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IEC 62304 Standard

Apply Simulink and Embedded Coder to the IEC 62304 Standard

Applying Model-Based Design to a safety-critical system requires extra consideration and rigor so that the system adheres to defined safety standards. Standard: IEC 62304, Medical device software - Software life cycle processes, is such a standard.

MathWorks® provides an IEC Certification Kit product that you can use to certify MathWorks code generation and verification tools for projects based on the IEC 62304 standard. For more information, see IEC Certification Kit.

Check for IEC 62304 Standard Compliance Using the Model Advisor

If you have a Simulink® Check™ product license, you can check that your Simulink model or subsystem and the code that you generate from it complies with selected aspects of the IEC 62304 standard.

To check your model or subsystem:

  1. Open the Model Advisor.

  2. Navigate to By Task > Modeling Standards for IEC 62304.

  3. Run the IEC 62304 (Simulink Check) checks.

For more information on using the Model Advisor, see Check Your Model Using the Model Advisor.