NAMSA assists medical device manufacturers seeking to conduct clinical trials or commercialize products in various international markets.

Most Common Market Registrations and Filings Requested

  • EU member nations
  • Canada
  • Australia
  • Switzerland

Common Assignments

  • Establishing clinical trial regulatory requirements and preparing filings
  • Identifying and recommending suitable Notified Body (or Bodies)
  • ISO 13485 consulting and certification
  • CE Mark assistance
  • EU Technical File assistance
  • ISO 14971 medical device risk management
  • Canada Medical Device License (CMDL)
  • Canada Medical Devices Registration
  • Australia Therapeutic Goods Administration (TGA)
  • Australia Register of Therapeutic Goods (ARTG)

We also have experience supporting medical device manufacturers in numerous other international locations.