Regulation of SaMD in the U.S.: Webinar

Randy Horton
Randy Horton
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Mystified by the regulatory process for SaMD in the U.S.? Unsure of how to begin your regulatory journey? Worried about securing essential clearance from the FDA? Orthogonal’s upcoming webinar with MATTER Chicago has you covered. We’re hosting a discussion between two MedTech experts who have helped bring SaMD to market for well over a dozen firms.

Join us on Wednesday, August 24th at 1-2 PM EDT for a webinar on the regulation of SaMD in the U.S., led by Clay Anselmo, Shriner and Associates Principal Quality and Regulatory Consultant, and Bernhard Kappe, Orthogonal CEO and Co-Founder. 

Clay and Bernhard will draw on their wealth of experience to answer hot-button questions on how to address the regulatory challenges of SaMD in the U.S. They’ll touch on the current status of SaMD regulation, the shape of existing regulatory pathways and the ongoing regulatory innovation at the FDA, as well as give their best practices for the development, launch and evolution of SaMD under current regulatory frameworks and guidance. You’ll leave with an understanding of how to successfully navigate the ins and outs of FDA regulation and secure clearance for your SaMD.

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