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.
Medical Device Complaint Intake Automation
Medical Device Complaint Intake Automation
Medical Device Complaint Intake Automation
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.
FDA-Compliant AI Voice Agent for Medical Device Companies
FDA-Compliant AI Voice Agent for Medical Device Companies
FDA-Compliant AI Voice Agent for Medical Device Companies
FDA-Compliant AI Voice Agent for Medical Device Companies
Adverse Event Reporting Call Intake
Captures required details on any call that touches a potential adverse event, and routes it to your quality team.
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.
Every call that touches a possible adverse event has to be captured correctly, and our quality team cannot staff the phones around the clock. Before, after-hours reports risked slipping through. Brilo AI now intakes each one, routes it to quality, and keeps our complaint records clean.
Karen Delgado
-
Director of Quality Assurance, Northpoint Medical Devices
Every call that touches a possible adverse event has to be captured correctly, and our quality team cannot staff the phones around the clock. Before, after-hours reports risked slipping through. Brilo AI now intakes each one, routes it to quality, and keeps our complaint records clean.
Karen Delgado
-
Director of Quality Assurance, Northpoint Medical Devices
Brilo 2.0
How It Works for Medical Device Support Hotlines
How It Works for Medical Device Support Hotlines
How It Works for Medical Device Support Hotlines
How It Works for Medical Device Support Hotlines
From first ring to a compliant, structured record — nothing skipped, nothing guessed.
From first ring to a compliant, structured record — nothing skipped, nothing guessed.
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
ISO 13485-Aware, Part 11-Compliant Call Handling
ISO 13485-Aware, Part 11-Compliant Call Handling
ISO 13485-Aware, Part 11-Compliant Call Handling
ISO 13485-Aware, Part 11-Compliant Call Handling
Built for device manufacturers already running a QMS — Brilo connects in without disrupting your existing complaint-handling workflow.
Built for device manufacturers already running a QMS — Brilo connects in without disrupting your existing complaint-handling workflow.
Veeva
Brilo works alongside Veeva so call details reach the systems your quality team already runs.
Greenlight Guru
Brilo passes complaint intake details into Greenlight Guru so nothing is retyped by hand.
MasterControl
Brilo works with MasterControl so support calls land in an audit ready record.
Twilio
Brilo connects to Twilio so hotline calls route through the numbers you already use.
Veeva
Brilo works alongside Veeva so call details reach the systems your quality team already runs.
Greenlight Guru
Brilo passes complaint intake details into Greenlight Guru so nothing is retyped by hand.
MasterControl
Brilo works with MasterControl so support calls land in an audit ready record.
Twilio
Brilo connects to Twilio so hotline calls route through the numbers you already use.
Veeva
Brilo works alongside Veeva so call details reach the systems your quality team already runs.
Greenlight Guru
Brilo passes complaint intake details into Greenlight Guru so nothing is retyped by hand.
MasterControl
Brilo works with MasterControl so support calls land in an audit ready record.
Twilio
Brilo connects to Twilio so hotline calls route through the numbers you already use.
Veeva
Brilo works alongside Veeva so call details reach the systems your quality team already runs.
Greenlight Guru
Brilo passes complaint intake details into Greenlight Guru so nothing is retyped by hand.
MasterControl
Brilo works with MasterControl so support calls land in an audit ready record.
Twilio
Brilo connects to Twilio so hotline calls route through the numbers you already use.
Veeva
Brilo works alongside Veeva so call details reach the systems your quality team already runs.
Greenlight Guru
Brilo passes complaint intake details into Greenlight Guru so nothing is retyped by hand.
MasterControl
Brilo works with MasterControl so support calls land in an audit ready record.
Twilio
Brilo connects to Twilio so hotline calls route through the numbers you already use.
Veeva
Brilo works alongside Veeva so call details reach the systems your quality team already runs.
Greenlight Guru
Brilo passes complaint intake details into Greenlight Guru so nothing is retyped by hand.
MasterControl
Brilo works with MasterControl so support calls land in an audit ready record.
Twilio
Brilo connects to Twilio so hotline calls route through the numbers you already use.
