Hello,
I have recently participated in a Medical Device Single Audit Program (MDSAP) audit and am currently preparing for the second part of the same audit within the end of this year. MDSAP is a single audit for medical devices that covers regulatory requirements for the US, Canada, Brazil, Australia, and Japan.

For more information: https://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM430563.pdf

The first part of the audit was conducted at the location where the technical files are managed, so the DHFs of the products were not the primary focus. The DHFs will be the focus for the anticipated upcoming MDSAP audit at the R&D location where the DHFs are managed. From my experience in the past where we had two auditors for the mock-MDSAP audit, the DHF was the primary focus of one of the auditors while the other auditor focused primarily on open CAPAs. The targeted areas in the DHF that an auditor investigates is revolved around quality, risk management, and the key milestones (technical reviews, product development committee reviews, and key decisions made).

Lastly, I would like to help clarify your last question.

Design History File (DHF): design history file contains all documentation and records necessary to demonstrate the product’s design development (requirements, specifications, etc.), verification, and validation.

Device Master Record (DMR): device master record contains all documentation for manufacturing the product. This would include Bill of Materials (BOM), technical drawings, packaging/labeling specifications, manufacturing locations, production procedures/methods, quality assurance, etc.

Device History Record (DHR): device history record contains everything to make the device. This includes the quantities made, dates of being manufactured, distribution models, barcode labeling (UDI/UPC), etc.