A device master record is a collection of every document needed to manufacture, package, and possibly service a medical device. 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,. In reading 820.181 and the fda guidance for device master record i cannot find any actual requirement for a controlled document called a dmr index. Okay, here is a generic example of a dmr template for a medical device. The model of the dmr table should have a formal index form as.
