Jan 25, 2024 · This guide provides an overview of IEC 62304, clarifies terminology, and addresses misconceptions in medical device software development.

Mar 13, 2024 · Medical device software updates and patches implement bug fixes, security protections, or new features per changing user needs. Depending on the updated …

May 5, 2025 · A comprehensive guide to software as a medical device (SaMD) packed with insights into how these products are regulated and what manufacturers should expect when …

Jul 22, 2025 · Explore the intricacies of medical device software development, ensuring a deeper understanding of the pivotal steps and processes involved.

Looking to start medical device software development? Learn the critical steps, from regulations and usability to scaling and partner selection.

Nov 19, 2024 · Using this program, the FDA qualifies tools that medical device sponsors can use in developing and evaluating medical devices.

Medical device software development is a field where innovation and regulation are inextricably linked. Developing medical device software requires a rigorous focus on safety classification, …

Medical Device Firmware and Software Parlay is designed for the stringent needs of medical devices. The self-instrumenting codebase and libraries provide unmatched visibility and …

Aug 24, 2023 · SaMD development challenges From dealing with detailed paperwork and timelines, to following strict rules set by the regulatory bodies, medical device software …

Apr 22, 2024 · Discover how medical device software development helps build secure, regulation-ready apps. Learn why software design for medical devices is key to successful engineering, …