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.
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
Get a Demo
We’ll can show you insights into any of your key suppliers, FDA investigators, inspection trends, and much more.