Case Study: Comparing EU and FDA Cybersecurity Guidance for Medical Devices

Let's Talk Risk! Podcast · Sep 22, 2025 · 16m

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 guidance converge, and where they diverge.

* Thematic gaps: authentication, cryptography, secure…