i4Kids-Europe is a european project that aims at establishing an efficient, perdurable and inclusive European pediatric innovation ecosystem that integrates all pertinent stakeholders from emerging, moderate and strong innovator countries, offering the necessary services and resources to improve the pediatric innovation capacity of the EU countries.
To tackle the identified gaps and barriers within the european pediatric ecosystem, we will provide 12 modules to decrease access barriers and reach a wide and diverse stakeholders.
Each module will focus on a specific identified challenge to provide the tools needed to take advantage of innovation opportunities in the pediatric field, including first-hand experiences from key actors of the European ecosystem.
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Paediatrics start-ups often face significant regulatory challenges (as expressed in our report), with the stricter Medical Devices Regulation (MDR) considered as posing a considerable barrier, especially regarding specific age groups requirements. Francisco Rodríguez Gómez, Scientific and Regulatory Affairs Associate Manager at Asphalion, will lead the capsule, guiding you towards a compliance roadmap. |
