• Are you getting ready to export your medical device to the U.S. for the first time?
  • Are you confused about the Quality System Regulations or have you failed an FDA inspection?
  • Has there been a problem with your device that resulted in a serious injury?
  • Have you been given a condition-of-approval that requires a post-marketing study?

GEMAR has more than 25 years' experience in dealing with various aspects of the FDA regulatory system. We can work with you from the beginning with registering your facility and listing your products through designing your quality systems and dealing with any post-marketing issues that may arise - contact us for further information.
For additional information on US regulatory requirements, visit our Regulatory References webpages.