Guided FMEA workflow
Move from scope and hazards to failure modes, controls, actions, and review through a consistent process.
SmartRisk 1
A clearer, faster way to build and maintain FMEAs.
SmartRisk 1 turns risk analysis into a guided, collaborative workflow—helping regulated teams spend less time managing spreadsheets and more time making defensible decisions.
Request an SR1 demoFocused risk decisions
Make severity, occurrence, detectability, and priority judgments visible and reviewable.
Decision-ready outputs
Create structured risk documentation that is easier to review, maintain, and reuse.
Less manual administration
Reduce the spreadsheet coordination and formatting work that slows cross-functional teams.
Document workspace
From FMEA to the complete risk record.
Explore the 31 document types organized in the SmartRisk 1 workspace, including risk management, design controls, validation, traceability, post-market, quality, and audit outputs.
Explore SR1 documentsWorkflow
From risk question to approved output.
SmartRisk 1 creates a common operating structure for the people who identify hazards, evaluate risk, define controls, and approve action.
01
Define
Set scope, intended use, system boundaries, and participants.
02
Analyze
Capture functions, failure modes, causes, effects, and current controls.
03
Prioritize
Evaluate risk consistently and identify the actions that matter most.
04
Document
Produce traceable, review-ready outputs and maintain the living analysis.
Engagement options
Start with a focused pilot.
A guided pilot proves time savings and output quality with a real team and a real risk-analysis project.
PilotFocused FMEA90 days
- Five users
- Three active projects
- Onboarding and training
- First completed FMEA
Annual plansTeam accessOngoing support
- Professional and business tiers
- Implementation options
- Consultant partner access
- Enterprise configuration