Safety Intelligence

Aggregate and analyze FDA recalls, MAUDE adverse events, and enforcement actions for competitive intelligence and risk assessment. This free tool saves consultants 3-4 hours per analysis by automatically collecting and organizing safety data from multiple FDA sources.

How It Works

Safety Intelligence aggregates safety data from multiple FDA sources:

check_circle
Recall Database Search: Searches FDA recall databases by device type, manufacturer, product code, or date range to identify relevant recalls, including Class I, II, and III recalls with detailed recall reasons and affected lot numbers.
check_circle
MAUDE Event Analysis: Queries the MAUDE (Manufacturer and User Facility Device Experience) database to identify adverse events, device malfunctions, and patient injuries associated with similar devices or competitors.
check_circle
Enforcement Action Tracking: Identifies FDA warning letters, 483 observations, and enforcement actions related to device manufacturers, providing insights into regulatory compliance issues.
check_circle
Competitive Intelligence: Analyzes safety patterns across competitor devices to identify common failure modes, design issues, or manufacturing problems that may inform your client's device development.
check_circle
Risk Trend Analysis: Identifies trends in adverse events over time, helping consultants assess whether safety issues are increasing or decreasing for specific device categories.

What It Does

This tool generates comprehensive safety intelligence reports:

fact_check
Safety Summary Report: Consolidated view of all recalls, MAUDE events, and enforcement actions relevant to the device category or competitors
fact_check
Risk Assessment: Analysis of common failure modes and safety issues that may impact device design or regulatory strategy
fact_check
Competitive Analysis: Comparison of safety profiles across competitor devices to identify market opportunities or risks
fact_check
Regulatory Intelligence: Insights into FDA enforcement trends and areas of regulatory focus for specific device types
fact_check
Exportable Report: Professional PDF report with your branding that can be shared with clients or included in regulatory documentation

⏱️ How It Saves Time

Saves 3-4 hours per analysis by automating safety data collection:

schedule
Automated Database Queries: Eliminates 1-2 hours of manually searching multiple FDA databases (recalls, MAUDE, enforcement actions)
schedule
Data Aggregation: Saves 1-2 hours of compiling and organizing safety data from disparate sources into a cohesive analysis
schedule
Trend Analysis: Automates 30-60 minutes of identifying patterns and trends in safety data across time periods
schedule
Report Generation: Provides ready-made report structure, saving 30-60 minutes of document creation and formatting

ROI: for FDA 510k Consultants performing 5+ safety analyses per month, this tool saves 15-20 hours monthly while providing comprehensive competitive intelligence.

Perfect For

check_circle
FDA 510k consultants performing competitive intelligence and market analysis for clients
check_circle
Regulatory teams assessing safety risks and failure modes for device development
check_circle
Firms providing due diligence services for medical device acquisitions or investments
check_circle
FDA 510k consultants preparing risk assessments and safety evaluations for regulatory submissions

Get Free Access to Safety Intelligence

This tool is completely free for verified FDA 510k consultants in the Cruxi network. Join thousands of regulatory professionals who use our tools to save 20+ hours per week.

Join 510k Consultant Network (Free)

✓ No subscription fees • ✓ All 15 tools included • ✓ Export with your branding