Carlos Galamba

Carlos Galamba is a seasoned professional in the diagnostics industry, with a wealth of experience in both consultancy and regulatory roles. He is the founder of MDx CRO and Vice President for Diagnostics at RQM+, one of the world’s largest consultancies fully dedicated to medtech. In this role, he is responsible for the overall strategic direction and subject matter leadership for diagnostics. Carlos also spent 7 years at the Notified Body BSI, where he managed, coached, and developed a global team of IVD technical experts. He was BSI’s first in-house clinician for IVDs, where he led the implementation of the BSI clinical oversight process, made hundreds of CE marking recommendations for IVDs and supported IVDR Notified Body designations. Prior to BSI, Carlos held roles at the UK competent authority, the MHRA, and was a lead scientist in the UK National Health System, specializing in transfusion and transplantation medicine. He played a key role in hospital and laboratory preparedness for emerging infectious diseases, including the Ebola crisis in 2014 when the first cases were detected in Europe.