Lifecycle

FDA's cybersecurity guidance uses this term to make clear that security work does not end at clearance or approval. Threats, vulnerabilities and patches have to be managed for as long as the device is in use, and planning for end of support is part of the lifecycle too.

all phases in the life of a medical device, from the initial conception to final decommissioning and disposal [SOURCE: ISO 14971:2007, 2.7]

ISO 13485:2016, clause 3.9

series of all phases in the life of a medical device (3.10), from the initial conception to final decommissioning and disposal [SOURCE: ISO/IEC Guide 63:2019, 3.5]

ISO 14971:2019, clause 3.8

all phases in the life of a medical device, from initial conception to final decommissioning and disposal.

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