Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

IoT applications and data must integrate with enterprises' overall IT and OT computing environments. Over the past two years, high-profile IoT services such as Google IoT Core, the IBM Watson IoT ...

PCCPs allow device manufacturers to implement preapproved modifications to their devices in lieu of obtaining separate authorizations for each significant change prior to implementation. A PCCP ...

The software supply chain is critical to ensuring a secure medical device that can prevent injury, according to Gregg Van Citters, MS, PhD, a principal software quality engineering consultant at ...

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 ...

Deploying software to large fleets of Linux-based devices is a complex and critical process that requires careful planning and automated execution. Start with these best practices. The internet of ...