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Certification of a Blood Management and Analysis Software as a Medical Device: A Comprehensive Study on the development of Technical Documentation and a Quality Management System under MDR and IVDR rules
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Resumo(s)
This 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.
Descrição
Tese de mestrado, Engenharia Biomédica e Biofísica, 2024, Universidade de Lisboa, Faculdade de Ciências
Palavras-chave
Software como Dispositivo Médico Regulamentação da União Europeia Sistema de Gestão e Qualidade Documentação Técnica Digitalização Teses de mestrado - 2024