Brilo 2.0
Handle patient onboarding, device setup coaching, and MDR complaint intake with FDA-aware call handling and Part 11-compliant recording.
AI Voice Agent for Medical Device Manufacturers — Compliant Support Hotlines
Medical device support hotlines carry real regulatory weight — a mishandled complaint call is an MDR reporting risk, not just a bad customer experience. Brilo answers every call, captures what's needed for compliance, and escalates conservatively instead of guessing.
Complaint calls get missed or mishandled
MDR complaint intake AI voice agent captures every required detail on the first call and routes it to your quality team immediately.
Major Problems & Solutions
Setup coaching calls tie up support staff
Device setup coaching call automation handles routine onboarding, freeing your team for complex cases.
Follow-up calls after implant or device use go unmade
Post-implant follow-up call automation checks in with patients on schedule and flags anything abnormal for review.
No compliant record of support calls
Part 11-compliant call recording software logs every call in an audit-ready format.
Brilo 2.0
Adverse event reporting call intake, device adherence monitoring, and medical device QMS integration — built with an FDA-aware, conservative escalation posture from the first call.
Adverse Event Reporting Call Intake
Captures required details on any call that touches a potential adverse event, and routes it to your quality team.
Device Adherence Monitoring
Automated check-in calls track whether patients are using the device as directed.
Medical Device QMS Integration
Connects into the quality management system you already run for closed-loop complaint tracking.
Brilo 2.0
1
Patient or provider calls in
2
Call is triaged
3
Structured intake matches your MDR and QMS requirements
4
Compliant record created
Brilo 2.0
