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Taking SaMDs to market in the US

Replay

The use of software as a medical device (SaMD) has grown over the past few years. Given their unique features and broad applications, it can be confusing to determine if a device should be classified as a SaMD, and if so, how to effectively obtain market clearance for it. Watch the replay of our panel discussion with Principal at MDQR Solutions, Prabhu Raghavan, and Rimsys Co-Founder and Chief Solutions Officer, Brad Ryba, as they provide insights about what's classified as an SaMD, cybersecurity considerations to make, how AI/ML is being regulated by the FDA, and how to ensure a properly validated algorithm.

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Check out these additional resources
Introducing Rimsys Intel: A Free, Centralized Global Regulatory Intelligence Hub for Medtech
Introducing Rimsys Intel: A Free, Centralized Global Regulatory Intelligence Hub for Medtech
A primer on medical device classification
A primer on medical device classification
Quick reference guide - global medical device UDI requirements and timelines
Quick reference guide - global medical device UDI requirements and timelines
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