Magdalena Wirt is a Clinical Development Consultant at GBA Key2Compliance, with a strong research background and expertise in IVDs. She holds a PhD in Biomedicine from Karolinska Institute and an MSc in Applied Biotechnology from Uppsala University, Sweden. With five years of industry experience, she has worked across product development, performance evaluation, and post-market surveillance, with a focus on regulatory compliance under the IVDR.
In her current role, Magdalena supports clients with medical writing, systematic literature reviews, and regulatory consulting, particularly in the areas of performance evaluation and clinical performance studies for IVD products.