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ROI CalculatorThe Device History Record (DHR) is the controlled record that proves each specific device or batch was manufactured according to the approved Device Master Record (DMR).
FDA 21 CFR 820.184 requires DHRs to include dates of manufacture, quantities released, acceptance records, labeling used, and identification of the device or lot. ISO 13485 similarly requires records to demonstrate conformity of each production batch.
Why it matters: inspectors use the DHR to verify what actually happened in production. Missing or inconsistent DHRs are a frequent source of major audit findings and recalls.
