High-quality professional portrait of a confident male healthcare professional in a bright modern medical office, emphasizing MedTech innovation and healthcare excellence.
IVD Precision Medicine CDx

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.

Book a meeting

Latest Articles

Request the Precision Medicine Services Pack​
Gain access to MDx’s Precision Medicine Services Pack—detailing our capabilities in clinical research, regulatory strategy, and companion diagnostics. Learn how we support pharma, CDx, and advanced therapy developers across the clinical and regulatory lifecycle.