-
Viraj D replied to the topic DHF vs. Tech File/Design Dossier in the forum The Design History File 8 years, 6 months ago
Definitely great points made, but with the DHF even though it contains all revisions, changes, and mistakes from the devices inception it will also contain design input requirements and user requirement specifications. This essentially gives an overview of the device similar to the technical file. I believe though in the end the DHF would be more useful than the technical file because it contains all aspects from quality system regulations to verification/validations, which shows the planning and that proper documentation was kept throughout.