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 coding (EU) vs. network security and resilience (FDA).

* Why existing vulnerabilities often stem from implementation failures, not policy gaps.

* A proposed structural fix: separating high-level principles from device-specific technical guidance.

* How stronger enforcement or penalties could change manufacturer behavior.

For professionals in regulatory affairs, risk management, and MedTech development, this conversation highlights where guidance is falling short, and what’s needed to drive consistent, secure practices across the industry.

🎧Listen to the audio brief above for an overview of the AI/ML device recalls, emerging vulnerabilities and trends to watch.

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Note:

This audio brief was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used in our analysis:

* Cybersecurity requirements for medical devices in the EU and US - A comparison and gap analysis of the MDCG 2019–16 and FDA premarket cybersecurity guidance, Research Letter | Computational and Structural Biotechnology Journal, July 2025.

This summary was created using ChatGPT-5 (September 2025) with expert review. It distills publicly available information on EU and FDA cybersecurity guidance for medical devices. While reviewed for accuracy and relevance, it does not constitute legal, regulatory, or medical advice. Cybersecurity in healthcare is a rapidly evolving field, and details may change after publication.

We encourage listeners to interpret these findings in the context of these constraints.

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