Risk Management System
Create ISO 14971:2019 risk files with hazard ID, risk matrices, controls, residual risk and benefit analysis. Ensure full traceability linking risks to design and CAPA activities.
Every step links back to the one before it, so the full history stays retrievable.
NeuSoft Risk Management System helps organisations manage product risks through a structured and traceable process aligned with ISO 14971:2019. It brings hazard identification, risk analysis, risk evaluation, risk controls, residual risk assessment and risk-benefit analysis into one connected environment.
Risk management information is often maintained across separate spreadsheets, documents and design records, making it difficult to maintain consistency and traceability. NeuSoft centralises risk information and connects hazards, identified risks, control measures and verification evidence within a structured Risk Management File (RMF).
The system also connects risk management with design inputs, design outputs and CAPA activities, helping teams assess how design changes or quality issues may affect existing risks. This provides better visibility throughout the product lifecycle and supports consistent risk documentation and reporting.
What Risk Management does
Risk Management File (RMF)
- Structured Risk Management File aligned with ISO 14971:2019
- Centralised management of risk-related information
- Maintains risk documentation throughout the product lifecycle
Hazard Identification Library
- Pre-populated library of common medical device hazards
- Supports consistent hazard identification
- Allows product-specific hazards to be added as required
Configurable Risk Analysis Matrix
- Configure severity and probability criteria
- Evaluate risks using defined severity × probability combinations
- Adapt the matrix according to organisational risk procedures
Risk Evaluation
- Evaluate identified risks against defined acceptability criteria
- Clearly identify acceptable and unacceptable risks
- Maintain documented risk evaluation decisions
Risk Control Measures
- Document risk control measures for identified risks
- Link controls with applicable hazards and risks
- Track implementation of selected risk controls
Residual Risk Evaluation
- Evaluate remaining risk after implementation of controls
- Document residual risk assessment
- Maintain traceability between initial and residual risk
Risk-Benefit Analysis
- Structured framework for risk-benefit evaluation
- Document justification where further assessment is required
- Maintain supporting rationale within the risk file
End-to-End Risk Traceability
- Maintain traceability from hazards to risks
- Connect risks with applicable control measures
- Link risk controls with verification evidence
- Provide a clear relationship across the complete risk management process
- Hazard → Risk → Control → Verification
Risk Management Report Generation
- Generate structured risk management reports
- Compile risk information from the maintained RMF
- Reduce manual consolidation of risk documentation
Integration With Design Inputs & Outputs
- Link identified risks with relevant design inputs
- Connect risk control measures with applicable design outputs
- Improve traceability between risk management and design activities
Integration With CAPA
- Link CAPA activities with affected product risks
- Review risk information when quality issues are identified
- Maintain connections between corrective actions and risk-management records
Works with
See Risk Management in Action
This is a demonstration of Risk Management.