A Device History Record (DHR) is the complete production record for a specific unit or batch of a medical device. It includes every piece of evidence that the device was manufactured according to the Device Master Record (DMR): materials used, process parameters recorded, inspections performed, test results, operator identities, and dates of each operation.
The DHR must demonstrate that the device was produced in accordance with the approved design and validated processes. Any deviations must be documented, investigated, and dispositioned. The DHR is reviewed and approved before the device is released for distribution.
Paper-based DHRs are a significant bottleneck in medical device manufacturing. Review of paper records is slow, error-prone, and consumes quality engineering time that could be spent on improvement. Electronic DHRs with automated data capture, real-time exception flagging, and digital sign-offs can reduce review time from days to hours.