Published by
@ShahidNShah
@ShahidNShah
June 29 to June 30, 2022
Saint Paul, Minnesota, United States
Finding your way through the regulations, standards, and interpretations applicable to health software – particularly software as a medical device (SaMD) – can be daunting. In this two-day, in-person workshop, regulatory experts will explore the current and evolving global regulatory requirements affecting SaMD, how to determine when software is considered regulated as SaMD and how to determine correct class/classifications under global requirements. Attendees will learn how to address the numerous challenges in performing risk management/assessment for software by completing required evaluations using practical case studies. Navigating the expectations for software products is particularly challenging and requires a different approach from other medical devices. Since performing risk management/assessment for software is generally more challenging, attendees will work through completing required evaluations using practical case studies.
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