Hilo · Health tech

Complaint Management for Medical Devices

How Digilac built complaint management for Hilo's medical devices: traceability from verification to corrective action, approval workflows, automated reports.

Hilo is a clinically validated blood pressure monitoring system that automatically measures your blood pressure day and night. No cuff, no reminders, and you don’t have to lift a finger. With proven accuracy and reliable technology, it is a CE-certified Class IIa medical device, compliant with ISO 81060-2 and by 4 clinical studies.

Why Better Monitoring Is Important? high blood pressure is one of the leading risk factors for cardiovascular disease worldwide. Yet it often goes undetected or is poorly controlled.

What we delivered

Complaint Management of defective devices, allowing the tracebility of each step from problem verification, root cause analysis and corrective actions
Interactive dashboard with key indicators about open requests and their status
Approval workflow process to handle device disposal
Automated daily reports for the Canadian authority

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