Four modules. One compliance ecosystem.
The CURA Platform
CURA™ brings together all essential regulatory workflows in a single modular SaaS platform. Each module is designed to automate documentation, ensure full traceability and simplify compliance for MedTech manufacturers.
Connected compliance
Connected modules for end-to-end compliance
The CURA™ platform offers modular, AI-powered solutions that automate complaint handling, regulatory reporting, post-market surveillance, and vigilance. Each module is purpose-built to reduce manual effort, ensure data consistency, and accelerate compliance performance across the entire lifecycle.
Designed as a next generation automation engine for MedTech quality and regulatory teams, the platform eliminates manual effort and human error from critical workflows while ensuring compliance and efficiency at scale. By combining the power of automation with the vision of continuous improvement, it helps MedTech innovators move beyond reactive compliance toward proactive quality management.
Automated Workflows
Reduce manual workload and improve data consistency.
Predictive Analytics
Gain real-time insights to detect risks early and enhance product performance.
Integrated Compliance
Ensure full regulatory traceability across all processes and reports.
Streamlined complaint management
Complaint Handling Module
CURA™’s Complaint Handling module streamlines the entire lifecycle of product complaints – from intake to resolution. At its core is a fully configurable web complaint form that allows customers, clinicians, or internal teams to submit issues directly. The form is designed to trigger automated triage and preliminary assessment the moment it is filled out, ensuring that critical information is captured and categorized in real time.
Complaints are automatically prioritized based on severity, routed to the appropriate teams, and tracked through resolution with full audit trails. This proactive approach not only accelerates response times but also enhances regulatory compliance and product safety monitoring. With real-time dashboards and trend analysis, the module empowers MedTech companies to detect patterns early and drive continuous improvement.
Key features:
• Centralized complaint registration and categorization
• Evaluation workflow with approval process
• Automatic generation of complaint reports
• Continuous documentation for audits
• MDR and FDA compliant process control
Automated regulatory submissions
Adverse Event Reporting (AER) Module
CURA™’s AER module automates the identification, documentation, and submission of adverse events to regulatory authorities such as the FDA and MDR. It intelligently extracts relevant data from complaints and incident reports, applies decision logic to determine reportability, and generates fully formatted submissions. The module supports country-specific requirements and ensures timely reporting through automated reminders and escalation paths. This reduces compliance risk and streamlines regulatory communication.
Key features:
• Structured data entry for all report types
• Automatic form generation for MDR, IVDR and FDA
• Validation of completeness and data accuracy
• Central storage of all submitted reports
• Continuous traceability for audits
Real-time insights for better decisions
Post-Market Surveillance (PMS) Trending Module
The PMS Trending module continuously monitors field data to identify emerging risks and performance patterns. Using advanced analytics and machine learning, it detects trends in complaints, adverse events, and product usage. The module visualizes key metrics and safety signals, helping quality and regulatory teams make informed decisions. It supports proactive risk management and aligns with EU MDR and FDA expectations for ongoing product evaluation.
Key features:
• Centralized aggregation of PMS and complaint data
• Real-time dashboards with trend graphs and KPIs
• Configurable filters and views for analysis
• Automated updates for continuous monitoring
• Early detection of potential risks
Consistent documentation & audit readiness
Post-Market Surveillance (PMS) Report Generation Module
CURA™’s PMS Report Generation module automates the creation of regulatory documents such as PSURs, PMS Reports, and CAPA summaries. It pulls structured data from across the platform, applies predefined templates, and generates audit-ready reports with minimal manual input. The module ensures consistency, acCURA™cy, and compliance with global regulatory standards. It significantly reduces the time and resources needed for documentation, freeing teams to focus on strategic quality initiatives.
Key features:
• Automatic generation of PMS and PSUR reports
• Integration of complaint and trending data
• Consistent data across all reporting modules
• Export in MDR, IVDR and ISO 13485 formats
• Central archive for audits and inspections
Data that flows not fragments
One platform.
Unified data.
CURA™ eliminates data silos by connecting regulatory, quality and clinical processes. Every action, report and document is linked within the same ecosystem. Teams work with shared information, improving transparency and decision making across all departments.
Each CURA™ module can operate independently or as part of a unified compliance ecosystem. Together they provide complete traceability, seamless integration and full confidence in regulatory compliance.
Built to integrate seamlessly with existing systems and databases, CURA™ serves as the digital backbone for modern MedTech compliance without disrupting current infrastructure.
