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Regulation of AI in Healthcare
In this lecture, Michaela will discuss the regulation of digital technologies and software as a medical device (SaMDs). In today's digital world, e-health interventions and software play a significant role in healthcare management and delivery. The regulation of these technologies differs significantly from traditional medical devices and requires a more streamlined regulatory oversight. This session will provide participants with a fundamental understanding of the standards and guidelines of regulations for SaMDs and AI-based medical technologies.

Please note that this lecture was originally scheduled for May 13th. It is now rescheduled to be held on October 14th 2021 1:00PM-2:00PM Eastern Time.

N.B. This webinar will be presented in English. A recording will be available with English and French subtitles.

Oct 14, 2021 01:00 PM in Eastern Time (US and Canada)

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Speakers

Michaela Shaw
Medical Device Regulatory Affairs and Quality Assurance Consultant
Michaela Shaw is a regulatory consultant with 15 years of experience within the medical device industry, leading a variety of start-up companies through the FDA, Health Canada and EU regulatory approval process. Michaela’s experience includes many noteworthy, product and device regulatory approvals in the area of medical imaging, cardiovascular and respiratory therapy, medical device software and point-of-care diagnostic devices. She is the founder of Shaw Quality Solutions, guiding clients through certification and management of ISO13485 and FDA compliant Quality Management Systems, and regulatory submissions for market approvals in US, Canada, Europe, Australia and Asia.