Device Registration & Approval

Device-RegistrationNeed assistance with medical device registration and approval? AlvaMed can help you obtain medical device approval in all the major world markets. Our medical device registration experts in these markets have established relationships with their Health Authorities, and know how to complete your registration in order to obtain medical device approval as efficiently as possible.

Services Offered:

  • FDA Establishment Registration for Medical Device Companies
  • ISO 13485 Certification
  • Submissions for CE Mark approval
  • US FDA Agent Representation


Case Study:

FDA Registration