Val Theisz, MSc RAC is Eclevar Australia’s VP Clinical & Regulatory Affairs.
Val Theisz has been Principal Consultant, Co-founder and non-executive Director, Certification Body Australia
Val is a regulatory affairs professional with over 15 years of experience in medical devices of all risk classes, including life-sustaining, high-risk active implantables, and software as medical devices (SaMD) using Artificial Intelligence (AI) algorithms. Val has a Masters degree in electrical engineering and holds Regulatory Affairs Certification credentials for EU and US regulations (RAC EU, RAC US) from the US- based Regulatory Affairs Professionals Society (RAPS).
Val’s experience within the field covers clinical trials for high-risk innovative medical devices; submissions and pre-market approvals in established markets (CE Marking, FDA 510(k) and PMA, TGA registration). Val has also been the Director of Regulatory & Clinical Affairs, Code of Practice with the Medical Technology Association of Australia (MTAA), leading industry advocacy initiatives with the Therapeutic Goods Administration and the Australian Department of Health.