Dr Clare Heaysman is a Senior Lecturer in MedTech Regulatory Affairs based at the London Institute for Healthcare Engineering, King’s College London.

She is a certified ISO 13485 Lead Auditor and Director of the Medical Engineering Quality and Regulatory Team. The Medical Engineering Quality and Regulatory Team offers a Quality Management System (QMS) and bespoke regulatory support for medical device development. They support projects with their technical file creation and adherence to medical device regulatory requirements. Clare’s experience also includes the manufacturing of complex medical devices and she holds the responsibility and authority for quality management of the national facility for the Manufacture of Active Implants and Surgical Instruments (MAISI) at St Thomas’ hospital.

Clare has been working with academic groups on applying the required regulatory design control practices in translational research projects since 2014 on projects including; developing a novel intraoperative ultrasound probe for first-in-human transsphenoidal surgery, guided instrumentation for fetal therapy and surgery, digital mental health interventions and a unique implantable polymer-based glaucoma device.

Prior to that she spent 10 years working in industry on the development of drug-device combination products for interventional oncology; generating intellectual property and technical transfer from academic and industrial partners. 

Teaching

Dr Clare Heaysman leads teaching on the following courses:

• 7MBI1010 Quality Management Systems and Regulation
• 6MBI1011 MedTech and Healthcare of the Future