A long-standing challenge for regulators has been how to incorporate new technologies into the current regulatory framework. This is especially applicable to telemedicine and e-health systems.
Sylvie Le Glédic, Marielle Fournier, Sabah Malek
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In our previous posts, we explored software tools used in digital health and set the foundations around potential applications of…
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Previously, we talked about how the EU regulates Software as Medical Device (SaMD), including AI-based software. Given that UK is…
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Previously, we talked about how the FDA regulates Software as Medical Device (SaMD), in this blog post we will discuss…
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Software as a medical device (SaMD) has been used in the healthcare sector for many years, particularly in the space…
