Matela, Nuno Miguel de Pinto Lobo e, 1978-Cruz, CéliaPeixoto, Mariana Marques2024-12-302024-12-3020242024http://hdl.handle.net/10400.5/96737Tese de mestrado, Engenharia Biomédica e Biofísica, 2024, Universidade de Lisboa, Faculdade de CiênciasThis dissertation focuses on the certification of Software as a Medical Device (SaMD) following the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). It provides all the information needed to develop a Technical Documentation (TD) and Quality Management System (QMS), which are crucial for a medical device (MD) certification. This work addresses the main challenges usually faced by companies of all sizes when certifying an MD, focusing on SaMD and demonstrating how these challenges affect decision-making when obtaining the CE marking. A multifaceted approach to research methodologies was employed to strengthen the reliability of the information, offer different viewpoints, and broaden the study scope. This work employed three principal qualitative research approaches: case study, literature review, and framework development. The case studies examine the use of QMS and TD in two distinct companies. At the same time, the literature review emphasizes the primary requirements for TD development in MDSW projects and QMS implementation, along with the digital technologies used to improve both processes. A framework was established to assist all organizations in implementing a QMS, particularly for MD design and development, following ISO 13485 requirements. Digital technologies are essential in developing and certifying MDSW, aiding documentation management, assuring traceability, and allowing adherence to regulatory requirements. Nevertheless, particular challenges remain concerning the customization and integration of these technologies, particularly in highly regulated industries such as MD development. The analysis reveals that smaller organizations face difficulties due to limited resources, while larger, more established companies struggle with challenges related to data integration and security concerns. Digital technologies are crucial in addressing these challenges and enhancing compliance processes. Nevertheless, additional adaptability is necessary to meet different sectors' specific requirements and fully integrate into an organization and its policies.engSoftware como Dispositivo MédicoRegulamentação da União EuropeiaSistema de Gestão e QualidadeDocumentação TécnicaDigitalizaçãoTeses de mestrado - 2024master thesis203878000