MAUDE (Manufacturer and User Facility Device Experience)
A Maude search is required as part of and IDE or PMA submission to the FDA. The
purpose of the search it to make sure the company has identified all currently
known risks of the device and has in place the appropriate mitigation.
The job requires pulling down the information off of the FDA site into ACCESS or EXCEL, filtering and organizing he information and then reviewing the adverse event encounters to categorize them. There could be as many as 5000 event encounters.