Dr Valentina Paggi
Project Associate
Dr Valentina Paggi is a microengineer with a strong expertise in biomedical systems. She holds a PhD in Microsystems and Microelectronics from EPFL and a joint MSc in Micro and Nanotechnologies from Politecnico di Torino, EPFL, and INP Grenoble. During her PhD, Valentina worked on the development of implantable devices for nerve modulation, gaining a deep understanding of the complexities and requirements of medical devices. With her multifaceted scientific background, she excels at designing and managing multidisciplinary projects, and has showcased her scientific writing skills through the publication of research and review articles. She supports you in designing preclinical studies, conducting clinical evaluations, preparing technical documentation, V&V, and engaging in regulatory activities. Valentina speaks English, Italian and French.
Dr Rima Padovani
Senior Consultant
Dr. Rima Padovani is a senior regulatory professional with RAC (Devices) certification and 10+ years of experience in the field of medical devices. She holds a PhD in Microsystems and Microelectronics from EPFL (Switzerland), and a Master of Science degree in Biomedical Engineering from the Polytechnic of Turin (Italy). Her R&D background and passion for innovation enable her to provide in-depth support for D&D, V&V, and Risk Management of medical devices. Rima offers her expertise in defining and implementing strategical regulatory activities for medical devices (including AIMDs, combination products, cardiovascular implants, ATMPs and IVDs) for regulatory approval in Europe and US. She provides support from the early development phase (e.g., regulatory pathway, pre-market clinical strategy, consultation with regulatory authorities) to the post-market phase (e.g., transition to MDR, clinical development plan and PMCF). Rima is fluent in English, French and Italian.
Stivani Peto
Project Associate
Stivani holds a MSc in Medicine with Industrial Specialisation from Aalborg University and is specialized in Medical Market Access. Stivani has experienced in project management and is proficient in scientific writing. She is also supporting Medidee clients with Quality Management System deployment, assembly of technical files with a focus on usability. She also supports projects with health technology assessment and ethical aspects of clinical research. Thanks to her Medicine with Industrial Specialisation she has an understanding of anatomy, physiology, general pathology, and pharmacology. With her academic background Stivani is ready to support you in regulatory aspects and quality assurance. Stivani speaks fluently English, Danish and Assyrian Neo-Aramaic.
DR Rosalinde Pots
Project Associate
Dr. Rosalinde Pots is an applied physicist with a passion for medical applications. She was a PhD candidate at the RWTH Aachen and performed her research in the Crystal Clear group at CERN. There she focused on the development of state-of-the-art instrumentation for medical PET scanners, especially concentrating on reaching extremely high time resolution. She has experience working in various interdisciplinary collaborations for the development of the necessary technologies. Rosalinde also contributed to numerous science education, training and outreach activities and has a special interest in helping bridge the R&D to market process of medical devices. She supports you in clinical evaluations, review of technical documentation and regulatory strategies.
Rosalinde speaks English, French and Dutch.