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The Device Master Record Contents Template is a listing of items that may appear in a Device Master Record. Upon completion of the design phase of a device, a formal document plan will be initiated and will be called the Device Master Record. The configuration and structure of the master record is determined by the Engineering and Manufacturing managers.
After agreement, the master record will be created, document numbers assigned, status of drawings indicated and the record approved by Engineering and Manufacturing. ENG104-1 DEVICE MASTER RECORDS CONTENTS includes categories such as manufacturing information, labeling and packaging, and control procedures and activities.