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 provides innovative tools that automate time-consuming testing tasks and provide management with intelligent analytics necessary to focus on what matters. Parasoft’s technologies reduce the time, effort, and cost of delivering secure, reliable, and compliant software, by integrating static and runtime analysis; unit, functional, and API testing; and service virtualization. Parasoft supports software organizations as they develop and deploy applications in the embedded, enterprise, and IoT markets. With developer testing tools, manager reporting/analytics, and executive dashboarding, Parasoft enables organizations to succeed in today’s most strategic development initiatives — agile, continuous testing, DevOps, and security.