Integrated Risk Management Suite
This tool quantifies the benefit-risk profile using real-world data sources like Post-Market Clinical Follow-up (PMCF) for benefits and complaint data (PPM) for risks.
Session Management
Save your work progress and resume later. Perfect for year-long reporting tasks.
Your sessions are securely stored in dedicated cloud folders for easy access anytime.
Cloud Storage - Saved Sessions
Automatically organize your work in dedicated folders. Access from any device, any time.
Choose an existing folder or type a new name to organize your sessions
Local Device - Quick Backup
Save to your computer for offline backup or sharing via email.
Scale Definitions
Magnitude of Benefit / Severity of Harm:- 1: Minor / Inconvenience
- 2: Prevents minor injury / Temporary injury (no intervention)
- 3: Prevents injury requiring intervention / Injury requiring intervention
- 4: Prevents permanent impairment or life-threatening injury
- 5: Life-saving / Patient Death
Ad-Hoc Benefit-Risk Ratio Calculator
Use this for quick analysis. Select a data source, provide the corresponding real-world data, and calculate an immediate ratio.
Data Source Reference
| Input | Primary Classification | What It Represents |
|---|
Benefits
| Benefit Source | Specific Description (Optional) | Magnitude (1-5) | Frequency (%) | Action |
|---|
Risks (Harms)
| Risk Source | Specific Description (Optional) | Severity (1-5) | Probability (PPM) | Action |
|---|
Overall Benefit-Risk Dashboard (PSUR / RMF)
| Risk Description (from RMF) | Severity | Baseline PPM | New Events | Current PPM |
|---|---|---|---|---|
| Select a device profile to load the RMF data. | ||||