Medical Device Software Development: Following FDA Guidelines for Software Validation

See a point-to-point index of FDA principles and the Parasoft capabilities that support them.

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As an effective way to gain approval, the FDA recommends that medical device software development teams take a software development lifecycle (SDLC) approach that integrates risk management strategies with principles for software validation.

Developing software for medical devices that complies with the FDA’s Quality System regulation is a challenging endeavor that’s as much a business issue as it is an engineering feat.

In this paper, we identify software development challenges that medical device makers face when attempting to integrate the principles outlined by the FDA, and describe how Parasoft’s automated defect prevention solutions help organizations overcome the challenges of an integrated SDLC approach. For clear compliance efforts moving forward, we provide a point-to-point index of FDA principles and the Parasoft capabilities that support them.

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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