Chosen by global leaders and innovators

Custom MedTech Dashboards by Redica Systems are best suited for medium to large MedTech specification developers/manufacturers with moderate to high risk products.

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WHAT IS IT?

Take advantage of Redica Systems’ unmatched dataset for MedTech quality and regulatory intelligence. Together, we will build dashboards specifically for your company that are automatically updated from the industry’s most comprehensive dataset. These dashboards are powered by analytics across MedTech Postmarket Quality Product Data, Inspection, Enforcement, and Regulatory Intelligence. Enable continuous monitoring and reporting of the latest quality and regulatory data that matters most to your business. Postmarket Quality data dashboards include global FSCA, Recalls, Adverse Effects and Vigilance data to enable: Automatic Postmarket Regulatory Reporting and Records, Risk Management File Updates, Design Inputs Risk Mitigation, Organizational, Site, and Product Quality Benchmarking, Quality Issue Trend Analysis, Premarket submission Regulatory Risk Identification and more.

LEVERAGE AN UNRIVALED
MEDTECH DATASET

Complete, Effective, Custom Dashboards and Reporting Across MedTech Postmarket Quality Product Data, Inspection, Enforcement, and Regulatory Intelligence.

Medtech table

HOW WE PARTNER
WITH YOU

Redica Systems works with you to:

  • Select the KPIs most important to your business 
  • Customize dashboards for your specific needs
  • Redica Systems automatically keeps your dashboard(s) updated with current data
  • Data-as-a-service partners will have an early seat at the table helping to inform how we productize these capabilities
Recall Trends Medtech

DATA AND FEATURES
Fed by an unrivaled global data set including:

  • > 400,000 MedTech Sites
  • > 34,000 MedTech Organizations
  • > 253,000 MedTech Inspections
  • > 3.5M Unique Device Identification
  • ~ 50,000 Recalls
  • ~ 170,000 Premarket Submissions
  • ~ 3.9M Products
  • > 1M Product Families
  • > 200k USA Licenses
  • > 62K AUS Licenses
  • > 200K HC Licenses
  • > 60k Recalls (USA, HC, AUS, Japan)
  • > 16M MAUDE Reports
  • > 1M HC Vigilance
  • Labeling Databases
  • Documents
  • Linkages between inspections, recalls, adverse
    events and products

USE CASES
Automate postmarket quality data collection
across multiple geographies to inform:

  • Postmarket regulatory reporting
    • CER
    • PSUR
    • PMSR
  • Regulatory files
    • technical documentation
    • RMF
  • TPLC
    • Design Inputs
    • Change Controls
  • Management Review
  • Quality metrics and early risk detection
  • Quality Benchmarking
  • Risk Models