Case Study
Let's Talk Risk! Podcast
Case Study: Comparing EU and FDA Cybersecurity Guidance for Medical Devices
- Published
- September 22, 2025
- Duration
- 16:22
- Summary source
- description
- Last updated
- Jul 5, 2026
Discusses In this audio brief, We unpack an academic study that compares the EU’s MDCG 2019-16 and the FDA’s c…
Summary
In this audio brief, We unpack an academic study that compares the EU’s MDCG 2019-16 and the FDA’s cybersecurity guidance, benchmarking them against international best practices. Both documents cover the basics, but each leaves troubling gaps, especially in areas like authentication, secure coding, network security, and resilience.Key points in this audio…
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Show notes
In this audio brief, We unpack an academic study that compares the EU’s MDCG 2019-16 and the FDA’s cybersecurity guidance, benchmarking them against international best practices. Both documents cover the basics, but each leaves troubling gaps, especially in areas like authentication, secure coding, network security, and resilience.Key points in this audio brief:* The biggest risks of connected medical devices and why cybersecurity is now inseparable from patient safety.* Where the EU and FDA gui