What is Software as a Medical Device? The term Software as a Medical Device is defined by the International Medical Device Regulators Forum (IMDRF) as " software intended to be...

aspects of change implementation contribute to the accurate depiction of a device and/or its risk-profile. Medical device software can pose risks that are distinct and unique, such as those that …

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

Oct 8, 2024 · Software as a Medical Device (SaMD) is becoming increasingly prevalent in healthcare. But what is it, exactly, and why should medtech companies pay close attention? …

Aug 3, 2025 · According to the International Medical Device Regulators Forum (IMDRF), software as a medical device is defined as “software intended to be used for one or more medical …

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 …

Discover comprehensive insights into medical device software development. Learn about regulatory frameworks, compliance, and best practices to ensure successful implementation.

Feb 16, 2025 · Software as a Medical Device (SaMD) is software intended to perform medical functions independently of a physical medical device. This includes mobile apps, AI diagnostic …

Mar 13, 2024 · Software has become an integral part of medical devices, enabling more precise sensing, control, and analysis capabilities than ever before. From infusion pumps to MRI …

Feb 8, 2024 · Welcome to a plain language guide on the practical aspects of Software as a Medical Device (SaMD). This guide will break down the regulatory terms and help you …