Steve Lee
Regulatory Advisor @Regmetrics
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WORK HISTORY
Regulatory Advisor @Regmetrics
London, GB
EDUCATION
Aston University
Biology and Biochemistry, Biochemistry
Institute of Biomedical Science
Fellowship, Medical Microbiology
Institute of Biomedical Science
Chartered Scientist, Biomedical Sciences, General
University of Greenwich
Postgraduate Diploma, Computing and Information Sciences
SKILLS
ABOUT STEVE LEE
30 years experience of in vitro diagnostic medical devicesEx-MHRA IVDR senior regulatory policy managerFormer Chair of European Commission\'s IVD Working GroupImplementation of IVD Regulation (2017/746): performance evaluation; companion diagnostics; software/bioinformatics; classification; health institution exemption; conformity assessment; reference labs.A lifelong learner, Chartered Scientist, Fellow of the Institute of Biomedical Science, Fellow of The Organisation for Professionals in Regulatory Affairs.
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