SaMD


  • Software is central to nearly all of today’s medical devices – essential to the diagnosis, treatment and management of medical conditions. But from the FDA’s vantage, there are two types of medical device software and the difference between them comes down to a pair of small but vital words: “in”…

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  • The software-as-a-medical-device (SaMD) lifecycle encompasses two important and often confusing processes: verification and validation. Verification comes before validation and provides the evidence that the specified requirements have been met and that design outputs match design inputs.…

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  • Focusing on challenges related to developing AI-based Software as a Medical Device (SaMD), this blog explores current regulations and guidelines in the U.S and EU. For more on SaMD, join us at 1 pm EST on March 3 for a live webinar 5 Key Considerations at the Start of SaMD Development. We'll cover…

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  • There were more than 107,000 healthcare apps available in the Apple App Store and Google Play at the beginning of 20211 — a number that is growing rapidly. The total global market for mobile medical applications is expected to exceed $11 billion dollars by 2025. Driving this explosive growth is…

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  • 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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