Worksheet

Device record readiness sheet

This worksheet has six rows: device history, material lots, inspection, calibration, complaints and service. Across each row, note where the data lives today, who owns it, whether it carries the serial or lot number, and how many minutes a lookup takes. The last line holds the time your mock recall drill took.

Name: ______________________   Business: ______________________   Date: ______________

Scroll the table sideways to see every column.

Cross out or rewrite any heading that does not fit your business. From the guide “Medical device manufacturing software: what it must hold”, www.gullysystem.com/blog/medical-device-manufacturing-software-what-it-must-hold