Vice President IVD, Intelligence & Innovation
RQM+
Carlos Galamba joined RQM+ in September 2021 in the role of Vice President, IVD after 7 years at BSI where he was responsible for managing, coaching, and developing a global team of IVD technical experts in his role as a Technical Team Manager. Among many of Carlos’s achievements he was BSI’s first in-house clinician for IVDs where he led the implementation of the BSI clinical oversight process and has made hundreds of CE marking recommendations for IVDs.
At BSI he supported and led IVDR Notified Body designations, was responsible for the development of clinical procedures, technical guidance for BSI reviewers and consulted on MDCG draft guidance prior to publication, including for example IVD batch verification, summary of safety and performance, IVD classification rules and performance evaluation for SARS-CoV-2.
Through diagnostics, Carlos has helped change thousands of lives; for instance, he was at the forefront of the Ebola crisis in 2014 when the first cases were detected in Europe and played a key role in hospital and laboratory preparedness for emerging infectious diseases. Equally, Carlos was also involved in reviewing the first HIV self-tests CE marked in Europe
Prior to BSI, Carlos has held roles at the UK competent authority, the MHRA and was a senior biomedical scientist in the UK National Health System, working for some of the largest IVD testing laboratories including Imperial College and University College of London Hospitals. Carlos has a background in haematology, clinical chemistry and haemostasis and specialises in high risk class D IVDs including those used in the fields of transfusion and transplantation.
Disclosure information not submitted.
Monday, September 12, 2022
2:00 PM – 3:00 PM MST
Tuesday, September 13, 2022
12:45 PM – 1:15 PM MST