ISO 14971 Wizard
Conversational risk assessment with live updates from SBOM/SOUP.
1) Risk Context
Product ID
Clinical Criticality
Non-critical
Critical
Intended Use
Environment
Save Context
High-level Classification
2) SBOM & SOUP
SBOM (name@version, comma-separated)
SOUP (name@version | license)
Update Components
Run In-Depth Assessment
3) Hazards & Sequences
Known Hazards
Event Sequence (comma-separated)
Add Hazard & Sequence
4) Controls
Select Controls
Map Controls to Hazards
Results
High-level Class:
—
Residual Risk Acceptable:
—
Hazard
Before
After
Residual
Open Results Page
Download Report (PDF)