A mobile diabetes software app for patients with diabetes to assist them in the management of their disease by monitoring blood glucose levels, activity, food intake and insulin. Client approached VCLS for strategic and regulatory assistance for Medical Device Software development and certification (CE) mark for the EU market.
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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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In the Part 1 of the blog post, we explored the regulations relating to medical devices and cosmetic products in…
