Hugo Leis Martinez

Hugo Leis Martínez is a Senior Quality Assurance and Regulatory Affairs expert with over 15 years of experience in in vitro diagnostics (IVDs), quality management, and regulatory compliance. As Knowledge & Training Manager at MDx CRO, he specialises in IVDR, ISO 13485, quality management systems, product registration, and regulatory strategy. Throughout his career, Hugo has supported the development, certification, and global market access of diagnostic technologies, helping manufacturers achieve compliance while maintaining high standards of quality and performance.