There are situations where uncommon medical devices are difficult to classify and where their classification and submission strategy should be verified by the FDA.
PROSYSTEM accomplishes all steps to get a classification for your device. Based on the description of the device we set up a request to obtain an official classification ruling from FDA.
PROSYSTEM will help to set up and write the relevant documents, set up the product description and communicate with FDA on your behalf .
Use our long lasting experience with FDA and let us help you to reach your goals faster and more efficient.