FDA Software Validation

Validate MATLAB® products for use in an FDA regulated medical device design workflow.


Is MATLAB validated or certified by the FDA?


The FDA does not certify or validate software development tools. It regulates and approves medical devices and pharmaceuticals. Medical device manufacturers have the responsibility of validating the software tools they use by demonstrating that the tools have an acceptably low risk of harm even given an incorrect output.

Software written in MATLAB has been validated by many medical device and pharmaceutical users as part of their compliance process. The device manufacturers develop and execute their own plan for validating MATLAB in their workflows.


How do I validate the software I wrote in MATLAB?


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

  1. Develop and execute a validation plan to ensure the software tool (i.e., MATLAB and add on products) is working as anticipated and producing the right results. (Exhaustive testing at this stage isn’t expected.)
  2. Validate and ensure your algorithm is working as you expect. Is it producing the right results based on your requirements?

We can help with the first step (independent of use). MathWorks Consulting Services can work with you as needed for step two.


How do I create a software tool validation plan?


There are essentially three main steps:

  1. Create a tool validation plan: Identify risks, define contexts of use, and perform 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: This includes test cases, expected results, and assumptions.
  3. Execute that validation protocol: Run test cases, and create a final tool validation report to document the validation activity.


What is MathWorks pedigree? Does MathWorks provide quality statements?


MathWorks has been in business for over 30 years, and its products are used in a variety of industries and safety critical applications. There are over a million users worldwide.

MathWorks can provide 1-page quality statements that describe quality driven development processes for the core platform products, MATLAB and Simulink. There are also detailed audit reports from a third-party independent testing body, TÜV SÜD in Germany. These are provided with the IEC Certification Kit in regards to tool certification requirements of IEC 61508 standard, and attest that the software development and validation practices followed by MathWorks adhere to the highest standards in the industry.

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


Can MathWorks help my organization with its tool validating efforts?


Yes. Take advantage of MathWorks Consulting Services. Many of the consultants have experience in creating tool validation plans. 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. This kit was designed to be extended with additional test cases, so new test cases can be easily added as your usage of the tool evolves over time. This lets you focus on your algorithm and system development activities in MATLAB, while automating the FDA software tool validation activities.

Contact us if you are interested in hearing more about the tool validation planning kit prototype, or if you would like to speak with one of our tool validation experts in Consulting Services.

File Exchange

Tool Validation Kit

You can now download this Tool Validation Kit from MATLAB File Exchange.

If you have any questions on how to use this kit, have feedback, or need additional consulting help, please contact us at medical@mathworks.com.

FDA-MathWorks Research and Collaboration Agreement Summary