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,. Dmr is maintained on the company computer network in a microsoft word table, excel or equivalent format. The device master record is a regulatory requirement for all medical device companies. 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.
