Developing Software as a Medical Device (SaMD)
Complex considerations around this increasingly important category of software
Software as a Medical Device (SaMD) is a fast-growing sector of the medical device industry. The SaMD market is expected to exceed $86 billion in 2027, and grow at a CAGR of 21.9% from 2020 to 2027.
The software used in the healthcare industry can be divided into two groups: software that meets the definition of a medical device, and software that does not. Software that meets the definition of a medical device includes software intended for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease or other conditions. This type of software not only drives a medical device but also has a defined medical purpose. Software that does not meet the definition of a medical device includes wellbeing apps, software used in the manufacture or testing of medical devices, and software that drives a medical device but does not have a medical purpose on its own.
Understanding exactly what SaMD is and how it works is essential if your organization is developing medical devices. We’ve created this eBook to provide you with a solid foundation on SaMD development, including a look at everything from compliance to validation and verification testing.