ISO 27001 & ISO 9001 Certified

AI-Powered Medical Device Risk Management

Streamline compliance. Mitigate risks. Ensure safety. Transform manual processes into automated systems with real-time intelligence.

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10+
Enterprise Clients
50K+
Reports Generated
99.9%
Uptime SLA
70%
Faster Compliance

Features

Everything you need for regulatory excellence

A complete suite of tools for medical device compliance — from risk intelligence to automated reporting.

Customized Data Analytics

Intelligence tailored to your risk profile

Transform raw regulatory data into precision intelligence. Our customizable analytics engine aligns perfectly with your KPIs to ensure comprehensive compliance, powered by predictive machine learning capabilities.

Organizational Alignment

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

1:1 KPI Matching

Our data reports match your KPIs and risk file to ensure 1:1 match and comprehensive compliance coverage.

Custom Trend Charts

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.

SLICING & DICING VIEWER

KPI Match Confidence

99.8%
Total Signals Detected
2,845
ML Processing Time
< 0.4s
Custom Trend Projections
Live
Risk File Completeness 1:1 Aligned

Real-Time Risk Intelligence

Stay ahead of regulatory disruptions

Harness the power of AI to constantly monitor your global compliance footprint. Detect anomalies, receive instant alerts, and neutralize risks before they escalate into compliance violations.

AI-Driven Monitoring

Monitor global data streams automatically to detect safety signals before they become critical issues.

Instant Compliance Alerts

Receive real-time notifications on regulatory changes, FDA warnings, and global compliance shifts.

Dynamic Risk Scoring

Our engine instantly recalculates Risk Priority Numbers (RPN) dynamically based on incoming real-world evidence.

Threat Trajectory

Anticipate emerging safety issues using predictive forecasting applied to product line data.

LIVE RADAR
Critical Signal Detected
Spike in adverse event reporting for Class III implants in EU database.
Current Risk Horizon
Elevated
Sources Scanned Last Hour
14.2k
↑ 22% increase
Live Anomaly Tracking Global
Anomaly Detected

Automated PSUR Generation

Write reports in hours, not weeks

Eliminate the massive manual overhead of regulatory reporting. Our AI platform centralizes your safety data and automatically synthesizes comprehensive Periodic Safety Update Reports (PSURs) with absolute regulatory accuracy.

Intelligent Data Compilation

Automatically aggregate clinical evidence, literature, and post-market safety data into a single repository.

AI Drafting & Analysis

Leverage LLMs to draft complex benefit-risk assessments and signal evaluation summaries instantly.

Regulatory-Ready Formatting

Exports to perfectly formatted templates strictly compliant with EU MDR, IVDR, and FDA guidelines.

70% Faster Cycle Times

Transform what used to take weeks of manual clerical effort into a streamlined review process.

AI DOCUMENT GENERATOR
Drafting PSUR - Class III Cardiac Implant
85% Complete
Extract
Analyze
Drafting
Review
Sources
412
Sections
14/16
Est. Time
2 min
Section 6.1: Benefit-Risk Evaluation
AI Drafted

Dashboards & Reporting

Command your compliance posture

Replace fragmented spreadsheets with a centralized Command Center. Gain absolute visibility into compliance status, team performance, and critical risk metrics through dynamic, presentation-ready interfaces.

Global Compliance View

A unified single-pane-of-glass integrating real-time compliance status from all international markets.

Performance Metrics

Track team efficiency, reporting timelines, and compliance KPIs with granular real-time visual metrics.

Interactive Drill-Downs

Click into any high-level metric to instantly access the raw underlying safety incidents and data grids.

Exportable Intelligence

Generate beautiful, management-ready PDF reports and presentation decks directly from your live dashboard.

