The Device Master Record (DMR)

The Device Master Record (DMR) The Device Master Record (DMR) is what may be described as the complete documentation required in the manufacture of medical devices that meet quality standards. The DMR, along with the Device History Record (DHR), is an extremely important element of the Quality System Regulation (QSR) in relation to FDA cGMP. […]

Is a completeDevice History Record a must?

Is a completeDevice History Record a must? This is the same as asking if a teacher needs to complete her entire syllabus for the class. There is considerable debate in the medical devices industry circles about whether some portions of a DHR can be done away with. Please, please, do not take the DHR for […]