Carlos Galamba

Carlos is the founder and Head of IVD at MDx CRO, a leading organisation dedicated to delivering regulatory and clinical services to the IVD industry. He has spent the past 18 years in the IVD sector, primarily at the renowned Notified Body, BSI. There, he not only built an extensive global network with leading EU Notified Bodies but also pioneered as the first in-house clinician for IVDs. Carlos spearheaded the BSI clinical oversight process, paving the way for hundreds of CE markings for IVDs. Prior to his regulatory roles, Carlos honed his expertise as a senior scientist in prestigious UK diagnostic institutions, working with various IVD technologies giving him a thorough understanding of the field’s unique demands. Beyond BSI, Carlos served as Vice President for Diagnostics at a large medtech consultancy and was also an inspector with the MHRA. Currently, he serves as an independent advisor to the EU Commission, sharing his vast knowledge and experience with a variety of stakeholders.