In 2013, IMDRF formed the Software as a Medical Device Working Group (WG) to develop guidance supporting innovation and timely access to safe and effective Software as a Medical Device globally.

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

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 building one.

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 classification, these need to …

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

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

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, risk …

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 access to the …

Mar 23, 2025 · Guide to medical device software development covering key regulations, best practices, and lifecycle steps for delivering safe, effective healthcare solutions.