The medical device industry is experiencing a swift evolution, primarily fuelled by the growing incorporation of software into medical devices. Software as a Medical Device (SaMD), also known as Medical Device Software (MDSW), refers to software designed for one or more medical functions, operating independently without being integrated into a physical medical device. This category comprises various technologies such as mobile health (mHealth) applications, software powered by artificial intelligence (AI), and programs that control, manage, analyse, or interpret medical data.
SaMD introduces unique regulatory considerations and challenges compared to traditional hardware-based medical devices. Software’s inherent characteristics, such as its flexibility, adaptability, and potential for remote deployment, raise concerns about its safety, effectiveness, and reliability. Furthermore, the rapid pace of technological advancements in software development often surpasses the pace of traditional regulatory processes, creating difficulties for regulatory professionals and bodies to stay in sync with the constantly changing environment.
In this post, Adi Ickowicz goes over the Regulatory challenges and considerations for SaMD within the Regulatory framework and guidelines.
Read the whole article here: Navigating the Complex Landscape of Software as a Medical Device (SaMD)
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