Sara Gallinetti Senior consultant
PhD in Biomedical Engineering
sara.gallinetti@regsmart.se
+46 (0)730 – 62 66 04
Sara is an expert in clinical documentation under the new medical device regulation (MDR) and in biomedical materials.
Before joining RegSmart, Sara has been working as a senior scientist in academic and industry positions for more than 7 years. She has been working under ISO 13485 and her main focus has been the transition from MDD to MDR compliance of clinical documentation, including clinical evaluation, post market surveillance, post market clinical follow-up (PMCF), periodic safety update report (PSUR) as well as summary of safety and clinical performance of both custom-made and certified products.
Beside her experience with clinical documentation, Sara has been developing and characterizing material formulations, managing in vitro and pre-clinical studies as well as being the external reviewer for R&D documentation. Furthermore, Sara has experience with audits, both internal and external and with release of goods for European and American markets.
With the passion of a researcher, Sara wants to help medical device companies with compliance of their technical documentation and optimization of their product development.