MATLAB and Simulink Seminars

Software as AI Medical Device (SaMD)


What is Software as a Medical Device?

The term Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."

Use of SaMD is continuing to increase.  It can be used across a broad range of technology platforms, including medical device platforms, commercial "off-the-shelf" platforms, and virtual networks, to name a few. Such software was previously referred to by industry, international regulators, and health care providers as "standalone software," "medical device software," and/or "health software," and can sometimes be confused with other types of software.

Furthermore, Artificial Intelligence (AI) and Machine Learning (ML) technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. Medical device manufacturers are using these technologies to innovate their products to better assist health care providers and improve patient care. One of the greatest benefits of AI/ML in software resides in its ability to learn from real-world use and experience, and its capability to improve its performance.

MATLAB and Simulink are the perfect pairing to assist in the development of AI-based software as a medical device, join us.

Software as AI Medical Device (SaMD)

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