Device Master Record Procedure
The Device Master Record Procedure prescribes the responsibilities for preparing Device Master Records (DMR) and to ensure the completeness of DMR Indexes (indices).
A Device Master Record should be prepared and maintained for all devices (products) manufactured or under development. All equipment specifically including medical devices manufactured by the company are covered under the Device Master Record Procedure. (14 pages, 2,077 words)
Device Master Record Definitions:
Device Master Record (DMR) – A compilation of records containing the description, design, formulation, specifications, complete manufacturing procedures, quality assurance requirements, and labeling of a finished device. In addition to the device specifications, a DMR contains documents that cover typical manufacturing activities including procurement, assembly, labeling, testing, and inspection and packaging.
DMR Index – Table of contents for the master record of a device; can contain information on the breakdown of the device into assemblies and/or manufacturing steps. Called a “document plan” during planning and early development of a new product.
Device Master Record Procedure Activities
- Preparation of Device Master Record
- Records Retention and Location
- Authorization and Change Control
Device Master Record Procedure Forms
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