OEM CONFIGURATION 21A digital pen direction with local information about prior use. The project must define what is recorded, how long it remains available and how the user interprets the display.
Compatible platform to define
Memory function to specify
OEM CONFIGURATION 22A connected device project using Bluetooth as a proposed communication interface. The app, firmware and phone environment are part of the scope rather than optional details after hardware selection.
Pen and firmware to define
Bluetooth integration; feasibility review
OEM CONFIGURATION 23A connected pen direction using near-field communication for a defined data transfer workflow. The intended user action and supported reading devices need explicit requirements.
Pen and memory to define
User-initiated transfer concept
OEM CONFIGURATION 24A device and app project centered on reminders and user feedback. A reminder can support a workflow, but it should not be presented as proof of treatment adherence or a dose recommendation.
Device and app scope to define
Reminder logic to specify
OEM CONFIGURATION 25An integration brief connecting pen records with a compatible glucose data source. The initial scope should state whether it is visualization, review or another defined function.
Named integration to evaluate
Data sharing; not default closed loop
OEM CONFIGURATION 26A connected device program organized around a study protocol and its data needs. The intended measure determines the event definitions, version control and site support requirements.
Protocol-specific platform
Event data and exports to define
OEM CONFIGURATION 27A connected delivery project that makes records available for a defined remote review workflow. Transmitting information does not itself provide continuous clinical supervision or emergency response.
Device, app and service to define
Monitoring responsibilities required
OEM CONFIGURATION 28A feasibility inquiry for a precisely stated AI function associated with an injection device. The goal may involve event interpretation or analysis; no autonomous dosing capability is assumed.
Hardware and algorithm to define
AI function and evidence to specify