Alice Toomey-Smith

Alice Toomey-Smith is Regulatory Director for In Vitro Diagnostics at MDx CRO, where she specializes in guiding diagnostic manufacturers through the complex and evolving landscape of global regulatory compliance. With particular expertise in AI-driven and software-integrated IVDs, Alice supports companies in navigating the challenges of clinical evidence generation, performance evaluation, and regulatory approval under frameworks such as the EU IVDR and FDA regulations.

Her work focuses on translating regulatory obligations into practical strategies for innovation, helping developers of next-generation diagnostics achieve compliant, scalable, and timely market access, ultimately supporting the safe integration of digital health technologies into clinical practice.