Working at the intersection of engineering, data and governance – helping organisations design, assure and scale technologies where safety, reliability and trust are critical.
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Over more than three decades, James has worked across the full testing, inspection and certification (TIC) spectrum – from medical device manufacturing and hospital engineering, through Notified Body operations and global consultancy leadership, to the development of AI-enabled regulatory platforms.
Founder
James has held senior roles including Executive Vice President for Medical Devices at NSF, Director of R&D (RegNav AI) at Element Materials Technology, and earlier positions at BSI Notified Body.
His background combines hands-on product assurance, audit and technical leadership with the direction of large, multidisciplinary teams delivering complex outcomes under EU MDR, IVDR, FDA and other global frameworks.
James has held senior roles including Executive Vice President for Medical Devices at NSF, Director of R&D (RegNav AI) at Element Materials Technology, and earlier positions at BSI Notified Body.
His background combines hands-on product assurance, audit and technical leadership with the direction of large, multidisciplinary teams delivering complex outcomes under EU MDR, IVDR, FDA and other global frameworks.
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