This is part of an ongoing series of “droplet” videos intended to communicate key concepts in the medical device development process.
Creating a Device Master Record, or DMR, is part of any GMP medical device development program.
The requirements for your DMR are defined by the FDA.
In short, the regulation says that your DMR must include device, production, quality assurance, packaging and label specifications, and, if applicable, to your device, installation, maintenance, and servicing procedures.
A specification defines what is to be achieved with a verifiable level of detail such that the requirements can be confirmed through testing.
So, what is a DMR?
Think of the DMR as the recipe book for how to build your device from scratch to obsolescence, from ordering and receiving raw components, assembly instructions and equipment, packaging for the defined shelf life, sterility requirements, proper installation, and any maintenance to keep the device working as intended for the life of the device. It might help to think of each of these specifications as documents in a binder.
The size of the DMR is directly related to the complexity of the device and could range from a few dozen pages to a few hundred.
The DMR is owned and controlled by the manufacturer of record; however, activities required by the DMR can be completed by approved third parties such a contract manufacturer for assembly or sterilization through an external vendor.
Lastly, each of the documents in your DMR must be approved and controlled in accordance with FDA regulation.
To learn more, check out the links in the description.