Build capacity for inherent safe-by-design, standardisation, quality and regulatory assurance through co-creation and co-design via individual training and coaching tailored to the needs of biomedical technology, medical technology, biotech and pharma industry.

The guidance will navigate the framework for complex technologies in health and medical care, especially borderline cases, customised and personalised solutions that are challenging due to regulatory barriers, considering its current TRL level and the value chain. 

Key features:

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

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

• Demonstrate the viability by early end-user feedback and check the manufacturability, cost, acceptability, accessibility, and market relevance of the final design. 
• Incorporate requirements of the intended or potential market areas in the research and development phase, avoid costly redesign phases and increase user safety of the innovation considering multicultural design features.
• Incorporate target market-specific design features and carry out clinical evaluations to ensure regulatory compliance.

The aim is to accelerate innovations for health and medical care with high quality that are ready for the regulatory approval process and user-safe.

The service is directed to EIC pathfinder, EIC transition and EIC accelerator innovators by dedicated in-house or external experts depending on the target market via online, offline or hybrid models.