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Is OPTOVERA a medical device?

OPTOVERA is a safety decision-support platform, not a medical device.

No. OPTOVERA is not a medical device.

OPTOVERA is a workforce-readiness and safety decision-support platform used to help organizations manage readiness and fatigue-related risk in operational environments.

OPTOVERA provides objective, time-of-assessment information that can support proactive safety decisions before a User performs safety-critical work. It is intended to support the Customer’s internal safety workflow, supervisor review, and confirmation procedures.

OPTOVERA is not intended to diagnose, treat, monitor, or manage medical conditions. It does not replace medical evaluation, clinical judgment, or the organization’s internal safety procedures.