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,. It is a repository of all essential information about your company’s medical devices. Okay, here is a generic example of a dmr template for a medical device. The document defines four types of records that are important for medical device development and manufacturing: The requirement for a device master record is outlined in the fda’s quality system.
