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Compliance Glossary

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Entries 1 to 6 of 6

D:
Defect
Deming Cycle
DHF - Design History File
DHR - Device History Record
DMR - Device Master Record
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DHR - Device History Record
FDA requirement for medical device manufacturers. The DHR should reflect that all operations, processes, etc., described in the master record have been accomplished for all finished devices manufactured and includes: date(s) of manufacturing, quantity manufactured, quantity released for distribution, any device identification(s) and control number(s) used, the primary identification label and labeling used for each production unit, and, the acceptance records which demonstrate the device is manufactured in accordance with the DMR.