Medical Device Adverse
Event Reporting Services
Adverse Event Reporting Capabilities
Ameridial enables structured, compliant adverse event intake and escalation to support patient safety and regulatory obligations.
Medical device manufacturers and DME providers must respond quickly and accurately to reported adverse events. Delayed intake, incomplete documentation, or improper escalation can expose organizations to regulatory risk and compromise patient safety.
Ameridial provides medical device adverse event reporting through trained agents, standardized intake workflows, and HIPAA-aligned systems. Our teams capture complaints, assess reportability, and escalate events in accordance with FDA MDR requirements and client-defined protocols.
Service Offerings for Medical Device
Adverse Event Reporting
All adverse event services are delivered through standardized workflows, device-trained teams, and compliance-led execution.
Adverse Event Intake and Complaint Capture
Receive and document adverse events reported by patients, providers, or caregivers.
FDA MDR Reportability Assessment Support
Support preliminary assessment of reportability based on defined criteria and protocols.
Timely Escalation and Case Routing
Escalate reportable events to designated safety, quality, or regulatory teams.
Structured Case Documentation
Maintain complete, auditable records to support regulatory review and inspections.
AI Solutions That Enhance Adverse Event Reporting Accuracy
AI capabilities improve intake consistency, documentation quality, and compliance oversight.
100% call monitoring for QA & compliance
Improves real-time voice clarity
Real-time agent guidance & compliance prompts
Why Choose Ameridial for Medical Device
Adverse Event Reporting
Ameridial combines MedTech expertise, regulatory discipline, and scalable delivery to support compliant safety reporting.
HIPAA-Compliant Contact Center Infrastructure
All adverse event interactions occur within secure, audited, and HIPAA-compliant environments.
Device-Trained & Clinically Aware Workforce
Agents understand complaint intake requirements, safety terminology, and escalation protocols.
Scalable Support for Any Device Program
Support scales across pilot programs, commercial launches, and post-market operations.
24/7/365 Safety Intake Coverage
Always-on availability supports timely reporting and escalation.
AI-Driven Efficiency and Quality Controls
AI-enabled monitoring improves documentation accuracy and compliance adherence.
Customizable Reporting and KPI Dashboards
Dashboards provide visibility into event volumes, escalation timelines, and trends.
PCI DSS 4.0.1
ISO 27001:2022
HIPAA Compliant
SOC 2 Type II
MBE
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Frequently Asked Questions (FAQs)
These FAQs address reporting scope, compliance standards, scalability, and implementation timelines.
What is medical device adverse event reporting?
It captures, documents, and escalates device-related safety events in compliance with regulations.
Does Ameridial support FDA MDR reporting workflows?
Yes. Services support intake and escalation aligned with FDA MDR requirements.
Are adverse event reporting services HIPAA compliant?
Yes. All systems, workflows, and training meet HIPAA requirements.
Who can report adverse events through Ameridial?
Patients, providers, caregivers, and DME partners can submit reports.
How quickly can adverse event reporting services be launched?
Most programs launch within 4–6 weeks, depending on scope and integrations.
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