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,. Section 820.3(j) of the federal. Device master record template $ 150.00 form/template used to organize and consolidate product information intended to provide the technical documentation details associated with a. A device master record is a collection of every document needed to manufacture, package, and possibly service a medical device. 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.
