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
- 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.