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AI-Powered Medical Device Risk Management & Compliance Software
Streamline Your Compliance. Mitigate Risks. Ensure Safety.

DATA REALITY. your trusted data management partner

AI-Driven Risk Identification & Assessment

  • Automated Risk Detection: AI models analyze risk factors, device performance data, and user feedback to spot emerging issues early.

  • Data-Driven Insights: Use data from clinical trials, post-market surveillance, and manufacturing to identify hidden risks.

  • Predictive Analytics: Anticipate potential risks before they materialize, helping you mitigate safety concerns and avoid costly recalls.

  • Slicing and dicing data that is in alignment to your organizational understanding.

  • Our data reports match your KPIs and risk file to ensure 1:1 match

  • Our trend charts and visualizations can be customized from the large suite of tools created by our expert team.

  • Machine learning models help analyze and categorize vast amounts of data, making processes faster and more efficient.

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Customized Data Analytics

  • Validated and qualified processes

  • FDA 21 CFR Part 11 compliant where applicable

  • Full and free software validation support

  • We validate our AI!

  • 100% audit and inspection support

Quality & Compliance Solutions

  • Interactive dashboards offering insights, alerts, and trends for real-time decision-making.

  • Choice of multiple and customizable dashboards

  • From complaints, to recalls, literature events, clinical events,  510ks, adverse events, risk events, non conformance - our dashboards can do it all

  • Advanced statistical visualizations to conform with new FDA and EU MDR Article 88 requirements

  • Dynamic Dashboards: Visualize risk data with intuitive, customizable dashboards that provide insights at a glance.
    Incident Management: Record and track incidents, deviations, and non-conformances in real-time, ensuring that corrective actions are implemented swiftly.
    Real-Time Notifications: Receive automated alerts when new risks or regulatory changes are detected, ensuring immediate attention and action.​

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Real time risk tracking and reporting 

Leverage the power of artificial intelligence to automatically identify, assess, and prioritize potential risks throughout the lifecycle of your medical devices. Our software analyzes historical data, regulatory trends, and real-time usage data to flag risks that need immediate attention, helping you make informed decisions and take proactive action.

  • Collaborate with your team, regulatory bodies, and third-party stakeholders seamlessly within a single platform.

  • Multi-User Access: Enable team members to collaborate on risk assessments, audit preparations, and compliance reports, all within a secure environment.

  • Role-Based Access Control: Customize permissions to ensure that the right stakeholders have access to the relevant data at each stage of the process.

  • Third-Party Integration: Integrate with existing systems (e.g., ERP, PLM, QMS) and collaborate with third-party vendors for seamless risk management.

Collaborative Compliance Workflow

  • Generate comprehensive and compliant documentation quickly and accurately, powered by AI to ensure precision and consistency across all reports.

  • Automated Risk Reports: Generate risk assessment reports, risk control measures, and mitigation plans in line with regulatory guidelines.

  • Audit Trails: Maintain secure, immutable audit trails for all activities related to risk management and compliance, ensuring traceability and accountability.

AI POWERED Documentation & Report Generation

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In the realm of advanced AI-driven analytics, the Data Reality product suite places cybersecurity at the forefront of its architectural framework. The platform leverages a multi-layered approach to secure data processing, storage, and access, ensuring that the integrity, confidentiality, and availability of data are maintained at all stages of its lifecycle. Below is a detailed technical overview of the cybersecurity controls embedded in the Data Reality AI-based product suite.

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1. Zero-Trust Architecture (ZTA)

2. Data Encryption

3. AI-Powered Intrusion Detection and Prevention

4. Secure API Management

5. Role-Based Access Control (RBAC)

6. Real-Time Monitoring and Audit Logging

7. Recovery and Redundancy

By integrating these advanced cybersecurity measures, Data Reality not only protects its AI-based systems but also builds trust with clients operating in sensitive industries such as healthcare, finance, and government. This layered security approach ensures robust protection against an evolving landscape of cyber threats.

our cybersecurity commitment

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