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 Unit/Management Review

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.

Request a Demo

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

Request Demo for MedTech

Postmarket Regulatory Records

The MedTech market is vast, covering a wide range of product types and categories. Not all are relevant for your specific product benchmarking. Now you can access Postmarket Dashboards that display postmarket events specific to individual products or product lines. Postmarket documentation such as PSUR, PMSR, and CER just got much more streamlined.

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 (Coming soon)
PMDA (Coming soon)

Example Reports:

US FDA recall trends
MAUDE event trends
Risk model for products
Inspection, Enforcement, and Postmarket Events with timelines and relational analytics
Automated Postmarket Monitoring

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.