The difference between DHF and DMR can be confusing, particularly as medical device companies develop products in a more digital, and less paper-based world than when the FDA defined some of its foundational regulations and definitions. A key example is the question of where to place certain information such as specifications: as part of the DHF or the DMR? First, remember the FDA requires that manufacturers reference each record only once. Second, as the DMR is actually referenced by the DHF, all DMR content will be linked to the DHF and vice versa—an easy linking for any full product-centric QMS system. Therefore, companies can focus on logical positioning of the “questionable” records based on process flows. If a medical device company creates device specifications, labeling, packaging, or quality assurance procedures earlier in the design and development processes, the company can reference them in the DHF. Or, it can place these later in the DMR definition if created during the design output phase.