The Solutions
CURA offers modular, AI-powered solutions that automate complaint handling, regulatory reporting, post-market surveillance, and vigilance.
Each service is designed to reduce risk, boost efficiency, and ensure full compliance - so your team can focus on innovation, not administration.
The Modules
Customized modules for every challenge
01
Complaint Handling
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Automated Processing: Reduces manual workload and eliminates human error.
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Faster Resolution: Speeds up complaint triage and follow-up actions.
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Centralized Oversight: Provides a unified view of all complaints for better tracking and accountability.
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Audit-Ready: Ensures every complaint is documented and traceable for regulatory inspections.
02
Adverse Event Reporting
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Regulatory Compliance: Automatically formats and submits reports to authorities like FAERS and EUDAMED.
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Standardization: Uses IMDRF/NCIT coding to ensure consistent and compliant reporting.
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Real-Time Alerts: Flags critical events for immediate attention and action.
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Global Readiness: Supports multi-region reporting requirements with ease.
03
PMS Trending & Reporting
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Trend Detection: Identifies emerging issues through automated analysis of complaint and performance data.
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Data-Driven Decisions: Supports continuous improvement in product design and manufacturing.
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Custom Reports: Generates PMS reports tailored to regulatory and internal needs.
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Performance Benchmarking: Tracks KPIs over time to measure product and process improvements.
04
Vigilance
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Proactive Risk Management: Detects and escalates potential safety issues before they escalate.
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Integrated Surveillance: Combines complaint data, adverse events, and trend analysis into one vigilance workflow.
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Regulatory Alignment: Ensures compliance with EU MDR and FDA vigilance requirements.
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Zero Gaps: Eliminates missed signals and ensures full lifecycle monitoring.
Ready to boost productivity?
Unlock faster workflows, zero errors, and full compliance.
CURA does the heavy lifting so your team can focus on what matters most.
The Numbers
We're good with numbers
100+
Years of Experience
15+
Countries Covered
100K+
Medical Devices Optimized
Thousands
Complaint Data Points Generated
Millions
Patient Lifes Improved
5+
Partners
Our Valued Partners