Software as a Medical Device (SaMD) refers to standalone software that performs medical functions without being part of a hardware medical device. Examples include apps that calculate insulin doses or AI tools that analyze radiology images. SaMD is regulated under MDR in the EU and by the FDA in the US, depending on its intended purpose and risk.
28DIGITAL invests in strategic areas to accelerate the market uptake and scaling of research-based digital technologies (deep tech) focusing on Europe’s key societal challenges: Digital Tech, Digital Cities, Digital Industry, Digital Wellbeing, and Digital Finance.
28DIGITAL provides online and blended Innovation and Entrepreneurship education to raise quality, increase diversity and availability of the top-level content provided by our partner network of leading technical universities around Europe.
28DIGITAL is at the centre of digital in Europe and works with other EU organisations, such as the European Innovation Council, the European Central Bank and the European Investment Fund.
ICARUS AI is a fully customizable AI enabled e-learning platform.
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