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 device master record is a regulatory requirement for all medical device companies. Proprietary information in this index is replaced by x's. A device master record is a collection of every document needed to manufacture, package, and possibly service a medical device. The requirement for a device master record is outlined in the fda’s quality system.
