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DHR FOR MEDICAL DEVICE
A Device History Record states “a compilation of records containing the
procedures and specifications for a finished device.” A Device History Record
refers to the location of processing activities, such as procurement,
processing, labeling, test and inspection, and packaging. The Device History
Record also contains information on the design, formulation, specifications,
complete manufacturing procedures, quality assurance requirements,
acceptance criteria, packaging, and labeling of a finished product.
Each manufacturer shall establish and maintain procedures to ensure that
DHR’s for each batch, lot, or unit are maintained to demonstrate that the
device is manufactured in accordance with the DMR requirements.
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DHR containing dates of manufacture, quantities manufactured, quantities
released for distribution, acceptance records which demonstrate the device is
manufactured in accordance with the DMR, the primary identification label
and labeling used for each production unit, and any device identification and
control number. The DHRs will also include information on incoming material
acceptance, on the manufacturing process, and on testing results that can be
used to perform trend analyses. These requirements are in the Quality
System regulation because the DHR covers the "beginning to end" of a
product so helps the product Traceability.
