A French based research company were looking for guidance on developing a medical device to ensure MD safety validation. VCLS became an extension of their team, designing a comprehensive Clinical Study Management program which optimized the timeline to first-in-patient, ensuring full regulatory compliance along the way.
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2024 is here and will be a crucial year for your clinical trials in the European Union (EU) and European…
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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…