Company Performance Metrics
BioVera provides regulatory and technical consulting services focused on orthopedic devices and biomaterials. The company assists clients with FDA and Health Canada regulatory submissions, including pre-submissions, 510(k) notifications, de novo submissions, and Medical Device Licence Applications. BioVera plans and manages pre-clinical in vitro
and in vivo testing programs and prepares related technical reports and scientific documentation. It advises on technical file preparation for CE marking and on regulatory strategies for class 2, 3, and 4 orthopedic devices. The firm also helps apply new and existing biomaterials such as ceramics and cross-linked polyethylene to implant designs with attention to performance and regulatory requirements. BioVera serves companies, investors, universities, and individuals engaged in research, development, and commercialization of orthopedic implants and related technologies.
