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As a result, simulation engineers creating medical devices can produce their model-based designs (MBDs) with greater confidence.
Simulink will offer these engineers access to qualified artifacts, certificates, test suites and tractability matrices that are accepted under this standard through the MathWorks IEC certification kit.
These documents will guide the user through the medical device software development. The kit will also provide artifacts which can be embedded into MBD software as evidence for compliance.
“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.”
Some of the Simulink tools covered by the IEC 62304 compliance include:
- Simulink verification and validation: to help automate requirements tracing, modeling standard compliance checking and model coverage
- Simulink design verifier to create test cases for structural coverage
- Simulink test to create/manage/execute tests of the simulation and processor-in-the-loop (PIL)
- Embedded coder for code generation
- Polyspace Bug Finder/Code Prover to verify handwritten and generated code
The IEC 62304 standard was created in collaboration with the International Organization for Standardization (ISO). TÜV SÜD Consulting conducted the certification assessment.
Simulink has also been certified for its compliance with other standards including:
- IEC 61508 for functional safety
- ISO 26262 for road vehicle functional safety
- EN 50128 for railway and mass transit software
To learn more about MathWorks products, read this previous article “MATLAB, Simulink 2016a Released.”