FDA Software Validation

Are MATLAB and Simulink validated or certified by the US FDA?

The FDA does not currently certify or validate general-purpose software development tools. Medical device manufacturers have the responsibility of validating the software tools they use in the development of a medical device by demonstrating that the tools have an acceptably low risk of harm even in the presence of an incorrect output.

Software written in MATLAB has been validated by many medical device companies as part of their regulatory processes. Manufacturers develop and execute plans for validating MATLAB in their workflows to support either design controls (Quality System Regulations) or electronic records (21 CFR part 11) requirements, including a variety of MATLAB and Simulink products and use cases, such as:

• Analyzing and reporting data with MATLAB and MATLAB Report Generator
• Using MATLAB Compiler to deploy signal and/or image processing diagnostic software

Also, device manufacturers have developed validated applications using Simulink to model medical device behavior, including:

• Modeling physical systems and physiology with MATLAB, Simulink, and Simscape
• Generating embedded software for medical devices from Simulink and Stateflow with Embedded Coder

Polyspace Bug Finder and Polyspace Code Prover can verify coding standard compliance, such as MISRA C^® and CERT^® C, and run-time robustness of embedded applications developed with or without the use of Simulink and Embedded Coder.

How do I validate the software I created in MATLAB and Simulink?

Validating your MATLAB code, or any other software, is comprised of two main steps:

1. Develop and execute a validation plan to ensure MATLAB and add-on products work as anticipated and produce the right results. Confirmatory testing can be acceptable for many risk levels. MathWorks performs exhaustive in-house testing to deliver high-quality products.
2. Validate and ensure your algorithm works as expected and produces the right results based on your requirements.

For MATLAB applications, the Tool Validation Kit is a good starting point for many built-in language features, and it is extensible to support additional use cases.

Validation of Simulink models and generated code for embedded applications is supported by the IEC Certification Kit and Simulink verification and validation products. MathWorks Consulting Services can work with you as needed for application-specific algorithm verification and validation.

How do I create a software tool validation plan?

There are three main steps:

1. Document the plan
   Identify and document risks, define contexts of use, and select validation activities to reduce risk to an acceptable level. Typical items to document include hazard assessment, tool role in the development process, standard operating procedures, validation approaches, resources, and schedule.
2. Develop a validation protocol
   If the risks warrant testing the output from the tool, create a protocol including test cases, expected results, and assumptions.
3. Execute validation protocol
   If needed, run test cases, and collect evidence into a tool validation report to document the validation activity.

What is MathWorks pedigree? Does MathWorks provide quality statements?

MathWorks has been in business for more than 40 years, and its products are used in a variety of industries and high integrity applications. There are millions of users worldwide.

MathWorks can provide 1-page quality statements that describe quality-driven development processes for MATLAB and Simulink. There are also detailed audit reports from a third-party independent testing body, TÜV SÜD. These are provided with the IEC Certification Kit to support tool certification requirements of IEC 62304 and 61508 standards, and attest that the software development and validation practices followed by MathWorks are suitable for use in the development of medical devices.

These documents, in conjunction with tool validation reports, can be used as part of the software tool validation documentation in your FDA submission.

Can MathWorks help my organization with its tool validating efforts?

Yes, leverage the expertise of MathWorks Consulting Services. Consultants can help create a validation plan, develop a validation protocol, and capture evidence of the execution of the protocol as part of a tool validation report. The Tool Validation Kit and IEC Certification Kit were designed to be extended with additional test cases, so new test cases can be easily added as your usage of the tool evolves. This lets you focus on your algorithm and system development activities in MATLAB and Simulink while reducing the effort of software tool validation activities.

Contact MathWorks Consulting Services to hear more about the tool validation or IEC 62304 certification, or to speak with a software validation expert.