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James is the Senior Director of global medical technology testing, inspection, and certification for Element RegNav. He is an accomplished technical expert with a 25-year career in medical technology product safety and market access. He has audited hundreds of medical device companies as part of the European CE marking requirements.
James was a Lead Assessor at BSI for ~5-years between 2001 and 2005 where he specialised in auditing orthopaedic and active medical devices, and approving them to market. He moved on to become BSI’s Global Head of Business Development and Medical Device Training in 2006.
Post-BSI, James founded his own medical technology and combination product consultancy that was acquired by NSF International in 2011. He subsequently spent 10-years at NSF, rising to become the Director of Certification in Ireland, and then the Senior Director of their Health Sciences practice.
He joined Element in 2021 to run support Element’s global expertise in medical technology testing, inspection and certification.
James is based in our London office, and works on Element RegNav
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