![]() Heres the full text of that part for reference: Each manufacturer shall maintain device master records (DMRs).Įach manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40. ![]() ![]() Design Master Record Design History File Full Text Of ![]() The FDA regulations for DMR appear in 21 CFR Part 820.181, under subpart M which handles record-keeping requirements for medical device companies. While the device history record makes reference to specific lots, units, or batches of product, the DMR contains specifications for producing an individual device. Should include the instructions for all manufacturing processes, drawings, documented specifications, and, packaging requirements. Design Master Record Design History File Full Text Of.
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