BioVera possesses expertise in regulatory affairs, applied research, FDA applications, in-vitro and in-vivo testing, clinical trial planning, and scientific publicity of orthopaedic devices and biomaterials.
Physician communications; development of presentations and publications.
FDA pre-submissions, 510(k) applications, IDE planning, PMA support, Health Canada applications.
Applied Research and Testing
Strategic planning of applied research and device testing towards commercialization.
Management of pre-clinical testing.
Technical reporting and documentation for design files and regulatory applications.
Strategic planning and protocol development as an integral part of commercialization strategy.