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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
Quick reference guide - global medical device UDI requirements and timelines
Quick reference guide - global medical device UDI requirements and timelines
5 ways a RIM system can accelerate time-to-market for MedTech companies
5 ways a RIM system can accelerate time-to-market for MedTech companies
Learn why UDI is relevant to regulatory affairs and how Rimsys can help medtech RA teams manage the growing complexities associated with UDI data.
Learn why UDI is relevant to regulatory affairs and how Rimsys can help medtech RA teams manage the growing complexities associated with UDI data.
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