Ana Brito

Ana Brito (F) holds a Master's degree in Biomedical Engineering, Imaging and Radiation profile, and a PhD in Health Sciences, field of Biomedical Sciences, from the University of Coimbra.  Since 2014, she has worked in Medical Devices manufacturers and Biotechnology companies where she worked as a Quality, Project and Regulatory Affairs Manager, being responsible for product certification (MDR), Quality Management Systems implementation and certification (ISO 13485), Research, Development and Innovation Systems implementation and certification (NP 4457), and design of pre-clinical and clinical studies. Ana has extensive experience in the certification of medical devices and in vitro diagnostic medical devices according to European regulations (MDR and IVDR). Additionally, Ana also has experience in certifying MDs and IVDs in other territories such as the US, following FDA guidelines (510(k), De Novo Classification request, PMA), as well as in the communication with Notified Bodies, Competent Authorities and CROs. Her expertise extends to various applicable standards, including ISO 14971, IEC 62366, IEC 62304, IEC 82304, ISO 14155 and ISO 10993. Still in the area of medical devices, Ana is part of the teaching staff for postgraduate courses in Medical Devices and Clinical Research in Health Services at EstesC. She integrated the Laboratory for Automation and Systems from Instituto Pedro Nunes, in July 2022, acting as a Project Manager and Consultant in the area of Medical Devices Regulatory Affairs. Ana also has extensive experience in Life and Health Sciences research, from basic research, through pre-clinical, translational and clinical research, being author and co-author of 24 scientific papers and 154 abstracts.