Risk management core
- Risk Management Plan (RMP)
- Risk Acceptability Criteria
- Hazard Analysis
- FMEA
- Risk Control Measures Documentation
- Residual Risk Evaluation
- Benefit-Risk Analysis
- Risk Management File (RMF/RMR)
- Risk Management Review
SmartRisk 1 / Documents
The documents behind a defensible risk process.
Browse the document types in the SmartRisk 1 workspace. Teams can draft and maintain records, bring evidence together, and compile review-ready outputs as their project progresses.
Request an SR1 demoDocument catalog
31 document types. One connected workflow.
Document creation depends on the underlying project evidence. Some records support AI-assisted drafting, others require team-authored content and approval, and the regulatory and audit outputs compile existing records.
Design controls
- Design & Development Plan
- Design Inputs Documentation
- Design Outputs Documentation
- Design Reviews
- Design Change Record
Verification, validation & clinical
- V&V Plan
- V&V Evidence Report
- Validation Summary
- Clinical Evaluation
Traceability & impact
- Traceability Matrix
- Change Impact Analysis
Post-market & CAPA
- PMS Plan
- PMS Report
- CAPA
Usability & human factors
- Usability Risk Analysis
- Human Factors Validation
Quality system & governance
- Document Control Procedure
- Training Records
- Supplier Risk Assessment
Regulatory & audit outputs
- Essential Requirements Checklist
- Submission Index
- Audit Package
From record to review
Built around the evidence your team actually has.
Risk and design documents can draw on linked project work; the Risk Management File brings those records together with human review. The Essential Requirements Checklist, Submission Index, and Audit Package are compiled views of available evidence, with gaps kept visible for review.