I agree that there exists an advantage to have the entire design process documented in a DHF versus a snapshot of the design process with the Design Dossier or Tech File. For one thing, we are able to see every aspect of the product from start to finish. It is the proof that the product was designed to be safe, meets user needs and requirements, and is of upmost quality. The fact that EU regulatory does not require the DHF shows that US FDA controls are much tighter and stricter. This can be a disadvantage for US products that want to be out in the market, but are delayed due to strict FDA regulation. However, if it means producing a high quality product, these controls are needed.