Top Device History Record Pain Points

By James Jardine

Many manufacturing companies continue to rely on manual, paper-based systems to maintain their production records, or device history records (DHRs), for compliance purposes. These systems often fall short, exposing medical technology organizations to inefficient processes, poor data tracking, inaccurate or missing information, and other unnecessary risks. Such risks often result in shipment delays, product quality issues, recalls, warning letters, even consent decrees.

This white paper focuses on the pains of a manual paper system, the quality/compliance concerns around the device history record life cycle, and how a digital system alleviates such pains and concerns.