Yvonne Middlefell is the Executive Director at Stellar Regulatory Consulting Ltd, providing global RA consulting, training, and education for the IVD and Medical Device Sector. Yvonne holds a 2:1 Hons degree in Science, Technology, and Management from the Open University and is a fellow of RAPS. With RA certification in the US, Yvonne has more than 29 years of Global RA experience, having held positions as an Executive Director of Global QA/ RA and Director Global RA. She gained extensive knowledge during a 10-year period when she worked in the USA. With a subsequent year spent in Paris, France, she has worked for several key multinational corporations. These include Amersham Nycomed, Eastman Kodak, Bausch & Lomb, and Johnson & Johnson. She has held board positions and has set up QA/ RA functions for start-up companies. Her RA experience covers a broad sector. Yvonne has written and filed multiple 510(k)’s for a range of products that include immunoassays, clinical chemistry analyzers, infectious disease products, contact lenses, and solutions. She has written and filed a PMA and led RA activities for mergers and acquisitions.