Veeva
Brilo works alongside Veeva so call details reach the systems your quality team already runs.
Greenlight Guru
Brilo passes complaint intake details into Greenlight Guru so nothing is retyped by hand.
MasterControl
Brilo works with MasterControl so support calls land in an audit ready record.
Twilio
Brilo connects to Twilio so hotline calls route through the numbers you already use.
Veeva
Brilo works alongside Veeva so call details reach the systems your quality team already runs.
Greenlight Guru
Brilo passes complaint intake details into Greenlight Guru so nothing is retyped by hand.
MasterControl
Brilo works with MasterControl so support calls land in an audit ready record.
Twilio
Brilo connects to Twilio so hotline calls route through the numbers you already use.
Veeva
Brilo works alongside Veeva so call details reach the systems your quality team already runs.
Greenlight Guru
Brilo passes complaint intake details into Greenlight Guru so nothing is retyped by hand.
MasterControl
Brilo works with MasterControl so support calls land in an audit ready record.
Twilio
Brilo connects to Twilio so hotline calls route through the numbers you already use.
Veeva
Brilo works alongside Veeva so call details reach the systems your quality team already runs.
Greenlight Guru
Brilo passes complaint intake details into Greenlight Guru so nothing is retyped by hand.
MasterControl
Brilo works with MasterControl so support calls land in an audit ready record.
Twilio
Brilo connects to Twilio so hotline calls route through the numbers you already use.
Veeva
Brilo works alongside Veeva so call details reach the systems your quality team already runs.
Greenlight Guru
Brilo passes complaint intake details into Greenlight Guru so nothing is retyped by hand.
MasterControl
Brilo works with MasterControl so support calls land in an audit ready record.
Twilio
Brilo connects to Twilio so hotline calls route through the numbers you already use.
Veeva
Brilo works alongside Veeva so call details reach the systems your quality team already runs.
Greenlight Guru
Brilo passes complaint intake details into Greenlight Guru so nothing is retyped by hand.
MasterControl
Brilo works with MasterControl so support calls land in an audit ready record.
Twilio
Brilo connects to Twilio so hotline calls route through the numbers you already use.
Brilo 2.0
Frequently asked questions
Frequently asked questions
Is this FDA compliant for medical device companies?
Is this FDA compliant for medical device companies?
Does it integrate with our QMS?
Does it integrate with our QMS?
Is call recording actually Part 11 compliant, or just marketed that way?
Is call recording actually Part 11 compliant, or just marketed that way?
Is call recording actually Part 11 compliant, or just 'compliant-ish'?
Is call recording actually Part 11 compliant, or just 'compliant-ish'?
Does it work for CGM, insulin pump, or cardiac monitor manufacturers?
Does it work for CGM, insulin pump, or cardiac monitor manufacturers?
Does it help reduce FDA warning letters related to complaint handling?
Does it help reduce FDA warning letters related to complaint handling?
Does this replace our quality team's complaint review process?
Does this replace our quality team's complaint review process?
Never Miss a Customer Call Again. Let AI Close the Loop—24/7.
Never Miss a Customer Call Again. Let AI Close the Loop—24/7.
Never Miss a Customer Call Again. Let AI Close the Loop—24/7.
Never Miss a Customer Call Again. Let AI Close the Loop—24/7.
Join 1,000+ businesses using Brilo to answer, qualify, and convert calls with AI—instantly.
Join 1,000+ businesses using Brilo to answer, qualify, and convert calls with AI—instantly.
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Join Discord
Connect with our community, ask questions, and stay updated on product news.
Book a Call
Schedule a quick call with our team to explore solutions for your needs.
Get started
Industries
Usecases
Integrations
Legal & Community
Join Discord
Connect with our community, ask questions, and stay updated on product news.
Book a Call
Schedule a quick call with our team to explore solutions for your needs.
Get started
Industries
Usecases
Integrations
Legal & Community
Join Discord
Connect with our community, ask questions, and stay updated on product news.
Book a Call
Schedule a quick call with our team to explore solutions for your needs.
Get started
Industries
Usecases
Integrations
Legal & Community