A lot of the documents are not in the device master record, but are referenced in the dmr as to where the document is located (document control office, engineering library,. The document defines four types of records that are important for medical device development and manufacturing: The food and drug administration (fda) requires manufacturers of medical devices to create and maintain a device master record (dmr). The requirement for a device master record is outlined in the fda’s quality system. Okay, here is a generic example of a dmr template for a medical device.
