Device history file – Each medical device has a document that displays the design history. This document is initiated as the design starts and moves on through development process. According to the FDA the design history should contain all the records necessary to demonstrate the design was developed in accordance with the designed plan and requirements of part 21CFR.

The device history record includes everything one needs to build and test the device contained in the record. It should include device specification, production process, quality assurance procedures and specs, packaging and labeling and installation. I have not been in an audit for medical device but I have been in an audit for a drug company and consumer products. The FDA checks to see if proper SOP guidelines and work instructions are used per their requirements and the companies guidelines.