Medical Device Software
Medical Device Software (MDS) refers to software applications or systems that are intended to be used for medical purposes, either as standalone products or as components of medical devices. It includes software for diagnosis, treatment, monitoring, or prevention of diseases, and must comply with strict regulatory standards such as FDA (U.S.) and MDR/IVDR (EU) to ensure safety and effectiveness. This encompasses a wide range of applications, from embedded firmware in hardware devices to mobile health apps and clinical decision support systems.
Developers should learn and use Medical Device Software when working in healthcare technology, as it is essential for creating products that directly impact patient care and require adherence to rigorous quality and regulatory frameworks. Specific use cases include developing diagnostic imaging software, wearable health monitors, electronic health record (EHR) integrations, and telemedicine platforms, where reliability, security, and compliance are critical to avoid legal risks and ensure patient safety.