ResearchAndMarkets.com held a seminar in San Diego on Sept. 12 and 13 entitled, "Managing Your Complaints and Obstacles in Post-Market Requirements – Results from Top Medical Device Observations During an Inspection.”
The conference sought to help manufacturers achieve compliance with FDA inspections of medical devices. The most common pitfalls include handling of complaints, proper handling of medical device reports and recalls. Conference organizers said these areas result in 80 percent of the failures in FDA’s inspections.
The seminar included case examples of how recalls, reports and complaints are to be properly handled. The goal was to reduce the risk to manufacturers of FDA enforcement actions, fines and other penalties.
Speakers included experts in the field of regulatory oversight and compliance.
