I believe that the DHF is more useful than the Tech File/Design Dossier. The FDA is highly concerned with a company’s DHF because it involves everything from risk analysis to an end product where product specifications and customer needs are verified/validated, respectively. The files are very important in both the design and development process of creating a medical device from start to finish. However, if a DHF is put together correctly by the team, then a technical file, which is primarily a snapshot of the design, can certainly be placed into the DHF.