Services
User problem domain
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- User and stakeholder needs gathering and analysis
- Use case mapping and detailed workflow analysis
- System validation planning, protocols, and execution
- Human factors analysis
Solution domain
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- Model-based systems engineering
- Product line engineering
- Requirements development and allocation
- System architecture and decomposition
- System integration and interface definition
- Embedded medical device software
- Software as a Medical Device (SaMD)
- User interface design
- Traceability modeling and analysis
- Safety systems analysis
- Design for Reliability (DFR), Design for Manufacturability (DFM), and Design for Service (DFS)
- Cost analysis and modeling
- System verification planning, protocols, and execution
- Design of experiments, Taguchi modeling, pairwise testing
- FDA (820.30 Design Controls), Health Canada, and CE Mark regulations and standards
Risk management
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- System hazard analysis
- Safety assurance case analysis (SAC)
- Use error risk analysis (UERA)
- Fault tree analysis (FTA)
- Failure modes and effects analysis (FMEA)
- ISO 14971
Process Improvement
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- CMMi-based process modeling with emphasis on lean, compliant, easy-to-follow processes
- Product development
- Systems engineering
- Risk management (ISO 14971)
- Software engineering (IEC 62304)
- Verification
- Validation
- Change management and issue tracking
Tools
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- Requirements modeling: DOORS (tables, attributes), Magic Draw (SysML, UML), RequisitePro
- Issue tracking: JIRA, ClearQuest
- Quality function deployment (QFD)
- Tool validation (IQ, OQ, PQ, PPQ)
