benefit from our long experience with hundreds of 510(k) submissions

A Premarket approval application (PMA) is the most stringent type of device marketing application required by FDA. It demands a highly efficient project management to keep time and costs within a limit.

PROSYSTEM guides you through the FDA Registration of your production sites and lists your devices intended for marketing in the United States.

The Food and Drug Administration demands from all medical device manufacturers outside the USA to name a US-Agent located in the United States.

We assist you to optain an official classification ruling from FDA