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.

Competencies include: 

• 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