I believe that one of the most important aspects of the monitoring and controlling phase is the design review meeting. Any additional changes, metrics, variances, and updates can be discussed in these meetings. To ensure all members are on the right track and pace, they should be held on a weekly basis. After the team reviews the previous design and changes that need to be made, members can confirm the documents that need to be filed on a timely basis. Variance will also be discussed, to make sure the expectations do not differ too greatly from the output/results. This is crucial since any adjustments should be made as early as possible. Updates to the FDA guidelines should also be addressed to prevent unintentional violations that can lead to delays from fines or license revocation.