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Cameo Safety and Reliability Analyzer Plugin provides risk analysis during the whole product modeling process. For now, the plugin is designed to analyze risks in modeling of medical devices and is build on the Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) standard.
Risk analysis brings the value of:
- Being able to demonstrate that risks are addressed by safety requirements/risk control measures.
- Increased agility in between Risk/Hazard Analysis, Design, and FMEA: a lot frequent exchange of information between risks/hazards and FMEA cross-functional teams, shorter development cycles followed by shorter risk analysis and FMEA.
- Ensured traceability of risks to requirements, design elements, critical quality attributes (CQA) and other artifacts, traceability from design elements to FMEA, two-way traceability between FMEA and risks/hazard analysis.
- Performing safety analysis: automatic Risk Score Number calculations, risk reduction analysis.
- Impact Analysis: validation rules highlight risks with high or medium risk score, risks without risk control measures, failure modes that need attention from hazard analysis cross-functional team and have not been addressed yet, etc.
The Cameo Safety and Reliability Analyzer Plugin is compatible with the following modeling tool editions: