Catarina Sepúlveda

Catarina Sepúlveda is an IVD Director and regulatory affairs specialist with over 10 years of experience in in vitro diagnostics (IVDs), medical devices, and life sciences. She has extensive expertise in IVDR conformity assessment, regulatory strategy, technical documentation, and quality management systems, having held leadership roles within both industry and a Notified Body. Catarina specialises in guiding manufacturers through IVDR compliance, FDA submissions, and product development, helping bring safe, innovative diagnostic technologies to market.