The model of the dmr table should have a formal index form as. 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. The requirement for a device master record is outlined in the fda’s quality system. Dmr is maintained on the company computer network in a microsoft word table, excel or equivalent format. 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.
