Just to clarify, the term audit is used when an internal company department performs evaluation of the company procedures, processes, facilities, etc. whereas inspection is when a regulatory agency visits a company to review the company documents, processes, procedures, facilities, etc. In my experience, regulatory agencies do not ask for the DHF (i.e. compilation of all documents), but they ask for specific documents from the DHF such as DDP, Verification and Validation matrix document, Human Factors evaluation, etc.

The DHF is a compilation of all documents generated during development that describe the history of a finished device. The DHR is a history/ traceability of each batch lot and unit produced pertaining to the production of the finished medical device.