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title: "FDA SaMD guidance: Software risk classification | Sanner"
description: Learn how IMDRF categories inform SaMD risk classification, design controls, verification and validation, and QMS integration with Sanner’s Michael Marks.
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WEBINAR

## Decoding FDA SaMD Guidance: Risk Stratification Beyond Traditional Device Classes

Learn how to classify your Software as a Medical Device using the IMDRF risk framework. Michael Marks, Staff Systems Engineer at Sanner, explains how the significance of your software’s information and the seriousness of the patient’s condition determine its risk category.

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