Static Analysis for FDA Software Validation Compliance

Adopt static analysis as part of an integrated, comprehensive compliance process 

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The FDA has publicly recommended that software developers use static analysis for ensuring medical device software safety and reliability, and has touted static analysis as a critical component of an effective software development process.

But static analysis is only one piece of the software development puzzle. The FDA also recommends that medical device software development teams take a software development lifecycle (SDLC) approach that integrates risk management strategies with principles for software validation.

To assist organizations that are exploring static analysis for FDA compliance, this paper describes Parasoft’s static analysis capabilities in the context of FDA compliance. Because we recognize that static analysis is not a silver bullet for FDA compliance, this paper also describes Parasoft’s broader software solution for medical device software development.

About Parasoft

Parasoft’s software testing solutions support the entire software development process, from when the developer writes the first line of code all the way through unit and functional testing, to performance and security testing, leveraging simulated test environments along the way. Parasoft's unique analytics platform aggregates data from across all testing practices, providing insights up and down the testing pyramid to enable organizations to succeed in today's most strategic development initiatives, including Agile/DevOps, Continuous Testing, and the complexities of IoT. Parasoft’s automated software testing innovations fuel software development organizations, helping teams reduce the time, cost, and effort of delivering high-quality software to the market.

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