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Introduction

Watch a recording of our webinar "Integrating Safety and Reliability Analysis into MBSE Toolkit"

Cameo Safety and Reliability Analyzer Plugin enable a model-based approach to safety and reliability analysis. This new functionality integrates into the No Magic MBSE toolkit. The plugin supports:

  • The failure mode, effects, and criticality analysis (FMECA) according to IEC 60812:2006 standard
  • Hazard analysis according to the following medical standards:
    • IEC 62304
    • ISO 14971:2007, Corrected version 2007-10-01 (Medical devices - Application of risk management to medical devices)

As the plugin evolves, it will provide support for the following:

  • Fault Tree Analysis (FTA)
  • ISO 26262 (Road vehicles – Functional safety)

Using Cameo Safety and Reliability Analyzer brings the following values:

  • Being able to demonstrate that risks are addressed by safety requirements/risk control measures, design elements, critical quality attributes (CQA).
  • Automatically validate the model to ensure that the entire design went through safety and reliability analysis.
  • Increased agility between design, safety and reliability analysis phases:
    • A lot frequent exchange of information between safety and reliability analysis cross-functional teams.
    • Shorter development cycles followed by shorter safety and reliability analysis cycles leading to a lot more precise detections of risks and faults and safer.
    • More reliable products.
  • 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.

The Cameo Safety and Reliability Analyzer plugin comes with the following predefined samples:

Features

Cameo Safety and Reliability Analyzer plugin currently supports the following features (click images to enlarge):

  • Safety analysis for medical devices and software according to IEC 62304 and ISO 14971:2007 medical standards
  • Reliability analysis via FMEA
  • The ability to link design to reliability analysis, reliability analysis to safety analysis, and safety analysis to design

  • Predefined reports for safety and reliability analysis
  • The plugin is customizable, allowing users to add their own data columns and customize risk calculation rules and reports

Resources

Documentation

Samples

Papers