
Our services
Regulatory Affairs Consulting
PMA Pre-Market
- Table of Content Review
- Summary Review (Includes Device description, Alternative Practices and Procedures, Marketing History, Summary of Studies)
- Device Description (Manufacturing, operating principles, each component) Performance standard references
- Non-clinical laboratory data review
- Clinical data review
- Label proposal review
- Environmental Assessment Review
- Financial Certification and Disclosure Statement Review
Our brands and projects




