When comparing both types of documents, the DHF document would seem more useful than the Tech File / Design Dossier. The DHF file gives an overall informative description of the product. The Tech File / Design Dossier document just gives a generic idea of what the product will consist of. The DHF document takes in to consideration all the design element involved and keeps track of them. In addition, this document shows the development involved in the design before publishing it and after the transfer. On the other hand, the Tech File / Design Dossier file does not include a record of all the elements involved in the design. Also, it only displays the product when it is released. Of the two documents the DHF document seems more valuable. The document has all the information on the product logged so it provides more details.
It depends what you are looking for.
The DHF would be more useful all around for people in Quality, Regulatory, Supply Chain, and even Product Development. This is because this will provide more then enough information for all the departments to satisfy whatever needs they may have at the moment. I believe it mainly comes down to what the project is and how large the scope of the project is. For example, if you are in Regulatory and doing BSI changes for 100 products that are similar, then the Tech File/Design Dossier should be sufficient in terms of acquiring most of the necessary information needed. If you are in Product Development or R&D and managing a project for a single product, then the DHF would be more useful as the scope is just one product line and managing that information for that single DHF would be more manageable and most likely useful.
I believe comparing the two documents and ranking them in terms of more usefulness might not be the best because the DHF is used widely by the FDA and Technical File and Medical Device (MDD) are for the Medical Device Directive. Both documents are methods of design control. The biggest difference is the FDA looks are the history of the device whereas the MDD looks the safety and efficiency of the current design. Depending on the companies goals, the route can be through either the FDA or MDD, but each document is tailored to the methods of each agency.
Document History File is more useful than a Tech File in terms of traceability. Document History File is a living document, it contains any mistakes or scrapped information that were made along the process of designing the device. A Tech File only contains snapshots of the final design, it does not explain the thought process which people went through to come up with their final decision. A DHF shows the inputs compared to the outputs while s Tech File does not. Design Controls can be found within the DMR of a DHF but a Tech File does not contain indexes. The time frame that a Doc History File covers is the development leading to the release and after transfer while a Tech File shows information after the transfer. A Tech File is reviewed by a notified body while a DHF is reviewed by the FDA. Maintaining a doc history file is a law based on the compilation of records. It contains all the information needed and more in terms of design when compared to a Tech File.
I believe the design history file (DHF) is more useful because it is a compilation of documentation that describes the design history of the medical device and gives a better history outline of what the medical device has gone through during the development process while the tech file only gives "snapshots" of the final medical device. I also feel like the DHF is better organized, and contained all details of the device because it has to be reviewed by the FDA, while the Tech file only gets reviewed by the notified body. The DHF realistically should contain everything you need in order to create a tech file, hence why it is more useful.
