Steve Lee
Director, Diagnostics and Digital Regulation
ABHI Groups
Biography
Steve Lee leads ABHI engagement on UK, EU and global regulatory frameworks for medical devices, in vitro diagnostics and digital health.
He represents industry in dialogue with the MHRA, UK, European and international partners, focusing on advancing regulatory recognition and reliance, strengthening patient safety, improving patient outcomes and supporting innovation and clinical research. His work centres on ensuring regulatory systems are proportionate, aligned and support timely access to safe and effective technologies.
Steve works closely with ABHI members to ensure their priorities are clearly reflected in regulatory discussions, providing a consistent, evidence-based and credible industry voice across all areas of HealthTech regulation.
He brings a long career across the NHS, industry and the MHRA, with experience spanning diagnostics, devices and digital technologies.
In 2019, Steve was awarded the TOPRA Award for Regulatory Excellence.