James Pink

Since starting his healthcare career in medical physics and clinical technology in the late 1990s, James Pink has become a recognised authority in medical device safety, regulatory strategy, and AI assurance. He has developed implantable devices, designed accredited testing laboratories, and led one of the world’s largest medical device remediation consultancies.

Through James Pink Advisory Services, James now helps manufacturers, investors, and healthcare systems integrate safety and compliance into digital health and AI-enabled technologies. His work goes beyond advisory: he has designed AI systems and data science frameworks, run model experimentation programmes, and structured federated data sources to support regulatory decision-making.

James has held senior leadership positions at BSI, NSF, and Element Digital’s RegNav venture, and has delivered over 100 global consulting and education projects. Known for his straight-talking and practical insight, he bridges innovation and regulation to ensure MedTech and digital health solutions are safe, trusted, and impactful.