Configuration management

In device development it ties together software versions, settings and documentation so that what was tested is what is released. Poor configuration management makes it hard to prove which version is in the field.

a collection of activities focused on establishing and maintaining the integrity of information technology products and information systems, through control of processes for initializing, changing, and monitoring the configurations of those products and systems throughout the system development lifecycle.

FDA guidance: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (February 2026), Appendix 5, Terminology