Dr. Clare Heaysman

Biography

Clare Heaysman is a Senior Lecturer in MedTech Regulatory Affairs at the London Institute of Healthcare Engineering, King’s College London. She is a certified ISO 13485 Lead Auditor and serves as the Director of the Medical Engineering Quality Regulatory Team. This team provides bespoke regulatory support for medical device development, focusing on Quality Management System (QMS) compliance and assisting with technical file creation to meet medical device regulatory requirements. Clare's experience includes overseeing the manufacturing of complex medical devices, with significant responsibilities at a national facility that produces active implants and surgical instruments at St. Thomas’ Hospital. She has been actively involved in academic collaborations that apply necessary regulatory design control practices in various translational research projects. Noteworthy projects include developing a novel intraoperative ultrasound probe for first-in-human transsphenoidal surgery, instruments for fetal therapy surgery, and innovative digital mental health interventions. Before her academic role, Clare spent ten years in industry, working on the development of drug-device combination products within interventional oncology, while generating intellectual property and facilitating technical transfer between academic institutions and industry partners. In addition to her research work, Clare leads several courses, including 'Quality Management Systems Regulation' and 'MedTech Healthcare Future Safety'.

Research Interests

Courses