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Latest / The Med Device Cyber Podcast

Understanding Cybersecurity Measures and Metrics for Medical Devices

How do measures and metrics differ, and why is this distinction crucial for FDA submissions?

In this episode, Christian and Trevor demystify the difference between cybersecurity measures and metrics in the context of FDA guidance. They explore what the FDA expects in submissions, emphasizing patch timelines, vulnerability tracking, and post-market data collection. They also discuss the importance of actionability over mere compliance and include real-world challenges like device downtime and risk in different environments.

Key points:

(0:30) Measures vs Metrics Defined

* Measures are raw…

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