COMMAND CENTER
Global Audit Readiness
94% ↑ 2.4%
Market Distribution
3 Regions
EU FDA ROW
Submission Timeline
MonTueWedThuFri
Pending Reports
Q3 PMCF - Implant A
ID: REV-092
Under Review
Annual PMSR - Device B
ID: REV-093
Drafting (60%)

Quality & Compliance

Architect your standard of care

Consolidate your entire quality documentation ecosystem. Ensure robust traceability and maintain an impeccable, audit-ready compliance posture from clinical trials through post-market surveillance.

Unified QMS Integration

Master FMEA, Clinical Risk Analysis (CRA), and Hazard Analysis seamlessly within a singular, connected workflow.

Dynamic Traceability Matrix

Ensure 100% compliance with automated, bidirectional traceability from risk inputs directly to verifications.

Immutable Audit Trails

Fully compliant with 21 CFR Part 11 and EU Annex 11. Every change is logged with electronic signature capturing.

Intelligent Gap Analysis

Instantly pinpoint missing controls, broken links, or undocumented risks before your regulatory audit begins.

TRACEABILITY MATRIX TRACKER
Document Workflow Integrity
Live Sync
FMEA 100%
Clinical Risk Analysis 92%
Hazard Log 68%
Node Traceability Map
R1
R2
Verified
2 Gaps Detected in Traceability
Hazard ID: HZ-044 is missing verification linkages in the CRA matrix. Review generated FMEA.

AI-Powered Insights

Intelligence beyond human scale

Leverage proprietary Machine Learning specifically trained on regulatory and clinical data. Uncover hidden signals, predict compliance risks, and accelerate your time-to-market.

Predictive Risk Modeling

Anticipate potential safety issues before they escalate. Our ML models forecast adverse event trends based on historical data.

NLP Literature Parsing

Instantly extract key regulatory metadata, signals, and outcomes from thousands of unstructured clinical literature sources.

Automated Root Cause

The AI engine identifies hidden correlations in vast complaint databases to instantly suggest highly probable root causes.

Intelligent Guidance

Receive context-aware, actionable recommendations directly aligned with updated EU MDR/FDA regulatory frameworks.

INSIGHTS ENGINE

Signal Clustering Model

Real-time NLP entity extraction

Anomaly Cluster
High correlation detected in "Material Fatigue" reports across EU.
AI Recommendation Generative Output
Based on the anomaly cluster, the AI recommends initiating an immediate CAPE review for Component X-12. Regulatory trend analysis indicates an 84% probability of inquiry from the BfArM within the next 30 days. Recommend generating a preemptive Field Safety Notice draft.

Solutions

Built for modern compliance teams

Every aspect of medical device regulatory compliance, from post-market surveillance to risk management.

Vigillent

Intelligent trending & predictive analytics

An intelligent AI-powered trending and data analytics tool for Vigilance Reporting, Article 88 reporting and post market safety monitoring.

Automated Trending

Intelligent automation creates preloaded charts and visualizations, saving time and minimizing errors.

Seamless Integration

Connect to global adverse event databases with real-time data updates and charting.

Auto Flagging & Rules

AI detects out-of-bound data and flags signals for your attention in real time.

Complaint System Sync

Backend connection to your complaint system trends internal and external vigilance data.

Intuitive Dashboards

Visualize key metrics through customizable dashboards offering robust statistical methodologies.

Global Compliance

Ensure seamless alignment with evolving international regulatory requirements.

SIGNAL DETECTION DASHBOARD
Adverse Event Trend Analysis
30D 90D
1,247
Events Tracked
12
Signals Detected
5
DB Sources
Signal Flagged: Elevated Event Rate
Device class III — complaint rate exceeds threshold by 2.3σ.

With Vigillent, managing your post-market surveillance trending processes has never been more efficient. We provide accurate data sliced and diced in the way you want to enable best and most efficient decision making.
Simplify post market and complaints trending with Vigillent—your trusted tool from Data Reality.

PSUR Wizard

AI-powered compliance reporting

An intelligent AI-powered cloud-based platform designed to simplify and enhance compliance for Periodic Safety Update Reports (PSUR) and Post-Market Surveillance Reports (PMSR).

