Alex Shvartsberg

Alex has a proven track record of medical product development and helping clients bring medical devices to market. He is experienced in directing R&D programs leading to multiple patent filings for medical devices and regulatory approvals. Alex holds a B.Sc. in Mechanical Engineering and an M.Sc. in Management Science from the University of Waterloo in Canada.

Alex has worked on many types of medical device product development projects, ranging from implants and disposables to highly complicated neurosurgical and general surgery robotic systems, Neurosurgical Brain Navigation systems, intro-operative MRI systems, patient handling devices, and therapeutic ultrasound systems.

Alex successfully led the regulatory clearance and the transfer to manufacturing of over 30 Class I&II (510K) and Class III (PMA) medical devices and has extensive hands-on experience with materials’ biocompatibility validation and implants’ sterilization validation.