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Case Study 1

DMR and DHR Remediation and Submission to USFDA

A US-based, labeler, packager, and distributor company, approached Trinity M Consulting for support with Device Master Record (DMR) and Device History Record (DHR) remediation and submission to United States Food and Drug Administration (USFDA).

Trinity M Consulting, Regulatory Affairs team conducted a comprehensive gap analysis to the Quality Management System (QMS), Device Master Record (DMR), and Device History Record (DHR) against FDA Quality System Regulation (QSR), 21 CFR 820 and prepared initial assessment of findings to address remediation activities.

Applicable QMS documentation were updated per QSR 21 CFR 820 and staff Training was completed for the new updated process. Project was successfully completed on time.

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