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ROI CalculatorThe Device Master Record (DMR) is the controlled set of documents that defines how a medical device is built, tested, packaged, labeled, and serviced.
FDA 21 CFR 820.181 requires manufacturers to maintain a DMR that includes device specifications, production processes, quality assurance procedures, packaging and labeling specifications, and installation or servicing methods. ISO 13485 aligns with this by requiring documented production and service provision controls.
Why it matters: the DMR is the single source of truth inspectors use to verify that every batch was manufactured consistently and under approved conditions.
