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