Bosnia and Herzegovina
- Belgium
- Brazil
- Chile
- Austria
- Cyprus
- Denmark
- Albania
- Estonia
- Czechia
- Bulgaria
- Canada
- Croatia
- Singapore
- Monaco
- Slovakia
- Portugal
- Iceland
- Finland
- South Africa
- Norway
- San Marino
- Poland
- Israel
- Sweden
- Serbia
- Italy
- Romania
- Hungary
- France
- Spain
- Netherlands
- Malta
- Montenegro
- Germany
- Ireland
- Slovenia
- Lithuania
- Ukraine
- Luxembourg
- North Macedonia
- Switzerland
- Greece
- Latvia
General information
- Short Summary
- A cross-border SME consortium developing an agentic, regulatory-compliant AI platform for Hemodialysis Workflows is seeking an experienced european partner to strengthen clinical validation infrastructure, MDR/AI act certification capacity, and healthcare market access. The consortium offers a unique compliance-by-design architecture with built-in high-risk AI governance, targeting a large and underserved european clinical market.
- Full Description
-
This international consortium consists of innovative SMEs developing a next-generation AI system specifically designed for hemodialysis units. The consortium's solution addresses the critical administrative burden on clinical staff — currently consuming up to 40% of valuable clinical time — while embedding full regulatory compliance (EI AI act, MDR, GDPR) directly into the software architecture from day one. The project combines advanced AI orchestration, legal-technology expertise, and clinical domain knowledge. Having completed initial architecture and market validation, the consortium is now expanding to close strategic gaps in:
- Real-world clinical pilot execution and ethics-approved validation studies
- Medical device software certification (MDR class IIB) and notified body navigation
- Direct commercial channels to dialysis equipment manufacturers and provider networks
We seek a partner that brings established clinical credibility, regulatory track record, and healthcare industry relationships in western or central europe. - Advantages and Innovations
-
- Compliance-by-design architecture: Unlike retrofit approaches, consortium's system embeds EU AI Act articles 9-15, GDPR, and MDR requirements as core functional logic — creating a defensible competitive moat.
- Agentic AI for clinical workflows: Autonomous data ingestion, intelligent flagging, and predictive analytics specifically tuned for hemodialysis — not a generic health it tool.
- Vendor-neutral interoperability: FHIR/HL7-aligned architecture designed to integrate across mixed fleets of dialysis equipment and hospital emr systems.
- Cross-border value chain: Current partners bring complementary strengths in AI engineering, regulatory technology, and clinical innovation. Adding a partner with clinical validation sites + certification expertise + OEM relationships will complete an end-to-end innovation-to-market pipeline. - Technical Specification or Expertise Sought
-
Consortium welcomes expressions of interest from organisations possessing one or more of the following capabilities:
1- Clinical validation infrastructure direct access to hemodialysis/nephrology units in university hospitals or large dialysis centre networks; Proven experience in clinical pilot design, ethics committee navigation, and health data governance.
2- Medical device regulatory expertise demonstrated track record in MDR class IIB software certification, AI Act high-risk system conformity assessment, and engagement with european notified bodies. Experience with V-Model/Agile hybrid development for regulated medical software is highly valued.
3- Healthcare market access & OEM relationships existing commercial relationships with major dialysis equipment manufacturers or large dialysis provider networks; Ability to secure pilot customers, letters of intent, or early-adopter commitments.
4- Healthcare interoperability deep expertise in FHIR, HL7, and European Health Data Space (EHDS) alignment; Experience integrating AI tools into existing hospital it ecosystems. Ideal profile: Innovative SME (11–249 employees) or university-affiliated clinical research unit based in Germany, France, Netherlands, Belgium, Sweden, Italy, Spain, or Austria. Previous EUROSTARS, EUREKA, or HORIZON EUROPE consortium experience is a strong plus. - Stage of Development
- Under development
- Sustainable Development Goals
- Goal 3: Good Health and Well-being
- Goal 12: Responsible Consumption and Production
- Goal 9: Industry, Innovation and Infrastructure
- IPR status
- IPR applied but not yet granted
- IPR notes
- IPR applied but not yet granted.
Partner Sought
- Expected Role of a Partner
-
- Co-lead clinical framework and validation work packages (requirements engineering, pilot site management, clinician engagement, TRL7 evidence generation),
- Contribute to regulatory strategy and MDR/AI Act technical documentation for notified body submission,
- Accelerate post-project commercialization through existing healthcare industry relationships and pilot customer introductions,
- Participate in consortium governance, risk management, and dissemination activities. - Type and Size of Partner
- SME 50 - 249
- R&D Institution
- SME 11-49
- University
- SME <=10
- Type of partnership
- Research and development cooperation agreement
Call details
- Framework program
- Eureka
- Call title and identifier
-
EUROSTARS — EUREKA EUROSTARS Programme (11th call/ resubmission with enhanced consortium)
- Submission and evaluation scheme
-
Two-stage international expert evaluation. Consortium is preparing a resubmission with a significantly strengthened consortium addressing previous evaluator feedback on clinical expertise, regulatory depth, and market access evidence.
- Anticipated project budget
-
Total consortium budget: Approxi
- Coordinator required
-
No
- Deadline for EoI
- Deadline of the call
- Project duration in weeks
-
96
- Eureka
Dissemination
- Technology keywords
- 01004001 - Applications for Health
- 01003003 - Artificial Intelligence (AI)
- 06005003 - Health information management
- Market keywords
- 02007012 - Medical/health software
- 02007021 - Other Artificial intelligence related
- Targeted countries
- Bosnia and Herzegovina
- Belgium
- Brazil
- Chile
- Austria
- Cyprus
- Denmark
- Albania
- Estonia
- Czechia
- Bulgaria
- Canada
- Croatia
- Singapore
- South Korea
- Monaco
- Slovakia
- Portugal
- Iceland
- Finland
- South Africa
- Norway
- San Marino
- Poland
- Israel
- Sweden
- Serbia
- Italy
- Romania
- Hungary
- France
- Spain
- Netherlands
- Malta
- Montenegro
- Germany
- Ireland
- Slovenia
- Lithuania
- Ukraine
- Luxembourg
- North Macedonia
- Switzerland
- Greece
- Latvia