SaMD


  • In the first installment in ICS’ series What You Need to Know About Developing SaMD we provided an overview of software used within a healthcare environment and touched on key regulations in the U.S and in the EU. In this article, we take a closer look at some of the regulatory considerations for…

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  • Software that meets the definition of a medical device, commonly referred to as Software as a Medical Device (SaMD), is subject to different requirements than software that does not meet this strict definition. In ICS’ new series What You Need to Know About Developing SaMD we explore the…

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