The ability to innovate and optimize internal design processes is crucial for companies operating in the medical device sector, where regulatory compliance is essential. This thesis, conducted in collaboration with INTRAUMA S.p.A., presents the improvement of Design and Development Procedure applied to a new series of Osteotomy Plates. The aim is to enhance the effectiveness of the internal design process, focusing on both the technical phases of design and the regulatory compliance pathway, in accordance with the Medical Device Regulation (MDR). The MDR is a set of regulations approved by the European Union, that establishes more rigorous standards compared to the outdated Medical Device Directive (MDD).