Design Reviews are designed to be checkpoints during medical device product development to ensure the product design is safe, effective, and progressing. In order to have a proper meeting for the design review and a project to move as swiftly as possible, I agree with Dr. Simon’s suggestion by sending the documents ahead of time in order to get the approval faster. Furthermore, if there are any issues, it would be taken care of or at least it is known prior to the design review meeting.