Design History File (DHF)
According to FDA 21 CFR Part 820.30, DHF is the record that holds all the details necessary to demonstrate that the design was developed in accordance with the approved design plan.
Device Master Record (DMR)
FDA 21 CFR Part 820.40 focuses on Device Master Record. A DMR must be created for each type of device, including device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and installation and maintenance methods.
Device History Record (DHR)
Device History Record (DHR) includes the dates of manufacture, quantity manufactured, quality released for distribution, acceptance records, primary identification label, and UDI or IPC.