The 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 can be used together with the ISO 26262 Functional Safety Plugin. The plugin supports the ISO 26262 standard which is derived from IEC 61508. ISO 26262 is intended for electric and/or electronic systems in production vehicles. This includes driver assistance, propulsion, and vehicle dynamics control systems. The goal of ISO 26262 is to ensure safety throughout the lifecycle of automotive systems and equipment.