Procedure improvement for designing and developing medical devices in compliance with MDR and ISO 13485: case study on osteotomy plates series.

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MDR is a set of regulations approved by the European Union, that establishes more rigorous standards compared to the outdated Medical Device Directive (MDD). Throughout the thesis, an original procedure for preparing the technical documentation is presented, necessary for submitting the device to the certification body, with the aim of obtaining the CE certification. The update of the internal procedure must not only respond to regulatory changes but also make it clearer and less redundant, thus allowing the company to save significant time and resources. This approach is fundamental to ensure that every medical device placed on the European market is safe, effective and meets high-quality standards. The thesis is structured into three distinct chapters: •??Chapter 1 – Background. The first chapter is dedicated to an in-depth analysis of the literature on human anatomy relevant to osteotomy surgical procedures. In this context, the different types of trauma and orthopedic plates available are detailed; establishing the basic requirements and criteria that a new plate must meet to be considered significantly innovative in the orthopedic field. •??Chapter 2 – Design and Development Procedure. The second chapter outlines the creation of a standardized procedure for developing medical devices. It is specifically tailored for the partner company in this project, and it is based on MDR 2017/745 and ISO 13485:2016. The development procedure is divided into three primary phases, each including a review, followed by a final validation review, resulting in the creation of more than 20 modules in total. The initial phase focuses on defining design inputs based on clinical and engineering requirements, closely linked to user needs. This is followed by the second phase, which includes formulating product specifications integrated with a thorough risk analysis and clinical evaluation. Third phase involves the product engineering and the definition of design transfer protocols. It culminates with the pre-series production, subjected to performance tests, essential for evaluate the device's characteristics and functionalities. The final phase consists of gathering design outputs, representing the realization of the initial inputs. •??Chapter 3 – Case Study: Development of Osteotomy Plates Series. The final chapter concretely applies the developed procedure to the INTRAUMA Osteotomy Plates. Here, the development phases are detailed, including testing protocols and analyses necessary to ensure that the final product meets the minimum safety and performance requirements. This chapter demonstrates the applicability and effectiveness of the developed design procedure, offering a useful and replicable model for the company's future projects. The thesis concludes with a summary of the results obtained, confirming the importance of optimizing the company's internal procedures, along with a brief overview of potential future procedure developments and improvements.