Debbie Grygier

Program Analyst, Food and Drug Administration CDRH

The Center for Devices and Radiological Health (CDRH) is a branch of the Food and Drug Administration (FDA) that is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products. One of our key functions is to review new device applications and approve them based on safety and effectiveness. After a review, a document indicating whether the application has been approved or disapproved is posted in an internal imaging system accessible by our whole center. QAI performs the scanning of those documents into our system. Over the past year alone, QAI has scanned more than 400,000 pages for CDRH.

Since working with QAI, it has been much easier for our reviewers to find and access the scanned documents. Also, QAI is very fast and efficient in their scanning services. They are always willing and able to bend over backwards to make sure we get exactly what we need when we need it, often in a day’s turnaround. The company is wonderful to work with and very accommodating.