Difference Between DHF, DMR & DHR

Understanding the difference between DHF, DMR & DHR is essential for medical device regulatory compliance and quality management. Though related, DHF, DMR & DHR serve distinct roles across the product lifecycle.

DHF (Design History File) documents the complete design and development history. It includes design inputs, risk management, verification, validation, and design transfer records. DHF proves the device was developed according to regulatory requirements.

DMR (Device Master Record) contains the official manufacturing instructions and specifications. It includes drawings, bill of materials, production processes, quality checks, labeling, and UDI details. DMR explains how the device must be built and tested.

DHR (Device History Record) captures the actual production history of each unit or batch. It includes manufacturing records, inspection results, sterilization details, rework information, and quantity released. DHR proves the device was manufactured according to the DMR.

In simple terms, the difference between DHF, DMR & DHR is:
Design documentation (DHF), Manufacturing instructions (DMR), and Production records (DHR).

Together, DHF, DMR & DHR ensure traceability, compliance, and product quality in medical device manufacturing.