A clear Device Master Record (DMR) definition can be thus: it is the sum total of all documentation that is required in the manufacture of any medical device that meets quality standards. The DMR, as well as the Device History Record (DHR), are very important aspects of Quality System Regulation (QSR) set out in the FDA’s cGMP.
What is a proper device master record definition?
In order to get the device master record definition right, we need to understand that the DMR can be thought of as material that goes on to make the QSR, while the DHR can be thought of as the final product. In other words, if the DMR is what goes into the QSR, the DHR shows the process and way in which these materials worked together or singly to churn out the final product.
To give a clearer device master record definition, it can be said to be a master record which gives employees a kind of direction map of the exact functions that have to be performed to manufacture a medical device.
The QSR, into which the DMR is built, needs to have a Standard Operating Procedure (SOP). In this, the precise contents of the DMR are laid out, which in turn makes way for the creation of an SOP for DHR, too.
No strict rule about arrangement of information
All the components of a device master record definition and requirements are set out in Section 820.181 of the FDA. This section however, does not specify a very strict method of arrangement of data about the device. Manufacturers can write information about the device in any convenient way, with the only mandatory requirement being that it should be easily accessible.
Device specification –the core of the device master record definition
Device specification lies at the core of the contents of the DMR. This section of the DMR briefly lists out all important details of the external nature of the device. Usually, a DMR device specification has the following:
- the device’s product trade and common name(s)
- intended use(s)
- user safety characteristics
- regulatory classification
- physical characteristics
- performance characteristics and theory of operation
- important components and formula (if applicable)
- environmental limitations and product stability
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