Trusted expertise in AI systems, medical technology safety, product quality and regulatory affairs.
Working at the intersection of engineering, data and governance – helping organisations design, assure and scale technologies where safety, reliability and trust are critical.
Leading the industry for over 30 years
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.
James Pink
Founder
Experience
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.
Expertise
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.
Looking for expert guidance?
Send us an email using the form below and we'll get in touch.
Email us: hello@jamespinkadvisory.co.uk
Phone: 01234 567891