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How the FDA’s guidance has shifted
The types of devices covered by 524B
What Section 524B of the FD&C Act actually says
You will learn:
The U.S. Food and Drug Administration’s 2022 passage of the Food, Drug, and Cosmetic (FD&C) Act requires new or updated connected medical devices to meet cybersecurity standards. Section 524B of the act raises the bar for premarket submissions. What are the implications for new devices in planning vs. existing devices? How can device manufacturers ensure that their premarket submissions are accepted?
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Wind River On-Demand
Web Seminar
Tuesday, August 29, 2023
8 a.m. PT | 11 a.m. ET
Navigating Section 524B: Ensuring Cybersecurity in Medical Devices
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Ryan Zheng
Industry Solutions Leader
Wind River
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Ryan Zheng is the director of Industry Solutions for Medical, Industrial, and Robotics at Wind River . His experience spans product management and engineering roles in edge-to-cloud computing companies. His domain knowledge includes IoT, SaaS, and AI/ML applications for both established and start-up companies.
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BIO
Ryan Zheng
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Hear our discussion of the new requirements’ practical impact and suggested technology strategies for compliance.
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Industry Solutions Leader
Wind River
The mindset changes needed for medical device cybersecurity
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