Automated Field Filling

Intelligent automation pre-populates report fields, saving time and minimizing errors.

Seamless Integration

Connect to global adverse event databases with real-time data updates.

AI-Generated Summaries

Advanced AI creates clear, concise summaries tailored to regulatory standards.

Secure Cloud Repository

Organize, store, and access PSUR documents securely, audit-ready at all times.

Intuitive Dashboards

Visualize key metrics and insights through user-friendly, customizable dashboards.

Global Compliance

Ensure seamless alignment with evolving international regulatory requirements.

PSUR WIZARD DASHBOARD
Report Generation Progress ● Active
Data Collection100%
AI Summary Generation78%
Regulatory Validation45%
24
Reports Generated
98%
Compliance Rate
3.2h
Avg. Time Saved
New PSUR Deadline Approaching
MDR Article 86 report due in 14 days. AI pre-fill ready for review.

With PSUR Wizard, managing your post-market surveillance processes has never been more efficient. Shift your focus from compliance complexities to innovation, knowing your reports are handled with precision.
Simplify compliance with PSUR Wizard—your trusted tool from Data Reality.

Intellirisk

The most advanced AI/ML engine in medical devices

A fully modular and customizable platform equipped with validated connections to your risk files. Intellirisk AI learns your specific risk file syntax.

Automated Categorization

AI-assisted complaint categorization out-of-the-box with validated accuracy.

IMDRF Coding & Calculations

Automatic IMDRF Coding and real-time risk file calculations.

Instant Reporting Determination

AI-based immediate adverse event reporting determination for rapid response.

FDA MDR Reportability

Learns your risk file syntax and automatically handles FDA MDR reportability.

RISK MATRIX ENGINE
Risk Assessment Matrix ISO 14971
← Severity Probability →
IMDRF Code
E0403
Material Degradation
Risk Level
Medium
Occ: 3 × Sev: 4
AI Determination: Not Reportable
FDA MDR analysis complete. No mandatory reporting required.

Leveraging advanced technology, we empower our partners with actionable insights derived from data, enabling them to make informed decisions, mitigate risks, and achieve business success.

Intellirisk IQ

Turn complaints into actionable risk intelligence

Structured Risk Intelligence. AI-powered complaint analysis that maps directly to your hazard profiles and risk files.

Complaint-to-Hazard Mapping

Automatically links complaint data to hazard profiles for rapid safety signal identification.

Data-Driven Risk Insights

Integrates sales data with complaints to normalize event rates and prioritize risks.

Rapid Setup, Immediate Value

Upload complaint workbook and hazard analysis — processing begins instantly.

Export-Ready Reports

Download complete risk intelligence reports in PDF and Excel formats.

COMPLAINT INTELLIGENCE
Complaint → Hazard Mapping ● Processing
CMP-2847 → HZ-012 Mapped
CMP-2848 → HZ-007 Mapped
CMP-2849 → Analyzing... AI
Occurrence Rate
0.42%
↓ 12% vs last period
Severity Score
3.2
↑ 0.4 from baseline
Risk Report Ready
PDF and Excel exports available. 847 complaints analyzed.

Cybersecurity Risk Assessment

Most user friendly CRA on the market

Identify vulnerabilities, evaluate threats, and prioritize controls with intelligence, speed, and confidence for connected medical devices.

Automated Risk Scoring

CVSS 3.1/4.0 scoring engine with customizable weighting for your device.

Threat Libraries Built-In

MITRE ATT&CK, OWASP Top 10, and emerging ransomware profiles included.

Continuous Monitoring

Upload from vulnerability scanners and SIEM tools to keep risk files live.

Audit-Ready Reports

One-click outputs for EU CRA, FDA, EU MDR/IVDR, HIPAA, and SOC 2.

THREAT ASSESSMENT CONSOLE
Vulnerability Scan Results ● Live
Critical
2
High
5
Medium
12
Low
18
8.7
CVSS Score
94%
Controls Active
3
Frameworks
CVE-2025-1847 Detected
Remote code execution vulnerability — patch recommended within 48h.

