If you’re a medtech professional who’s been working with the quality system regulation (QSR) in the United States, then you’re probably familiar with the three terms the U.S. Food and Drug Administration uses for record-keeping requirements: 1) device master record (DMR), a compilation of records containing the procedures and specifications for a finished device; 2) design history file (DHF), a compilation of records describing the design history of a finished device; and 3) device history record (DHR), a compilation of records containing the production history of a finished device.

The DMR, DHF, and DHR have been around for decades. But in the FDA’s Final Rule on the new Quality Management System Regulation (QMSR), these terms don’t make an appearance.

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