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What is Data Reality?

Data Reality is a Post‑Market Surveillance and Quality Event Monitoring platform. It centralizes device event data, recall information, and regulatory workflows to help organizations maintain compliance and reduce risk.

Data Reality Overview

Primary goals​

  • Compliance and audit readiness: align with regulatory reporting requirements and maintain an auditable history.
  • Risk mitigation: identify trends early and prioritize corrective actions.
  • Operational insights: support Engineering, Quality, Safety, and Regulatory teams with actionable dashboards and exports.
Data Reality Goals

Who uses Data Reality?​

  • Quality and Safety teams monitoring events and injuries
  • Regulatory teams preparing Vigilance, PSUR, or CRA documentation
  • Product teams tracking malfunctions and corrective actions
Data Reality Users

Additional Users and Fields:

  • Data Analysts synthesizing complex datasets to identify emerging safety signals and quality trends.
  • Regulatory Compliance Officers ensuring high-level organizational adherence to global standards (e.g., FDA, EMA, ISO).
  • Clinical Data Managers maintaining data integrity and consistency across clinical study reports.
  • Medical Safety Officers conducting medical assessments of reported adverse events and product complaints.
  • Quality Engineers utilizing data to investigate root causes and drive continuous product improvement initiatives.
  • Risk Managers leveraging aggregate data insights to assess and mitigate enterprise liability.
  • Internal and External Auditors reviewing consolidated documentation trails in preparation for regulatory inspections.
  • Manufacturing Operations Leaders monitoring production quality metrics to preemptively address line issues.