Simulink certified for use in IEC 62304 processes

MathWorks has attained TÜV SÜD certification for its Simulink technology for use in IEC 62304-compliant development processes. The certification gives engineers designing medical devices greater confidence when using the company’s model-based design tools for IEC 63204 standard and FDA certification development processes.

In addition to ISO 26262, IEC 61508 and EN 50128, MathWorks’ IEC Certification Kit now includes certificates for the IEC 62304 standard, which guides medical device software development processes.

With the successful completion of an audit by TÜV, organisations can now use the certification kit artifacts as evidence of compliance with IEC 62304 for Model-Based Design tools, including:

• Simulink Verification and Validation for automating requirements tracing, modelling standards compliance checking and model coverage.
• Simulink Design Verifier for generating test cases that satisfy structural coverage objectives.
• Simulink Test for developing, managing and executing tests during simulation and processor-in-the-loop (PIL).
• Embedded Coder for generating production quality code for field deployment.
• Polyspace Bug Finder and Polyspace Code Prover for formal verification of handwritten and generated code.

“Given the regulatory certification and compliance requirements medical device manufacturers need to meet, they are increasingly relying on Model-Based Design to help them simplify and perfect complex workflows,” said Arvind Ananthan, medical devices industry manager, MathWorks.

“By offering IEC 62304 validated tools, MathWorks strengthens efforts to help these engineers reduce time and effort spent on tool validation, allowing them to focus on design iteration and development quality.”