Project 1 - Device Master File

Device Master File means the detailed information concerning the Product which is submitted to the relevant Governmental Authority and which is intended for incorporation into the Regulatory Dossier.

Master Files for Devices (MAFs) are MFs that may be used to provide confidential, detailed information [about facilities, manufacturing processes (e.g., sterilization), packaging materials, and contract packaging, as well as nonclinical and clinical study data] associated with Premarket Approval Applications (PMAs)               

Article Talk. A Device Master Record (DMR) is a compilation of all the instructions, drawings and other records that must be used to produce a product. The term is used in Quality Management Systems that cover product design and production.

Master files are files of a fairly permanent nature, e.g., customer ledger, purchase ledger, inventory pay roll etc. They include some information which is continuously updated by recent transactions.

DMR stands for Digital Mobile Radio and is an international standard that has been defined for two-way radios. The DMR standard allows equipment developed by different manufacturers to operate together on the same network for all the functions defined within the standard.