Complaint Handling
Software Built for Medical Devices, and Beyond.
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and FHR using Salesforce and MuleSoft.
Our Partners in Healthcare
Medical Device Manufacturers
Stay Audit Ready % Patient-Centered with Every Complaint
- Automate FDA 21 CFR Part 820 complaint workflows
- Align with ISO 13485 for CAPA and traceability.
- Centralize responses across devices, SKUs, and geographies
- Enable SLA tracking and root cause documentation
- Real-time integration with Salesforce Health Cloud or Service Cloud
Our Solution
Challenge
Automated workflows tailored for medical devices.
Manual complaint processes leading to delays.
Integration with existing systems for seamless data flow.
Risk of non-compliance with regulatory standards.
Real-time tracking and reporting capabilities.
Siloed systems hindering efficient resolution.
Platform Capabilities
What You Get Out Of The Box
Complaint case management templates
Pre-configured escalation and SLA paths
Full audit trails & digital signatures
Integration with EHR and external systems via FHIR/HL7
Configurable dashboards & analytics
How does it work?
Download the app or sign up online
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