The FDA recommends that development teams take an integrated approach to their software development lifecycle (SDLC), which combines risk management strategies with principles for software validation. 

But developing software for medical devices that complies with the FDA's Quality System regulation is a challenging business endeavor and engineering feat.

This paper helps you navigate these murky waters by covering the following topics:

  • Where hidden challenges of the FDA's "Least Burdensome Approach" can cost you development resources.
  • How policy-driven development bridges the business/development gap to help you gain FDA approval
  • How Parasoft's proven automated defect prevention technologies help you follow FDA software validation recommendations




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Parasoft researches and develops software solutions that help organizations deliver defect-free software efficiently. To combat the risk of software failure while accelerating the SDLC, Parasoft offers a Development Testing Platform and Continuous Testing Platform. Parasoft's enterprise and embedded development solutions are the industry's most comprehensive—including static analysis, unit testing, requirements traceability, coverage analysis, API testing, dev/test environment management, service virtualization and more. The majority of Fortune 500 companies rely on Parasoft in order to produce top-quality software consistently and efficiently as they pursue agile, lean, DevOps, compliance, and safety-critical development initiatives.