Edo Knijff, born in the Netherlands, combines a strong scientific background with Regulatory and R&D experiences. Originally a Biotechnology graduate, he started as a researcher at the University of Verona, Italy, publishing several papers on antibiotic resistance of bacteria. After a few years, he started in the Regulatory Affairs department of Orthofix SRL, in Verona. There, he was responsible for 510K clearance and CE marking of their products, working closely with not only R&D but also with FDA and Notified Bodies. Since 2007 he heads the Clinical Affairs Department. Apart from clinical studies, he is also involved in the development of new products. Since the release of the first draft of the MDR, he and his team have been involved in the gap-analysis and action plan to be aligned with the new requirements of the MDR.