There are usually CAPA that are open to address these failures that are managed by the department head and the quality system. If there are failures with regulatory there is not must that can be done except to deal with the consequences per the FDA or which ever regulatory branch that is associated with your device. However, with proper project management the issue should not be failure in the project but rather the standards not being met. Having a close relationship with quality and regulatory it should be possible to stay in compliance and meet the requirement to prevent failures.