In the fields of orthopedic devices and biomaterials, BioVera possesses expertise in FDA and Health Canada regulatory submissions, in-vitro and in-vivo testing, applied research, and scientific publicity.
- Regulatory Affairs
- FDA pre-submissions, 510(k) applications, de novo submissions, breakthrough designations, etc…
- Health Canada Medical Device Licence Applications (MDLA) for class 2, 3, and 4 orthopedic devices
- Applied Research and Testing
- Strategic planning of applied research and device testing towards commercialization
- Management of pre-clinical testing