Medical devices have been used for centuries but are only being regulated recently to ensure patient safety. Every medical device must meet the requirements of the regulations in a country or region before entering the market. Very recently, going digital has changed not only our lifestyles but also the operations of medical devices. In such cases, not only the devices themselves need to meet the requirements but also the software used to diagnose or drive a clinical decision and considered a medical device.<\/p>\n
Software as Medical Device<\/u><\/strong> Some examples of SaMDs are as follows:<\/p>\n A SaMD can often attain its intended medical purpose independent of the hardware counterpart. The software does not meet the definition of IMDRF if its intended purpose is to drive a hardware medical device and the software used to power hardware or drive a hardware device; this is known as Software in a Medical Device (SiMD).<\/p>\n 10 Types of Testing for SaMD<\/u><\/strong> It’s important to note that the testing requirements for SaMD can vary depending on regulatory guidelines, intended use, risk classification, and other factors. The testing process should align with the applicable standards and industry best practices.<\/p>\n In recent times, where the digital world is expanding exponentially, SaMDs are also expected to ensure the safety of patients and provide the intended performance. As more devices are integrated to meet the needs of the current era, the emergence of more SaMDs and regulations to ensure their safety is expected to evolve. SaMDs significantly raise the requirement for quality engineering\/assurance to ensure that the performance is as expected and that no harm is done directly or indirectly to the patient.<\/p>\n Software testing is a familiar ground for Cigniti, and we offer solutions with a strong emphasis on regulations, compliance, quality, and more.<\/p>\n
\nSoftware as Medical Device (SaMD), generally referred to as SaMD, was classified by the International Medical Device Regulators Forum (IMDRF) in which the Food and Drug Administration (FDA) and European\u00a0Union\u00a0(EU) are part of stakeholders along with several other countries. IMDRF defined SaMD as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” It is vital to pay attention to the phrase \u201cwithout being part of,\u201d which implies that the software itself functions independently of any existing medical device.<\/p>\n\n
\nNow that we know what a SaMD is, let\u2019s see what types of testing are required. Below are ten key testing recommendations for SaMD to ensure its safety, effectiveness, and reliability.<\/p>\n\n
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