Ian McGill is the Lead US Diagnostics Regulatory Affairs at Novateur. He is a regulatory affairs professional with broad industry experience having worked on novel in vitro diagnostics and life sustaining active implantable devices marketed globally. Ian focuses on creative regulatory strategy that results in efficient interactions with regulatory agencies. He has experience in 510(k), de novo, PMA, CE Marking, Medical Device License Application and Emergency Use Authorization submissions. Ian started his career in industry working in research and development and transitioned to regulatory affairs. He is familiar with the challenges facing startups and small businesses and provides regulatory guidance tailored to smaller organizations. Ian holds a bachelor’s degree in Microbiology and a master’s degree in Medical Diagnostic Laboratory Science from the University of Arizona and is a current American Society for Quality Certified Biomedical Auditor.