Carlos Galamba

With more than 18 years of experience in the IVD sector, including hands-on work as a scientist in transfusion medicine and infectious disease diagnostics, and regulatory review experience at BSI, one of the EU's largest Notified Bodies, Carlos Galamba brings a uniquely integrated perspective to IVD regulatory strategy. Their work spans Class C/D IVDs, companion diagnostics, NGS-based assays, and software-based IVDs, with a current advisory role to the European Commission on regulatory matters. At MDx CRO, they lead regulatory strategy for complex IVD programs across EU IVDR, FDA, and global markets.