Mattia Ronchetti has more than 15 years of Regulatory and Clinical Affairs experience in Medical Devices, Combination Devices, and CRO Management.
Mattia has driven multiple portfolio transitions to EU MDR ensuring business continuity worldwide for device classes IIa, IIb, and software as a medical device (SaMD). He has achieved multiple marketing approvals including multiple 510(k) clearances, CE marking of new products, PMDA , Health Canada and Anvisa approvals.
Managed and executed multiple medical devices and combination products clinical investigations from phase I to phase IV. Including pre-approval and first in human trials.
Mattia holds a degree in Industrial Biotechnology from Università di Modena e Reggio Emilia and conducted post-graduate research at Thomas Jefferson University, Philadelphia, PA, USA with a focus on pathogenesis and disease progression of chronic myelogenous leukaemia.
Currently serves as Senior Director, Global Clinical and Regulatory Affairs at BVI, an ophthalmic device manufacturer, offering a range of consumables, equipment, intraocular lenses (IOLs) and surgical fluids and gases.