UC-419
Complaint Intake and Reportability Clock
Reads each complaint as it lands, drafts device and event coding, and puts a reportability recommendation to the regulatory reviewer.
TBDBuild time
Medical Devices · Use-Case Library
AI use cases for Medical Devices
5 reports built for Medical Devices. Each one shows the challenge, how the agents work, and the value it unlocks - open any report for the full detail.
UC-420
EU MDR Technical File Currency Watch
Holds every technical file section against its cited evidence, flags what has gone stale, and drafts the periodic regulatory updates.
TBDBuild time
UC-421
Design History File Traceability Matrix
Links every user need to its requirement, verification test and design change, and shows which links break when a change is approved.
TBDBuild time
UC-422
Installed-Base Reliability and Field Service
Reads service work orders and device logs across the installed base, ranks which models and sites fail early, and plans parts and visits.
TBDBuild time
UC-423
510(k) Predicate and Equivalence Pack
Finds comparable cleared devices, lines up technological characteristics side by side, and drafts the substantial equivalence table.
TBDBuild time