Device master record index template. However the dmr is a living document that only shows the most current design outputs for a device while a dhf may require repeating various verification and validation testing if the initial design. The need to maintain dmr dmr is a part of the quality system regulation qsr of fda to maintain standards in the manufacture and maintenance of medical equipment. Upon compilation of all documents to be included in the master record a device master record index template should be prepared to identify all items in the record and locations of these records. The device master record is often referred to as simply dmr.
Dmr device master record shall consist of a listing of a summarized bill of material that lists all parts required for the manufacture of the associated products. Ladies and gentlemen in this weeks guidance dr. This list also references the appropriate manufacturing procedure for each component or each material specification for each raw material. Device master record contents template the device master record contents template is a listing of items that may appear in a device master record.
Package consists of the procedure and a device master record index log. Device master record index template. For a device master record dmr i recommend creating a dmr index using a template that is organized in accordance with an international standard to meet the needs of a dmr and a technical file. Simply put device master record dmris acollection of all the documents required to manufacture and test a medical device.
Dmr device master record dhr device history record you start with the history of the design which leads to the record of how to build and test the device which leads to the history of the device you actually made. Medical device standard operating procedure template describes the organization content creation and use of the device master record employed in the production of all medical devices distributed by the company. The failure to maintain the device master record dmr or in some cases the complete failure to create one. Device specification there may be many specifications in the device master record.