Best Practices for Maintaining Device Master Records (DMR) for Medical Devices

• By: Staff Editor
• Date: September 30, 2011

The Food and Drug Administration (FDA) requires manufacturers of medical devices to create and maintain a device master record (DMR). Section 820.3(j) of the Federal Code defines device master record. DMR is a set of documents containing procedures and specifications for a finished medical device. 

This article gives the best practices for maintaining DMR to comply with medical device regulations.