Lesley: Lesley Plön, M.Sc., is a consultant at the Johner Institute GmbH for various external regulatory roles, such as external QMR, external PRRC and In-Country-Representative for the EU, UK, Switzerland and the US. She holds a Master's degree in Quality Development and Management in Healthcare. Her professional experience includes serving as a Quality Management Officer in a hospital setting and leading projects for the economic development agency of Hanover in the Medtech sector. At the Johner Institute, Lesley specializes in advising for regulatory requirements across several jurisdictions (MDR, MeDO, UK MDR, 21 CFR).