Maps to
FDA QMSR (Part 820): §820.30(j)
ISO 13485: ISO 13485 §7.3
Requirement text
A Design History File (DHF) must be established and maintained for each type of device. The DHF must contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and applicable regulatory requirements.
Atomic constraints
- •A Design History File must be established and maintained for each device type.
- •The DHF must contain or reference all design control records (planning, inputs, outputs, reviews, verification, validation, transfer, changes).
- •The DHF must demonstrate design was developed per the approved design plan.
- •The DHF must be retrievable and available for FDA inspection.
- •Design change records must be incorporated into the DHF.
Evidence signals
- •
FILE_EXISTS
(Design.*History.*File|DHF|Design.*History|DHF.*Index)
- •
CONTENT_MATCH
Does this document serve as or reference a design history file, listing design control records including planning, inputs, outputs, reviews, verification, validation, and transfer for a specific device?
Audit defense
The Design History File for [your product] is maintained as [your document ID]. The DHF index references all design control records — from the Design and Development Plan through design transfer — demonstrating that [your product] was developed in accordance with the approved design plan and QMSR 820.30 requirements. The DHF is available for FDA inspection.