Carlos Galamba

Carlos Galamba is the CEO and Head of IVD at MDx, a leading EU-based CRO and regulatory consulting firm specializing in medical devices, IVDs and Precision Medicine. With over 18 years in the IVD sector, he has held key roles in regulation, clinical oversight, and scientific research.
At BSI, one of Europe’s top Notified Bodies, Carlos was the first in-house clinician for IVDs, spearheading the clinical oversight process and shaping the CE marking of hundreds of IVDs. His scientific foundation as a senior scientist in UK diagnostic institutions gives him a unique end-to-end perspective on the industry.
Carlos has also served as VP for Diagnostics at a major medtech consultancy, an Inspector at the MHRA, and is currently an independent advisor to the European Commission. A recognized IVD regulatory expert, he helps companies navigate the evolving EU landscape with clarity and confidence.