Chair of ISO/TC 194 (Biological and clinical evaluation of medical devices) and Director of Regulatory Affairs
ICON plc
Jeremy Tinkler ERT, Chair of ISO/TC 194 - Biological and Clinical Evaluation of Medical Devices, Director of Regulatoruy Affairs, ICON plc.
Jeremy Tinkler has been conducting biological evaluations of medical devices ever since 1987, when he joined what is now the MHRA, where, as Principal Specialist in Biosciences and Implants, he was responsible for the technical direction of safety assessments and investigation activities for a wide range of devices. In 2007, he joined MedPass International, a Clinical Research Organisation and regulatory consultancy in Paris, which was acquired by the major clinical research organisation, ICON plc, in 2020.
Throughout that time, he has taken a leading role in standards development as a member of many ISO Working Groups and as chair of UK committees covering biological safety, risk management and cardiovascular and neurological implants. He played a key role in introducing risk management principles from ISO 14971 into other standards, such ISO 22442 (animal tissues), ISO 5840 (heart valves) ISO 10993 (biological evaluation) and ISO 14155 (clinical investigation). He has also served on the secretariat or membership of a many official committees, including the EMA Cell Products Working Party and the Independent Advisory Group on Silicone Gel Breast Implants. As a stakeholder member of the European Commission’s Clinical Investigation and Evaluation Working Group, he participated in the revision of MEDDEVs on clinical evaluation (MEDDEV 2.7/1 rev4) and SAE reporting. Since January 2018 he has been Chair of ISO/TC 194, responsible for the development of international standards in biological and clinical evaluation (including ISO 10993, ISO 14155 and ISO 18969).
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Friday, May 16, 2025
10:30 - 11:30 CEST