What is the difference in the clinical evaluation of a software that drives a medical device (often referred to as "embedded software" or "software in a medical device") and software as a medical device (SaMD)?

In a "software that drives a medical device", the clinical evaluation must consider the combined performance of the software and the hardware it controls. This includes assessing how the software interacts with the physical components of the device and ensuring that the integrated system functions safely and effectively. The evaluation often focuses on how the software enhances or enables the performance of the medical device; and the testing may include device-specific scenarios, such as hardware-software integration testing, and real-world use conditions. The clinical evaluation must address risks associated with the integration of software and hardware, including failure modes and their impact on patient safety.

In a SaMD, there's a standalone functionality, where the SaMD functions independently and does not rely on hardware integration. The clinical evaluation focuses solely on the software's performance in achieving its intended purpose. Since the SaMD can be used in various settings, including on different hardware platforms (e.g., mobile devices, cloud-based systems), the evaluation needs to address compatibility and performance issues across these platforms. Additionally, there is a significant emphasis placed on usability and human factors engineering to ensure that the SaMD is user-friendly and meets the needs of healthcare providers and patients.

Despite these differences, both types of software follow some common steps in their clinical evaluation, and need to meet the necessary clinical and regulatory requirements for market certification.