Core Capabilities

SBOM Management

Import, parse, and manage Software Bill of Materials with automated vulnerability matching.

Threat Intelligence

Auto-fetch latest CVEs and advisories from NVD, CISA, and vendor-specific feeds.

Control Mapping

Map mitigations to NIST, IEC 62443, and AAMI TIR57 controls with gap analysis.

Why Data Reality CRA?

60% faster risk assessments vs manual methods

Continuous monitoring with automated alerting

Multi-framework compliance out of the box

IntelliFMEA

Latest revolution in Failure Modes and Effects Analysis

Leveraging advanced technology, we empower partners with actionable insights derived from data for informed decisions and risk mitigation.

AI-Assisted Field Fill

Automatic FMEA field population using AI trained on your device history.

Automatic Coding & Calculations

FMEA coding and risk file calculations performed automatically in real-time.

Risk Mitigation Suggestions

AI-based control suggestions drawn from industry best practices and standards.

FMEA WORKSHEET
Failure Mode Analysis AI Assisted
Failure ModeSevOccRPN
Seal degradation 7 3 63
Sensor drift 9 4 108
AI Suggested 5 2 30
AI Control Suggestion
Add redundant sensor with cross-validation check to reduce RPN from 108 → 30.

How It Works

From data to compliance in four steps

A streamlined process that transforms complex regulatory workflows into simple, automated steps.

  1. Connect Your Data

    Integrate your medical device data sources — safety databases, clinical reports, and regulatory submissions — into one unified platform.

    3+ data sources

  2. AI Analyzes & Detects

    Our AI engine processes data in real-time, identifying risks, detecting safety signals, and generating actionable insights automatically.

    < 30s analysis

  3. Generate Reports

    Automatically generate PSURs, FMEA reports, and compliance documentation — reducing manual effort by up to 70%.

    70% time saved

  4. Submit & Monitor

    Submit regulatory documents with confidence. Continuously monitor post-market data and receive alerts on emerging risks.

    Real-time alerts

Testimonials

Trusted by industry leaders

"Data Reality transformed our compliance workflow. What used to take weeks now takes hours — with better accuracy and real-time visibility."

SC
Dr. Sarah Chen
VP of Regulatory Affairs, MedTech Solutions

"The AI-powered PSUR generation saved us 70% of our reporting time. The safety signal detection is a game-changer for our team."

MT
Michael Torres
Quality Assurance Director, Global Medical Devices

"Finally, a platform that understands medical device regulations. The dashboards give us complete visibility into our compliance posture."

EW
Dr. Emily Watson
Chief Medical Officer, HealthTech Innovations
"Our solution transforms traditional, often manual and error-prone processes into efficient, automated systems that provide real-time insights and actionable intelligence."
Ummer Shervani
Chief Architect & Technical Officer, Data Reality

Pricing

Plans that scale with your needs

Flexible pricing tailored to your organization's size and regulatory requirements.

Starter

For small teams beginning their compliance journey.

Custom
  • Up to 5 medical devices
  • Basic PSUR generation
  • Standard dashboards
  • Email support
  • Single user access
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Most Popular

Professional

For growing organizations with complex needs.

Custom
  • Unlimited medical devices
  • AI-powered PSUR automation
  • Advanced analytics
  • Priority support
  • Up to 10 users
  • FMEA & hazard analysis
  • API access
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Enterprise

Full customization and dedicated support.

Custom
  • Everything in Professional
  • Unlimited users
  • Custom integrations
  • Dedicated account manager
  • SLA guarantee
  • On-premise option
  • Custom AI training
Contact Sales

FAQ

Frequently asked questions

Still have questions?

Contact our team →
Contact Us

Get in Touch With Us

Reach out to us for any inquiries or collaborations. We are eager to hear from you and discuss how we can assist in leveraging healthcare data solutions for your business.

Phone (608) 856-4757
Email sales@thedatareality.com