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  • Chris Vasquez replied to the topic DHF vs. Tech File/Design Dossier in the forum The Design History File 8 years, 4 months ago

    As Fady mentioned, essentially they have the same content, but the major difference is that the technical file has the current standards/specifications for the device and it does not take into consideration the design history. In my opinion, the DHF is an important tool in a validation/verification aspect, but this extra content may not be useful to lets say an individual that is just testing current specifications. The addition of the older historical data may cause confusion.

    Chris