Biography MBA – Medical Device Regulatory Specialist. A founding partner of InViva Healthcare Management specialising in UK, European and USA medical device, medicinal product and Advanced Therapy Medicinal Product (ATMP) regulation. With two decades of experience in innovation and technology transfer, Bryan has supported universities and SMEs in bringing new healthcare products to market. During COVID, he led the University of Leeds’ Technology Pipeline team to identify, qualify and fund early-stage opportunities, developing strategy for potential out-licensing or spin-out company formation, and co-founded a successful company leading to Series A investment. Bryan has experience in the use of Artificial Intelligence (AI) and Machine Learning in Software as a Medical Device, an example being project managing the development of an imaging system for use by the UK NHS Blood & Transplant, during organ transplantation. Such projects require careful and informed regulatory strategies. It is an emerging, dynamic and challenging area both within medical device and AI regulation steeped with complexities and lack of consensus, but vital to understand in order to gain UKCA, CE mark, or FDA approval. The InViva team is available to support regulatory planning for novel technologies that are likely to be regulated as medical devices, at the same time accounting for other factors such as the capital required to develop, test and market a product through to commercialisation.