Welcome to RegSmart, Sara Gallinetti, senior consultant, medical devices and biomaterials

Sara is an expert in clinical documentation under the new medical device regulation (MDR) and in biomaterials.

Before joining RegSmart, Sara has held senior scientist positions in academia and industry for 7 years. Her main focus has been the transition from MDD to MDR compliance of 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.

Sara has also vast experience from developing and characterizing material formulations, managing in vitro and pre-clinical studies as well as external reviews for R&D documentation.

Last but not least, Sara is experienced from internal and external audits and release of goods for European and American markets.

Sara is ready to support you on your way to get your medical device ready for MDR, as well as development of biomaterials.

Sara´s experience within compliance in clinical documentation of medical devices and in biomaterials will be a great contribution to broaden the competence and expertise within RegSmart!