Expert in medical device regulation joins Institute for Clinical Trials at University of Galway

Associate Professor Tom Melvin with Professor Fidelma Dunne, Director of the Institute for Clinical Trials at University of Galway.
Mar 10 2025 Posted: 11:01 GMT

University of Galway has announced the appointment of Dr Tom Melvin as an Associate Professor to support its mission of advancing clinical trial methodologies and regulatory science.

The appointment of Dr Melvin a globally recognised expert in medical device regulation, will enhance the Institute for Clinical Trial’s collaboration with the medtech industry, supporting innovation and the development of safe, effective medical technologies.

Through his expertise, Dr Melvin will provide strategic guidance on regulatory pathways, ensuring that cutting-edge medical devices can reach patients efficiently while maintaining the highest safety and ethical standards.

Launched in 2023, the Institute for Clinical Trials is dedicated to transforming how clinical trials are designed, conducted and translated into practice, with a strong focus on industry partnerships, education and regulatory leadership.

            Professor Melvin said: “I am delighted to be joining University of Galway’s Institute for Clinical Trials - a place where operational and scientific excellence drive the ambition to rapidly translate research into impact. The translational development of a new medical technology is a complex journey that has become more challenging as a result of the revised framework for the regulation of medical devices in Europe.

“The Institute for Clinical Trials is playing a vital role in supporting developers to translate their technology from idea and prototype to first clinical use. I look forward to providing support to medical technology developers, and to engage in research to develop improved methodological approaches for the evaluation of medical technologies.”

            Professor Fidelma Dunne, Director of the Institute for Clinical Trials at University of Galway, said: “Dr Melvin’s expertise in medical device regulation will be invaluable to the Institute for Clinical Trials at University of Galway. His appointment strengthens our position as a leader in clinical trials and regulatory science, reinforcing our role in supporting industry and academic partners in bringing new innovations to patients.”

            Professor Martin O’Donnell, Dean of University of Galway’s College of Medicine, Nursing and Health Sciences, welcomed the appointment: "Expanding the expertise and capacity of the Institute for Clinical Trials is a key priority as we build a world-class environment for clinical research. Dr Melvin’s appointment reflects our commitment to growing a team of leading experts who will drive innovation and impact in clinical trials and medical device regulation. His knowledge and leadership will be instrumental in further strengthening the Institute’s role in supporting industry, academia, and healthcare in Ireland and beyond."

Dr Melvin brings extensive experience from his role as Associate Professor in Medical Device Regulatory Affairs at Trinity College Dublin and his previous positions as Clinical Manager and Senior Medical Officer for medical devices at the Health Products Regulatory Authority and Chair of the European Commission Clinical Investigation and Evaluation Working Group.

He is also Chair of the Regulatory Affairs Committee of the Biomedical Alliance in Europe, and a member of the Regulatory Affairs Committee of the European Society of Cardiology, the National Research Ethics Committee for Medical Devices, and the European Medicines Agency Expert Panels for Medical Devices.

Ends

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