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Device History Record Procedure

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The Device History Record Procedure governs the creation of a Device History Record (DHR) of a finished device or critical component for each work order and establishes the process for final release into finished goods.

  • Includes Related Forms

  • MS Word Format

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Device History Record Procedure

The Device History Record (DHR) Procedure governs the creation of a Device History Record (DHR) of a finished device or critical component for each work order and establishes the process for final release into finished goods.

Device History Record Procedure - Overview

The Device History Record (DHR) Procedure governs the process of compiling and completing documentation made part of the DHR. Completion of the Device History Record, and associated DHR checklists, becomes documented evidence that the device batch / lot has been manufactured in accordance with the Device Master Record (DMR).

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