SDLC guides teams to plan, build, test, and deliver software. Discover phases, KPIs, tools, and checklist with our quick start guide. Picture this: You and your team have spent a tremendous amount of ...

Medical devices have to be designed so that people can use them easily and reliably. Human factors considerations have gained increased attention since the release of FDA's guidance document, Medical ...

On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The ...

Creating embedded software can be a challenging endeavor. The experience can range from a well-defined and controlled process to shoot-from-the-hip Wild West-style development. No matter where ones ...

When purchasing enterprise software, detailed requirements must be developed at the start of the project or during implementation. By examining uses for requirements, we make the case that ...