Can your company prove its device has been manufactured in accordance with its DMR?
The DMR is nothing more than the recipe (a.k.a. secret sauce), while the DHR is documented evidence of compliance.
Having a robust device master record is not optional.
Get an instant warning letter with repeat Form 483 observations.
You must have a Device Master Record, so just go ahead and create one; once the DMR has been assembled, do not forget to update it.
In this edition of Devine Guidance , Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.181 (Device Master Record). Ensuring the DMR is the receptacle for the appropriate type of records and the ongoing sustaining of the DMR are the basic salient requirements associated with 820.181. Remember, the DMR will never remain in a steady state.