The model of the dmr table should have a formal index form as. Proprietary information in this index is replaced by x's. The requirement for a device master record is outlined in the fda’s quality system. 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,. 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.
