Integrate Due Diligence and build capacity to accelerate innovations for regulatory approval and early co-development tailored to the needs of the healthcare sector. The guidance helps innovators navigate the stringent regulatory framework for complex technologies in medical care, including borderline cases and customised, personalised solutions challenged by regulatory barriers. A typical duration is from one to six months of sessions. 
 

Key features include: 

• Design of Experiments (DoE) and Human Factors Engineering (HFE).
• Proof of Concept (PoC) and prototyping • Inherent Safe-by-Design, and cross-cultural and cross-national design.
• Standardisation, Risk Management and QARA • Verification and Validation.
• Clinical design; clinical investigation sites and piloting.

Benefits for EIC beneficiaries in i) research stage, ii) spinout/startup, and iii) scale-up: 

Guidance reinforces Foundational Compliance (QMS/GCP), including best practices for Clinical Investigation and Piloting Execution and early Technical Filing readiness via HTAR pathways, alongside specialised quality risk management (QRM), advanced CMC documentation, long-term safety surveillance (LTFU/PMCF), and digital health compliance (SaMD/AI) and global data governance. 

A Strategic Partnership Readiness Audit benchmarks the innovation against large BioPharma/MedTech partners seeking portfolio expansion. 

The expected outcome is a validated innovation with auditable clinical records, and a strong position for co-development and regulatory submission, allowing beneficiaries to carry out clinical evaluations to ensure target market-specific regulatory compliance, avoiding costly redesigns. 

Designed for EIC Pathfinder, EIC Transition, and EIC Accelerator innovators (dedicated in-house or external experts, via online or hybrid models).