Problem to be solved

The challenge addressed by IAGILITY is the current lack of integration, automation and predictive capabilities in product development, validation and certification processes in highly regulated sectors, such as healthcare, wellbeing, and children’s products and leisure. These processes are characterised by a high dependence on manual tasks, fragmented management of user information, the increasingly complex analysis of regulatory requirements, and user validation that requires significant resources and time. This situation creates bottlenecks, rework, increased costs and delays in product launches, particularly hindering the innovation and competitiveness of SMEs.

In addition, there is a limited availability of tools capable of natively integrating user research, design, technical and regulatory validation, and documentation generation, as well as anticipating user behaviour through simulation and synthetic models. The absence of these capabilities limits the early implementation of in silico validation, makes continuous traceability of evidence more difficult, and increases dependence on external technological solutions and services. IAGILITY addresses this challenge through an ecosystem of Artificial Intelligence, intelligent agents and synthetic users designed to automate and connect these activities from the earliest stages of development, moving towards a more agile, traceable, predictive and sovereign Compliance-by-Design development model.

Objectives

Project funded by the European Union through the European Regional Development Fund (ERDF), within the framework of the call for grants aimed at technology centers in the Valencian Community for the development of non-economic R&D projects in STEP areas, corresponding to the 2026 funding period.

Linked to the S3 smart specialization strategy line: Digital transformation