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. The model of the dmr table should have a formal index form as. A device master record is a collection of every document needed to manufacture, package, and possibly service a medical device. Going by the fda’s definition a dmr is: 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,.
