Chosen by Global Leaders and Innovators

Automate Postmarket Surveillance

Tailored for the specific needs of Quality and Regulatory MedTech experts, Redica Systems helps you monitor product risks and automate postmarket data collection and analysis. Global recall, FSCA, and vigilance data and analytics provided for your specific products automates monitoring and provides early risk detection. Redica’s data linkage, cleaning, and enrichment deliver increased functionality and previously inaccessible insights.

Quality Intelligence for Management Review and Reporting

Automated Organizational Quality benchmarking and Postmarket Product Surveillance

Continuous monitoring of recalls and vigilance in product quality within the industry, including recalls and adverse events
Benchmarking of organization and product quality performance relative to competitors
Early trend detection & risk identification at the Organization, Site, and Product level for recalls and adverse events

Redica Systems provides an integrated timeline of inspection and enforcement activities with postmarket filings, enabling a complete analysis of regulatory compliance and product performance events.

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Elevate your MedTech quality and regulatory strategies with our comprehensive intelligence solutions.

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Postmarket Regulatory Records

The complex MedTech regulatory landscape requires precision. Our customizable Postmarket Dashboards filter through thousands of records to deliver insights relevant to your specific products and categories. Streamline your regulatory documentation – from PSURs and PMSRs to CERs – with automated data collection and intelligent analysis that saves time and reduces compliance risk.

Design Control/Change Control

Redica enables quantitative Risk Management files for new and existing products with novel product tags, filters. Etc.

Roles we typically serve best:

Postmarket Quality
Regulatory and/or Postmarket Reporting
Product Lifecycle Management
Product R&D

Data Sources:

FDA
Health Canada
TGA
Anvisa
PMDA (Coming soon)

Example Reports:

Postmarket Benchmarking
Product Risk Monitoring
MAUDE Trends
Premarket Regulatory Trends
Unified Inspection and Postmarket

See our MedTech Data in Action

This presentation demonstrates Redica Systems’ postmarket data and dashboards with examples of risk identification and benchmarking tools. The data shown empowers users with early identification and continuous postmarket monitoring for more effective quality and regulatory records.