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Quality Replay: Device History Record ‘Oversights’ A Clear Path To Quality Troubles, FDA Says

Executive Summary

From our digital archives: Manufacturers are overlooking various key elements that should be included in device history records, including up-to-date labels, dates of product manufacture and missing signatures on documents, US FDA says. Because DHRs touch virtually every part of a firm’s quality system, a flawed DHR can prompt agency investigators to dig deeper during inspections. Experts from device firms Baxter and Thoratec weigh in.

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