Erica Conway, PhD, has more than twenty years of regulatory affairs and quality assurance experience, primarily within the In Vitro Diagnostic (IVD) medical device field. Conway joined MCRA, a consultancy company, in August 2022 as VP, IVD Regulatory Affairs. Prior to MCRA, Conway’s first industrial experience started in the regulation of pharmaceuticals before moving into clinical trials for medicinal products. Conway moved into the field of IVD medical devices in 2006 for a major diagnostics manufacturer, before becoming an independent consultant, working within the IVD and medical device fields on aspects of regulatory affairs and quality management systems. Latterly, Conway spent 8.5 years as global head of IVDs and the head of IVD Notified Body (NB) at the British Standard Institution (BSI). At BSI, Conway was pivotal in the implementation of the IVD Regulation (IVDR., [EU] 2017/246) and the successful designations of both the UK and the Netherlands organizations to the IVDR. Conway has a bachelor of science (BSc Hons) in physiology from the University of Sheffield, UK; a doctorate of philosophy (PhD) specializing in neurophysiology from the University of Bristol, UK; and completed a short postdoctoral fellowship at the University of Cambridge before joining industry.
Articles by Erica Conway, PhD
