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tme3 replied to the topic DHF vs. Tech File/Design Dossier in the forum The Design History File 8 years, 2 months ago
I believe the DHF to be more valuable than the dossier. I base this off the fact that the DHF is fully auditable by the FDA. Everything from the customer need, risk analysis, design input and output, drawings and verification and validation. These are very valuable in terms of building a product from start to finish with all the associated files. In fact, a tech file may well be included in the DHF in terms of design input from the drawings provided.