HARA Analysis
Hazard Analysis and Risk Assessment workflows following ISO 14971.- Identify Hazards and Harm Scenarios — Link hazards and harms from the catalog, describe hazardous situations
- Evaluate Initial Risk (Pre-Mitigation) — Score P1 and P2 probabilities, determine pre-mitigation risk level
- Assign Risk Controls to Hazards — Link risk controls following the ISO 14971 hierarchy
- Evaluate Residual Risk (Post-Mitigation) — Score post-mitigation probabilities and determine residual risk
- Perform Benefit-Risk Analysis — Document clinical benefit and evaluate benefit vs. risk for Investigation-zone records
- Use Hazard and Harm Catalogs — Browse, search, and link catalog entries
DFMEA Analysis
Design Failure Mode and Effects Analysis workflows for systematic failure analysis.- Identify Functions and Failure Modes — Define functions and their potential failure modes
- Score Severity, Occurrence, and Detection (RPN) — Calculate Risk Priority Numbers
- Add DFMEA Risk Mitigation Actions — Link mitigation tasks and risk controls
- Evaluate Post-Mitigation RPN — Re-score after applying mitigations
PFMEA Analysis
Process Failure Mode and Effects Analysis for manufacturing risk.- Create a Process FMEA — Set up process steps, inputs, outputs, and equipment
Solution Setup and Configuration
Initial configuration and project setup tasks.- Create System Elements — Build the product decomposition hierarchy
- Create a New Risk Analysis Document — Create HARA, DFMEA, or PFMEA documents from templates
- Configure the Risk Control Plan — Set up the centralized risk control register
- Configure PowerSheet RTM Views — Set up traceability views
Reports and Dashboards
Generating and reading risk management reports.- Generate the ISO 14971 HARA Report — Export the full HARA report for regulatory submission
- Read the Risk Matrix Report — Interpret the pre/post-mitigation 5x5 risk matrices
- Read the DFMEA Summary Report — Interpret the executive DFMEA dashboard
Approval Workflows
Document review, approval, and rework processes.- Review and Approve a Risk Document — Send for review, collect signatures, approve
- Rework a Risk Document — Return a document for changes with signature invalidation