Kim Stephenson is a Clinical and Regulatory Affairs professional with over 10 years of experience spanning clinical research, medical devices, digital health and regulatory affairs. She currently serves as Clinical and Regulatory Affairs Lead at AI Diagnostics, a South African medical technology company developing accessible, AI-enabled diagnostic solutions.

At AI Diagnostics, Kim supports the clinical and regulatory development of Ostium™, a digital stethoscope platform, and AID.TB™, an AI-enabled solution designed to support decentralised tuberculosis screening. Her work includes developing regulatory strategies and preparing technical documentation to support medical device submissions across multiple markets. This involves translating regulatory requirements into product development and evidence-generation activities, supporting clinical evaluation and human factors programmes, and coordinating submission documentation for emerging and AI-enabled medical technologies. Her work considers both national regulatory requirements and broader global access pathways, including WHO and international procurement frameworks relevant to diagnostics in high-burden settings.

Kim has a particular interest in regulatory pathways for emerging medical technologies, AI-enabled medical devices and decentralised diagnostics, and how regulatory reliance and global access mechanisms can support earlier and more equitable access to healthcare innovation.