Data Reality’s Automated AI-Based PSUR

Data Reality
3 days ago
3 min read

Reimagining the Periodic Safety Update Report

The Periodic Safety Update Report (PSUR) is a cornerstone of post-market surveillance (PMS) for medical devices and in vitro diagnostics under the EU MDR and IVDR frameworks. Traditionally, PSUR compilation demands extensive data gathering, trend analysis, and clinical evaluation updates—often consuming weeks of manual effort.

Data Reality transforms this process with its AI-powered Automated PSUR System, bringing real-time intelligence, traceability, and compliance automation to the forefront of modern quality management.

The Problem: Manual Complexity and Delayed Insight

Conventional PSUR processes involve siloed data streams—complaints, vigilance reports, CAPAs, field actions, literature, and PMS plans—each requiring tedious human review. This manual approach introduces:

Inconsistent data interpretation across sites and reviewers.
Lag in detecting adverse trends or emerging risks.
Resource strain for Quality, Regulatory, and Clinical Affairs teams.
Risk of non-compliance with MDR Annex III, Section 1.1(c) and IVDR Article 81 reporting timelines.

The Solution: AI-Driven PSUR Automation

Data Reality’s Automated PSUR Engine integrates data from QMS, complaint databases, CAPA systems, and post-market clinical follow-up (PMCF) sources. The system uses advanced Natural Language Processing (NLP), Bayesian trend detection, and semantic risk correlation to automatically generate PSUR-ready insights.

Core Capabilities

Module	Functionality
AI Signal Intelligence	Detects statistical anomalies and trending adverse events using adaptive Bayesian algorithms.
Automated Data Harmonization	Normalizes global complaint and vigilance data, ensuring consistency across multiple markets.
Dynamic Literature Scanning	Continuously scans and summarizes relevant scientific publications, vigilance databases (e.g., Eudamed, MAUDE), and safety alerts.
Risk Correlation Engine	Maps post-market findings directly to Risk Management Files (RMFs) under ISO 14971, identifying control gaps and residual risk shifts.
Automated Draft Generation	Produces a ready-to-review PSUR draft aligned with MDR Annex III and IVDR Article 81 templates.
Continuous Compliance Dashboard	Monitors real-time metrics (complaint rates, CAPA effectiveness, benefit-risk balance) with automated reminders for review cycles.

How It Works

Data Ingestion: APIs connect to PMS, CAPA, complaint, and regulatory databases.
Data Normalization: AI harmonizes terminologies (IMDRF codes, harm categories, risk indices).
Signal Detection: Statistical models detect trends exceeding control limits or AOQL thresholds.
Automated Drafting: NLP synthesizes executive summaries, device-specific findings, and trend analysis into the PSUR format.
Human Validation: Reviewers verify AI-generated narratives, approve conclusions, and submit via the regulatory portal.

Compliance and Traceability by Design

Each AI-generated statement in the PSUR is trace-linked to source evidence—complaint IDs, CAPA numbers, clinical data points—ensuring transparency and auditability.The system’s audit-ready PSUR dossier includes:

Version control and reviewer sign-offs.
Risk-benefit analysis tables.
Trend justification with statistical confidence intervals.
Change logs for notified body inspections.

Key Benefits

80% Reduction in report preparation time.
Automated cross-linking between PSUR, PMCF, and Risk Management Files.
Standardized insights across device families and geographies.
Continuous learning, improving signal detection accuracy over time.
Regulatory readiness, ensuring compliance with MDR/IVDR and ISO 20416.

Future Vision: PSUR Intelligence as a Service

The next evolution—PSUR Intelligence Cloud—will enable predictive safety analytics, connecting Data Reality’s AI modules across multiple manufacturers and regulatory jurisdictions. This federated model will allow:

Benchmarking of safety signals across device classes.
Automated alerts for emerging field issues.
Integration with AI-based CAPA prioritization and management.

Conclusion

Data Reality’s AI-Based PSUR redefines how manufacturers approach post-market safety reporting. By combining automation, semantic intelligence, and regulatory precision, it turns compliance into a continuous, data-driven advantage.

With Data Reality, safety reporting isn’t a regulatory burden—it’s a strategic capability.