NAMSA is a leading Clinical Research Organization (CRO), and the world’s only Medical Research Organization (MRO), that 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.